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. You can buy 13485 2016 complete documentation kit for your certification based on 13485 2016 standards.

  • A Manual
  • Required Procedures
  • Formats
  • Sample Filled Forms

Original price was: $650.00.Current price is: $400.00.



Our documentation kit is written in simple language to make easily customized without having any expertise. it is user friendly, easy to learn and time saving.

There are 3 tiers of these documents. which means this product include:

Tier 1- Manual: This provides the reference to each requirement of the standard.

Tier 2- Procedure: This provide additional information about how to perform specific activity in your organization.

Tier 3– Formats: These are the actual documents that are used to show compliance with the standard.

Sample Filled Forms:

Some filled forms are also added for your guidance and to understand.

Content of 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 (40 pages in MS-word format)
  2. ISO 13485 Procedures (54 pages in MS-word format)
  3. Exhibits (04 exhibits – 4 pages in MS-Word format)
  4. Sample Formats / Templates (61 blank formats in MS-Word and MS-Excel format)
  5. Quality SOP (06 SOPs – 19 pages in MS-word format)
  6. Filled forms
  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 this iso 13485 checklist to make your own internal audit checklist.
  8. Medical Device File (21 files in MS-Word format)

Part – 1. Presentation: –

Under this directory further files are made in power point presentation as per the chapter listed below.
Topic wise power point presentation in 7 modules as listed below.

1. Overview of ISO 13485:2016 food safety management system

It covers Overview of ISO 13485:2016, benefits and summary of overall system and change process for ISO 13485:2016 quality management system.

2. ISO 13485:2016 principles

It covers 7 principles of quality management system based on ISO 13485:2016 and covers all details how such principles to be considered in making the system.

3. ISO 13485:2016 requirements

It covers ISO 13485:2016specifications, requirements, it gives explanation for many new concepts and given in plain English for easy understanding of revised changes given in ISO 13485:2016 and many places clarifications are given.

4. ISO 13485 Documents and Records

It covers documented information for ISO 13485:2016.

5. Risk Management

It covers techniques to implement the risk based thinking and identify opportunities

6. ISO 13485:2016 Quality Management System Internal Audit

It covers internal audit process for ISO 13485:2016 quality management system.

7. ISO 13485:2016 Internal audit records

It covers internal audit records for ISO 13485:2016.

8. Steps for ISO 13485:2016 QMS Installation & Certification

It covers steps to carry out quality management system internal audit based on ISO 13485:2016.

Part – 2. A trainer’s guide and handouts in editable form to understand ISO 13485:2016 subject well:-

This topic covers write up for the ready reference to the participant for understanding and reading the subject to get in depth knowledge on the subject
It is given in word. You may also use it for further reading and circulations within audience.

  1. Overview of ISO 13485:2016
  2. ISO 13485:2016 Principles
  3. ISO 13485:2016 Requirements
  4. Control of Documents and Records
  5. Risk Management
  6. ISO 13485:2016 Quality Management System Internal Audit
  7. ISO 13485:2016 Internal audit records
  8. Steps for ISO 13485:2016 QMS Installation & Certification
  9. Workshop – 1 & 2
  10. Case Study – 1 & 2

Part –3. Workshops and Case studies to evaluate effectiveness of training 02 workshops and 02 case studies:-

This topic covers workshops and case study to evaluate effectiveness of training. Each participant needs to solve this workshops and case study after undergoing the training. After successful completion of workshop and case studies the ISO 13485:2016.

Part – 4. Quality management system audit questions:-

The ready to use ISO 13485:2016 audit questions as below.

  1. ISO 13485:2016 Clause wise questions
  2. ISO 13485:2016 Department wise audit questions

Part – 5. ISO 13485:2016 management system audit forms:-

This topic covers audit forms to carry our internal audit of ISO 13485:2016 and 3 forms are given.

Part – 6. Sample Copy of ISO 13485:2016 Internal Auditor Certificate:-

Sample ISO 13485:2016 Internal Auditor training certificate copy. This sample certificate helps to create training certificate for participants after completing the ISO 13485:2016 Internal Auditor
training using our training kit.

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 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.
  • This documentation kit provides you with sample templates and ISO 13485 2016 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.
It is recommended that the documentation kit should be reviewed by the senior management, managers, and employees relevant to this department, so, they can easily understand the ISO 13485:2016 standards.
The ISO 13485:2016 documentation kit contains a ISO 13485 Quality manual that address clause wise details for how ISO 1385 systems are designed and implemented in your organization.


There are no reviews yet.

Only logged in customers who have purchased this product may leave a review.