ISO 9001: difference between revisions
Diff·revision 20 → 21·16:43, 19 Sep 2025
Difference between revision 20 and revision 21 of ISO 9001. 3 lines changed; the page grew by 380 bytes.
| Revision 20 — 11:09, 18 Aug 2025 Compounding_Cate (talk) expand §What the standard requires 3,898 bytes ±0 | Revision 21 — 16:43, 19 Sep 2025 Compounding_Cate (talk) fix a dangling clause 4,278 bytes +380 | ||
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| 38 | Directly, it implies nothing about any particular lot. A certified organisation can ship a defective lot, and an uncertified one can ship excellent material; certification bears on the probability of the former, not on the fact of it. | 38 | Directly, it implies nothing about any particular lot. A certified organisation can ship a defective lot, and an uncertified one can ship excellent material; certification bears on the probability of the former, not on the fact of it. |
| 39 | 39 | ||
| + | 40 | For a purchaser the practical position is that ISO 9001 is a real and verifiable claim about an organisation, and that it answers a different question from the one a [[Certificate of analysis|certificate of analysis]] answers.{{r|usp1503}} | |
| + | 41 | ||
| 40 | == References == | 42 | == References == |
| 41 | {{reflist}} | 43 | {{reflist}} |
| ⋮ | ⋮ | ||
| 43 | <ref name="ich_q7">International Council for Harmonisation, ''Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients'' (2000).</ref> | 45 | <ref name="ich_q7">International Council for Harmonisation, ''Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients'' (2000).</ref> |
| 44 | <ref name="reports">PeptidePedia Wiki community test-report tally, 2024–2026 (self-reported; see [[Project:Sourcing_guidelines]]).</ref> | 46 | <ref name="reports">PeptidePedia Wiki community test-report tally, 2024–2026 (self-reported; see [[Project:Sourcing_guidelines]]).</ref> |
| + | 47 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | |
| 45 | 48 | ||
| 46 | == See also == | 49 | == See also == |