ISO 22716:2007 Documentation Kit

Considering the need of ISO 22716:2007 Documentation Kit, and how consultants make huge money by selling the papers to organizations just changing the names in those documents instead of real services as expected from consultants, ISOFOLDER is a place where we are trying to make the system effective for documentation for any certification or compliance globally by providing pre-written documentation kit.

Our ISO 22716:2007 Documentation Kit is written in plain English to make easily customized by you without expertise in standards. We developed the documentation kit while making it user-friendly, easy to learn and time-saving.

We have added sample filled documents, comments of information to be added and other helping tools for you. We are available for lifetime support via email for helping you to make a documentation kit that works for you.

Contents of ISO 22716:2007 Documentation Kit

ISO 22716:2007 Documentation Kit is designed in following documents

• ISO 22716 Manual: A sample manual and each of the chapters are explained in easy to understand language. The ISO 22716 manual describes how a user can implement ISO 22716 system.
• Procedures: It includes total 10 mandatory procedures to implement the Cosmetic-Good Manufacturing Practices system in the company.
• Standard operating procedures: The 28 SOPs per ISO 22716 are available to establish control and make system in the organization.
• Blank sample formats: A set of 42 blank formats to maintain records as well as establish control and create system in the organization.
• ISO 22716 Audit Checklists: It covers more than 180 audit questions based on the ISO 22716 requirements to make audit questionnaire for auditing on the basis of ISO 22716.
• ISO 22716 compliance matrix: It contains ISO 22716 requirement wise list of documented information for easy reference.

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.

Documentation kit contains a Manual that address clause wise details for how management systems are designed and implemented in your organization.

10 procedures, which helps you to manage your operations and address requirements of standard through the implementation of procedures.

1. Procedure for Management review
2. Procedure for Document and Data Control
3. Procedure for Control of records
4. Procedure for Intemal Audit
5. Procedure for Training
6. Procedure For Corrective and Preventive Action
7. Procedure For Control of Monitoring and Measuring Equipment
8. Procedure for Purchasing
9. Procedure for Control of Non—Conforming Products
10. Procedure for identification of products

28 SOPs, which helps you to manage your operations and address requirements of standard through the implementation of procedures.

1. SOP for SOP
2. SOP for Control of Version, Archival and Retrieval of Data
3. SOP for Receipt and Handling of Market Complaints
4. SOP for Product recall
5. SOP for Handling of market returns
6. SOP for Change control system
7. SOP for Deviation and Investigation
8. SOP for Vendor quality audit
9. SOP for Out of Calibration (OOC)
10. SOP for Out of specification (OOS)
11. SOP for Batch release of Finished Products
12. SOP for Rework procedure
13. SOP for In-process Inspection During Manufacturing
14. SOP for Handling and storage of controlled samples
15. SOP for Retain samples and its disposal
16. SOP for Mock recall
17. SOP for Receipt of Raw & Packaging Materials
18. SOP for Receipt, Storage& Dispatch of Finished Goods
19. SOP for Waste management
20. SOP for Cleaning and sanitization
21. SOP for Pest control
22. SOP for Line clearance
23. SOP for Equipment cleaning and sanitization
24. SOP for General housekeeping
25. SOP for Entry / Exit procedure — Personnel hygiene
26. SOP for Floor cleaning
27. SOP for Cleaning of doors, Windows, Walls and tube light and fan
28. SOP for Incident reporting

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

1. Purchase order
2. Indent cum Incoming inspection report
3. Approved Vendor list cum open purchase order
4. Supplier Registration form
5. Open purchase order
6. Daily stock statement
7. Gate pass
8. Breakdown history card
9. Preventive maintenance schedule
10. Equipment Wise preventive maintenance checkpoints
11. Daily pm check point
12. PM Checkpoints for Building & civil work
13. Order form/ confirmation
14. Customer Complaint report
15. Customer feedback form
16. Customer property monitoring register
17. Master list cum distribution list of documents
18. Change note
19. Calibration status of instrument / equipment
20. Master list of records
21. Quality objective monitoring report
22. Audit plan / schedule
23. Internal Audit Non—Conformity Report
24. Clause-wise Document-wise Audit Review Report
25. Continual Improvement Plan
26. Corrective Action Report
27. Preventive Action Report
28. Qualitative Process Monitoring Report
29. Vendor Rating
30. List of license/certificate
31. Training Calendar
32. Training Need Cum Records Sheet
33. Induction Training Report
34. Job Description and Specification
35. Skill Matrix
36. Training Report
37. Skill Matrix for QC Personnel
38. Housekeeping record
39. Visitor gate pass
40. Incident Reporting form
41. Rodent trapping record
42. Sanitation report