ACCREDITATION PROCESS OVERVIEW ISO 17021-1 AND ACCREDITATION PROCESS 02 November 2017 1

Implementation of this standard ensures the following: Competence ISO 17021-1 Standard which specifies requirements for bodies providing audit and certification of management systems. Implementation of this standard ensures the following: Competence Consistency Impartiality 2

Responsiveness to Complaints PRINCIPLES ISO 17021 Impartiality Competence Responsibility Openness Confidentiality Responsiveness to Complaints Risk based Approach 3

OVERRVIEW OF ISO 17021 REQUIREMENTS Legal and Contractual matters - 5.1 Management of Impartiality - 5.2 Liability and Financing – 5.3 Structural Requirements - 6 Resource requirements - 7 Information Requirements - 8 Confidentiality - 8.4 Process Requirements - Clause 9 Management System Requirements - Clause 10 4

LEGAL AND CONTRACTUAL MATTERS Legal Responsibility Certification Agreement Responsibility for certification decisions 5

MANAGEMENT OF IMPARTIALITY Management commitment to impartiality Conflict of interest Consultancy Undue pressures Committee to safeguard Impartiality 6

STRUCTURAL REQUIREMENTS Organisation structure Duties, responsibilities and authorities of personnel Responsibilities and authorities for top management 7

Technical competence of auditors RESOURCE REQUIREMENTS Technical competence of auditors Competence of auditors on auditing techniques Demonstration of competence prior to carrying out specific functions Process for selection, training and authorisations of auditors Criteria for continual monitoring of competence Personnel records 8

Conditions under which outsourcing might take place OUTSOURCING (SUBCONTRACTING) Conditions under which outsourcing might take place Decision making shall never be outsourced Responsibility for outsourced activities Competence of bodies used for outsourcing 9

INFORMATION REQUIREMENTS The Certification body shall make the following information publicly accessible: Information describing audit and certification process Information about Certification granted, suspended or withdrawn. Directory of certified clients 10

Policy and arrangements to safeguard confidentiality Personnel shall safeguard confidential information obtained during performance of the certification body’s activities Ensure secure handling of confidential information 11

Initial certification audit conclusion CERTIFICATION PROCESS 1 Application 2 Application review 3 Initial Audit – Stage 1 4 Initial Audit – Stage 2 5 Initial certification audit conclusion 6 Granting of Certification 7 Surveillance audit 8 Recertification 9 Special Audits 12

Option 1: Option 2: Clause 10 of ISO 17021 MANAGEMENT SYSTEM REQUIREMENTS Option 1: Management System in accordance with ISO 9001 Address Requirements of ISO 17021 clauses 5 to 9 Option 2: Management System s in accordance with ISO 17021 Clause 10 Clause 10 of ISO 17021 Control of documents Control of Records Management review Internal Audits Corrective & Preventive Actions 13

ACCREDITATION PROCESS 14

ACCREDITATION Accreditation: Third–party attestation related to a Conformity Assessment Body conveying formal demonstration of its competence to carry out specific conformity assessment tasks. Accreditation Process: The process of evaluating a CAB’s compliance with the requirements of Accreditation, which commences upon the receipt of an application form from a CAB and ends at the end of the Accreditation Cycle. Accreditation Cycle: The period of validity of the Accreditation Certificate, commencing on the date on which Accreditation is granted, and ending on the date on which Accreditation ceases to be effective 15

MANAGEMENT SYSTEM OF CERTIFICATION BODY Policies and procedures of the CB Accreditation Requirements IAF Requirements Requirements of the Relevant Standard ISO 17021 TR & R Documents 16

Pre assessment - Optional ACCREDITATION PROCESS Application and document review Pre assessment - Optional Initial Assessment Decision Making – AC Granting of Accreditation Six Months follow up Surveillance assessment Reassessment 17

SUMMARY ISO 17011 IAF REQUIREMENTS ISO 17021 IAF MD9 SANAS REQUIREMENTS CERTIFICATION BODY ISO 13485 Regulation(s) CERTIFIED CLIENT 18

QUESTIONS 19

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