This online training class will provide you training on ISO/TS 16949:2002. It uses excerpts of the standards ISO/TS 16949:2002 (Dark blue) and provides guidance using ISO 9004:2000 and ISO 9000:2000. Each training slide is followed by a quiz. YOUR answer will be CIRCLED and a check mark will indicate the correct answer. If the check mark is inside the circle, that will mean that your answer was correct. You will be continually evaluated based on your scores on the quizzes. Your average ongoing scoring and percent progression into the course will be posted on the upper right hand corner of your user screen.

Take your time in reading the course material, rushing into the quizzes will most likely result in a low score and failure of the course, even for experienced auditors or trainers. Some quiz answers may seem straightforward, but it is most often not the case.

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The standard/specification text material (Dark blue) is read-only and cannot be printed.
 

The structure of the class is as follows:

QUALITY MANAGEMENT SYSTEMS
 

Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies).  The work of preparing international Standards is normally carried out through ISO technical committees.  Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee.  International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.  ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

ISO/TS 16949:2002 was prepared by the International automotive Task Force (IATF) and japan Automobile Manufacturers Association, Inc. (JAMA), with support form ISO/TC 176, Quality management and quality assurance.  The second edition of ISO/TS 16949 cancels and replaces the first edition (ISO/TS 16949:1999), which has been technically revised.

In ISO/TS 1649:2002, the word "SHALL" indicates a requirement.  The word "SHOULD" indicates a recommendation.  Paragraphs marked "NOTE" are for guidance in understanding or clarifying the associated requirement.  Where term "SUCH AS" is used, any suggestions given are for guidance only.
 

0.1 General

The adoption of a quality management system should be a strategic decision of an organization. The design and implementation on organization's quality management system is influenced by varying needs, particular objectives, the products provided, the processes employed and the size and structure of the organization. It is not the intent of the International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.

The quality management system requirements specified in the International Standard are complementary to requirements for products.
 

Rationale for quality management systems (ISO 9000:2000 2.1)
Quality management systems can assist organizations in enhancing customer satisfaction.

Customers require products with characteristics that satisfy their needs and expectations.  These needs and expectations are expressed in product specifications and collectively referred to as customer requirements.  Customer requirements may be specified contractually by the customer or may be determined by the organization itself.  In either case, the customer ultimately determines the acceptability of the product.  Because customer needs and expectations are changing, organizations are driven to improve continually their products and processes.

The quality management system approach encourages organizations to analyze customer requirements, define the processes that contribute to the achievement of a product which is acceptable to the customer, and to keep these processes under control.  A quality management system can provide the framework for continual improvement to increase the probability of enhancing customer satisfaction and the satisfaction of other interested parties.  It provides confidence to the organization and its customers that it is able to provide products that consistently fulfill requirements.
 

0.2 Process Approach

The International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements.

For an organization to function effectively, it has to identify and manage numerous linked activities. An activity using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Often the output form one process directly forms the input to the next.

The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management, can be referred to as the "process approach".

An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction.

When used within a quality management system, such an approach emphasizes the importance of

The model of a process-based quality management system shown in Figure 1 illustrates the process linkages presented in clauses 4 to 8. This illustration shows that customers play a significant role in defining requirements as inputs. Monitoring of customer satisfaction requires the evaluation of information relating to customer [perception as to whether the organization has met the customer requirements. The model shown in Figure 1 covers all the requirements of the International Standard, but does not show processes at a detailed level.

Note: In addition, the methodology known as "Plan-DO-Check-Act" (PDCA) can be applied to all processes. PDCA can be briefly described as follows.

THE STANDARDS

The International Organization of Standardization, based in Geneva (Switzerland), manages the release of standards for various industries and applications. The standards are named ISO because it means "same" in Greek.

ISO 9001:2000 is the third edition of ISO 9001. It was originally released in 1987 and went through one revision in 1994. The name of the standard was changed from "Quality Systems-Model for Quality Assurance in Design, Development, Production, Installation, and Servicing" to "Quality Management Systems - Requirements".

The reason for this change of title is because the new standard not only addresses the quality assurance of product and/or service conformity, but also includes the need for an organization to demonstrate its capability to achieve customer satisfaction. The formatting of the new edition is very different and follows the "process model". It departs radically from the "20 elements" format of ISO 9001:1994, and is now compatible in structure with ISO 14000, the Environmental Management standard.

ISO 9001:2000 is released along with ISO 9004:2000 "Quality Management Systems -Guidance for performance improvement".

ISO/TS 16949:2002 is based on ISO 9001:2000.  ISO 9001:2000 was augmented with automotive specific requirements, and guidance in order to generate ISO/TS 16949:2002.  All the requirements as well as the overall structure of ISO 9001:2000 are included in ISO/TS 16949:2002.
 

0.3 Relationship of ISO 9001:2000 with ISO 9004

The present editions of ISO 9001 and ISO 9004 have been developed as a consistent pair of quality management system standards which have been designed to complement each other, but can be used independently. Although the two International Standards have different scopes, they have similar structures in order to assist their application.

ISO 9004 gives guidance on a wider range of objectives of a quality management system than does ISO 9001, particularly for the continual improvement of an organization's overall performance and efficiency, as well as its effectiveness. ISO 9004 is recommended as a guide for organizations whose top management wishes to move beyond the requirements of ISO 9001, in pursuit of continual improvement of performance. However, it is not intended for certification or for contractual purposes.
 

0.3.1 IATF Guidance to ISO/TS 16494:2002

ìIATF Guidance to ISO/TS 16949:2002î is a document containing recommended automotive industry practices, examples, illustrations and explanations, and provides assistance in the application to conform to the requirements of ISO/TS 16949:2002.

This IATF Guidance document is not intended for certification or for contractual purposes
 

0.4 Compatibility with other management systems (ISO 9001:2000 )

ISO 9001:2000 has been aligned with ISO 14001:1996 in order to enhance the compatibility of the two standards for the benefit of the user community.

ISO 9001:2000  does not include requirements specific to other management systems, such as those particular to environmental management, occupational health and safety management, and financial management or risk management. However, this International Standard enables an organization to align or integrate its own quality management system with related management system requirements. It is possible for an organization to adapt its existing management system(s) in order to establish a quality management system that complies with the requirements of this International Standard.
 

0.5 Goal of ISO/TS 16949:2002

The goal of this Technical Specification is the development of a quality management system that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain.

This Technical Specification, coupled with applicable customer-specific requirements, defines the fundamental quality management system requirements for those subscribing to this document.

This Technical Specification is intended to avoid multiple certification audits and provide a common approach to a quality management system for automotive production, and relevant service part organizations.
 

Relationship between the ISO family of Standards: (ISO 9000:2000)

The ISO family of standards listed below has been developed to assist organizations, of all types and sizes, to implement and operate effective quality management systems.

• ISO 9000 describes fundamentals of quality management systems and specifies the terminology for quality management systems.
• ISO 9001 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide products that meet customer and applicable regulatory requirements and aims to enhance customer satisfaction.
• ISO 9004 provides guidelines that consider both the effectiveness and efficiency of the quality management system.  The aim of this standard is improvement of the performance of the organization and satisfaction of customers and other interested parties.
• ISO 19011 provides guidance on auditing quality and environmental management systems (not released yet)*.

ISO 10011:1990 is the current guideline document on how to audit quality management systems*.
 
 

1 SCOPE

1.1 General

The International Standard specifies requirements for a quality management system where an organization

The specification ISO/TS 16949:2002 , in conjunction with ISO 9001:2000, defines the quality management system requirements for the design and development, production and, when relevant, installation and service of automotive-related products.

ISO/TS 16949:2002  is applicable to sites of the organization where customer-specified parts, for production and/or service, are manufactured.
Supporting functions, whether on-site or remote (such as design centres, corporate headquarters and distribution centres), form part of the site audit as they support the site, but cannot obtain stand-alone certification to this Technical Specification.

This Technical Specification can be applied throughout the automotive supply chain.
 

1.2 Application

All requirements of the International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.

Where any requirement(s) of the International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.

Where exclusions are made, claims of conformity to the International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.
 

Permitted exclusions

The only permitted exclusions for this Technical Specification (ISO/TS 16949:2002) relate to 7.3 where the organization is notresponsible for product design and development.  Permitted exclusions do not include manufacturing process design
 

Example of permissible exclusion:
 

Due to applicable regulatory requirements: "Design and development (7.3)" can be excluded if regulatory agencies do not allow an organization to change or affect the design of a product. (i.e. an engine repair facility is not allowed by the manufacturer to change or redesign any component of the engine being serviced.) He can thus exclude the requirement of 7.3, and claim the exclusion is his Quality Manual.

2. Normative reference

The Normative reference for ISO 9001 is: ISO 9000:2000, Quality management system -Fundamentals and vocabulary.
 
 

3 Terms and definitions

For the purposes of ISO 9001 and wording definitions of ISO 9000:2000, the terminology used is:

• Supplier: is the vendor or subcontractor
• Organization: is the one seeking ISO 9001 compliance or certification (your organization)
• Customer: is the client of the organization

The word "product" used in the standard can be:

• Hardware (e.g. engine mechanical part, computer)
• Software ((e.g. computer programs)
• Services (e.g. transport, real estate or customs brokerage)
• Processed materials (e.g. lubricant)

Most products are combinations of some of the four generic product categories. Whether the combined product is then called hardware, processed material, software or service depends on the dominant element.
 

