1. ACCREDITATION PROCESS
OVERVIEW ISO
AND
ACCREDITATION PROCESS
02 November 2017 1

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

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

4. 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

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

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

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

8. 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

9. 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

10. 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Information about Certification granted, suspended or withdrawn.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

11. 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

12. 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

13. 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 clauses 5 to 9
Option 2:
Management System s in accordance with ISO Clause 10
Clause 10 of ISO 17021
Control of documents
Control of Records
Management review
Internal Audits
Corrective & Preventive Actions 13

14. ACCREDITATION PROCESS14

15. 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

16. 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

17. 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

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

19. QUESTIONS 19

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