Quality Management Systems — Requirements
Specifies requirements for a quality management system for organisations that need to demonstrate the ability to consistently provide products and services that meet customer and applicable statutory/regulatory requirements.
Any organisation regardless of size, type, or product. In pharmaceutical context, ISO 9001 is the baseline QMS framework upon which ICH Q10 pharmaceutical-specific requirements are built.
- 01Context of the organisation — internal and external issues, interested parties
- 02Risk-based thinking — identification and treatment of risks throughout QMS
- 03Process approach — understanding and management of interrelated processes
- 04PDCA cycle — continual improvement through plan-do-check-act
- 05Performance evaluation — internal audit, management review, KPIs
2015 revision was last major update. Introduced risk-based thinking and context of the organisation. Replaces ISO 9001:2008.
ISO 9001:2015: frequently asked questions
Quick answers to common questions about ISO 9001:2015.
What is ISO 9001:2015?
ISO 9001:2015 — Quality Management Systems — Requirements — is a standard issued by the International Organization for Standardization. Specifies requirements for a quality management system for organisations that need to demonstrate the ability to consistently provide products and services that meet customer and applicable statutory/regulatory requirements.
Who does ISO 9001:2015 apply to?
Any organisation regardless of size, type, or product. In pharmaceutical context, ISO 9001 is the baseline QMS framework upon which ICH Q10 pharmaceutical-specific requirements are built.
What are the key requirements of ISO 9001:2015?
ISO 9001:2015 requires, among other things: Context of the organisation — internal and external issues, interested parties; Risk-based thinking — identification and treatment of risks throughout QMS; Process approach — understanding and management of interrelated processes; PDCA cycle — continual improvement through plan-do-check-act.
When was ISO 9001:2015 last updated?
The current version of ISO 9001:2015 dates from September 2015. 2015 revision was last major update. Introduced risk-based thinking and context of the organisation. Replaces ISO 9001:2008.
Live openFDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
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