Terms and definition per ISO 9000:2000:

Quality: degree to which a set of inherent characteristics fulfills requirements. (3.1.1 )
Requirement: need or expectation that is stated, generally implied or obligatory. (3.1.2 )
Customer satisfaction: customer's perception of the degree to which customer's requirements have been fulfilled. (3.1.4)
Quality management system: management system to direct and control an organization with regard to quality. (3.1.1)
Quality policy: overall intentions and direction of an organization related to quality as formally expressed by top management. (3.2.4)
Quality objective: something sought, or aimed for, related to quality. (3.2.5)
Continual Improvement: recurring activity to increase the ability to fulfill requirements. (3.2.13)
Effectiveness: extent to which planned activities are realized and planned results achieved. (3.2.14)
Efficiency: relationship between the result achieved and the resources used. (3.2.15)
Interested party: person or group having interest in the performance or success of an organization. (3.3.7)
Process: set of interrelated or interacting activities which transforms inputs into outputs. (3.4.1)
Product: result of a process. (3.4.2)
Procedure: specified way to carry out an activity or a process (3.4.5)
Conformity: fulfillment of a requirement. (3.6.1)
Quality Manual: document specifying the quality management system of an organization. (3.7.4)
 

Terms and definition for the automotive industry:

control plan: documented description of the systems and processes required for controlling product. (3.1.1 )

Control plans are addressed in Annex A below:

A1. Phases of the control plan

The control plan shall cover three distinct phases as appropriate.

a) Prototype; a description of the dimensional measurements, material and performance tests that will occur during building of the prototype.  The organization shall have a prototype control plan if required by the customer.

b) Pre-launch: a description of the dimensional measurements, material and performance tests that occur after prototype and before full production.  Pre-launch is defined as a production phases in the process of product realization which may be required after prototype build.

c) Production: documentation of product/process characteristics, process controls, tests and measurement systems that occur during mass production.

Each part shall have a control plan but, in many cases, family control plans may cover a number of similar parts produced using a common process.  Control plans are an output of the quality plan.

A2. Elements of the control plan

The organization shall develop a control plan that includes, as a minimum, the following contents:

a) General data
- control plan number,
- issue date,
- customer information
- organization's name/site designation,
- part number(s),
- part name/description,
- engineering change level,
- phase covered (prototype, pre-launch, production),
- key contact,
- part/process step number,
- process name/operation description.

b) Product control
- product-related special characteristics,
- other characteristics for control (number, product or process),
- specification/tolerance.

c) Process control
- process parameters,
- process-related special characteristics,
- machine, jigs, fixtures, tools for manufacturing.

d) Methods
- evaluation measurement technique,
- error-proofing
- sample size and frequency,
- control method.

e) Reaction plan and corrective actions
- reaction plan (include or reference),
- corrective action.
 

Terms and definition for the automotive industry (cont.):
 

For the purposes of ISO/TS 16949, the terms and definitions given in ISO 9000:2000 and the following
apply.

control plan: documented description of the systems and processes required for controlling product (see annex A)

design responsible organization: organization with authority to establish a new, or change an existing, product specification
NOTE This responsibility includes testing and verification of design performance within the customerís specified application.

error proofing: product and manufacturing process design and development to prevent manufacture of nonconforming products

laboratory: facility for inspection, test or calibration that may include, but is not limited to, chemical, metallurgical, dimensional,
physical, electrical or reliability testing

laboratory scope: controlled document containing

ï specific tests, evaluations and calibrations that a laboratory is qualified to perform,
ï list of the equipment which it uses to perform the above, and
ï list of methods and standards to which it performs the above

manufacturing: process of making or fabricating

ï production materials,
ï production or service parts,
ï assemblies, or
ï heat treating, welding, painting, plating or other finishing services

predictive maintenance: activities based on process data aimed at the avoidance of maintenance problems by prediction of likely failure
modes

preventive maintenance: planned action to eliminate causes of equipment failure and unscheduled interruptions to production, as an output
of the manufacturing process design

premium freight: extra costs or charges incurred additional to contracted delivery
NOTE This can be caused by method, quantity, unscheduled or late deliveries, etc.

remote location: location that supports sites and at which non-production processes occur

site: location at which value-added manufacturing processes occur

special characteristic: product characteristic or manufacturing process parameter which can affect safety or compliance with regulations, fit, function, performance or subsequent processing of product
 
 

4.1 GENERAL REQUIREMENT

The organization shall establish, document, implement, and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.

The organization shall:

Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system.

Note Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement.

4.1.1 General requirements - supplemental

Ensuring control over outsourced processes shall not absolve the organization of the responsibility of conformity to all customer requirements.
 

What is the difference between processes and procedures:
 

-Processes transform inputs into outputs through use of resources,

-Processes are driven by achievement of a desired outcome, while procedures are driven by the completion of a task.

-Processes are operated, while procedures are implemented.

Managing systems and processes:

Leading and operating a corporation successfully requires managing it in a systematic and visible manner. Success should result from implementing and maintaining a management system that is designed to continually improve the effectiveness and efficiency of the organization's performance by considering the needs of interested parties. Managing an organization includes quality management, among other management disciplines.

Top Management should establish a customer-oriented organization.

A quality management principle is a comprehensive and fundamental rule or belief, for leading and operating an organization, aimed at continually improving performance over the long term by focusing on customers while addressing the needs of all other stakeholders.
 

To lead and operate an organization successfully, it is necessary to manage it in a systematic and transparent manner. The guidance to management offered in the International Standard is based on eight quality management principles.

These principles have been developed for use by top management in order to lead the organization toward improved performance. These quality management principles are integrated in the contents of this International Standard and are listed below

Successful use of the eight management principles by an organization will result in benefits to interested parties, such as improved monetary returns, the creation of value and increased stability.
 
 

4.2 Documentation requirements
 

4.2.1 General

The quality management system documentation shall include:

NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to

4.2.2 Quality manual

The organization shall establish and maintain a quality manual that includes:

4.2.3 Control of documents

Documents required for the quality management system shall be controlled. Quality Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.

A documented procedure shall be established to define the controls needed:

The organization shall have a process to assure the timely review, distribution and implementation of all customer engineering standards/specifications and changes based on customer-required schedule. Timely review should be as soon as possible, and shall not exceed two working weeks.

The organization shall maintain a record of the date on which each change is implemented in production. Implementation shall include updated documents.

NOTE A change in these standards/specifications requires an updated record of customer production part approval when these specifications are referenced on the design record or if they affect documents of production part approval process, such as control plan, FMEAs, etc.
 

4.2.4 Control of records

Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.
 

NOTE 1 ìDispositionî above includes disposal.

NOTE 2 ìRecordsî also include customer-specified records.
 

4.2.4.1 Records retention

The control of records shall satisfy regulatory and customer requirements.
 

Documentation:

Management should define the documentation, including the relevant records, needed to establish, implement and maintain the quality management system and to support an effective and efficient operation of the organization's processes.

The nature and extent of the documentation should satisfy the contractual, statutory and regulatory requirements, and the needs and expectations of the customer and other interested parties and should be appropriate to the organization. Documentation may be in any form or media suitable for the needs of the organization.

In order to provide documentation to satisfy the needs and expectations of interested parties management should consider

5 MANAGEMENT RESPONSIBILITY
 
 

5.1 Top Management commitment

Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by

5.1.1 Process efficiency

Top management shall review the product realization processes and the support processes to assure their effectiveness and efficiency.
 

Leadership, commitment and the active involvement of top management are essential for developing and maintaining an effective and efficient quality management system leadership, to achieve benefits for interested parties. To achieve these benefits, it is necessary to establish, sustain and increase customer satisfaction. Top management should consider actions such as

Methods include

Issues to be considered:

When developing, implementing and managing the organization's quality management system, management should consider the quality management principles outlined in 4.3.

On the basis of these principles, top management should demonstrate leadership in, and commitment to, the following activities:

Top management should identify the organization's product realization processes, as these are directly related to the success of the organization. Top management should also identify those support processes that affect either the effectiveness or efficiency of the realization processes or the needs and expectations of interested parties.

Management should ensure that processes operate as an effective and efficient network. Management should analyze and optimize the interaction of processes, including both realization processes and support processes.

Consideration should be given to

Top management shall ensure that customer needs and expectations are determined, converted into requirements and fulfilled with the aim of enhancing customer satisfaction.
 
 

Every organization has interested parties, each party having needs and expectations. Interested parties of organizations include

The success of the organization depends on understanding and satisfying the current and future needs and expectations of present and potential customers and end-users, as well as understanding and considering those of other interested parties.

In order to understand and meet the needs and expectations of interested parties, an organization should

The organization should define financial and other results that satisfy the identified needs and expectations of owners and investors.

Management should consider the potential benefits of establishing partnerships with suppliers to the organization, in order to create value for both parties. A partnership should be based on a joint strategy, sharing knowledge as well as gains and losses. When establishing partnerships, an organization should

Management should ensure that the organization has knowledge of the statutory and regulatory requirements that apply to its products, processes and activities and should include such requirements as one of the quality management system elements. Consideration should also be given to

Top management shall ensure that the quality policy:

An organization's quality policy should be an equal and consistent part of the organization's overall policies and strategy.

In establishing the quality policy, top management should consider

5.4 Planning

5.4.1 Quality objectives

Top management shall ensure that quality objectives, including those needed to meet requirements for product, are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy.
 

5.4.1.1 Quality objectives _ Supplemental

Top management shall define quality objectives and measurements that shall be included in the business plan and used to deploy the quality policy.

