One of the first things I look when I arrive at a Medical Device company or to one supplier is the ISO 13485 Quality Manual.

ISO is an international quality management standard for medical devices. This page presents an overview of ISO and provides a PDF sample of our approach. Download free ISO 13485 materials. Checklist of Mandatory Documentation Required by ISO White paper, PDF format. 13485Academy is one of the.

Why?

Because this is the first document that you should know if you want to understand the Quality Management System.

Do you know one of the common issues I see when I review some Quality Manual?

I see a lot of companies that have an ISO 13485 Manual that is built like a book. With tones of pages to describe everything and nothing.

When I see it, I suppose that this company wants to show off, otherwise, it means they have a complex Quality System which is not better.

What will you learn today?

Today you will learn what is the minimum requirement that should be on a Medical Device Quality Manual. Don’t miss it until the end!

I even created an ISO 13485 Quality Manual Example so you can see how short it can be. This Quality manual template is provided to you for free so don’t hesitate to download it.

I made it like if Easy Medical Device is a company manufacturing medical device products. But don’t stick to the full content as everything is a fiction. Just understand the idea.

Included you will also see an ISO 13485 Quality Policy example. It will help you to define how does this look like.

Use that template to help you build a solid Quality Manual that can help you organize your company not create a wall between your employees and your system. The secret is to make it simple.

To whom does this apply?

If you are looking for building a Quality Manual for a small manufacturing company or a big one, all that you will learn today is applicable.

Why you need ISO 13485:2016?

Don't forget that for companies that want to comply to the new Medical Device Regulation MDR 2017/745 or In-Vitro Diagnostic Regulation IVDR 2017/746, you need to justify of a Quality System. And ISO 13485:2016 would be one that can help you reach that objective.

So keep in mind that your Quality Management System (QMS) is key for your success.

A Medical Device Quality Manual is a Document required by ISO 13485 2016 which is one of the most famous standards for Quality Management System of Medical Device companies. But you can also apply this for the FDA 21 CFR Part 820.

The purpose of the Quality Manual is to help you navigate your Quality System.

As mentioned before, it’s a document that has some minimum requirements coming from ISO 13485.

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Get a copy of your ISO 13485:2016 standard by clicking the below button.

But most of the companies are using it as a marketing tool or includes way too much information on it.

Consequence, it looks too complex and people who should read it and use it to understand your Quality Management System are lost.

It should be a controlled document that will be part of your Quality Management System. No other document on your Quality System is superior to the Quality Manual.

For companies that have a paper-based quality system, then include that as your first document on your QMS folder with all the required signatures to prove that it’s released.

For those that have an eQMS (Electronic platform to management quality documents), then you need to create a new document and send it for signature on your workflow. If you have the possibility to link it directly to all procedures then it would be an asset in case of a change.

This document should be also trained to all employees of the company. This is one of the documents that everyone should know. With this document, they can navigate on your QMS.

Read More on ISO 13485:2016

• I created an FAQ for questions on ISO 13485:2016
• If you want another question and answer to be include, please put that on comment

If we look at your document structure we can imagine a Pyramid.

On top of the pyramid there should be the Quality Manual and below it all the other document types (SOP, Work instruction, Document, records, guidance…)

This structure should be reflected on your QMS or eQMS to help people to navigate on it.

The best way is to identify the processes that are linked to the document on the reference number.

• IA-XXX for Internal Audit
• MR-XXX for Management Review
• …

Be creative so people are not lost but have a clear rule that you will describe on your Document Control procedure.

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Now we are ready to describe the content of your ISO 13485 Manual. Essentially there are 4 things that are requested.

We just described previously one of them which is the document structure.

This structure should appear on the Quality Manual. It will help to understand the types of documents that are on your system.

Here are the 3 others:

You’ll need to mention on your Quality Manual the scope of your Quality System.

TIPS: What I have seen on some Quality Manual is the History of the company. This is not a specific requirement but I would recommend to include it.

