ISO 9001:2008 Quality Management Systems Requirements

ISO 9001:2008 Quality Management Systems Requirements

ISO 9001:2008 Quality Management Systems Requirements

ISO 9001:2008 Quality Management Systems Requirements where an organizationneeds to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, andaims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

All requirements of ISO 9001:2008 Quality Management Systems Requirements are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.

Where any requirement(s) of ISO 9001:2008 Quality Management Systems Requirements 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 ISO 9001:2008 Quality Management Systems Requirements 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 statutory and regulatory requirements.

Contents of ISO 9001:2008 Quality Management Systems Requirements — Requirements is a document of approximately 30 pages which is available from the national standards organization in each country.

Outline contents are as follows:

  • Page iv: Foreword
  • Pages v to vii: Section 0 Intro
  • Pages 1 to 14: Requirements
  • Section 1: Scope
  • Section 2: Normative Reference
  • Section 3: Terms and definitions (specific to ISO 9001, not specified in ISO 9000)
  • Pages 2 to 14 132 1
  • Section 4: Quality Management System
  • Section 5: Management Responsibility
  • Section 6: Resource Management
  • Section 7: Product Realization
  • Section 8: Measurement, analysis and improvement

In effect, users need to address all sections 1 to 8, but only 4 to 8 need implementing within a QMS. ISO 9001:2008 Quality Management Systems Requirements

  • Pages 15 to 22: Tables of Correspondence between ISO 9001 and other standards
  • Page 23: Bibliography

The standard specifies six compulsory documents:

  • Control of Documents (4.2.3)
  • Control of Records (4.2.4)
  • Internal Audits (8.2.2)
  • Control of Nonconforming Product / Service (8.3)
  • Corrective Action (8.5.2)
  • Preventive Action (8.5.3)

ISO 9001:2008 Quality Management Systems Requirements


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