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ISO 9000, 14000, 13485, 16949, AS 9100, GMP Certification

ISO 9000: ISO 9000 actually refers to a family of standards: ISO 9000 (contains vocabulary and definitions), ISO 9001 (contains the actual requirements that an organization has to comply with to become certified), and ISO 9004 (contains guidelines on how to improve a quality management system). ISO 9000 is a standard for quality management and sets requirements for all aspect of the operation of an organization (Sales, Purchasing, Manufacturing, service delivery, etc...). Areas that are not covered specifically by this standard are: accounting, finance and personnel. Human resources such as hiring and training are covered though. The purpose of this standard is to ensure that your organization will consistently provide products or services that meet customer and applicable regulatory requirements, and that your organization will enhance customer satisfaction by being effective in your operation and continually improving them. Once you implement processes and procedures that comply with the requirements listed in the ISO 9001 document, you can be audited by a third party organization called Registrar such as TUV or UL who will certify your organization to this standard. ISO 9001 is generic and is applicable to all types of organizations: manufacturers, service providers, non-profit organizations, software etc... To achieve compliance, you can train employees who will drive the implementation internally, and/or use a consulting firm that can assist in the training and implementation. Providing training on the basis of the standards for key players in your organization so that they can understand what it entails, is a good starting point. ISO 9000 Course or ISO 9000 & Auditor Course would be good courses to take.

ISO 14000: ISO 14000 refers to a family of standards: ISO 14000 (contains vocabulary and definitions), ISO 14001 (contains the actual requirements that an organization has to comply with to become certified), and ISO 14004 (contains guidelines on development and implementation of environmental management systems and principles). ISO 14000 is a standard for environmental management and sets requirements for implementing, maintaining and improving an environmental management system and ensuring compliance with environmental laws and regulations. Once you implement processes and procedures that comply with the requirements listed in the ISO 14001 document, you can be audited by a third party organization called Registrar such as TUV or UL who will certify your organization to this standard. ISO 14001 is generic and is applicable to those environmental aspects (water discharge, exhaust fumes, recycling, etc..) which and organization has control and over which it can be expected to have an influence. To achieve compliance, you can train employees who will drive the implementation internally, and/or use a consulting firm that can assist in the training and implementation. Providing training on the basis of the standards for key players (usually in the production and maintenance areas) in your organization so that they can understand what it entails, is a good starting point. ISO 14000 Course or ISO 14000 Auditor Course would be good courses to take.

ISO 13485: ISO 13485:2003 (Medical devices - Quality management systems - Requirements for regulatory purposes) is essentially ISO 9001 adapted to meet the requirements of the medical device industry and it addresses most FDA requirements (21CFR820). The main difference between ISO 9001 and ISO 13485 is that ISO 13485 is more focused towards ensuring medical device safety and efficacy rather than enhancing customer satisfaction and continual improvement. Once you implement processes and procedures that comply with the requirements listed in ISO 13485:2003, you can be audited by a third party organization called Registrar such as TUV or UL who will certify your organization to this standard. It will also meet most of the FDA requirements to have a Quality System in compliance with the QSRs set forth by 21CFR820. To achieve compliance, you can train employees who will drive the implementation internally, and/or use a consulting firm that can assist in the training and implementation. Providing training on the basis of the standard and the FDA's current Good manufacturing Practice (cGMP) for key players (QC personnel, QA personnel, RA personnel, engineering staff, p[production personnel) in your organization so that they can understand what it entails, is a good starting point. ISO 13485:2003 Course ,ISO 13485:2003 Auditor Course or cGMP for Medical Device Course would be good courses to take.