NOTE Quality objectives should address customer expectations and be achievable within a defined time period.
 

The organization's strategic planning and quality policy provide a framework for the setting of quality objectives. Top management should establish these objectives, leading to improvement of the organization's performance. The objectives should be capable of being measured in order to facilitate an effective and efficient review by management. When establishing these objectives, management should also consider

• current and future needs of the organization and the markets served,
• relevant findings from management reviews,
• current product and process performance,
• levels of satisfaction of interested parties,
• self-assessment results
• benchmarking, competitor analysis, opportunities for improvement, and
• resources needed to fulfill the objectives.

5.4.2 Quality management system planning

Top management shall ensure that

a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives, and

b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.
 
 

Management should take responsibility for the quality planning of the organization. This planning should be focused on defining the processes needed to fulfill effectively and efficiently the organization's quality objectives and requirements consistent with the strategy of the organization.
 

Inputs for effective and efficient planning include

5.5 Responsibility, authority and communication
 

5.5.1 Responsibility and authority

Top management shall ensure that the responsibilities, authorities are defined and communicated within the organization.
 

Top management should define and then communicate the responsibility and authority in order to implement and maintain an effective and efficient quality management system.

People throughout the organization should be given responsibilities and authority to enable them to contribute to the achievement of the quality objectives and to establish their involvement, motivation and commitment.
 

5.5.1.1 Responsibility for quality

Managers with responsibility and authority for corrective action shall be promptly informed of products or processes which do not conform to requirements.

Personnel responsible for product quality shall have the authority to stop production to correct quality problems.

Production operations across all shifts shall be staffed with personnel in charge of, or delegated responsibility for, ensuring product quality.
 
 

5.5.2 Management representative

Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes:

NOTE  The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system.
 

5.5.2.1 customer representative

Top management shall designate personnel with responsibility and authority to ensure that customer requirements are addressed. This includes selection of special characteristics, setting quality objectives and related training, corrective and preventive actions, product design and development.
 

Management Representative(s) should be appointed and given authority by top management to manage, monitor, evaluate and coordinate the quality management system. This appointment is to enhance effective and efficient operation and improvement of the quality management system. The representative (s) should report to top management and communicate with customers and other interested parties on matters pertaining to the quality management system.
 
 

5.5.3 Internal Communication

Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system.
 

The management of the organization should define and implement an effective and efficient process for communicating the quality policy, requirements, objectives and accomplishes. Providing such information can aid in the organization's performance improvement and directly involves its people in the achievement of quality objectives. Management should actively encourage feedback and communication from people in the organization as a means of involving them.

Activities for communicating include, for example

5.6 Management review

5.6.1 General

Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. The review shall include assessing opportunities for improvement and the need for changes to the quality management system, including quality policy and quality objectives.

Records from management reviews shall be maintained.

5.6.1.1 Quality management system performance

These reviews shall include all requirements of the quality management system and its performance trends as an essential part of the continual improvement process.

Part of the management review shall be the monitoring of quality objectives, and the regular reporting and evaluation of the cost of poor quality (see 8.4.1 and 8.5.1).

These results shall be recorded to provide, as a minimum, evidence of the achievement of

ï the quality objectives specified in the business plan, and
ï customer satisfaction with product supplied.

5.6.2 Review input

The input to management review shall include information on

5.6.2.1 Review input _ Supplemental

Input to management review shall include an analysis of actual and potential field-failures and their impact on quality, safety or the environment.
 

5.6.3 Review output

The outputs from the management review shall include any decisions and actions related to:

To add value to the organization from management review, top management should control the performance of realization and support processes by systematic review based on the quality management principles. The frequency of review should be determined by the needs of the organization. Inputs to the review process should result in outputs that extend beyond the effectiveness and efficiency of the quality management system. Outputs from reviews should provide data for use in planning for performance improvement of the organization.
 

Review input

Inputs to evaluate efficiency as well as effectiveness of the quality management system should consider the customer and other interested parties and should include

By extending management review beyond verification of the quality management system, the outputs of management review can be used by top management as inputs to the improvement process. Top management can use this review process as a powerful tool in the identification of opportunities for performance improvement of the organization. The schedule of reviews should facilitate the timely provision of data in the context of strategic planning for the organization. Selected output should be communicated to demonstrate to the people in the organization how the management review process leads to new objectives that will benefit the organization.

Additional outputs to enhance efficiency include, for example

6 RESOURCE MANAGEMENT
 
 

6.1 Provision of resources

The organization shall determine and provide the resources needed:

6.2 Human resources

6.2.1 General

Personnel performing work affecting product quality shall be competent on the basis of the appropriate education, training, skills and experience.
 

6.2.2 Competence, awareness and training

The organization shall:

6.2.2.1 Product design skills

The organization shall ensure that personnel with product design responsibility are competent to achieve design requirements and are skilled in applicable tools and techniques.

Applicable tools and techniques shall be identified by the organization.
 

6.2.2.2 Training

The organization shall establish and maintain documented procedures for identifying training needs and achieving competence of all personnel performing activities affecting product quality. Personnel performing specific assigned tasks shall be qualified, as required, with particular attention to the satisfaction of customer requirements.

NOTE 1 This applies to all employees having an effect on quality at all levels of the organization.
NOTE 2 An example of the customer specific requirements is the application of digitized mathematically based data.
 

6.2.2.3 Training on the job

The organization shall provide on-the-job training for personnel in any new or modified job affecting product quality,
including contract or agency personnel. Personnel whose work can affect quality shall be informed about the consequences to the customer of nonconformity to quality requirements.
 

6.2.2.4 Employee motivation and empowerment

The organization shall have a process to motivate employees to achieve quality objectives, to make continual improvements, and to create an environment to promote innovation. The process shall include the promotion of quality and technological awareness throughout the whole organization.

The organization shall have a process to measure the extent to which its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives [see 6.2.2 d)].
 

Top management should ensure that the resources essential to the implementation of strategy and the achievement of the organization's objectives are identified and made available. This should include resources for operation and improvement of the quality management system, and the satisfaction of customers and other interested parties. Resources may be people, infrastructure, work environment, information, suppliers and partners, natural resources and financial resources.
 
 

Issues to be considered

Consideration should be given to resources to improve the performance of the organization, such as

Management should improve both the effectiveness and efficiency of the organization, including the quality management system, through the involvement and support of people. As an aid to achieving its performance improvement objectives, the organization should encourage the involvement and development of its people

Management should ensure that the necessary competence is available for the effective and efficient operation of the organization. Management should consider analysis of both the present and expected competence needs as compared to the competence already existing in the organization.

Consideration of the need for competence includes sources such as:

Planning for education and training needs should take account of change caused by the nature of the organization's processes, the stages of development of people and the culture of the organization.

This is to provide people with knowledge and skills, which, together with experience, improve their competence.

Education and training should emphasize the importance of meeting requirements and the needs and expectations of the customer and other interested parties. It should also include awareness of the consequences to the organization and its people of failing to meet the requirements.

To support the achievement of the organization's objectives and the development of its people, planning for education and training should consider

6.3 Infrastructure

The organization shall determine, provide and maintain the infrastructure it needs to achieve the conformity to product requirements. Infrastructure includes for example

The organization shall use a multidisciplinary approach for developing plant, facility and equipment plans. Plant layouts shall optimize material travel, handling and value-added use of floor space, and shall facilitate synchronous material flow. Methods shall be developed and implemented to evaluate and monitor the effectiveness of existing operations.

NOTE These requirements should focus on lean manufacturing principles and the link to the effectiveness of the quality management system.
 
 

6.3.2 Contingency plans

The organization shall prepare contingency plans to satisfy customer requirements in the event of an emergency such as utility interruptions, labour shortages, key equipment failure and field returns.

The process to define the infrastructure necessary for achieving effective and efficient product realization should include the following:

6.4 Work environment

The organization shall determine and manage the work environment needed to achieve conformity to product requirements.
 

6.4.1 Personnel safety to achieve product quality

Product safety and means to minimize potential risks to employees shall be addressed by the organization, especially in the design and development process and in manufacturing process activities.

6.4.2 Cleanliness of premises

The organization shall maintain its premises in a state of order, cleanliness and repair consistent with the product and manufacturing process needs.

Management should treat data as a fundamental resource for conversion to information and the continual development of an organization's knowledge, which is essential for making factual decisions and can stimulate innovation. In order to manage information, the organization should

Management should establish relationships with suppliers and partners to promote and facilitate communication with the aim of mutually improving the effectiveness and efficiency of processes that create value. There are various opportunities for organizations to increase value through working with their suppliers and partners, such as

-optimizing the number of suppliers and partner

-establishing two-way communication at appropriate levels in both organizations to facilitate the rapid solution of problems, and to avoid costly delays or disputes,

-cooperating with suppliers in validation of the capability of their processes,

-monitoring of the ability of suppliers to deliver conforming products with the aim of eliminating redundant verifications,

-encouraging suppliers to implement programs for continual improvement of performance and to participate in other joint improvement initiatives,

-involving suppliers in the organization's design and development activities to share knowledge and effectively and efficiently improve the realization and delivery processes for conforming products,

-involving partners in identification or purchasing needs and joint strategy development, and

-evaluating, recognizing and rewarding efforts and achievements by suppliers and partners.

Natural resources

Consideration should be given to the availability of natural resources that can influence the performance of the organization. While such resources are often out of the direct control of the organization, they can have significant positive or negative effects on its results. The organization should have plans, or contingency plans, to ensure the availability or replacement of these resources in order to prevent or minimize negative effects on the performance of the organization.
 

