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Contain of ISO 13485 Documents Designed by GMG

Information about readymade ISO 13485 documents kit designed by Global Manager Group which includes requirements of Quality Management System for Medical Devices. This presentation guides you about content of the documentation, free demo as well as how to purchase it online. For more details visit @ www.globalmanagergroup.com

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Contain of ISO 13485 Documents Designed by GMG

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  1. Overview ISO 13485:2012 Documents By Global Manager Group

  2. What is ISO 13485? ISO 13485:2003 critical requirements for a high quality management system (QMS) wherever a company must demonstrate its ability to supply medical devices and connected services that systematically meet client needs and regulative needs applicable to medical devices and connected services.

  3. Why is ISO 13485? The aim of ISO 13485:2012 is to harmonize international regulations in the field of medical devices into one quality management system. ISO 13485: 2003 is not sufficient to comply with applicable law and regulations. Implementation of additional requirements based on local law and regulations is often required.

  4. Requirements of ISO 13485 ISO 13485 is quality management system standard for medical devices. This standard requirement is various factors in Quality management system. • Scope • Normative references • Terms and definitions • Quality management system • Management responsibility • Resource management • Product realization • Measurement, analysis and improvement

  5. Documents needs for ISO 13485 Certification? The key sections of ISO 13485 set out a range of documents requirements for developing, implementing and maintaining a Quality management system tailored to the design and production of medical devices. • ISO 13485 Quality Manual • ISO 13485 Procedures • Exhibits • Sample Formats / Templates • Quality SOP • ISO 13485 Audit Checklist

  6. ISO 13485 Total Documents by Global Manager Group The ISO 13485 documents by Globalmanagergroup.com are very useful for Medical Devices Quality Management System. This document includes QMS manual, procedures, exhibits, formats and audit checklist are very helpful of upgraded and implements QMS System and easy way of ISO 13485 certification. This document are written in English and easily editable, which saves much time. Click to Download Global Manager Group

  7. What is ISO 13485 Quality Manual? The ISO 13485 quality manual is a mandatory documents for ISO13485 certification, which maintain quality management system in medical devices. This quality manual included in total documentation kit by Global Manager Group, is given with ready to use templates for creating Company profile, Control and distribution, organization structure, Management Responsibility and more. The ISO 13485 quality manual shall outline the structure of the documentation used in the quality management system your organization.

  8. What is ISO 13485 Procedures? The ISO 13485 procedures are designed to help the organization in developing effective QMS procedures for medical devices as per ISO 13485:2012 requirements, which accelerates the process of certification.

  9. What is ISO 13485 Exhibits? The ISO 13485 exhibits are very helpful tool to teach all employees and staff about how to implements and improvements of Quality management system that helps organization to continues improvements and get number of benefits. Following list of Exhibits will be given along with documents. • Skill Requirements • Disposal of Non–conforming Products • Document codification system

  10. What is ISO 13485 Formats? The ISO 13485 formats documents are not compulsory to follow organization, but this documents very helpful of maintain records as well as establish control and make quality system in the organization.

  11. What is ISO 13485 SOPs? The ISO 13485 SOPs are given to help to any significant aspects issues and used as a training guide as well as to establish control and make system in the organization. Following list of Sample ISO 13485 SOPs are given by GMG. • 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

  12. What is ISO 13485 Audit Checklist? The ISO 13485 audit checklist is a good tool for the auditor to make audit question to make effective ISO 13485 internal audit for their organization. There are audit questions based on ISO 13485:2012 clausewise and department wise requirements are included in the total documentation kit for ISO 13485:2012.

  13. Futures of ISO 13485 Documents • Contains all necessary documents as listed above and comply with the requirements of ISO 13485:2012 guidelines for product and services development technical report. • 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 model of a Management system that is simple and free from excessive paperwork.

  14. Advantages of ISO 13485 Documents • By using these documents, you can save a lot of your precious time while preparing ISO 13485 documents for your company. • Take care for all the section and sub sections of ISO 13485:2012 guidelines and helps you in establishing better system. • Document kit enables usersto modify the documents as per their industry and create own ISO 13485:2012 documents for their organization. • Readymade templates and sample documents are available which can reduce your time in document preparation. • The audit questions helps in making perfect audit checklist. • You will get better control in your system due to our proven formats and templates.

  15. How to Purchase ISO 13485 Documents? You can go to our E shop and click option. After that give your credit card details and other details to purchase the product. We accept all the major credit cards through our secure payment processor as Visa, MasterCard, American Express, Diners Club, and Euro card. 2CO.com is our authorized third party payment gateway. All your personal data and credit card information is entered on it are encrypted so that all data remains completely secure. You may also pay by bank wire transfer.  Please Email us for more details.

  16. Thanks.. Get More information about ISO 13485 implementation, certification, integration and documentation for Quality Management System. Visit out website : www.globalmanagergroup.com Like us on Facebook at www.facebook.com/globalmanagergroup

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