D126: DEMO OF ISO 13485:2016 Medical Device Document Kit Price 399 USD Total editable documentation package Complete editable document tool kit (Quality manual, procedures, exhibits, formats, SOPs, process flow chart, audit checklist, medical device file etc.)
Buy: www.Documentationconsultancy.com List of Procedures (19 procedures) Sr. No. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19.
Procedure No. PRO/SYS/01 PRO/SYS/02 PRO/SYS/03 PRO/SYS/04 PRO/SYS/05 PRO/SYS/06 PRO/SYS/07 PRO/SYS/08 PRO/SYS/09 PRO/SYS/10 PRO/SYS/11 PRO/SYS/12 PRO/SYS/13 PRO/MKT/01 PRO/PUR/01 PRO/PRD/01 PRO/STR/01 PRO/STR/02 PRO/STR/03
Name of Procedure
Total Page
Procedure for Management review Procedure for Document and Data Control Procedure for Control of records Procedure for Internal Audit Procedure for Training Procedure For Corrective And Preventive Action Procedure For Control of Monitoring And Measuring Equipments Procedure for Control of Monitoring of work environment Procedure for validation of sterilization process Procedure For Monitoring And Measurement of Processes Procedure For Analysis of Data Procedure For Issue And Implementation of Advisory Notices Procedure For Hazard Identification Procedure for customer satisfaction survey Procedure for Purchasing Procedure for Control of Non–Conforming Products Procedure for identification of products Procedure for traceability Procedure for preservation Total Pages
03 07 03 03 03 04 04 02 03 03 02 02 01 02 05 02 02 02 02 55
3. Exhibits (04 Exhibits): It covers sample copy of guidelines covering all the details and for training to the user to implement the processes and get detail ideas for process implementation and improvement. List of Exhibits (04 Exhibits) Sr. No. 1. 2. 3. 4.
Guideline No. E/HRD/01 E/PRD/01 E/QCD/01 E/SYS/01
Name of Guidelines
Total Pages 01 01 01 01
Skill Requirements Disposal of Non–conforming Products Quality Plan Document codification system
Total Pages
04
4. Formats (61 Formats) It covers sample copy of 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.
List of Formats (61 Formats) Sr. No.
Format No.
Name of Format
1.
F/PUR/01
Purchase Order
2.
F/PUR/02
Indent cum Incoming inspection report
3.
F/PUR/03
Approved Vendor list cum open purchase order
4.
F/PUR/04
Supplier Registration form
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