Financial resources

Resource management should include activities for determining the needs for, and sources of, financial resources. The control of financial resources should include activities for comparing actual usage against plans, and taking necessary action.

Management should plan, make available and control the financial resources necessary to implement and maintain an effective and efficient quality management system and to achieve the organization's objectives. Management should also consider the development of innovative financial methods to support and encourage improvement of the organization's performance.

Improving the effectiveness and efficiency of the quality management system can influence positively the financial results of the organization, for example

a) internally, by reducing process and product failures, or waste in material and time, or

b) externally, by reducing product failures, costs of compensation of guarantees and warranties, and costs of lost customers and markets.
Reporting of such matters can also provide a means of determining ineffective or inefficient activities, and initiating suitable improvement actions.

The financial reporting of activities related to the performance of the quality management system and product conformity should be used in management reviews.
 
 

7 PRODUCT REALIZATION
 
 

7.1 Planning of product realization

The organization shall plan and develop the processes needed for product realization. Planning of the realization processes shall be consistent with the other requirements of the organization's quality management system.

In planning the product realization, the organization shall determine the following, as appropriate

a) quality objectives for the product,

b) the need to establish processes, documents, and provide resources specific to the product,

c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance.

d) records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4).

NOTE 1 A document specifying the processes of the quality management (including the product realization processes) and the resources to be applied to a specific product, project or contract may be referred to as a quality plan.

NOTE 2 The organization may also apply the requirements given in 7.3 to the development of product realization processes.

NOTE 3  Some customers refer to project management or advanced product quality planning as a means to achieve product realization. Advanced product quality planning embodies the concepts of error prevention and continual improvement as contrasted with error detection, and is based on a multidisciplinary approach.
 

7.1.1 Planning of product realization ó Supplemental

Customer requirements and references to its technical specifications shall be included in the planning of product realization as a component of the quality plan.
 

7.1.2 Acceptance criteria

Acceptance criteria shall be defined by the organization and, where required, approved by the customer.  For attribute data sampling, the acceptance level shall be zero defects (see 8.2.3.1).
 

7.1.3 Confidentiality

The organization shall ensure the confidentiality of customer-contracted products and projects under development, and related product information.
 

7.1.4 Change control

The organization shall have a process to control and react to changes that impact product realization. The effects of any change, including those changes caused by any supplier, shall be assessed, and verification and validation activities shall be defined, to ensure compliance with customer requirements. Changes shall be validated before implementation.

For proprietary designs, impact on form, fit and function (including performance and/or durability) shall be reviewed with the customer so that all effects can be properly evaluated.

When required by the customer, additional verification/identification requirements, such as those required for new product introduction, shall be met.
 

NOTE 1 Any product realization change affecting customer requirements requires notification to, and agreement from, the customer.
NOTE 2 The above requirement applies to product and manufacturing process changes.
 

Top management should ensure the effective and efficient operation of realization and support processes and the associated process network so the organization has the capability of satisfying its interested parties. While realization processes result in products that add value to the organization, support processes are also necessary to the organization and add value indirectly.

Any process is a sequence of related activities or an activity that has both inputs and outputs.  Management should define the required outputs of processes, and should identify the necessary inputs and activities required for their effective and efficient achievement.

The interrelation of processes can be complex, resulting in process networks. To ensure the effective and efficient operation to the organization, management should recognize that the output of one process may become the input to anther process.
 

Issues to be considered

Understanding that a process can be represented as a sequence of activities aids management in defining the process inputs. Once the inputs have been defined, the necessary activities, actions and resources required for the process can be determined, in order to achieve the desired outputs.

Results from verification and validation or processes and outputs should also be considered as inputs to a process, to achieve continual improvement of performance and the promotion of excellence throughout the organization. Continual improvement of the organization's processes will improve the effectiveness and efficiency of the quality management system and the organization's performance.

That can be used to assist in the identification of actions needed for continual improvement of the effectiveness and efficiency of processes.

Processes should be documented to the extent necessary to support effective and efficient operation. Documentation related to processes should support

-identifying and communicating the significant features of the processes,

-training in the operation of processes,

-sharing knowledge and experience in teams and work groups,

-measurement and audit of processes, and

-analysis, review and improvement of processes.

The role of people within the processes should be evaluated in order

-to ensure the health and safety of people,

-to ensure that the necessary skills exist,

-to support coordination of processes,

-to provide for input from people in process analysis, and

-to promote innovation from people.

Managing processes

Management should identify processes needed to realize products to satisfy the requirements of customers and other interested parties. To ensure product realization, consideration should be given to associated support processes as well as desired outputs, process steps, activities, flows, control measures, training needs, equipment, methods, information, materials and other resources.

An operating plan should be defined to manage the processes including

-input and output requirements (such as specifications and resources),

-activities within the processes,

-verification and validation of processes and products,

-analysis of the process including dependability,

-identification, assessment and mitigation of risk,

-corrective and preventive actions,

-opportunities and actions for process improvement, and

-control of changes to processes and products.

-managing information,

-training of people,

-financial related activities,

-infrastructure and service maintenance,

-application of industrial safety/protective equipment, and

-marketing.

Process inputs, outputs and review

The process approach ensures that process inputs are defined and recorded in order to provide a basis for formulation of requirements to be used for verification and validation of outputs. Inputs can be internal or external to the organization.

Resolution of ambiguous or conflicting input requirements can involve consultation with the affected internal and external parties. Input derived from activities not yet fully evaluated should be subject to evaluation through subsequent review, verification and validation. The organization should identify significant or critical features of products and processes in order to develop an effective and efficient plan for controlling and monitoring the activities within the process.

Examples of input issues to consider include

-Competence of people,

-Documentation,

-Equipment capability and monitoring, and

-Health, safety and work environment.

The management of the organization should undertake periodic review of process performance to ensure the process is consistent with the operating plan. Examples of topics for this review include

-reliability and repeatability of the process,

-identification and prevention of potential nonconformities,

-adequacy of design and development inputs and outputs,

-consistency of inputs and outputs with planned objectives,

-potential for improvements, and

-unresolved issues.

Product and process validation and changes

Management should ensure that the validation of products demonstrates that they meet the needs and expectations of customers and other interested parties. Validation activities include modeling, simulation and trials, as well as reviews involving customers or other interested parties.

Issues to consider should include

-quality policy and objectives,

-capability or qualification of equipment,

-operating conditions for the product,

-use or application of the product,

-disposal of the product,

-product life cycle,

-environmental impact of the product, and

-impact of the use of natural resources including materials and energy.

Process validation should be carried out at appropriate intervals to ensure timely reaction to changes impacting the process. Particular attention should be given to validation of processes

-for high value and safety critical products,

-where deficiency in product will only be apparent in use,

-which cannot be repeated, and

-where verification of product is not possible.

Any changes in the process affecting product characteristics should be recorded and communicated in order to maintain the conformity of the product and provide information for corrective action or performance improvement of the organization. Authority for initiating change should be defined in order to maintain control.

Outputs in the form of products should be validated after any related change, to ensure that the change has had the desired effect.

Use of simulation techniques can also be considered in order to plan for prevention of failures or faults in processes.

Risk assessment should be undertaken to assess the potential for, and the effect of, possible failures or faults in processes. The results should be used to define and implement preventive actions to mitigate identified risks. Examples of tools for risk assessment include
-fault modes and effects analysis,
 

-fault tree analysis,

-relationship diagrams,

-simulation techniques, and

-reliability prediction.

7.2 Customer-related processes
 
 

7.2.1 Determination of requirements related to the product

The organization shall determine

a) requirements specified by the customer, including the requirements for delivery and post-delivery activities,

b) requirements not stated by the customer but necessary for specified use or known intended use,

c) statutory and regulatory requirements related to the product, and

d) any additional requirements determined by the organization.
The first step is to develop a clear understanding of the nature of the various kinds of requirements.

NOTE 1 Post-delivery activities include any after-sales product service provided as part of the customer contract or purchase
order.

NOTE 2 This requirement includes recycling, environmental impact and characteristics identified as a result of the organizationís knowledge of the product and manufacturing processes (see 7.3.2.3).

NOTE 3 Compliance to item c) includes all applicable government, safety and environmental regulations, applied to acquisition, storage, handling, recycling, elimination or disposal of materials.
 

7.2.1.1 Customer-designated special characteristics

The organization shall demonstrate conformity to customer requirements for designation, documentation and control of special characteristics.
 

7.2.2 Review of requirements related to the product

The organization shall review the identified customer requirements related to the product. This review shall be conducted prior to the organization's commitment to supply a product to the customer (e.g. submission of tenders, acceptance of a contracts or orders, acceptance of changes to contracts or orders) and shall ensure that:

a) product requirements are defined,

b) contract or order requirements differing from those previously expressed are resolved, and

c) the organization has the ability to meet defined requirements.

Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance.

Where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements.

NOTE In some situations, such as Internet sales, a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or advertising material.
 

7.2.2.1 Review of requirements related to the product ó Supplemental

Waiving the requirement stated in 7.2.2 for a formal review (see note) shall require customer authorization.
 

7.2.2.2 Organization manufacturing feasibility

The organization shall investigate, confirm and document the manufacturing feasibility of the proposed products in the contract review process, including risk analysis.
 

For the various kinds of customer requirements a review needs to be conducted prior to issuing a quotation, submission of a tender or accepting an order or a contract.  The intent of this review is to ensure that the requirements (product specifications, pricing, delivery dates, adherence to external standards etc...) are clearly defined and any discrepancy in the understanding of these requirements resolved. i.e. differences between the organization's quote and the customer order.

