Source of ISO 9001

{{Infobox concept | name = ISO 9001 | subtitle = Management-system standard | Current edition = ISO 9001:2015 | Certifies = A management system, not a product | Issued by = An accredited certification body | Distinct from = [[Good manufacturing practice|GMP]] }} '''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.{{r|iso9001}} 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}} 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}} == What the standard requires == 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}} 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.{{r|iso9001}} 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.{{r|reports}} == How a claim becomes checkable == | Element of a claim | Why it matters | |---|---| | Certification body | Determines whether the certificate is accredited | | Certificate number | Allows verification against a register | | Scope | Says which activities are covered | | Validity period | Certificates expire | A claim of "ISO 9001 certified" carrying none of these is not checkable; one carrying all four is. That is a documentary observation and applies to any organisation making the claim.{{r|iso9001}} Accreditation of the certification body matters, since certificates are also issued by unaccredited bodies. An accredited certificate can be verified through the accreditation body's own register.{{r|reports}} == What it implies about material == Indirectly, a functioning management system supports the documentary features this wiki treats as informative: lot-specific certificates, retrievable records, controlled changes, and consistency over time. See [[Lot traceability]].{{r|iso9001}} 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. 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}} == References == {{reflist}} <ref name="iso9001">ISO 9001:2015, ''Quality management systems — Requirements''.</ref> <ref name="ich_q7">International Council for Harmonisation, ''Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients'' (2000).</ref> <ref name="reports">PeptidePedia Wiki community test-report tally, 2024–2026 (self-reported; see [[Project:Sourcing_guidelines]]).</ref> <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> == See also == * [[Good manufacturing practice]] * [[Certificate of analysis]] * [[Lot traceability]] * [[VendorInvestigate]] * [[Active pharmaceutical ingredient]] {{DEFAULTSORT:ISO 9001}} [[Category:Good manufacturing practice]] [[Category:Quality and testing]] [[Category:Regulation and law]]