ISO 9001: difference between revisions
Diff·revision 4 → 5·12:07, 1 Oct 2024
Difference between revision 4 and revision 5 of ISO 9001. 3 lines changed; the page grew by 450 bytes.
| Revision 4 — 08:54, 20 Sep 2024 ImportPolicyIggy (talk) add the jurisdiction to the legal statement 1,967 bytes +380 | Revision 5 — 12:07, 1 Oct 2024 LiraLotte (talk) clarify that personal importation and commercial importation are different questions 2,417 bytes +450 | ||
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| 11 | It certifies a system, not a product. An ISO 9001 certificate says nothing directly about the identity, purity or content of any material an organisation ships, and it is not a substitute for a product specification or a [[Certificate of analysis|certificate of analysis]].{{r|iso9001}} | 11 | It certifies a system, not a product. An ISO 9001 certificate says nothing directly about the identity, purity or content of any material an organisation ships, and it is not a substitute for a product specification or a [[Certificate of analysis|certificate of analysis]].{{r|iso9001}} |
| 12 | 12 | ||
| + | 13 | It is also distinct from [[Good manufacturing practice|good manufacturing practice]]. GMP is a regulatory framework enforced by medicines regulators through inspection; ISO 9001 is a voluntary standard certified commercially. Both can be genuine and they establish different things.{{r|ich_q7}} | |
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| 13 | == What the standard requires == | 15 | == What the standard requires == |
| 14 | The 2015 edition is built around context of the organisation, leadership, planning, support, operation, performance evaluation and improvement. Its central mechanisms are documented processes, risk-based thinking, defined responsibilities, internal audit and management review.{{r|iso9001}} | 16 | The 2015 edition is built around context of the organisation, leadership, planning, support, operation, performance evaluation and improvement. Its central mechanisms are documented processes, risk-based thinking, defined responsibilities, internal audit and management review.{{r|iso9001}} |
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| 21 | {{reflist}} | 23 | {{reflist}} |
| 22 | <ref name="iso9001">ISO 9001:2015, ''Quality management systems — Requirements''.</ref> | 24 | <ref name="iso9001">ISO 9001:2015, ''Quality management systems — Requirements''.</ref> |
| + | 25 | <ref name="ich_q7">International Council for Harmonisation, ''Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients'' (2000).</ref> | |
| 23 | <ref name="reports">PeptidePedia Wiki community test-report tally, 2024–2026 (self-reported; see [[Project:Sourcing_guidelines]]).</ref> | 26 | <ref name="reports">PeptidePedia Wiki community test-report tally, 2024–2026 (self-reported; see [[Project:Sourcing_guidelines]]).</ref> |
| 24 | 27 |