The other important review requirement is that of the ability or capability of meeting the defined requirement such as delivery date, and quantity.  This is typically done in conjunction with product realization functions such as scheduling, inventory management, capacity control etc...

These reviews need to be documented, and in case changes occur, relevant documents need to be amended and the relevant functions (usually having to do with product realization) are  informed of the changes.
 

7.2.3 Customer communication

The organization shall determine and implement effective arrangements for communication with customers in relation to:

a) product information,

b) inquiries, contracts or order handling, including amendments, and

c) customer feedback, including customer complaints.
 

The organization shall have the ability to communicate necessary information, including data, in a customerspecified language and format (e.g. computer-aided design data, electronic data exchange).
 

Processes related to interested parties

Management should ensure that the organization has defined mutually acceptable processes for communicating effectively and efficiently with its customers and other interested parties. The organization should implement and maintain such processes to ensure adequate understanding of the needs and expectations of its interested parties, and for translation into requirements for the organization. These processes should include identification and review of relevant information and should actively involve customers and other interested parties. Examples of relevant process information include
-requirements of the customer or other interested parties,

-market research, including sector and end-user data,

-contract requirements,

-competitor analysis,

-benchmarking, and

-processes due to statutory or regulatory requirements.
The organization should have a full understanding of the process requirements of the customer, or other interested party, before initiating its action to comply. This understanding and its impact should be mutually acceptable to the participants.
 
 

7.3 Design and development

NOTE The requirements of 7.3 include product and manufacturing process design and development, and focus on error prevention rather than detection.
 

7.3.1 Design and development planning

The organization shall plan and control design and development of the product.

During the design and development planning, the organization shall determine:

a) the design and development stages,

b) the review, verification and validation that are appropriate to each design and development stage, and

c) the responsibilities and authorities for design and development.

Planning output shall be updated, as appropriate, as the design and development progresses.
 

7.3.1.1 Multidisciplinary approach

The organization shall use a multidisciplinary approach to prepare for product realization, including

ï development/finalization and monitoring of special characteristics,
ï development and review of FMEAs, including actions to reduce potential risks, and
ï development and review of control plans.

7.3.2 Design and development inputs

Inputs relating to product requirements shall be determined and records maintained (see 4.2.4). These shall include:

a) functional and performance requirements,

b) applicable regulatory and legal requirements,

c) where applicable, information derived from previous similar designs, and

d) other requirements essential for design and development.

NOTE Special characteristics (see 7.2.1.1) are included in this requirement.
 

7.3.2.1 Product design input

The organization shall identify, document and review the product design inputs requirements, including the following:

ï customer requirements (contract review) such as special characteristics (see 7.3.2.3), identification,
ï use of information: the organization shall have a process to deploy information gained from previous design
ï targets for product quality, life, reliability, durability, maintainability, timing and cost.

7.3.2.2 Manufacturing process design input

The organization shall identify, document and review the manufacturing process design input requirements, including

ï product design output data,
ï targets for productivity, process capability and cost,
ï customers requirements, if any, and
ï experience from previous developments.

7.3.2.3 Special characteristics

The organization shall identify special characteristics and

ï include all special characteristics in the control plan,
ï comply with customer-specified definitions and symbols, and
ï identify process control documents including drawings, FMEAs, control plans, and operator instructions with the customerís special characteristic symbol or the organizationís equivalent symbol or notation to include those process steps that affect special characteristics.

7.3.3 Design and development outputs

The outputs of the design and development process shall be provided in a form that enables verification against the design and development inputs and shall be approved prior to release.

Design and development output shall:

a) meet the input requirements for design and development,

b) provide appropriate information for purchasing, production and service provision,

c) contain or reference product acceptance criteria, and

d) specify the characteristics of the product that are essential to its safe and proper use.
 

The product design output shall be expressed in terms that can be verified and validated against product design input requirements. The product design output shall include

ï design FMEA, reliability results,
ï product special characteristics and specifications,
ï product error-proofing, as appropriate,
ï product definition including drawings or mathematically based data,
ï product design reviews results, and
ï diagnostic guidelines where applicable.

The manufacturing process design output shall be expressed in terms that can be verified against manufacturing process design input requirements and validated. The manufacturing process design output shall include

ï specifications and drawings,
ï manufacturing process flow chart/layout,
ï manufacturing process FMEAs,
ï control plan (see 7.5.1.1),
ï work instructions,
ï process approval acceptance criteria,
ï data for quality, reliability, maintainability and measurability,
ï results of error-proofing activities, as appropriate, and
ï methods of rapid detection and feedback of product/manufacturing process nonconformities.

Design and development input and output

The organization should identify process inputs that affect the design and development of products and facilitate effective and efficient process performance in order to satisfy the needs and expectations of customers, and those of other interested parties. These external needs and expectations, coupled with those internal to the organization, should be suitable for translating into input requirements for the design and development processes.

Examples are as follows:
 

a) external inputs such as

-customer or marketplace needs and expectations

-needs and expectation of other interested parties,

-supplier's contributions,

-user input to achieve robust design and development,

-changes in relevant statutory and regulatory requirements,

-international or national standards, and

-industry codes of practice;

b) internal inputs such as

-policies and objectives,

-needs and expectations of people in the organization, including those receiving the output of the process,

-technological developments,

-competence requirements for people performing design and development,

-feedback information from past experience,

-records and data on existing processes and products, and

-outputs from other processes;

c) inputs that identify those characteristics of processes or products that are crucial to safe and proper functioning and maintenance, such as

-operation, installation and application,

-storage, handling and delivery,

-physical parameters and the environment, and

-requirements for disposal of the products.

The output should include information to enable verification and validation to planned requirements. Examples of the output of design and development include

-data demonstrating the comparison of process inputs to process outputs,

-product specification, including acceptance criteria,

-process specifications,

-material specifications,

-testing specifications,

-tainting requirements,

-user and consumer information,

-purchase requirements, and

-reports of qualification tests.

Design and development outputs should be reviewed against inputs to provide objective evidence that outputs have effectively and efficiently met requirements for the process and product.
 
 

7.3 Design and development (cont.)
 

7.3.4 Design and development review

At suitable stages, systematic reviews of design and development shall be conducted

a) to evaluate the ability of the results of design and development to fulfil requirements, and

b) to identify problems and propose necessary actions.
Participants in such reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed. Records of the results of the reviews and any necessary actions shall be maintained (see 4.2.4).

NOTE These reviews are normally coordinated with the design phases and include manufacturing process design and development.
 

7.3.4.1 Monitoring

Measurements at specified stages of design and development shall be defined, analysed and reported with summary results as an input to management review.

NOTE These measurements include quality risks, costs, lead-times, critical paths and others, as appropriate.
 

7.3.5 Design and development verification

Verification shall be performed in accordance with planned arrangements (see 7.3.1) to ensure the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions shall be maintained (see 4.2.4).
 

7.3.6 Design and development validation

Design and development validation shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Wherever practicable, validation shall be completed prior to the delivery or implementation of the product. Records of the results of the validation and any necessary actions shall be maintained (see 4.2.4).
 

NOTE 1 The validation process normally includes an analysis of field reports for similar products.
NOTE 2 The requirements of 7.3.5 and 7.3.6 above apply to both product and manufacturing processes.
 

7.3.6.1 Design and development validation ó Supplemental

Design and development validation shall be performed in accordance with customer requirements including programme timing.
 

7.3.6.2 Prototype programme

When required by the customer, the organization shall have a prototype programme and control plan. The organization shall use, wherever possible, the same suppliers, tooling and manufacturing processes as will be used in production.

All performance-testing activities shall be monitored for timely completion and conformity to requirements.
While services may be outsourced, the organization shall be responsible for the outsourced services, including technical leadership.
 

7.3.6.3 Product approval process

The organization shall conform to a product and manufacturing process approval procedure recognized by the customer.

NOTE Product approval should be subsequent to the verification of the manufacturing process.

This product and manufacturing process approval procedure shall also be applied to suppliers.
 
 

7.3.7 Control of design and development changes

Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of the design and development changes shall include evaluation of the effect of the changes on constituent parts and delivered product.

Records of the results of the review of changes and any necessary actions shall be maintained (see 4.2.4).

NOTE Design and development changes include all changes during the product programme life (see 7.1.4).
 

Top management should ensure that the organization has defined, implemented and maintained the necessary design and development processes to respond effectively to the needs and expectations of its customers and other interested parties.

When designing and developing products or process, management should ensure that the organization is not only capable of considering their basic performance and function, but all factors that contribute to meeting the product and process performances expected by customers and other interested parties. For example, the organization should consider lifecycle, safety and health, testability, usability, user-friendliness, dependability, durability, ergonomics, the environment, product disposal and identified risks.

Management also has the responsibility to ensure that steps are taken to identify and mitigate potential risk to the users of the products and processes or the organization. Risk assessment should be undertaken to assess the potential for, and effect of, possible failures or faults in products or processes. The results of the assessment should be used to define and implement preventive actions to mitigate the identified risks. Examples of tools for risk assessment of design and development include

-design fault modes and effects analysis,

-fault tree analyses,

-reliability prediction,

-relationship diagrams,

-ranking techniques, and

-simulation techniques.

Top management should ensure that appropriate people are assigned to manage and conduct systematic reviews to determine that design and development objectives are achieved. These reviews may be conducted at selected points in the design and development process as well as at completion.

