Definitions

Definitions

ISOReady provides services for the following quality management system requirements and regulations:

  • ISO 9001:2000
  • AS 9100 Rev. B- SAE
  • ISO 13485
  • ISO 14001:2004
  • ISO/TS 16949
  • OHSAS:18001
  • TL 9000 Version 3.5
  • CMDCAS Regulations
  • GMP Regulations
  • HACCP Regulations
  • ISO 22000 Food Safety Management Systems

ISO 9001:2000

ISO 9001:2000 is an international standard designed to provide companies and organizations with a common approach to applying a Quality Management System. Over 130 countries have adopted the standard since its inception in 1987. It also forms the base requirements for many other standards, including ISO 13485, AS-9100, TL 9000 and the recently released ISO/Technical Standard 16949.

There are 8 sections, which describe the intent and the requirements in the 2000 version. Within sections 4 through 8, there are a total of 136 "SHALL" statements.

The standard was reorganized from the 1994 version to more closely align with the Environmental Management System ISO 14001, OHSAS 18001 and the US Malcolm Baldrige Criteria.

Industry Specific Standards: There are a number of industry specific standards that apply the ISO 9001 standard to a specific industry such as Medical devices or automobiles. These standards all have ISO 9001 at their core and add additional requirements for the specific industry.

AS 9100 Rev. B- SAE

AS9100 is the quality system requirements for suppliers to the aerospace industry issued August of 2001. It was developed in the United States as AS 9000 in 1997, expanded to address international aerospace requirements and is now approved by aerospace companies in Asia and Europe as well.

The Standard has approximately 80 additional requirements plus other requirements and 18 amplifications of the ISO 9001:2000 Standard.

This book of requirements was developed by the International Aerospace Quality Group (IAQG) and is technically equivalent to AECMA prEN 9100 for European aerospace suppliers.

ISO 13485

ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes is an international standard designed to provide medical device suppliers with a common approach to applying a Quality Management System that addresses most FDA requirements. The ISO 13485:2003 standard is based on the ISO 9001:2000 standard (and includes the old ISO 13488). With the introduction of the new standard in 2003, those companies utilizing the 1996 standard have until July 15, 2006 to make the transition. At present the US FDA document 21CFR820 is still aligned with the old standard.

The main change is that there are 8 sections in the new standard, which describe the intent and the requirements biased on a process approach. As opposed to the 20 elements in the 1996 version; another change is that the ISO 9001 standard has, with a few exceptions*, been incorporated into the new standard.

*Unlike ISO 9001:2000 Continuous Improvement and Customer Satisfaction are not as stressed in ISO 13485 instead more emphasis is placed on regulatory requirements.

ISO 14001:2004

The ISO 14000 series of standards that includes ISO 14001 Environmental Management Systems (EMS) grew out of the international success of the ISO 9000 series of Standards and the emergence of excessive country and regional standards for managing the environment. ISO and IEC formed the Strategic Advisory Group for the Environment (SAGE) in 1991. ISO created Technical Committee TC 207 to develop the 14000 series of standards. Currently there are over 20 14000 series Standards. Organizations self certify or register to only the ISO 14001 Standard. The others are used for guidance, specifications and evaluation.

There are six (6) primary sections that classify the requirements in ISO 14001-2004 version. Within these six sections of the Standard are the specific requirements that an organization must apply to implement an EMS. Within the six sections there are a total of 52 so called "shall" statement requirements.

ISO/TS 16949

ISO/TS 16949 Quality systems — Automotive suppliers- It is the international equivalent of QS-9000, when coupled with customer-specific requirements. It combines the standards, but does not replace, of the USA (QS-9000), French (EAQF), German (VDA6.1) and Italian (AVSQ) automobile makers Quality Systems into one unified and equally recognized document. The intended customers for TS 16949 are the automotive production and service part organizations.

OHSAS:18001

The OHSAS 18000 series of standards that includes OHSAS 18001 Occupational Health and Safety Management Systems (OHSMS) grew out of the international success of the ISO 9000 and ISO 14000 series of Standards and the need for managing safety in the work environment. This Standard was created from the British Standard for Occupational Health and Safety Management Systems BS 8800:1996.

In addition to the OHSAS 18001 Occupational Health and Safety Management Specifications there is a guidance document in this series known as OHSAS 18002:2000 Occupational Health and Safety Management Systems Guidelines for the implementation of OHSAS 18001. Organizations self certify or register to only the OHSAS 18001 Standard.

There are six (6) primary sections that classify the requirements in OHSAS 18001. Within these six sections of the Standard are the specific requirements that an organization must apply to implement an OHSMS. The Standard tracks very closely with the ISO 14001 Standard and is designed to integrate with both the ISO 9001 and ISO 14001 managment systems. Many sub-clauses are very similar, such as management review, document control, and corrective and preventive action.

