CLASS OVERVIEW:

This online training class will provide you training and familiarization on ISO 9001:2000 standard. It uses excerpts of the standards ISO 9001:2000 (Dark blue) and provides guidance using ISO 9004:2000 and ISO 9000:2000. Each training slide is followed by a quiz.  After reading the content of the slide press the "Quiz" button to take the quiz on that slide and proceed further into the training. You can consult the training slides by using the "Previous" button or using your browser "Back" button. The structure of the class is as follows:

QUALITY MANAGEMENT SYSTEMS
 

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".
 

0.3 Relationship 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.
 
 

0.4 Compatibility with other management systems

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

This International Standard 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.
 
 

Relationship between the ISO family of Standards: (ISO 9000:2000 0.1)
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

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.

Within clause 7 ("Product realization"), the following are the most likely requirements (though not the only ones) that could be considered as not being applicable in certain circumstances:
 

• where the organization has no responsibility for the design and development of the products it provides.

• this clause would only be partially applicable where there is no specific traceability requirement for the organization's products

• where the organization uses no customer property in its product or product realization processes. Note that if the customer provides a proprietary design for the product, this may constitute intellectual property and must be covered by the organization's QMS.

7.6  ("Control of monitoring and measuring devices")

• where the organization needs no monitoring or measuring devices to provide evidence of conformity of its product. This may be the case for some service organizations, among others.

a) Due to the nature of the organization's product: A law firm has implemented a QMS based on ISO 9001:2000. The QMS includes the design and development of new services such as tax planning, as well as changes to the design of existing services to take advantage of electronic databases of applicable legislation. The firm also designs and develops customised services to meet specific customer requirements. Purchasing control includes the selection of computer hardware and software, as well as the subcontracting of specialist lawyers as needed. The only exclusion to ISO 9001:2000  (justified in the Quality Manual) relates to Clause 7.6 ("Control of measuring and monitoring devices"), since this specific law firm does not use measuring or monitoring devices in carrying out its business realization processes.

b) Due to customer requirements: "Design and development (7.3)" can be excluded if the customer is the one to always provide the design of the product. (I.e. a General Contractor will always use the building design provided by the customer through his architect). A General Contractor can thus exclude the requirement of 7.3 and claim the exclusion is his Quality Manual.

c) 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 aircraft engine repair facility is not allowed by Aviation Regulation 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)
 
 

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.
 
 

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.

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:

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.
 
 

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

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.
 
 

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.
 
 

5.5.2 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.
 

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.
 

5.6.2 Review input

The input to management review shall include information on

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:

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 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.

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.
 
 

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.
 

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.

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.
 

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
 

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.
 
 

7.3.2 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.

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.
 

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).
 

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).
 

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).
 

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).
 

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.
The organization shall ensure the adequacy of specified requirements prior or their communication to the supplier.
 

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.
 
 

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.

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