Examples of topics for such reviews include

-adequacy of input to perform the design and development tasks,

progress of the planned design and development process,

-meeting verification and validation goals,

-evaluation or potential hazards or fault modes in product use,

life-cycle data on performance of the product,

-control of changes and their effect during the design and development process,

-identification and correction of problems,

-opportunities for design and development process improvement, and

potential impact of the product on the environment.
At suitable stages, the organization should also undertake reviews of design and development outputs, as well as the processes, in order to satisfy the needs and expectations of customers and people within the organization who receive the process output. Consideration should also be given to the needs and expectations of other interested parties.

Examples of verification activities for output of the design and development process include

-comparison of input requirements with the output of the process,

-comparative methods, such as alternative design and development calculations,

-evaluation against similar products,

-testing, simulations or trials to check compliance with specific input requirements, and

-evaluation against lessons learned from past process experience, such as nonconformities and deficiencies.

Validation of the output of the design and development processes is important for the successful reception and use by customers, suppliers, people in the organization and other interested parties.

Participation by the affected parties permits the actual users to evaluate the output by such means as

-validation of engineering designs prior to construction, installation or application,

-validation of software outputs prior to construction, installation or application,

-validation of software outputs prior to installation or use, and

-validation of services prior to widespread introduction.

Partial validation of the design and development outputs may be necessary to provide confidence in their future application.

Sufficient data should be generated through verification and validation activities to enable design and development methods and decisions to be reviewed. The review of methods should include
-process and product improvement,
 

-usability or output,

-adequacy of process and review records,

-failure investigation activities, and

-future design and development process needs.
 
 

SECTION 20

7.4.1 Purchasing process

The organization shall control its purchasing processes to ensure purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent realization processes and the final product.

The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization's requirements. Criteria for selection, evaluation and reevaluation shall be established. Records of the results of evaluations and any necessary actions shall be maintained (see 4.2.4).
 

NOTE 1 Purchased products above include all products and services that affect customer requirements such as subassembly, sequencing, sorting, rework and calibration services.

NOTE 2 When there are mergers, acquisitions or affiliations associated with suppliers, the organization should verify the continuity of the supplierís quality management system and its effectiveness.
 

7.4.1.1 Regulatory conformity

All purchased products or materials used in product shall conform to applicable regulatory requirements.
 

7.4.1.2 Supplier quality management system development
The organization shall perform supplier quality management system development with the goal of supplier conformity with this Technical Specification. Conformity with ISO 9001:2000 is the first step in achieving this goal.

NOTE The prioritization of suppliers for development depends upon, for example, the supplierís quality performance and the importance of the product supplied.  Unless otherwise specified by the customer, suppliers to the organization shall be third party registered to ISO 9001:2000 by an accredited third-party certification body.
 

7.4.1.3 Customer-approved sources

Where specified by the contract (e.g. customer engineering drawing, specification), the organization shall purchase products, materials or services from approved sources.

The use of customer-designated sources, including tool/gauge suppliers, does not relieve the organization of the responsibility for ensuring the quality of purchased products.
 
 

7.4.2 Purchasing information

Purchasing information shall describe the product to be purchased, including where appropriate:

a) requirements for approval of product, procedures, processes and equipment,

b) requirements for qualification of personnel, and

c) quality management system requirements.

7.4.3 Verification of purchased product

The organization shall establish and implement the inspection or other the activities necessary for ensuring that purchased product meets specified purchase requirements.

Where the organization or its customer intends to perform verification activities at the supplier's premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information.
 

7.4.3.1 Incoming product quality

The organization shall have a process to assure the quality of purchased product (see 7.4.3) utilizing one or more of the following methods:

ï receipt of, and evaluation of, statistical data by the organization;
ï receiving inspection and/or testing such as sampling based on performance;
ï second- or third-party assessments or audits of supplier sites, when coupled with records of acceptable delivered product quality;

ï part evaluation by a designated laboratory;
ï another method agreed with the customer.

7.4.3.2 Supplier monitoring

Supplier performance shall be monitored through the following indicators:

ï delivered product quality;
ï customer disruptions including field returns;
ï delivery schedule performance (including incidents of premium freight);
ï special status customer notifications related to quality or delivery issues.

Purchasing process

Top management of the organization should ensure that effective and efficient purchasing processes are defined and implemented for the evaluation and control of purchased products, in order that purchased products satisfy the organization's need and requirements, as well as those of interested parties.

Use of electronic linkage with suppliers should be considered in order to optimize communication of requirements.

To ensure the effective and efficient performance of the organization, management should ensure that purchasing processes consider the following activates:

The organization should define the need for records of purchased products verification, communications and response to nonconformities in order to demonstrate its own conformity to specification.
 

Supplier control process

The organization should establish effective and efficient processes to identify potential sources for purchased materials, to develop existing suppliers or partners, and to evaluate their ability to supply the required products in order to ensure the effectiveness and efficiency of overall purchasing processes.

Examples of inputs to the supplier control process include

7.5 Production and service provision
 

7.5.1 Control of production and service provision

The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable

a) the availability of information that describes the characteristics of the product,

b) the availability of work instructions,

c) the use of suitable equipment,

d) the availability and use of measuring and monitoring devices,

e) the implementation of monitoring and measurement,

f) the implementation of release, delivery and post-delivery activities.
 

The organization shall

ï develop control plans (see annex A) at the system, subsystem, component and/or material level for the product supplied, including those for processes producing bulk materials as well as parts, and
ï have a control plan for pre-launch and production that takes into account the design FMEA and manufacturing process FMEA outputs.

ï list the controls used for the manufacturing process control,
ï include methods for monitoring of control exercised over special characteristics (see 7.3.2.3) defined by both the customer and the organization,
ï include the customer-required information, if any, and
ï initiate the specified reaction plan (see 8.2.3.1) when the process becomes unstable or not statistically capable.

NOTE Customer approval may be required after review or update of the control plan.
 

7.5.1.2 Work instructions

The organization shall prepare documented work instructions for all employees having responsibilities for the operation of processes that impact product quality. These instructions shall be accessible for use at the work station.

These instructions shall be derived from sources such as the quality plan, the control plan and the product realization process.
 

7.5.1.3 Verification of job set-ups

Job set-ups shall be verified whenever performed, such as an initial run of a job, material changeover or job change.

Work instructions shall be available for set-up personnel. The organization shall use statistical methods of verification where applicable.

NOTE Last-off-part comparisons are recommended.
 

7.5.1.4 Preventive and predictive maintenance

The organization shall identify key process equipment and provide resources for machine/equipment maintenance and develop an effective planned total preventive maintenance system. As a minimum, this system shall include the following:

ï planned maintenance activities;
ï packaging and preservation of equipment, tooling and gauging;
ï availability of replacement parts for key manufacturing equipment;
ï documenting, evaluating and improving maintenance objectives.

7.5.1.5 Management of production tooling

The organization shall provide resources for tool and gauge design, fabrication and verification activities.

The organization shall establish and implement a system for production tooling management including:

ï maintenance and repair facilities and personnel;
ï storage and recovery;
ï set-up;
ï tool-change programmes for perishable tools;
ï tool design modification documentation, including engineering change level;
ï tool modification and revision to documentation;
ï tool identification, defining the status, such as production, repair or disposal.

NOTE This requirement also applies to the availability of tools for vehicle service parts.
 

7.5.1.6 Production scheduling

Production shall be scheduled in order to meet customer requirements, such as just-in-time supported by an information system that permits access to production information at key stages of the process and is order driven.
 

7.5.1.7 Feedback of information from service

A process for communication of information on service concerns to manufacturing, engineering and design activities shall be established and maintained.

NOTE The intent of the addition of ìservice concernsî to this subclause is to ensure that the organization is aware of nonconformities that occur external to its organization.
 

7.5.1.8 Service agreement with customer

When there is a service agreement with the customer, the organization shall verify the effectiveness of

ï any organization service centres,
ï any special-purpose tools or measurement equipment, and
ï the training of service personnel.

The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies may become apparent only after the product is in use or the service has been delivered.

Validation shall demonstrate the ability of the processes to achieve planned results.

The organization shall establish arrangements for these processes including, as applicable:

a) defined criteria for review and approval of the processes,

b) approval of equipment and qualification of personnel,

c) use of specific methods and procedures,

d) requirements for records (see 4.2.4), and

e) revalidation.
 

The requirements of 7.5.2 shall apply to all processes for production and service provision.
 

Top management should go beyond control of the realization processes in order to achieve both compliance with requirements and provide benefits to interested parties. This may be achieved through improving the effectiveness and efficiency of the realization processes and associated support processes, such as

Where appropriate the organization shall identify the product by suitable means throughout product realization.

The organization shall identify the status of the product with respect to monitoring and measurement requirements.

Where traceability is a requirement, the organization shall control and record the unique identification of the product (see 4.2.4).

NOTE In some industry sectors, configuration management is a means by which identification and traceability are maintained.
 

NOTE Inspection and test status is not indicated by the location of product in the production flow unless inherently obvious, such as material in an automated production transfer process. Alternatives are permitted, if the status is clearly identified, documented and achieves the designated purpose.
 

7.5.3.1 Identification and traceability ó Supplemental

The words ìWhere appropriateî in 7.5.3 shall not apply.
 

The organization can establish a process for identification and traceability that goes beyond the requirements in order to collect data which can be used for improvement.

