ISO 17021 Documentation Kit

Content of Documentation Kit

Documentation Kit is designed by following four tiers of documents

• Tier 1 – Manual – This provides the reference to each requirement of the standard. We make the structure of the manual same as the standard, so that you can easily understand and follow requirements.
• Tier 2 – Procedures – This provides additional information referred in the manual that how you are doing specific activities in your organization
• Tier 3 – Formats – These are an actual document that you use to show your compliance with the standard.

We have added many documents for reference and use, however, you can add any additional document which is not part of our documentation kit, or can ignore those document which is not applicable to your activities from our documentation kit.

It is recommended the documentation kit shall be reviewed by senior management, managers, and employees as relevant to them which can help to understand ISO 17021-1:2015.

Documentation kit contains A Quality Manual that address clause wise details for how ISO 17021-1:2015 systems are designed and implemented in your organization.

1. [Company]
1.1 [Company] PROFILE
1.2 AUTHORIZATION STATEMENT
1.3 ORGANIZATION STRUCTURE
2. SCOPE OF MANUAL
2.1 SCOPE OF CERTIFICATION
2.2 OPERATIONAL AREA & SITE(S)
3. TERMS AND DEFINITIONS
4. PRINCIPLES
4.1 GENERAL
4.2 IMPARTIALITY
4.3 COMPETENCE
4.4 RESPONSIBILITY
4.5 OPENNESS
4.6 CONFIDENTIALITY
4.7 RESPONSIVENESS TO COMPLAINTS
4.8 RISK BASED APPROACH
5 GENERAL REQUIREMENTS
5.1 LEGAL AND CONTRACTUAL MATTERS
5.1.1 LEGAL RESPONSIBILITY
5.1.2 CERTIFICATION AGREEMENT
5.1.3 RESPONSIBILITY FOR CERTIFICATION DECISIONS
5.2 MANAGEMENT OF IMPARTIALITY
6 STRUCTURAL REQUIREMENTS
6.1 ORGANIZATIONAL STRUCTURE AND TOP MANAGEMENT
6.2 OPERATIONAL CONTROL
7 RESOURCE REQUIREMENTS
7.1 COMPETENCE OF PERSONNEL
7.1.1 GENERAL CONSIDERATIONS
7.1.2 DETERMINATION OF COMPETENCE CRITERIA
7.1.3 AUDIT PROCESS
7.1.4 OTHER CONSIDERATION
7.2 PERSONNEL INVOLVED IN THE CERTIFICATION ACTIVITIES
7.3 USE OF INDIVIDUAL EXTERNAL AUDITORS AND EXTERNAL TECHNICAL EXPERTS
7.4 PERSONNEL RECORDS
7.5 OUTSOURCING
8 INFORMATION REQUIREMENTS
8.1 PUBLIC INFORMATION
8.2 CERTIFICATION DOCUMENTS
8.3 REFERENCE TO CERTIFICATION AND USE OF MARKS
8.4 CONFIDENTIALITY
8.5 INFORMATION EXCHANGE BETWEEN [Company] AND ITS CLIENTS
8.5.1 INFORMATION ON THE CERTIFICATION ACTIVITY AND REQUIREMENTS
8.5.2 NOTICE OF CHANGES BY [Company]
8.5.3 NOTICE OF CHANGES BY A CERTIFIED CLIENT
9 PROCESS REQUIREMENTS
9. 1 PRE–CERTIFICATION ACTIVITIES
9.1.1 APPLICATION
9.1.2 APPLICATION REVIEW
9.1.3 AUDIT PROGRAM
9.1.4 DETERMINING THE AUDIT TIME
9.1.5 MULTI SITE SAMPLING
9.1.6 MULTI MANAGEMENT SYSTEM STANDARD
9.2 PLANNING AUDITS
9.2.1 DETERMINING AUDIT OBJECTIVES, SCOPE AND CRITERIA
9.2.2 AUDIT TEAM SELECTION AND ASSIGNMENTS
9.2.3 AUDIT PLAN
9.3 PLANNING AUDITS
9.3.1 INITIAL CERTIFICATION AUDIT
9.4 CONDUCTING AUDITS
9.4.1 GENERAL
9.4.2 CONDUCTING THE OPENING AUDIT
9.4.3 COMMUNICATION DURING THE AUDIT
9.4.4 OBTAINING AND VERIFYING INFORMATION
9.4.5 IDENTIFYING AND RECORDING AUDIT FINDINGS
9.4.6 PREPARING AUDIT CONCLUSION
9.4.7 CONDUCTING THE CLOSING MEETING
9.4.8 AUDIT REPORT
9.4.9 CAUSE ANALYSIS OF NON–CONFORMITIES
9.4.10 Effectiveness of correction and corrective action
9.5 CERTIFICATION DECISION
9.5.1 GENERAL
9.5.2 ACTIONS PRIOR TO MAKING A DECISION
9.5.3 INFORMATION FOR GRANTING INITIAL CERTIFICATION
9.5.4 INFORMATION FOR GRANTING RE–CERTIFICATION
9.6 MAINTAINING CERTIFICATION
9.6.1 GENERAL
9.6.2 SURVEILLANCE ACTIVITIES
9.6.3 RE-CERTIFICATION (TRIENNIAL)
9.6.4 SPECIAL AUDITS
9.6.5 SUSPENDING, WITHDRAWING OR REDUCING THE SCOPE OF CERTIFICATION
9.7 APPEALS
9.8 COMPLAINTS
9.9 CLIENT RECORDS
10 MANAGEMENT SYSTEM REQUIREMENTS
10.1 OPTIONS
10.2 OPTION A: GENERAL MANAGEMENT SYSTEM REQUIREMENT
10.2.1 GENERAL
10.2.2 MANAGEMENT SYSTEM MANUAL
10.2.3 CONTROL OF DOCUMENTS
10.2.4 CONTROL OF RECORDS
10.2.5 MANAGEMENT REVIEW
10.2.6 INTERNAL AUDITS
10.2.7 CORRECTIVE ACTIONS
10.3 OPTION B: MANAGEMENT SYSTEM REQUIREMENTS IN ACCORDANCE WITH ISO 9001
ANNEX 1 – QUALITY POLICY
ANNEX 2 – CONFIDENTIALITY AND IMPARTIALITY POLICY
ANNEX 3 – LIST OF PROCEDURES

