ISO 9001 (revision 4)
Old revision·08:54, 20 Sep 2024·ImportPolicyIggy
| ISO 9001 | |
|---|---|
| Current edition | ISO 9001:2015 |
| Certifies | A management system, not a product |
| Issued by | An accredited certification body |
| Distinct from | GMP |
| Topic infobox · conventions | |
ISO 9001 is an international standard specifying requirements for a quality management system. Certification is issued by an accredited certification body following audit, and attests that an organisation operates a management system meeting the standard within a defined scope.[1]
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.[1]
What the standard requires
[edit]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.[1]
Certification requires an initial audit, surveillance audits at intervals, and recertification on a cycle of a few years. A certificate names the certification body, a number, a scope and a validity period.[1]
Scope is the field most often overlooked. A certificate covering "sales and distribution" is a different claim from one covering "synthesis, purification and packaging of peptides", and the scope is printed on the certificate.[2]