02

ISAB Mandatory Documents (MD Series)

This section houses core mandatory requirements that accredited bodies must follow. It is best sorted numerically by MD number, followed by other named mandatory documents.

• ISAB MD 4: Use of ICT for Conformity Assessment

• ISAB MD 5: Determination of Audit Time

• ISAB MD 7: Harmonization of Sanctions and Dealing with Fraudulent Behaviour

• ISAB MD 8:2023: Application of ISO/IEC 17011:2017 in the Field of Medical Device Quality Management Systems (ISO 13485)

• ISAB MD 9:2023: Application of ISO/IEC 17021-1 in the Field of Medical Device Quality Management Systems (ISO 13485)

• ISAB MD 11: Application of ISO/IEC 17021-1 for IMS

• ISAB MD 12:2023: Accreditation Assessment of Conformity Assessment Bodies with Activities in Multiple Countries

• ISAB MD 15:2023: Collection of Data to Provide Indicators of Management System Certification Bodies’ Performance

• ISAB MD 16:2024: Application of ISO/IEC 17011 for the Accreditation of Food Safety Management Systems (FSMS) Certification Bodies

• ISAB MD 22: Certification of OH&SMS

• ISAB MD 23: Control of Entities

• ISAB MD 25: Criteria for Evaluation of Conformity Assessment Schemes

• ISAB MD 28: Upload and Maintenance of Data on ISAB Database

• ISAB Mandatory Document for the Application of ISO 14065:2020

• ISAB Mandatory Document for the Audit and Certification (Multi-site Organization)

• ISAB Mandatory Document for the Transfer of Accredited Certification

03

Accreditation Guidance Documents

This section groups practical guidance, best practices, and explanatory notes for auditors and evaluation teams alphabetically or by core audit workflow.

• ISAB Guidance on Assessor Competence

• ISAB Guidance on Auditing a CAB’s Conformity to ISO/IEC 17021-1 Clause 5.2.3

• ISAB Guidance on Auditing Accreditation Scopes

• ISAB Guidance on Auditor Code of Conduct and Ethics

• ISAB Guidance on Control of CABs’ foreign or remote locations

• ISAB Guidance on Integrated Assessments

• ISAB Guidance on Measurements Performed as Part of an Inspection Process

• ISAB Guidance on Process Approach Audits

• ISAB Guidance on Witnessing Audits

04

Standard-Specific Application Documents

Specific application documents mapped to particular ISO standards.

• ISAB Application of ISO/IEC 17020:2012 for the Accreditation of Inspection Bodies

05

Policies, Procedures & Evaluation Frameworks

Administrative, technical policies, and peer-evaluation rules governing the Accreditation Body (AB) itself.

• ISAB-A2: Requirements and Procedures for Evaluation of an Accreditation Body

• ISAB Policy for Measurement Uncertainty in Calibration

• ISAB Procedures for Handling Disputes, Complaints, and Appeals

04

Standard-Specific Application Documents

Specific application documents mapped to particular ISO standards.

• ISAB Application of ISO/IEC 17020:2012 for the Accreditation of Inspection Bodies