iso/iec 17021 documentation requirements

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ISO/IEC 17021 accreditation to certifying body is a procedure by which an accreditation body gives formal recognition of technical competence for specific certification based on third party assessment as per ISO/IEC 17021:2011 standard.ISO 17021 documentation which conforming to the requirements of ISO 17021 standard for Conformity Assessment.

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Page 1: ISO/IEC 17021 Documentation Requirements

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Page 2: ISO/IEC 17021 Documentation Requirements

Following are the key document s required

for ISO/IEC 17021 accreditation

Manual

Procedures

Work Instructions

Formats / Templates

Policies

Audit Checklist

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Page 3: ISO/IEC 17021 Documentation Requirements

ISO/IEC 17021:2011, Conformity assessment – necessities for

bodies providing audit and certification of management

systems, is meant to extend trust in certificates issued

attesting conformity to management system standards like ISO

9001, ISO 14001 and ISO 22000. Certificates to those and

alternative MSS are wide employed in world markets to

ascertain confidence between business partners and between

organizations and their customers, to qualify suppliers in

provide chains, and as a demand to tender for procurance

contracts.

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Page 4: ISO/IEC 17021 Documentation Requirements

The cover version retains these principles and

necessities, however adds new necessities developed in

response to promote feedback on the utilization of the

primary edition. The new necessities provided in ISO/IEC

17021:2011 relate to the competency of the auditors

United Nations agency do certification and to the means

during which they're managed and deployed.

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Page 5: ISO/IEC 17021 Documentation Requirements

It covers sample copy of ISO 17021 manual and clause

wise details for how ISO/IEC 17021:2011 systems are

implemented. It covers list of procedures as well as

overview of organization and covers tier1 of ISO/IEC

17021:2011 documents. It is having total 10 chapters

covering company profile, amendment sheet, index,

clause wise details as per ISO/IEC 17021:2011 for

implementation, sample Quality policy and organization

chart. It covers sample copy of Quality manual and clause

wise details for how ISO/IEC 17021:2011 systems are

implemented. It covers list of procedures as well as

overview of organization and covers tier1 of ISO/IEC

17021:2011 documents.

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Page 6: ISO/IEC 17021 Documentation Requirements

It covers sample copy of mandatory procedures covering all thedetails like purpose, scope, responsibility, how procedure isfollowed as well as list of exhibits, reference documents andformats.The list of sample procedures provided is as below.

List of Procedures

1. Procedure for document and data control

2. Procedure for record management

3. Procedure for Internal audit

4. Procedure for Corrective and Preventive actions

5. Procedure for management review

6. Procedure for Human resources

7. Procedure for complaints and appeals

8. Procedure for Marketing, contract and contract review

9. Procedure for audit – planning, conducting and reporting

10. Procedure for Certificate issue, suspension and withdrawal

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Page 7: ISO/IEC 17021 Documentation Requirements

It covers work instruction tables for guideline to

staff for working. It covers work instruction and

activities for good work practices. It covers

guideline for establishing controls on significant

aspects, work instructions for operators as well as

standard operating procedures. It is useful for

testing process control and establishes effective

laboratory management system with good

laboratory practices culture. It covers sample dos

and don’ts and guideline tables in the form of

exhibits as per details given below. The process

model is also given to give overall interlink ages

of all the documents. Continue……

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Page 8: ISO/IEC 17021 Documentation Requirements

WI_01 Work Instruction for auditor qualification

WI_02 Work Instruction for Sub contractor job

responsibility

WI_03 Work Instruction for Man day estimation

WI_04 Work Instruction for Guidelines for ISO

9001 audit

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Page 9: ISO/IEC 17021 Documentation Requirements

It covers sample copy of blank forms required to

maintain records as well as establish control and

make system in the organization. The samples

given are as a guide and not compulsory to follow

and organization is free to change the same to suit

own requirements. It can be used as templates

and more than 40 formats are prepared as per list

given below.

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Page 10: ISO/IEC 17021 Documentation Requirements

Internal Audit Schedule

Evaluation of threats to impartiality of certification

process for all standards risk treatment plan

Training calendar

Identification of training needs

Competency Measurement - Operations Director

Competency Measurement - MD & ED

Competency Measurement - Marketing

Competency Measurement - Impartiality Committee

Competency Measurement - Certification Committee

Competency Measurement - Auditor/Subcontractor

/Expert (ASE)

Competency Measurement - Appeals Committee

Competency Measurement - Admin Resource

List of Formats

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Page 11: ISO/IEC 17021 Documentation Requirements

Customer Satisfaction Survey Form

Deviation Note

Audit Report Review Checklist

Audit Notification

Change to Contract

Client contract review report

Questionnaire

Incident Report

Competence Authorization records & evidence

Summary

Continue……

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Page 12: ISO/IEC 17021 Documentation Requirements

Witnessed Audit Report

Auditor Training Plan

CPD Form

Corrective / Preventive Action Request

Internal Audit Report

New Standard / EAC Code Application Form

Contract of Employment

Sub-contractor Agreement

Annual Confidentiality, Impartiality and

Competency Declaration

QMS Auditor Qualification Summary

EMS Auditor Qualification Summary

Performance Appraisal FormContinue……

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Page 13: ISO/IEC 17021 Documentation Requirements

Quotation Format

Stage 1 Audit Report

Stage 2 & Surveillance Audit Report

Register of Approved Firms / withdrawn firms /

Suspended firms

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Page 14: ISO/IEC 17021 Documentation Requirements

It covers sample copy of mandatory policies

covering all the details as per ISO/IEC

17021:2011 requirements for Inspection Agency

(Issue the lists of operating policies are listed

below.)

1. Quality Policy

2. Confidentiality Policy

3. Impartiality Policy

4. Impartiality Committee Members

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