The need for identification and traceability may arise from

The organization shall exercise care with customer property while it is under the organization's control or being used by the organization. The organization shall identify, verify, protect and safeguard customer property provided for use of incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained (see 4.2.4).

NOTE 1 Customer property may include intellectual property.

NOTE 2 Customer-owned returnable packaging is included in this clause.
 

7.5.4.1 Customer-owned production tooling

Customer-owned tools, manufacturing, test, inspection tooling and equipment shall be permanently marked so that the ownership of each item is visible, and can be determined.
 

The organization should identify responsibilities in relating to property and other assets owned by customers and other interested parties and under the control of the organization, in order to protect the value of the property. Examples of such property are

The organization shall preserve conformity of product during internal processing and delivery to the intended destination. This preservation shall include identification, handling, packaging, storage and protection. Preservation shall also apply to constituent parts of a product.
 

7.5.5.1 Storage and inventory

In order to detect deterioration, the condition of product in stock shall be assessed at appropriate planned intervals.  The organization shall use an inventory management system to optimize inventory turns over time and assure stock rotation, such as ìfirst-in-first-outî (FIFO). Obsolete product shall be controlled in a similar manner to nonconforming product.
 

Management should define and implement processes for handling, packaging, storage, preservation, and delivery of product that prevent damage, deterioration, or misuse during internal processing and final delivery of the product. Management should involve suppliers and partners in defining and implementing effective and efficient processes to protect purchased material.

Management should consider the need for any special requirements arising from the nature of the product. Special requirements can be associated with software, electronic media, hazardous materials, and products requiring special people for service, installation or application, and products or materials that are unique or irreplaceable.

Management should identify resources needed to maintain the product throughout its life cycle to prevent damage, deterioration or misuse. The organization should communicate information to the interested parties involved about the resources and methods needed to preserve the intended use of the product throughout its life cycle.
 
 

7.6 Control of monitoring and measuring devices

The organization shall determine the monitoring and measurements to be undertaken and the measuring and monitoring devices needed to provide evidence of conformity of product to determined requirements (see 7.2.1).

The organization shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements.

Where necessary to ensure valid results, measuring equipment shall:

When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary.

NOTE 1 See ISO 10012-1 and ISO 10012-2 for guidance.

NOTE 2 A number or other identifier traceable to the device calibration record meets the intent of requirement c) above.
 

7.6.1 Measurement system analysis

Statistical studies shall be conducted to analyse the variation present in the results of each type of measuring and test equipment system. This requirement shall apply to measurement systems referenced in the control plan. The analytical methods and acceptance criteria used shall conform to those in customer reference manuals on measurement systems analysis. Other analytical methods and acceptance criteria may be used if approved by the customer.
 

7.6.2 Calibration/verification records
Records of the calibration/verification activity for all gauges, measuring and test equipment, needed to provide evidence of conformity of product to determined requirements, including employee- and customer-owned equipment, shall include

ï equipment identification, including the measurement standard against which the equipment is calibrated,
ï revisions following engineering changes,
ï any out-of-specification readings as received for calibration/verification,
ï an assessment of the impact of out-of-specification condition,
ï statements of conformity to specification after calibration/verification, and
ï notification to the customer if suspect product or material has been shipped.

7.6.3 Laboratory requirements

7.6.3.1 Internal laboratory

An organizationís internal laboratory facility shall have a defined scope that includes its capability to perform the required inspection, test or calibration services. This laboratory scope shall be included in the quality management system documentation. The laboratory shall specify and implement, as a minimum, technical requirements for

ï adequacy of the laboratory procedures,
ï competency of the laboratory personnel,
ï testing of the product,
ï capability to perform these services correctly, traceable to the relevant process standard (such as ASTM, EN, etc.), and
ï review of the related records.

7.6.3.2 External laboratory

External/commercial/independent laboratory facilities used for inspection, test or calibration services by the organization shall have a defined laboratory scope that includes the capability to perform the required inspection, test or calibration, and either

ï there shall be evidence that the external laboratory is acceptable to the customer, or
ï the laboratory shall be accredited to ISO/IEC 17025 or national equivalent.

NOTE 2 When a qualified laboratory is not available for a given piece of equipment, calibration services may be performed by the equipment manufacturer. In such cases, the organization should ensure that the requirements listed in 7.6.3.1 have been met.
 

Management should define and implement effective and efficient measuring and monitoring processes, including methods and devices for verification and validation of products and processes to ensure the satisfaction of customers and other interested parties. These processes include surveys, simulations, and other measurement and monitoring activities.

In order to provide confidence in data, the measuring and monitoring processes should include confirmation that the device is fit for use and in maintained to suitable accuracy and accepted standards, as well as a means of identifying the status of the device.

The organization should consider means to eliminate potential errors from processes, such as "fool-proofing", for verification of process outputs in order to minimize the need for control of measuring and monitoring devices, and to add value for interested parties.
 
 

8. MEASUREMENT, ANALYSIS AND IMPROVEMENT
 
 

8.1 General

The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed

8.1.1 Identification of statistical tools

Appropriate statistical tools for each process shall be determined during advance quality planning and included in the control plan.
 

8.1.2 Knowledge of basic statistical concepts

Basic statistical concepts, such as variation, control (stability), process capability and over-adjustment shall be understood and utilized throughout the organization.
 

Measurement data are important for making fact-based decisions. Top management should ensure effective and efficient measurement, collection and validation of data to ensure the organization's performance and the satisfaction of interested parties. This should include review of the validity and purpose of measurements and the intended use of data to ensure added value to the organization.

Examples of measurement of performance of the organization's processes include

The results of the analysis of data from improvement activities should be one of the inputs top management review in order to provide information for improving the performance of the organization.
 

Issues to be considered

Measurement, analysis and improvement include the following considerations:

8.2.1 Customer satisfaction

As one of the measurements of the performance of the quality management system, the organization shall monitor information relating to customer perception as to whether the organization has fulfilled customer requirements. The methods for obtaining and using this information shall be determined.

NOTE Consideration should be given to both internal and external customers.
 

8.2.1.1 Customer satisfaction ó Supplemental

Customer satisfaction with the organization shall be monitored through continual evaluation of performance of the realization processes. Performance indicators shall be based on objective data and include, but not be limited to:

ï delivered part quality performance,
ï customer disruptions including field returns,
ï delivery schedule performance (including incidents of premium freight), and
ï customer notifications related to quality or delivery issues.

Top management should ensure that effective and efficient methods are used to identify areas for improvement of the quality management system performance, Examples of methods include

Measurement and monitoring of customer satisfaction is based on review of customer-related information. The collection of such information may be active or passive. Management should recognize that there are many sources of customer-related information, and should establish effective and efficient processes to collect, analyze and use this information for improving the performance of the organization. The organization should identify sources of customer and end-user information, available in written and verbal forms, from internal and external sources. Examples of customer Ñrelated information include

The organization should establish and use sources of customer satisfaction information and should cooperate with its customers in order to anticipate future needs. The organization should plan and establish processes to listen effectively and efficiently to the "voice of the customer". Planning for these processes should define and implement data-collection methods, including information sources, frequency of collection, and data-analysis review. Examples of sources of information on customer satisfaction include.

The organization shall conduct internal audits at planned intervals to determine whether the quality management system:

The responsibilities and requirements for planning and conducting audits, and for reporting and maintaining records (see 4.2.4) shall be defined in a documented procedure.

The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes.

Follow-up activities shall include the verification of the implementation of actions taken, and the reporting of verification results.

NOTE See ISO 10011-1, ISO 10011-2 and ISO 10011-3 for guidance.
 

8.2.2.1 Quality management system audit

The organization shall audit its quality management system to verify compliance with this Technical Specification and any additional quality management system requirements.
 

8.2.2.2 Manufacturing process audit
 

The organization shall audit each manufacturing process to determine its effectiveness.
 

8.2.2.3 Product audit

The organization shall audit products at appropriate stages of production and delivery to verify conformity to all specified requirements, such as product dimensions, functionality, packaging and labelling, at a defined frequency.
 

8.2.2.4 Internal audit plans

Internal audits shall cover all quality management related processes, activities and shifts, and shall be scheduled according to an annual plan.

When internal/external nonconformities or customer complaints occur, the audit frequency shall be appropriately increased.

NOTE Specific checklists should be used for each audit.
 

8.2.2.5 Internal auditor qualification

The organization shall have internal auditors who are qualified to audit the requirements of this Technical Specification( see 6.2.2.2).
 

Top management should ensure the establishment of an effective and efficient internal audit process to assess the strengths and weaknesses of the quality management system. The internal audit process acts as a management tool for independent assessment of any designated process or activity. The internal audit process provides an independent tool for use in obtaining objective evidence that the existing requirements are fulfilled, since the internal audit evaluates the effectiveness of the organization.

It is important that management ensure improvement actions are taken in response to internal audit results. Planning for internal audits should be flexible in order to permit changes in emphasis based on findings and objective evidence obtained during the audit. Relevant input from the area to be audited, as well as from other interested parties, should be considered in the development of internal audit plans.

Examples of subjects for consideration by internal auditing include

8.2.3 Monitoring and measurement of processes

The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality management processes. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate, to ensure conformity of the product.
 

8.2.3.1 Monitoring and measurement of manufacturing processes

The organization shall perform process studies on all new manufacturing (including assembly or sequencing) processes to verify process capability and to provide additional input for process control. The results of process studies shall be documented with specifications, where applicable, for means of production, measurement and test, and maintenance instructions. These documents shall include objectives for manufacturing process capability, reliability, maintainability and availability, as well as acceptance criteria.

