ISO 9001 (revision 8)

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]

It is also distinct from 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.^[2]

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.^[3]