13485 Checklist How To Enable JavaScript

During the management review, they will examine data from the QMS activities to make sure that all processes have the resources they need to continue to be effective, and to improve over time.

13485 Checklist How To Enable JavaScript

Here are the instructions how to enable JavaScript in your web browser.

To get you going on the right track, Ive compiled this list of the 13 steps you need to take so that you dont miss anything as you work through your implementation and get ready for certification.

This step is number one for a reason: without management support, your ISO 13485 implementation project is doomed to failure (if it gets started at all).

Youll need to craft a well-though-out presentation outlining the benefits your company can realize through ISO 13485 implementation, and get your management team on board right from the start.

To help you get organized, check out this article on Six Key Benefits of ISO 13485 Implementation.

The next critical step toward a successful implementation is making sure that you ascertain all the requirements you need to satisfy with your QMS.

Such requirements usually include legal and regulatory requirements, customer requirements, and other requirements depending on your companys needs and culture.

You want to avoid applying the QMS to areas of your business that dont pertain to quality, but you dont want to make the scope so narrow that the company sees no benefit.

When you define your QMS scope, you will have a better idea of what needs to be done, and the boundaries of your implementation.

Your best tools to help you with scope definition are the quality policy and quality manual, so these need to be the first documents you develop for your QMS.

The ISO 13485 standard defines certain mandatory procedures that must be part of your QMS, but you will also need to determine what processes and procedures within your company must be defined in order to ensure adequate and consistent quality.

The first thing to do is to define all of your companys processes, and then see how they interact with each other.

For most companies, all that needs to happen is the documentation of existing processes and procedures to ensure consistent quality that meets requirements.

You dont have to document every process, but you do need to decide which processes need a documented procedure in order to guarantee consistency in the quality of products and services.

For more explanation, see Mandatory Documentation Required by ISO 13485:2016.

All personnel need to be trained on the basics of ISO 13485, so they get an idea of the purpose of implementation; in addition, they need to be aware of any changes to be made in the processes they are a part of.

In addition, they will also decide how effective your QMS is, and whether it shows continual improvement.

For help on choosing the right certification body for your company, take a look at this List of questions to ask an ISO 13485 Certification Body.

This is when you will collect the records that will be required in audits to show that your processes meet the requirements set out for them, that they are effective, and that improvements are being made in your QMS as needed.

Certification bodies need this to happen over a certain length of time, which they will identify, in order to ensure that the system is mature enough to show compliance.

After you have operated the QMS for the prescribed length of time, but before the certification body conducts their audit, you will need to perform an internal audit of each process.

This will tell you whether or not the processes are performing as planned, and if not, youll have the opportunity to take corrective action to resolve any issues you find.

For more information, check out Five main steps in ISO 13485 Internal Audit.

Not only must management be supportive of the companys ISO 13485 implementation it is imperative that they stay involved in the ongoing maintenance of the Quality Management System.

Iso 13485 Checklist