IAF Mandatory Document
IAF MD 8:2020 International Accreditation Forum, Inc. Issue 4 Application of ISO/IEC 17011:2017 in the Field of Page 2 of 19 Medical Device Quality Management Systems (ISO 13485) Issued: 29 June 2020 Application Date: 30 November 2020 IAF MD 8:2020 Issue 4
Download IAF Mandatory Document
Information
Domain:
Source:
Link to this page:
Documents from same domain
WITNESSING ACTIVITIES FOR THE ACCREDITATION OF …
iaf.nu7.9.3 of ISO/IEC 17011:2017. 0.2. In order to comply with these requirements of ISO/IEC 17011 (and other normative documents like application documents developed by IAF and legal requirements where relevant), ABs perform file review and witnessing of MS CBs activities, namely audits in the certification process (hereafter referred to as audits ...
IAF Mandatory Document APPLICATION OF ISO/IEC 17021-1 …
iaf.nuOccupational Health and Safety are also considered as management systems consultancy. These include, but are not limited to: i) performing the role of Occupational Health and Safety coordinator, ii) safety reporting, iii) performing risk assessments, iv) communication with regulatory authorities on behalf of the client, and
IAF Mandatory Document for the Audit and Certification of ...
iaf.nuAn organization covered by a single management system comprising an identified central function (not necessarily the headquarters of the organization) at which certain processes/activities are planned and controlled, and a number of sites (permanent, temporary or virtual) at which such processes/activities are fully or partially carried out.
IAF Mandatory Document
iaf.nuaudit/assessment. 4.1.4 When no agreement is reached for the use of ICT for audit/assessment, other methods shall be used to fulfil audit/assessment objectives. 4.2 Process Requirements 4.2.1 The body shall identify and document the risks and opportunities that may impact audit/assessment effectiveness for each use of ICT under the same
IAF Mandatory Document DETERMINATION OF AUDIT TIME …
iaf.nuAccreditation Bodies (ABs) in order that the results issued by Conformity Assessment Bodies (CABs) accredited by IAF members are accepted globally. Accreditation reduces risk for business and its customers by assuring them that accredited CABs are competent to carry out the work they undertake within their scope of accreditation.
Application of ISO/IEC 17021-1 in the Field of Medical ...
iaf.nuWhere ISO/IEC 17021-1 Clause 7.1.1 refers to (as relevant for the specific certification scheme) ISO 13485, this should be understood to mean medical devices and applicable legal requirements. All personnel involved in ISO 13485 certification shall meet the competency requirements of Annex B. 7.2 Personnel involved in the certification activities
IAF Mandatory Document Application of ISO/IEC 17021-1 in ...
iaf.nuclauses of ISO/IEC 17021-1 continue to apply, and this document does not supersede any of the requirements in that standard. This mandatory document is exclusively for the certification of organizations’ management systems to ISO 13485. 0. INTRODUCTION ISO/IEC 17021-1 is an International Standard that sets out the general requirements
TRANSITION REQUIREMENTS FOR ISO 50003:2021
iaf.nuassociated mandatory documents e.g., ISO/IEC 17065. The attestations made by CABs at the main scope level are considered to be equally reliable. • The sub-scope of the MLA includes conformity assessment requirements e.g., ISO 9001 and scheme specific requirements, where applicable, e.g., ISO TS 22003.
Related documents
Best Practice Guidelines For Cleaning, Disinfection and ...
www.health.gov.bc.caOntario for supporting inter-provincial learning in the area of medical device reprocessing. Key Revisions in this Document: This document incorporates revisions from the following updated Canadian standards: CSA Z314.3-09 Effective Sterilization in …
Update on Medical Device and IVD Regulation in Japan
www.pmda.go.jpClinical use standards and risk management plan developed in collaboration with academic society Extrapolation of indication to other therapeutic areas based on the function Early realization of application of device to other organs and body parts based on the function by risk management measures in the post-marketing phase.