Certification Documentation

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

D126 :
ISO 13485:2016 Documents


ISO 13485:2016 documents contain more than 100 editable MS-Word files. These editable documents address all the elements of medical device quality management system

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

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

  1. ISO 13485:2016 Manual: An ISO 13485 manual to establish quality system in accordance with the clause wise requirements for system implementation (40 pages in MS-word format)
  2. ISO 13485 Procedures: A list of mandatory procedures to follow during ISO 13485 certification procedure (19 procedures - 54 pages in MS-word format)
  3. Exhibits: Sample copies of mandatory exhibits (04 exhibits - 4 pages in MS-Word format)
  4. Sample Formats / Templates: Ready-to-use verified QMS forms for quick documentation (61 blank formats in MS-Word and MS-Excel format)
  5. Quality SOP: A set of sample standard operating procedures (06 SOPs - 19 pages in MS-word format)
  6. Filled forms: Asset register, risk assessment, risk treatment, scope document for quick record keeping.
  7. ISO 13485 Audit Checklist: It covers more than 900 ISO 13485 audit checklists based on ISO 13485:2016 clause wise and department wise requirements. You can customize these checklists to make your own internal audit checklist.
  8. Medical Device File: A set of sample technical documents for medical devices in accordance with ISO 13485:2016 requirements (21 files in MS-Word format)
  • The entire documents are written in easy to understand language.
  • Hand-outs are written in MS-Word 2007 and Windows 2000.
  • The soft copy of documentation kit and audit questions also forms a part of this kit.
  • Free Download of sample DEMO is available, which guide users and ISO 13485 consultants to understand the content of documentation included in the product.
  • ISO 13485 Manual and other quality system documents are developed under the guidance of the experienced quality experts.
  • The kit is designed to save much of your time in typing and preparing presentation as well as documentation.
  • It is user-friendly and easy to learn.
  • The set of ISO 13485 documents defines the baseline system with ISO 13485 audit checklist that satisfies standard requirements, which can be customized to suit your requirements.
  • It provides a model of quality system documentation that is natural, simple and free from excessive paperwork.
How useful?
  • Our documents kit 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 the quality management system for medical devices.
  • 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 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.
  • It is a perfect tool to educate all employees to achieve better performance of Medical devices in the pharma sector.
Other Details

Medical devices - Quality management systems - Requirements for regulatory purposes represent the requirements that the medical device manufacturers must incorporate into their management systems. These QMS requirements are becoming popular among the medical devices' manufacturers

The ISO 13485 Certification is based on the quality management system, which helps to implement medical device preventive system. The ISO 13485 certification 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 to comply with Medical Devices manufacturing QMS. Our ISO 13485 documents include Quality Manual, quality system procedures, SOPs, formats and ISO 13485 audit checklist. The entire set of ISO 13485 documents is designed in the editable .doc format. A user can use this ready-to-use tool while preparing for ISO 13485 Certification. It has been developed by and is also being used by our ISO 13485 consultants while conducting corporate training sessions and implementing ISO 13485 system in many pharma and medical device manufacturing companies. Our team has prepared these documents in compliance with all the necessary requirements. Our documents kit helps a user to modify the templates as per their products and create documents for their organization in a quick time.

Method of Delivery of Documentation Kit

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

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

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