ISO 13485 Documents Presentation

1. ISO 13485:2016 DOCUMENTATION REQUIREMENTS documentationconsultancy@gmail.com www.documentationconsultancy.com

2. What is ISO 13485:2016 ? • The ISO 13485 is an international standard for Medical Devices – Quality Management System Requirements for regulatory purposes represent the requirements that the medical device manufacturers must incorporate into their management systems. • Our ISO 13485:2016 Documentation kit includes Quality Manual, procedures, Exhibits, SOPs, audit checklist, etc. in ready to edit MS-Word documents. • The ISO 13485:2016 document kit is based on medical devices – quality management system with easy to modify templates. documentationconsultancy@gmail.com www.documentationconsultancy.com

3. ISO 13485:2016 Documentation Requirements • Quality Manual • Procedures • Exhibits • Standard Operating Procedures (SOPs) • Blank sample formats for all the departments • Process Flow Chart • ISO 13485 Audit checklist • Medical Device File documentationconsultancy@gmail.com www.documentationconsultancy.com

4. Quality Manual It covers sample copy of ISO 13485 manual and requirement wise details for how ISO 13485:2016 is implemented. It covers sample policy for all process areas, Quality policy and organization structure and covers 1st tier of ISO 13485:2016 documents. ISO 13485:2016 manual should normally contain, or refer to : • Context of the Organization • Leadership • Planning • Support • Operation • Performance evaluation • Improvement documentationconsultancy@gmail.com www.documentationconsultancy.com

5. ISO 13485:2016 Procedures Sample copies of mandatory procedures as per ISO 13485:2016 are provided, which cover all the details like purpose, scope, responsibility, how procedure is followed as well as the list of exhibits, reference documents and formats. It covers sample copy of procedures covering all the specific practice areas of 19 processes. Our procedures help the organization to make the best system and quick process improvements. documentationconsultancy@gmail.com

6. ISO 13485:2016 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 :- • Exhibits for Skill requirements • Exhibits for Disposal of non–conforming products • Exhibits for Quality plan • Exhibits for Document codification system documentationconsultancy@gmail.com www.documentationconsultancy.com

7. ISO 13485:2016 Standard Operating Procedure (SOPs) It covers sample copy of work instructions to link with significant aspects issues in the organization. It takes care of all such issues and used as a training guide as well as to establish control and make system in the organization. List of Standard Operating Procedure :- • Measurement Of Temperature And Humidity • Validation of Autoclave • Microbial Monitoring of Production Area • Temperature Monitoring of Sterility Room and Microbiology Laboratory • Temperature & Humidity Monitoring • Clean Room Condition Monitoring documentationconsultancy@gmail.com www.documentationconsultancy.com

8. ISO 13485:2016 Blank Sample Formats for all the Department • 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. documentationconsultancy@gmail.com www.documentationconsultancy.com

9. Process Flow Chart • Process approach for Despatch • Process approach for Design and Development • Process approach for Engineering • Process approach for Training • Process approach for Marketing • Process approach for Management Representative • Process approach for Production • Process approach for Purchase • Process approach for Quality Control • Process approach for Stores • Process approach for Installation and Commissioning • Process approach for Servicing documentationconsultancy@gmail.com www.documentationconsultancy.com

10. ISO 13485:2016 Audit Checklist • There covers audit questions based on ISO 13485:2016 requirements as well as for Clause wise questions and department wise question. It will be very good tool for the auditors to make audit Questionnaire / clause wise audit Questionnaire while auditing and make effectiveness in auditing. documentationconsultancy@gmail.com www.documentationconsultancy.com

11. Benefits • The kit takes care of all the sections and sub-sections of ISO 13485 standard and helps you to establish better system. • By using these documents, you can save a lot of your precious time while preparing the ISO 13485 documents. • This set of readymade documents is extremely useful to ISO 13485 consultants for complying with requirements. • It is a perfect tool to educate all employees to achieve better performance of Medical devices in the pharma sector. documentationconsultancy@gmail.com www.documentationconsultancy.com

12. ISO 13485:2016 Documentation Kit • The kit contains all necessary documents as listed above and complies with the requirements of ISO 13485 standard. • The documents are written in easy to understand English language. • It will save much time in typing and preparing your documents at your own. • This documentation kit provides you with sample templates and ISO 13485 2016 audit checklist that you need for effective quality documentation and system implementation. • The kit content is developed under the guidance of experienced experts. documentationconsultancy@gmail.com www.documentationconsultancy.com

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