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 Certification Documentation

D126 : Medical Devices - Quality Management System ISO 13485 :2016 Documentation Kit

399.00 USD Demo

Medical devices - Quality management systems - Requirements for regulatory purposes, represents the requirements that medical device manufacturers must incorporate into their management systems are becoming very popular in the medical device manufacturers. ISO 13485 Certification is based on quality management system, which helps to implement medical device preventive system that ensures very safe use of medical devices as per quality system guidelines.

Global Manager Group has designed Ready to use ISO 13485:2016 documents kit for Medical Devices manufacturing QMS, which covers Quality Manual, quality system procedures, SOPs, formats and iso 13485 audit checklist. The entire document set is designed in editable .doc format and can be used as best ready to use tool while ISO 13485 certification. It has been developed and is also being used by our iso 13485 consultant while conducting corporate training sessions and implementation of ISO 13485 system in many pharma and medical device manufacturing companies. Our team has prepared documents conforming to the requirements, which helps user to modify the templates as per their products and create documents for their organization in quick time.


Content of ISO 13485 2016 Manual Documentation Kit

Our ISO 13485 : 2016 documentation kit consists of the following documents in editable .doc format.

  • ISO 13485 2016 Manual - A quality system manual as per clause wise requirements for system implementation (40 pages in word document)
  • ISO 13485 Procedures - List of mandatory procedures to follow while ISO 13485 certification (19 procedures - 54 pages in word document)
  • Exhibits - Sample copy of mandatory exhibits (04 exhibits - 4 pages in word document)
  • Sample Formats / Templates - Ready to use verified QMS forms for quick documentation (61 blank formats in Word and Excel documents)
  • Quality SOP - Set of sample standard operating procedures (06 SOPs - 19 pages in word document)
  • ISO 13485 Audit Checklist - It covers more than 900 iso 13485 audit checklist as per ISO 13485:2016 clause wise and department wise requirements, which can be customized to make your own internal audit checklist.
  • Medical Device File - Set of sample technical documents for medical devices for ISO 13485:2016 (21 files in word document)
  • Written in Plain English.
  • Hand-outs written in word 7 and window 2000.
  • The soft copy of documentation kit and audit questions will be provided.
  • Free sample DEMO is available to download, which guide users and iso 13485 consultant to understand content of documentation included in the product.
  • ISO 13485 Manual and other quality system documents are developed under the guidance of experienced quality experts.
  • It will save much time in typing and preparation of presentation as well as documentation.
  • User-friendly and easy to learn.
  • Defines the baseline system with iso 13485 audit checklist that satisfies standard requirements that customized to suit your requirements.
  • Provides model of quality system documentation that is natural, simple and free from excessive paperwork.

How Documents are Useful for Quick ISO 13485 2016 Certification

  • Contains iso 13485 manual, procedures, SOPs, sample templates and formats that comply with system requirements.
  • Our ISO 13485:2016 documentation kit is ideal for individual learning as well as group training to ensure successful implementation of quality management system for medical devices.
  • This set of readymade documents are useful to iso 13485 consultants.
  • Provides you with sample templates and ISO 13485 audit checklist that you need for effective quality documentation and system implementation.
  • By using our globally used editable iso 13485 2016 documents, you can save a lot of your precious time and money while preparing the course materials for in-house documents and SOPs to create cultural change in the organization.
  • Perfect tool to educate all employees to achieve better performance of Medical devices in pharma sector.
  Other Details

Method of Delivery for Documentation Kit

By downloading Free DEMO, User can understand the content of documentation kit, which helps them to easily take decision of purchase the products. User can purchase it online via secure third party payment gateway or via Bank wire transfer as mentioned in Payment Option on each page. After purchase of ISO 13485:2016 Medical device - QMS documentation kit, we will provide username and password within 12 working hours for online E-delivery of our products by ftp download from our server.

This product kit softcopy is now on sale. This product is delivered by download from server/ E-mail.

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D126 : Medical Devices - Quality Management System ISO 13485 :2016 Documentation Kit 399.00 USD Demo