ISO 17029 Documentation

ISO 17029 Documentation is crucial for organizations seeking compliance with the standard, which outlines requirements for validation and verification bodies. The documentation process involves comprehensive preparation, including manuals, procedures, forms, and checklists. Each element plays a vital role in ensuring adherence to ISO 17029 standards and demonstrating a commitment to quality management systems. By focusing on ISO 17029 Documentation, organizations can streamline their operations, enhance credibility, and meet regulatory expectations in the field of validation and verification.

Our ISO 17029 Documentation serves as a roadmap for organizations navigating the complexities of validation and verification processes. By using our documented procedures and forms, organizations can ensure that activities are carried out consistently and in accordance with applicable requirements. This not only enhances efficiency but also minimizes the risk of errors or inconsistencies that could compromise the integrity of validation and verification activities.

Features of ISO 17029 Documentation

✔ Comprehensive Content: The documentation includes a diverse range of 80 editable files, covering essential aspects of quality management system documentation for validation/verification bodies.

✔ Aligned with Standard: All templates, including the quality manual, procedures, and forms, are developed to meet the requirements of the latest version of the ISO/IEC 17029 standard, ensuring alignment with industry best practices.

✔ Ready-to-Use: Templates Ready-to-use templates such as quality manual, procedures, exhibits, standard operating procedures (SOPs), blank forms, and sample risk assessment sheets accelerate the documentation process, saving time and effort for validation/ verification bodies.

✔ Customizability: The files provided in MS Word/Excel formats are fully editable, allowing customization to adapt to the specific needs and processes of individual validation/ verification bodies.

✔ Facilitates Compliance: With a comprehensive audit checklist comprising approximately 250 questions, the documentation kit facilitates thorough verification of the implemented quality management system, aiding in achieving ISO/IEC 17029:2019 accreditation.

✔ Support for Process Improvement: The inclusion of SOPs, filled risk assessment sheets, and various templates empowers validation/verification bodies to not only achieve accreditation but also drive continuous improvement in their processes and systems.

Contents of ISO 17029 Documentation

ISO 17029 Documentation has 1 Manual

A Comprehensive Manual, Based on the structure of ISO 17029. The solution comes with a detailed manual consisting of 11 chapters and 48 pages. The manual covers each and every requirement and gives reference to procedures related to specific requirements of the standard.

ISO 17029 Documentation has 18 Procedures

1. Impartiality Management Procedure for ISO 17029
2. Personnel and Training Procedure for ISO 17029
3. Management of competence of personnel Procedure for ISO 17029
4. Planning of validation / verification Procedure for ISO 17029
5. Execution of validation / verification activities Procedure for ISO 17029
6. Receive, evaluate and resolve complaints Procedure for ISO 17029
7. Management Review Procedure for ISO 17029
8. Identification and management of nonconformities and corrective action Procedure for ISO 17029
9. Document and Data Control Procedure for ISO 17029
10. Effective control of validation/ verification activities delivered by entities under its operational control Procedure for ISO 17029
11. Procurement of externally products and services Procedure for ISO 17029
12. Review of request for validation / verification Procedure for ISO 17029
13. Review and Reporting Procedure for ISO 17029
14. Receive, evaluate and make decisions on appeals Procedure for ISO 17029
15. Use of marks by client Procedure for ISO 17029
16. Internal Audit Procedure for ISO 17029
17. Risk Assessment Procedure for ISO 17029
18. Control of Records Procedure for ISO 17029

ISO 17029 Documentation has 07 Exhibits

1. Principles and scope of accreditation
2. Documentation structure and codification system
3. Impartiality policy
4. Confidentiality policy
5. Operational control plan
6. Competence requirements
7. Calibration periodicity

ISO 17029 Documentation has 03 SOPs

ISO 17029 Documentation has 48 Templates to keep records

1. Impartiality and confidentiality agreement
2. Impartiality check report
3. Control report
4. Training Calendar
5. Training Report
6. Induction Training Report
7. Job Description and Specification
8. Skill Matrix
9. Training Effectiveness check report
10. Interview report
11. Employee competence report
12. Competence assessment report
13. Purchase Order
14. Indent (Purchase requisition)
15. Supplier registration form
16. Approved External Providers List (Approved Vendor List)
17. Supplier Evaluation Report
18. Inspection Report
19. Sub-contractors/ External service provider’s agreement
20. Validation / Verification request
21. Planning register
22. Client feedback
23. Validation / Verification agreement
24. Validation / verification plan
25. Validation / verification execution report
26. Calibration status of equipment
27. Equipment History Card
28. Validation / verification review and decision report
29. Validation / verification statement
30. Appeal report
31. Appeal registers
32. Complaint report
33. Complaint register
34. Quality objective monitoring report
35. Improvement/ Minutes of meeting
36. Circular
37. Minutes of Meeting
38. Audit plan / schedule
39. Internal Audit Non—conformity report
40. Clausewise audit report — Management requirements
41. Clausewise audit report — Technical requirements
42. Non—conformity work report
43. Corrective Action Report
44. Risk assessment and opportunity sheet
45. Masterlist and Distribution list of Documents
46. Change Note
47. Periodic document review report
48. Masterlist of Records