ISO/TS 16949: ISO/TS 16949 is a technical specification which forms the requirements or the application of ISO 9001 for automotive production and relevant service part organizations. It is required by the large automotive industry manufacturers such as Ford (12/14/2006 deadline), GM (12/14/2006 deadline) and DaimlerChrysler (7/1/2004 deadline) and others. It is essentially ISO 9001 with additional automotive specific requirements. Once you implement processes and procedures that comply with the requirements listed in ISO/TS 16949, you can be audited by a third party organization called Registrar such as TUV or UL who will certify your organization to this standard. ISO/TS 16949 is applicable to all suppliers of products and services for the automotive industry. To achieve compliance, you can train employees who will drive the implementation internally, or use a consulting firm that can assist in the training and implementation. Providing training on the basis of the standards for key players (QA and QC personnel) in your organization so that they can understand what it entails, is a good starting point. ISO/TS 16949 Course or ISO/TS 16949 Auditor Course would be good courses to take.

AS 9100: SAE AS9100 is the revised standard available for use across the global aerospace community. It adds the additional requirements necessary to address both civil and military aviation and aerospace needs. It is now an internationally recognized aerospace standard for quality assurance in design, development, production, installation and servicing. It succeeds the AS9000 standard and is the first single standard accepted by and available for use across the global aerospace community. The current version is the accepted standard and includes the ISO 9001 standard verbatim with supplemental requirements for the Aerospace Industry. Areas that are not covered specifically by this standard are: accounting, finance and personnel. Human resources such as hiring and training are covered though. To achieve compliance, you can train employees who will drive the implementation internally, and/or use a consulting firm that can assist in the training and implementation.

TL 9000: TL 9000 is a standard which forms the requirements or the application of ISO 9001 for the telecommunications industry. It is essentially ISO 9001 with additional telecom specific requirements for Hardware, Software, and Service suppliers. Once you implement processes and procedures that comply with the requirements of TL 9000, you need to benchmark your performance using telecom industry metrics and collect sufficient data before you can be audited by a third party organization called Registrar such as TUV or UL who will certify your organization to this standard. To achieve compliance, you can train employees who will drive the implementation internally, or use a consulting firm that can assist in the training and implementation.

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cGMP: cGMP refers to the FDA's "current Good Manufacturing Practice". There are different GMPs for the various industries regulated by the FDA. i.e. Medical Device, Human Food, and Pharmaceuticals. The cGMP for medical devices is a set of quality system requirement very similar to the previous 1994 version of ISO 9000. The cGMP for Pharmaceuticals or Human Food set regulations, which have the force of law and require that manufacturers, processors, and packagers take proactive steps to ensure that their products are safe, and effective. Failure of firms to comply with GMP regulations is a federal offence and can result in recall, seizure, fines, and jail time. You are required to implement processes and procedures that comply with the requirements listed in the applicable cGMP before you can release your product, you can be audited by FDA inspectors at anytime. organization called Registrar such as TUV or UL who will certify your organization to this standard. To achieve compliance, you need to train employees who will drive the implementation internally, and/or use a consulting firm that can assist in the training and implementation. Providing training on the basis of the GMP for key players (in all areas of the organization that can have an impact on product safety and efficacy) in your organization so that they can understand what it entails, is a good starting point. GMP for Medical Devices ,GMP for Human Food or GMP for Pharmaceuticals would be good courses to take.

OHSAS 18000: OHSAS 18000 refers to a series of standards for Occupational Health and Safety Management Systems. OHSAS 18001 sets requirement on occupational and health safety for employees. In addition to the OHSAS 18001 Occupational Health and Safety Management Specifications there is a guidance document known as OHSAS 18002:2000 Occupational Health and Safety Management Systems Guidelines for the implementation of OHSAS 18001. Once you implement processes and procedures that comply with the requirements listed in the OHSAS 18001 document, you can be audited by a third party organization called Registrar such as TUV or UL who will certify your organization to this standard. OHSAS 18001 is generic and is applicable to types of organizations. It can also be integrated with ISO 9000 and ISO 14000 seamlessly. To achieve compliance you can train employees who will drive the implementation internally, or use a consulting firm that can assist in the training and implementation. You can use templates to implement your occupational health and safety program which will meet US OSHA requirements using OHSAS 18001 template kit.

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