ISO/IEC 17021 Documentation Requirements
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Transcript of ISO/IEC 17021 Documentation Requirements
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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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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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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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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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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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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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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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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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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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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
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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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Quotation Format
Stage 1 Audit Report
Stage 2 & Surveillance Audit Report
Register of Approved Firms / withdrawn firms /
Suspended firms
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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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