The organization shall maintain manufacturing process capability or performance as specified by the customer part approval process requirements. The organization shall ensure that the control plan and process flow diagram are implemented, including adherence to the specified

ï measurement techniques,
ï sampling plans,
ï acceptance criteria, and
ï reaction plans when acceptance criteria are not met.

The organization shall initiate a reaction plan from the control plan for characteristics that are either not statistically capable or are unstable. These reaction plans shall include containment of product and 100 % inspection as appropriate. A corrective action plan shall then be completed by the organization, indicating specific timing and assigned responsibilities to assure that the process becomes stable and capable. The plans shall be reviewed with and approved by the customer when so required.

 The organization shall maintain records of effective dates of process changes.
 

The organization should identify measurement methods and should perform measurements to evaluate process performance. The organization should incorporate these measurements into processes and use the measurements in process management.

Measurements should be used for managing daily operations, for evaluation of the processes that may be suitable for small-step or ongoing continual improvements, as well as for breakthrough projects, according to the vision and strategic objectives of the organization.

Measurements of process performance should cover the needs and expectations of interested parties in a balanced manner. Examples include

The organization shall measure and monitor the characteristics of the product to verify that product requirements are fulfilled. This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 7.1).

Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the person(s) authorizing release of product.

Product release and service delivery shall not proceed until all the planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by relevant authority, and where applicable by the customer.

NOTE When selecting product parameters to monitor compliance to specified internal and external requirements, the organization determines the types of product characteristics, leading to

ï the types of measurement,
ï suitable measurement means, and
ï the capability and skills required.

8.2.4.1 Layout inspection and functional testing

A layout inspection and a functional verification to applicable customer engineering material and performance standards shall be performed for each product as specified in the control plans. Results shall be available for customer review.

NOTE Layout inspection is the complete measurement of all product dimensions shown on the design records.
 

8.2.4.2 Appearance items

For organizations manufacturing parts designated by the customer as ìappearance itemsî, the organization shall provide

ï appropriate resources including lighting for evaluation,
ï masters for colour, grain, gloss, metallic brilliance, texture, distinctness of image (DOI), as appropriate,
ï maintenance and control of appearance masters and evaluation equipment, and
ï verification that personnel making appearance evaluations are competent and qualified to do so.

When selecting measurement methods for ensuring that products conform to requirements and when considering customer needs and expectations, the organization should consider the following:

The organization shall ensure that product which does not conform to requirements is identified and controlled to prevent unintended use or delivery. The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure.

The organization shall deal with nonconforming product by one or more of the following ways:

When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements.

When nonconforming product is detected after delivery or use has started, the organization shall take action appropriate to the effects, or potential effects, of the nonconformity.
 

8.3.1 Control of nonconforming product ó Supplemental

Product with unidentified or suspect status shall be classified as nonconforming product (see 7.5.3).
 

8.3.2 Control of reworked product

Instructions for rework, including re-inspection requirements, shall be accessible to and utilized by the appropriate personnel.
 

8.3.3 Customer information

Customers shall be informed promptly in the event that nonconforming product has been shipped.
 

8.3.4 Customer waiver

The organization shall obtain a customer concession or deviation permit prior to further processing whenever the product or manufacturing process is different from that which is currently approved.

The organization shall maintain a record of the expiration date or quantity authorized. The organization shall also ensure compliance with the original or superseding specifications and requirements when the authorization expires.

Material shipped on an authorization shall be properly identified on each shipping container.

This applies equally to purchased product. The organization shall agree with any requests from suppliers before submission to the customer.
 

Top management should empower people in the organization with the authority and responsibility to report nonconformities at any stage of a process in order to ensure timely detection and disposition of nonconformities. Authority for response to nonconformities should be defined to maintain achievement of process and product requirements. The organization should effectively and efficiently control nonconforming product identification, segregation and disposition in order to prevent misuse.

Where practical, nonconformities should be recorded, together with their disposition, to assist learning and to provide data for analysis and improvement activities. The organization may also decide that nonconformities to both product realization and support processes should be recorded and controlled.

The organization can also consider recording information on those nonconformities that are corrected in the normal course of the work. Such data can provide valuable information for improving the effectiveness and efficiency of processes.
 

Nonconformity review and disposition

The management of the organization should ensure the establishment of an effective and efficient process to provide for review and disposition of identified nonconformities. Review of nonconformities should be conducted by authorized people to determine if any trends or patterns of occurrence require attention. Negative trends should be considered for improvement, and as input to management review where reduction goals and resource needs are considered.

People carrying out the review should have the competence to evaluate the total effects of the nonconformity and should have the authority and resources to disposition the nonconformity and to define appropriate corrective action. Acceptance of nonconformity disposition may be a contractual requirement of the customer, or a requirement of other interested parties.
 
 

The organization shall determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvements of the quality management system can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources.

The organization shall analyze this data to provide information on:

ï development of priorities for prompt solutions to customer-related problems;
ï determination of key customer-related trends and correlation for status review, decision-making and longer
term planning;
ï an information system for the timely reporting of product information arising from usage.

Decisions should be based on analysis of data obtained from measurements and information collected as described in the International Standard. In this context, the organization should analyze data from its various sources to assess performance against plans, objectives and other defined goals, and to identify areas for improvement including possible benefits for interested parties.

Decisions based on facts require effective and efficient actions such as

For an effective evaluation by management of the total performance of the organization, data and information from all parts of the organization should be integrated and analyzed. The organization's overall performance should be presented in a format that is suitable for different levels of the organization. The results of this analysis can be used by the organization to determine

8.5.1 Planning for continual improvement

The organization shall plan and manage the processes necessary for the continual improvement of the quality management system.

The organization shall facilitate the continual improvement of the quality management system through the use of the quality policy, objectives, audit results, analysis of data, corrective and preventive action and management review.
 

8.5.1.1 Continual improvement of the organization

The organization shall define a process for continual improvement (see examples in annex B of ISO 9004:2000).
 

8.5.1.2 Manufacturing process improvement

Manufacturing process improvement shall continually focus upon control and reduction of variation in product
characteristics and manufacturing process parameters.

NOTE 1 Controlled characteristics are documented in the control plan.

NOTE 2 Continual improvement is implemented once manufacturing processes are capable and stable, or product characteristics are predictable and meet customer requirements.
 

Management should continually seek to improve the effectiveness and efficiency of the processes of the organization, rather than wait for a problem to reveal opportunities for improvement. Improvements can range from small-step ongoing continual improvement to strategic breakthrough improvement projects. The organization should have a process in place to identify and manage improvement activities. These improvements may result in change to the product or processes and even to the quality management system or to the organization.
 

Continual improvement of the organization

To ensure the future of the organization and the satisfaction of interested parties, management should create a culture, which involves people actively seeking opportunities for improvement of performance in processes, activities and products.

To involve people, top management should create an environment where authority is delegated so that people are empowered and accept responsibility to identify opportunities where the organization can improve its performance. This can be achieved by activities such as

Management should support improvements in the form of small-step ongoing activities integral to existing processes as well as breakthrough opportunities, in order to gain maximum benefit for the organization and interested parties.

Examples of inputs to support the improvement process include information derived from

8.5.2 Corrective action

The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence. Corrective actions shall be appropriate to the effects of the nonconformities encountered.

A documented procedure shall be established to define requirements for:

8.5.2.1 Problem solving

The organization shall have a defined process for problem solving leading to root cause identification and elimination.  If a customer-prescribed problem-solving format exists, the organization shall use the prescribed format.
 

8.5.2.2 Error-proofing

The organization shall use error-proofing methods in their corrective action process.
 

8.5.2.3 Corrective action impact

The organization shall apply to other similar processes and products the corrective action, and controls implemented, to eliminate the cause of a nonconformity.
 

8.5.2.4 Rejected product test/analysis

The organization shall analyse parts rejected by the customer's manufacturing plants, engineering facilities and dealerships. The organization shall minimize the cycle time of this process. Records of these analyses shall be kept and made available upon request. The organization shall perform analysis and initiate corrective action to prevent recurrence.

NOTE Cycle time related to rejected product analysis should be consistent with the determination of root cause, corrective action and monitoring the effectiveness of implementation.
 

Top management should ensure that corrective action is used as a tool for improvement. Corrective action planning should include evaluation of the significance of problems, and should be in terms of the potential impact on such aspects as operating costs, costs of nonconformity, product performance, dependability and the safety and satisfaction of customers and other interested parties. People from appropriate disciplines should participate in the corrective action process. Also, the effectiveness and efficiency of processes should be emphasized when actions are taken and the actions should be monitored to ensure that desired goals are met. Corrective actions should be considered for inclusion in management review.

In pursuing corrective action, the organization should identify sources of information, and collect information to define the necessary corrective actions. The defined corrective action should be focused on eliminating causes of nonconformities in order to avoid recurrence. Examples of sources of information for corrective action consideration include

In evaluating the need for actions to ensure that nonconformities do not recur, the organization should consider providing appropriate training for people assigned to corrective action projects.

The organization should incorporate root-cause analysis, as appropriate, into the corrective action process. Root-cause analysis results should be verified by testing prior to defining and initiating corrective action.
 
 

8.5.3 Preventive action

The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions taken shall be appropriate to the effects of the potential problems.

A documented procedure shall be established to define requirements for:

Appropriate organizational representatives should participate in the preventive actions.

Your organization should identify sources of information for planning and prioritizing preventive actions.

Examples of sources are:

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