Also see our ILO-OSH 2001 (International Labour Organization) Guidelines on occupational safety and health management systems page.

Intent: The OHSAS 18001 system is geared towards reducing and preventing accidents and accident-related loss of lives, time and resources.

Applicability: OHSAS 18001 can be applied to any type of business, organization or industry that wishes to manage its risks for Health & Safety in the work place.

TL 9000 Version 3.5

TL 9000 was created by QuEST (Quality Excellence for Suppliers of Telecommunications) Forum. QuEST has over 100 members from the telecommunications industry — service providers, suppliers (hardware, software and service), registrars, etc.

TL 9000 is a two book standard based on ISO 9001: Book One is TL 9000 Quality System Requirements; and, Book Two is TL 9000 Quality System Metrics.

TL 9000 has all the requirements from ISO 9001:2000 plus additional requirements to address industry specific needs. TL 9000 additional requirements are coded in Book One as follows and must be addressed based on your registration scope: C — Common, H — Hardware, S — Software, V — Services, HS — Hardware and Software, HV — Hardware and Services and VS — Services and Software.

Metrics must be determined based on registration scope and agreement with selected registrar. Prior to registration, three months of metric data must be sent to University of Texas — Dallas (UTD) who is the Metrics Administrator and supplier must have a letter stating this from the Forum Administrator who is American Society for Quality (ASQ).

A recognized accreditation body and the QuEST Forum must sanction selected registrar.

Migration paths are available from ISO 9001, QS-9000 and CSQP (Bellcore Customer/Supplier Process).

Intent: The intent is to apply a consistent set of quality system requirements and metrics that will help provide telecommunications users with faster, better and more cost-effective services.

Applicability: QuEST estimates over 10,000 suppliers to the telecommunications industry that could be affected by TL 9000.

CMDCAS Regulations

Under the quality system requirements of the Medical Devices Regulations, manufacturers of Class II medical devices must have their devices manufactured in accordance with the National Standard of Canada CAN/CSA-ISO 13488-98, Quality Systems — Medical devices — Particular requirements for the application of ISO 9002, as amended from time to time.

Manufacturers of Classes III and IV medical devices must have their devices designed and manufactured in accordance with the National Standard of Canada CAN/CSA-ISO 13485-98, Quality systems — Medical devices — Particular requirements for the application of ISO 9001, as amended from time to time.

As currently written, the quality system requirements state that a senior official of the manufacturer must submit, with their application for a medical device license, a written attestation that their device is in compliance with the applicable above-mentioned standard. The Medical Devices Regulations further require that the attestation be based on an audit by an organization that performs quality system audits. Presently, the quality system requirements do not apply to those manufacturers who will have device licenses prior to January 1, 2003.

GMP Regulations

GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act (See Chapter IV for food, and Chapter V, Subchapters A, B, C, D, and E for drugs and devices.) These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective.

GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. This in turn, protects the consumer from purchasing a product which is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time.

GMP regulations address issues including recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls. This provides much flexibility, but also requires that the manufacturer interpret the requirements in a manner which makes sense for each individual business.

HACCP Regulations

Hazard Analysis and Critical Control Point (HACCP) is a systematic approach to identifying and controlling hazards (microbiological, chemical or physical) that pose a danger to the preparation of safe food. HACCP seeks to control the safety of ingredients and supplies coming into a food business and what is done with them thereafter. The implementation of HACCP is a legal requirement for many American and most European food companies.

ISO 22000 Food Safety Management Systems

These are requirements for any organization in the food chain. This standard is aligned with the ISO 9001 and ISO 14001 standards and is an auditable standard for those organizations that are part of the food chain. It is based on the proven principles of food safety risk management (HACCP, Hazard Analysis and Critical Control Point System) and follows the popular Plan - Do - Check - Act model.

There are five (5) primary sections that classify the requirements, within these sections are the specific requirements that an organization must apply to implement the Food Management System (FMS).

They are:
  • Food Management System - General
  • Management Responsibility
  • Resource Management
  • Planning and realization of safe products
  • Validation, verification and improvement of the food safety management system
In addition to the above sections that contain the requirements the standard has additional guidance annexes:
  • Cross reference between ISO 22000:2005 and ISO 9001:2000
  • Cross reference between HACCP and ISO 22000:2005
  • Codex Reference with examples

Intent: The intent of the standard is to be a global used food management system that is applicable to all parts of the food chain. Like ISO 9001, it is a voluntary standard. It incorporates many of the elements of the ISO 15161 — Guidelines On The Application Of ISO 9001:2000 For The Food And Drink Industry but is intended to be auditable. Because of this the standard is more prescriptive than ISO 15161.