ISO IEC 17011-2017 PDF

Full title and description

ISO/IEC 17011:2017 — Conformity assessment — Requirements for accreditation bodies accrediting conformity assessment bodies. This international standard specifies requirements for the competence, consistent operation and impartiality of accreditation bodies that assess and accredit conformity assessment bodies (laboratories, inspection bodies, certification bodies, proficiency testing providers, reference material producers, etc.).

Abstract

ISO/IEC 17011:2017 sets out requirements for accreditation bodies' legal status, impartiality, confidentiality, resource and personnel competence, accreditation programme design and management, assessment processes (including remote assessment), accreditation decision-making, surveillance, handling of nonconformities, complaints and appeals, and the use of flexible scopes and risk-based approaches for accreditation.

General information

• Status: Published (confirmed review in 2023).
• Publication date: 29 November 2017 (Edition 2, 2017).
• Publisher: International Organization for Standardization (ISO) jointly with the International Electrotechnical Commission (IEC) — ISO/CASCO technical committee.
• ICS / categories: 03.120.20 (Product and company certification; conformity assessment).
• Edition / version: Edition 2 (2017).
• Number of pages: 29 pages (official ISO publication).

General information above is taken from the ISO record for the standard.

Scope

ISO/IEC 17011:2017 applies to accreditation bodies that perform accreditation of conformity assessment bodies across a wide range of activities (testing, calibration, inspection, certification of management systems, products, persons, production of reference materials, proficiency testing, validation and verification, etc.). The standard covers requirements to ensure accreditation bodies operate impartially and consistently, establish and maintain accreditation programmes and schemes, evaluate competence of conformity assessment bodies, and make and document accreditation decisions.

Key topics and requirements

• Legal entity, governance and documented accreditation agreement requirements.
• Impartiality policies, conflict of interest management, and stakeholder involvement to safeguard impartiality.
• Competence requirements for assessors, technical experts and accreditation personnel.
• Development and management of accreditation programmes and schemes (including flexible scope definitions).
• Assessment processes: application review, assessment planning, on-site and remote assessments, proficiency testing and review of evidence.
• Accreditation decision-making, surveillance, extension, reduction, suspension and withdrawal of accreditation.
• Management system activities: document control, internal audit, nonconformity handling, corrective action and continual improvement.
• Confidentiality, information security, public claims of accreditation, complaints and appeals handling.
• Risk-based approaches and recognition of remote assessment techniques where appropriate.

These key topics summarize the main clauses and requirements found in the standard.

Typical use and users

Primary users are national and regional accreditation bodies (governmental and non‑governmental) and their staff (assessors, technical experts, accreditation decision-makers). Secondary users include conformity assessment bodies seeking accreditation (testing and calibration laboratories, inspection bodies, certification bodies, proficiency testing providers, reference material producers), regulators that rely on accredited results, international recognition bodies (ILAC/IAF), and training or consultancy organizations supporting accreditation processes.

Related standards

ISO/IEC 17011 is closely associated with conformity assessment standards that define requirements for conformity assessment bodies and accreditation schemes, notably ISO/IEC 17025 (testing and calibration laboratories), ISO/IEC 17020 (inspection bodies), ISO/IEC 17021-1 (management systems certification), ISO/IEC 17024 (person certification), ISO 15189 (medical laboratories), ISO/IEC 17034 (reference material producers), ISO/IEC 17043 (proficiency testing), ISO/IEC 17065 (product certification), and guidance standards such as ISO 19011. It is also referenced by and used in conjunction with international recognition arrangements and guidance from ILAC and IAF.

Keywords

accreditation body; accreditation scheme; conformity assessment; competence; impartiality; accreditation decision; flexible scope; remote assessment; proficiency testing; risk-based approach; ILAC; IAF.

FAQ

Q: What is this standard?

A: ISO/IEC 17011:2017 is an international standard that specifies requirements for accreditation bodies that assess and accredit conformity assessment bodies, covering competence, consistent operation and impartiality.

Q: What does it cover?

A: It covers governance and legal requirements for accreditation bodies, impartiality and conflict‑of‑interest safeguards, competence of personnel, accreditation programme and scheme management, assessment processes (including remote assessment and proficiency testing), accreditation decisions and surveillance, management system requirements, and handling of complaints and appeals.

Q: Who typically uses it?

A: National and regional accreditation bodies, assessors and technical experts, conformity assessment bodies seeking accreditation (labs, inspection and certification bodies, PT providers, reference material producers), regulators, and organizations involved in international recognition of accreditation.

Q: Is it current or superseded?

A: The 2017 edition (Edition 2) is the current published edition; the ISO record indicates the standard was reviewed and confirmed in 2023 and remains current. It supersedes ISO/IEC 17011:2004.

Q: Is it part of a series?

A: It is part of the ISO/IEC conformity assessment family of documents (CASCO outputs) and is intended to be used together with other conformity assessment standards (ISO/IEC 17025, 17020, 17021‑1, 17024, 17034, 17043, 17065, ISO 15189, etc.) and recognition frameworks from ILAC/IAF.

Q: What are the key keywords?

A: Accreditation, accreditation body, conformity assessment, impartiality, competence, accreditation scheme, flexible scope, remote assessment, proficiency testing, risk‑based approach.