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Clause-by-clause explanation of ISO 13485:2016

Clause-by-clause explanation of ISO 13485:2016

White paper, PDF format

This document explains each clause of ISO 13485:2016 in plain English to help you better understand the requirements of the standard. The document provides guidelines on what needs to be done to meet each requirement of the standard.

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List of questions to ask an ISO 13485 certification body

List of questions to ask an ISO 13485 certification body

Checklist, MS Word format

With so many different companies to choose from, finding the right ISO 13485 certification body to work with can be confusing. Using the prepared questions outlined in this free list, you can plan in advance exactly what to ask each prospective body. Clear explanations for each question will help you to find the perfect ISO 13485 certification body for your certification.

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Project proposal for ISO 13485:2016 implementation

Project proposal for ISO 13485:2016 implementation

Template, MS Word format

Implementing a project like ISO 13485:2016 is easier with the support of management. Use our project proposal template to help achieve the approval and commitment necessary from top management to progress. Plus, you’ll gain invaluable insights about the project itself.

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How to budget an ISO 13485 implementation project

How to budget an ISO 13485 implementation project

White paper, PDF format

Implementing a project like ISO 13485 can be costly if you do not budget in advance. This white paper aims to help you budget effectively, and prevent any unnecessary expenses from occurring. Not only will you learn budgeting benefits and tips, but also how different implementation options can impact your overall budget.

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ISO 13485 White papers (6)

Clause-by-clause explanation of ISO 13485:2016

Clause-by-clause explanation of ISO 13485:2016

White paper, PDF format

This document explains each clause of ISO 13485:2016 in plain English to help you better understand the requirements of the standard. The document provides guidelines on what needs to be done to meet each requirement of the standard.

Click to download
How to budget an ISO 13485 implementation project

How to budget an ISO 13485 implementation project

White paper, PDF format

Implementing a project like ISO 13485 can be costly if you do not budget in advance. This white paper aims to help you budget effectively, and prevent any unnecessary expenses from occurring. Not only will you learn budgeting benefits and tips, but also how different implementation options can impact your overall budget.

Click to download
Implementing ISO 13485:2016 with a consultant vs. DIY approach

Implementing ISO 13485:2016 with a consultant vs. DIY approach

White paper, PDF format

Deciding which method to follow when implementing ISO 13485:2016 can be difficult and confusing. This white paper outlines the pros and cons of both going it alone, and hiring a consultant. It offers detail on both techniques, as well as what to look for in a good online solution, helping you make an informed decision on the best approach for your business.

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ISO 13485:2003 vs. ISO 13485:2016 matrix

ISO 13485:2003 vs. ISO 13485:2016 matrix

White paper, PDF format

This matrix shows the relationships between the requirements of ISO 13485:2003 and the new ISO 13485:2016, while providing an overview of requirements common to both versions. It also offers tips on how to make the transition to the new version with as little stress as possible.

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Twelve-step transition process from ISO 13485:2003 to the 2016 revision

Twelve-step transition process from ISO 13485:2003 to the 2016 revision

White paper, PDF format

This white paper is intended for companies that have implemented the ISO 13485:2003 standard, and are planning to transition to the 2016 revision. The paper describes the suggested steps in the transition process.

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Checklist of Mandatory Documentation Required by ISO 13485:2016

Checklist of Mandatory Documentation Required by ISO 13485:2016

White paper, PDF format

Knowing what documents and records are necessary for ISO 13485:2016 can be confusing. This white paper is designed to clear up any misunderstandings regarding documents required by this standard, as well as outlining non-mandatory documents that are commonly used. It also offers help on structuring these documents, in a straight-forward and easy-to-follow format.

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Presentations (1)

Project proposal for ISO 13485:2016 implementation

Project proposal for ISO 13485:2016 implementation

Presentation, MS PowerPoint template

When it’s time to present your ISO 13485:2016 implementation project to top management, you need to show them clearly and briefly why this project is important for your company. With our Project Proposal template in PowerPoint, you’ll have a head start in earning management’s support.

Click to download

Templates (2)

Project proposal for ISO 13485:2016 implementation

Project proposal for ISO 13485:2016 implementation

Template, MS Word format

Implementing a project like ISO 13485:2016 is easier with the support of management. Use our project proposal template to help achieve the approval and commitment necessary from top management to progress. Plus, you’ll gain invaluable insights about the project itself.

Click to download
Project Plan for ISO 13485 implementation

Project Plan for ISO 13485 implementation

Template, MS Word format

During implementation of ISO 13485, it’s critical to manage all aspects of the project. You’ll need to oversee everything from project milestones to individual roles and their responsibilities. With this Project Plan template, you can effectively organize your ISO 13485 implementation.

Click to download

Checklists (3)

List of questions to ask an ISO 13485 certification body

List of questions to ask an ISO 13485 certification body

Checklist, MS Word format

With so many different companies to choose from, finding the right ISO 13485 certification body to work with can be confusing. Using the prepared questions outlined in this free list, you can plan in advance exactly what to ask each prospective body. Clear explanations for each question will help you to find the perfect ISO 13485 certification body for your certification.

Click to download
Project Checklist for ISO 13485:2016 Implementation

Project Checklist for ISO 13485:2016 Implementation

Checklist, MS Word format

This checklist will enable you to easily keep track of all the steps of your ISO 13485 implementation project. There are 12 major steps and 43 tasks, starting with obtaining management support all the way through to your certification audit.

Click to download
Diagram of ISO 13485:2016 Implementation Process

Diagram of ISO 13485:2016 Implementation Process

Diagram, PDF format

Planning the implementation of ISO 13485:2016 is a crucial step in the success of your Medical Device Management System. With our ISO 13485:2016 Implementation Diagram you can see at a glance the step-by-step process to follow, ensuring nothing is forgotten.

Click to download
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