ISO 13485 Documentation Kit

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Medical Devices - Quality Management System ISO 13485:2016 Documentation Kit

ISO 13485:2016 Documentation Requirements ISO 13485 Manual ISO 13485 Procedures Exhibits Sample Formats / Templates ISO 13485 Audit Checklist sales@globalmanagergroup.com

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ISO 13485:2016 Manual • It covers sample copy of 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.

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ISO 13485:2016 Procedures • Medical devices - Quality management systems - Requirements for regulatory purposes represent the requirements that the medical device manufacturers must incorporate into their management systems.

List of Procedure • • • • • • • •

Procedure for Management review Procedure for Document and Data Control Procedure for Control of records Procedure for Internal Audit Procedure for Training Procedure For Analysis of Data Procedure For Hazard Identification Procedure for identification of products

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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 • Skill Requirements • Disposal of Non–conforming Products • Quality Plan • Document codification system sales@globalmanagergroup.com

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ISO 13485:2016 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 • • • • • •

Purchase Order Supplier Registration form Daily Stock Statement Design Validation Report Customer Complaint report Temperature Record

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• Temperature & Humidity Monitoring Record – General area • Testing Of Personnel By Finger Dab • Service report • Repairing card • Installation commissioning report • Change Note www.globalmanagergroup.com

ISO 13485:2016 Standard Operating Procedures (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 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 • • • •

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ISO 13485:2016 Process Flow Chart List of Process flow charts • • • • • • • • • • • •

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

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ISO 13485:2016 Audit Questionnaire • 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.

ISO 13485:2016 Medical Devices • There covers medical devices technical files for ISO 13485:2016.

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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.

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How Useful This Documentation?

• Our documents kit contains ISO 13485 manual, procedures, SOPs, sample templates, and formats that comply with system requirements.

• Our ISO 13485 documentation kit is ideal for individual learning as well as group training to ensure the successful implementation of the quality management system for medical devices.

• 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. sales@globalmanagergroup.com

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