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ISO 13485 Documentation Kit
The document provides a comprehensive overview of ISO 13485:2016 and the necessary documentation for achieving certification in a quality management system for medical device design and manufacturing. It includes templates for a quality manual, procedures, standard operating procedures, and formatted documents, all designed to aid organizations in implementing and improving their processes. Additionally, the documentation kit is user-friendly and aimed at saving time while ensuring compliance with ISO standards.
ISO 13485 Documentation Kit
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- 3. What is ISO13485:2016 Documentation? ISO 13485 was published for the first time in 1996. It presents the requirements for a comprehensive quality management system for the design and manufacturing of medical devices. To achieve ISO 13485 Certification, you must have to implement Quality Management System and prepare ISO 13485 documents that define implemented system well.
- 4. ISO 13485:2016 Documentation Requirements • QualityManual • Procedures • Exhibits • Formats / Templates • Standard Operating Procedures (SOPs) • Process Flow Chart • Audit Checklist • Medical Device File
- 5. Quality Manual • Itcovers a sample copy of the quality 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.
- 6. Procedures • It coversa sample copy of procedures covering all the specific practice areas of 19 processes. This procedures help the organization to make the best system and quick process improvements. All procedures are listed below. List of Procedures • 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 of work environment • And Many More...
- 7. Exhibits • It coversa 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 • Skill Requirements • Disposal of Non–conforming Products • Quality Plan • Document codification system
- 8. Formats • It coverssample copies of forms required to maintain records as well as establish control and make a system in the organization. The samples given are as a guide and not compulsory to follow and the organization is free to change the same to suit its own requirements. • Purchase Order • Supplier Registration form • Open Purchase Order • Design And Development Plan • Design Review Minutes Of Meeting • Preventive Maintenance Schedule List of Formats • Validation Of Autoclave By Biological Indicator • Differential Pressure Monitoring Record • Testing Of Personnel By Finger Dab • Installation commissioning report • Internal Audit Non–Conformity Report
- 9. Standard Operating Procedures •It covers a sample copy of work instructions to link with significant aspects of issues in the organization. It takes care of all such issues and is used as a training guide as well as to establish control and make a system in the organization. The samples given are as a guide and not compulsory to follow and the organization is free to change the same to suit its own requirements. List of SOPs • 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
- 10. • This documentskit contains ISO 13485 manual, procedures, SOPs, sample templates and formats that comply with system requirements. • This set of readymade documents is extremely useful to ISO 13485 consultants for complying with requirements. • This documentation kit provides you with sample templates and ISO 13485:2016 audit checklist that you need for effective quality documentation and system implementation. How This Documentation is Useful?
- 11. Features of Documentation kit •Written in Plain English • It will save much time in typing and preparation of documents alone. • User-friendly and easy to learn. • Developed under the guidance of experienced experts. • Provides a model of a Management system that is simple and free from excessive paperwork.
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