ISO 17029 Documentation Solution
Our solution for ISO 17029 includes comprehensive documents such as an ISO 17029 manual, procedures, forms and audit checklist, comprises 80 customizable files designed to facilitate the documentation process for the quality management system of any validation/verification body. Download demo to see more details
1199 USD
Manual
covering all clauses of ISO 17029
Procedures
detailed documented instructions
Templates
to keep records of implementation
Exhibits
for extended information
SOPs
to address micro level activities
Matrix
for compliance with ISO 17029
Enhance the speed
of implementation with our solution
When you write documents on your own, you spend more time in writing same documents which you can buy from us in few clicks
A Comprehensive Manual, Based on 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.
18 Documented Procedures for compliance
Each specific requirement that requires a documented procedure or more detailed process is covered with procedures.
Impartiality Management
Procedure for ISO 17029
Personnel and Training
Procedure for ISO 17029
Management of competence of personnel
Procedure for ISO 17029
Planning of validation / verification
Procedure for ISO 17029
Execution of validation / verification activities
Procedure for ISO 17029
Receive, evaluate and resolve complaints
Procedure for ISO 17029
Management Review
Procedure for ISO 17029
Identification and management of nonconformities and corrective action
Procedure for ISO 17029
Document and Data Control
Procedure for ISO 17029
Effective control of validation/ verification activities delivered by entities under its operational control
Procedure for ISO 17029
Procurement of externally products and services
Procedure for ISO 17029
Review of request for validation / verification
Procedure for ISO 17029
Review and Reporting
Procedure for ISO 17029
Receive, evaluate and make decisions on appeals
Procedure for ISO 17029
Use of marks by client
Procedure for ISO 17029
Internal Audit
Procedure for ISO 17029
Risk Assessment
Procedure for ISO 17029
Control of Records
Procedure for ISO 17029
07 Exhibits
- Principles and scope of accreditation
- Documentation structure and codification system
- Impartiality policy
- Confidentiality policy
- Operational control plan
- Competence requirements
- Calibration periodicity
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
Editable and Compatible
detailed documents & forms are prepared in MS Word
the registers and the logs are prepared in MS Excel
all documents are prepared in such a way to be compatible with any system
Other Features of Documentation Solution
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.
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349 USD only