Overview
EN ISO/IEC 17011:2017 (adopted by CEN) specifies requirements for the competence, consistent operation and impartiality of accreditation bodies that assess and accredit conformity assessment bodies. It is the international second edition (revising ISO/IEC 17011:2004) and applies to accreditation of testing and calibration laboratories, inspection bodies, certification bodies (products, processes, management systems, persons), proficiency testing providers, reference material producers and similar conformity assessment activities.
Key topics and requirements
The standard sets out a comprehensive framework covering organisational, technical and procedural elements an accreditation body must address. Major topics include:
- General requirements: legal entity, accreditation agreements, use of accreditation symbols, impartiality and conflict-of-interest controls.
- Structural and resource requirements: governance, organisational structure, staffing, outsourcing and record keeping.
- Competence: competence criteria and management for assessors and technical personnel, plus an informative annex on knowledge and skills.
- Process requirements: application handling, resource review, assessment planning, on-site and remote assessments, review of documented information, and accreditation decision-making.
- Accreditation cycle and scheme management: establishment of accreditation schemes, flexible scopes, extension, suspension, withdrawal or reduction of accreditation.
- Risk and modern assessment methods: introduction of a risk-based approach and explicit recognition of remote assessment and proficiency testing as accreditation activities.
- Information and confidentiality: handling of confidential information, public information and claims of accreditation.
- Management system: document and records control, internal audits, nonconformity management, corrective action, continual improvement, and management reviews.
- Complaints and appeals: formal requirements for receiving and handling complaints and appeals.
Practical applications and who uses it
ISO/IEC 17011 is used by:
- National and regional accreditation bodies establishing or improving accreditation programs.
- Conformity assessment bodies (labs, inspection and certification bodies) preparing for or maintaining accreditation.
- Regulators, procurement officers and supply‑chain managers who rely on accredited results for decision-making.
- International recognition bodies and stakeholders involved in mutual recognition arrangements and trade facilitation.
Practical uses include designing accreditation schemes, defining assessor competence, implementing impartiality safeguards, conducting risk‑based assessment programs, and supporting consistent accreditation decisions.
Related standards
Relevant standards and frameworks often used with ISO/IEC 17011:
- ISO/IEC 17025 (testing and calibration laboratories)
- ISO/IEC 17020 (inspection bodies)
- ISO/IEC 17021 (management systems certification)
- ISO/IEC CASCO guidance and other ISO conformity assessment documents
EN ISO/IEC 17011 is central to ensuring confidence in conformity assessment results and enabling consistent, impartial accreditation practice across sectors and borders.