15 procedures, which helps you to manage your operations and address requirements of ISO 17021-1:2015 through the implementation of procedures.

1. Procedure for Human Resource
2. Procedure for Contract Review
3. Procedure for Purchasing and Subcontracting
4. Procedure for Granting, Maintaining, Extending or Reducing scope, Suspending, Withdrawing or Refusing Certification
5. Procedure for Change Management
6. Procedure for Legal Compliance
7. Procedure for Use of Logo
8. Procedure for Control of Document and Record
9. Procedure for Internal Audit
10. Procedure for Management Review
11. Procedure for Corrective Action
12. Procedure for Complaint and Appeal
13. Procedure for Audit Planing, Conducting and Reporting
14. Procedure for Mandays Estimation
15. Procedure for Impartiality Management

31 Formats, which is actually used to implement the system and keep records to provide evidence of the fulfillment of standard requirements.

1. Subcontractor Agreement
2. Confidentiality and impartiality declaration
3. Questionnaire
4. Customer Complaint Report
5. Customers Feedback Form
6. Approved Vendor List
7. Approved Empanel Auditors List
8. Supplier Registration Form
9. Objectives & Targets
10. Internal Audit Plan
11. Internal Audit Checklist
12. Corrective and Preventive Action Report
13. Master list of equipment
14. Contract of Employment
15. Auditor Competence Matrix
16. Auditor evaluation form
17. Auditor Qualification Form
18. Training Need Identification
19. Annual Training Program
20. Induction Training Form
21. Job Description
22. Master List of Documents
23. Document Change Note
24. Master List of Records
25. Management of Change Plan
26. Training Attendance Sheet
27. Management Review Meeting Agenda
28. Management Review Meeting Minutes
29. Internal Audit Report
30. Identification and assessment of threats to impartiality
31. Terms & Conditions of Certification