Overview
ISO/IEC 17011:2017 specifies the requirements that accreditation bodies must meet when assessing and accrediting conformity assessment bodies (CABs). The standard focuses on ensuring the competence, consistent operation and impartiality of accreditation bodies. Activities covered include testing, calibration, inspection, certification (management systems, products, persons), proficiency testing, production of reference materials, validation and verification.
Key topics and technical requirements
The standard is organized to capture the full accreditation lifecycle and governance framework. Major technical topics include:
- General requirements
- Legal entity, accreditation agreement, use of accreditation symbols, financing and liability, impartiality.
- Structural requirements
- Governance, organizational structure and measures to safeguard independence.
- Resource requirements
- Competence of personnel, competence management, personnel records, outsourcing controls.
- Process requirements
- Accreditation scheme definition, application and resource review, preparation and execution of assessments (including remote assessment), review of documented information, decision-making, accreditation cycle, extending or reducing scope, suspension/withdrawal, handling complaints and appeals.
- Information requirements
- Management of confidential information and publication of accreditation information.
- Management system requirements
- Document and records control, handling nonconformities and corrective actions, internal audits, management review and continual improvement.
- Competence guidance
- Incorporates competence criteria and an informative annex on knowledge and skills for accreditation activities.
Notable additions in the 2017 edition include alignment with CASCO common elements, formal recognition of proficiency testing as an accreditation activity, introduction of risk-based concepts, and definitions for accreditation scheme, flexible scope of accreditation, and remote assessment.
Practical applications and who uses ISO/IEC 17011:2017
ISO/IEC 17011:2017 is used to:
- Provide confidence that accreditation bodies operate impartially and competently.
- Support national and international peer evaluation and mutual recognition arrangements.
- Facilitate trade and regulatory acceptance by ensuring consistent accreditation practices across borders.
- Guide the development and operation of accreditation schemes and policies.
Primary users:
- National and regional accreditation bodies
- Regulatory authorities and policymakers
- Conformity assessment bodies (laboratories, inspection bodies, certification bodies, proficiency testing providers)
- Organizations involved in peer evaluation and international recognition
Related standards
- ISO/IEC 17000 is cited as a normative reference for conformity assessment vocabulary and principles.
- ISO CASCO common elements inform the structure and shared requirements for conformity assessment standards.
- Accreditation bodies typically apply ISO/IEC 17011 alongside the relevant sector-specific conformity assessment standards and schemes.
Keywords: ISO/IEC 17011:2017, accreditation bodies, conformity assessment, impartiality, competence, accreditation scheme, scope of accreditation, remote assessment, proficiency testing, management system.