Title Of Document

Conformity assessment -- General requirements for accreditation bodies accrediting conformity assessment bodies

Abstract

ISO/IEC 17011:2004 specifies general requirements for accreditation bodies assessing and accrediting conformity assessment bodies (CABs). It is also appropriate as a requirements document for the peer evaluation process for mutual recognition arrangements between accreditation bodies. Accreditation bodies operating in accordance with ISO/IEC 17011:2004 do not have to offer accreditation to all types of CABs. For the purposes of ISO/IEC 17011:2004, CABs are organizations providing the following conformity assessment services: testing, inspection, management system certification, personnel certification, product certification and, in the context of this document, calibration.

Category of Standards

Category 1

Document number assigned by ASEAN

ISO/IEC 17011

ICS

HS

HS Range

MRA/Harmonised Regulations related to the Standard

ASEAN Agreement on Medical Device Directive (AMDD)

ASEAN Body responsible for Standard

ASEAN Medical Device Committee (AMDC)

Member States

 PH   TH 

Date of harmonisation in ASEAN

Date of Latest Review