ISO 9001 standard specifies the requirements for a Quality Management System, irrespective of the industry. For a product development organization/unit, we need to have proper planning, requirement analysis, design and implementation, followed by verification and validation activities. It means that for a product development organization/unit, majority of the ISO 9001 clauses would be applicable. Now what happens in case of a non-product development organization/unit? This article summarises the critical requirements/points to be ensured in such a case.

  1. Quality policy and Manual
  2. Organizational Structure
  3. Roles, responsibilities and authorities of the personnel defined and communicated

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