If you are a manufacturing plant, then, for example, the scope of your Quality System can be:

“ The scope of the Quality Manual is for all COMPANY companies located at ADDRESS 1, ADDRESS 2

Within these location the main activities are:

• Design and development
• Incoming inspection of products and raw material
• Manufacturing
• Inspection
• Packaging
• Labeling
• Release of products
• Management of suppliers
• Distribution to end customer
• Complaint handling

But we should exclude Chapter 7.5.3 “Installation activities” and chapter 7.5.4 “Servicing activities” which is under the responsibility of the customers who should use the Instruction for Use delivered with the product.

And finally, as our products are not intended to be implanted or delivered sterile, chapter 7.5.5 and 7.5.9.2 does not apply“

As you can see, on the scope I include all that the company is doing and also what the company is not doing. You should also define what an external third party is doing for you. For example

“Final cleaning and sterilization of Sterile products is performed by our Supplier XXXX”

The exclusion or non-application of some chapters of the ISO 13485 is authorized with a justification. This justification should be recorded in the Quality Manual.

You can include the documented procedures mentioned on this standard in the Quality System or easier, you can just reference to it.

This is one of the mistake that people are doing. They are creating a Quality Manual with many pages because instead of creating a separate procedure, they are including them on the Quality Manual.

Worst, they are including on the Quality Manual high level information and create a separated procedure. But when they update the separated procedure they always forgot to update the quality manual.

As mentioned there are 2 problems.

• It makes your Quality Manual big
• if you need to update one documented procedure, you’ll need to update each time your Quality Manual.

How we solve that?

You just need to create a chapter called “Documented Procedures” and then you create a table with 2 rows.

First row will be the reference to your procedure and second row will be the title of it.

Check an example on the Quality Manual Template I created for you.

If your documentation quantity is reasonable this should not exceed 1 or 2 pages.

Read also: ISO 13485:2016 Mandatory procedures.

TIPS: Some companies think that a small Quality Manual shows weakness to external people but in reality it shows clarity to your employees.

External people are reading that document only once but your employees are always referring to it. So think first of your employees who need to consider your quality system as a solution not as a problem.

How many processes do you have?

This is something that should be shown on your Quality Manual but not only that.

The objective is to describe how your processes are interacting. To make it easy I propose you to use a figure called process map.

How does this work?

A process should receive inputs and provide outputs. So usually every process of your Quality System is an input or an output of other processes.

Below is an example of a process map that you can customize for your company. I provide you an example on the Quality Manual Template (LINK)

Free Medical Device Regulation MDR 2017/745 Course​

I know I told you that the Quality Manual does need only the minimum requirement. But I usually include also some key element on it.

So I present you 4 items that can be good to have. Your choice to include them or not.

They will be part of the ISO 13485 Quality Manual Template that I created.

In the case your industry uses specific wording or abbreviation, it would be nice for the readers to understand them.

Glwiz download for windows 8. So I suggest that you include a section with the definition of all the difficult words or the abbreviations that you are using.

One of them is the Quality Policy. This is a requirement of chapter 5.3 but it doesn’t say specifically on which format this should be presented.

Why on the Quality Manual?

As mentioned before, the Quality Manual is a document for which every employee is trained. So this is important for them to also be trained on the Quality Policy of the company.

This should not stop you to display a signed copy of it on the wall of your company. But be careful if there is a change in it. All copies should be removed and updated. It’s why I recommend mentioning that the master copy is the one on the Quality Manual. And if there is a change of it, a process is in place to update also the ones displayed on the company.

Tips: Some notified body ask to have the Quality Policies displayed in the company as controlled document if they are dated and signed.

If you are considering them as controlled copies, then mention in a document linked to your procedure for Quality Policy update where are displayed the signed copies. This will also help your employees to know where to go to update them.

P.S: An ISO 13485 quality policy examples are available for you on my Free Quality Manual Template.

I saw on some companies that the organizational chart is included on the Quality Manual. This can be dangerous if you include the people’s names.

I always recommend to include only the functions and the reporting lines. In case of a change of the person itself, this should have no impact to your Quality Manual.

Tips: Anyway a change of your organization that is impacting your Quality System should be evaluated on your Quality System Management Review and you should define if this should be reported to your notified body.

If your company is selling their products all over the world. It’s also important to reference which regulation and standards you are following.

I am not asking you to list all the standards you use to design your products. But the main standards that you use to implement your quality system.

For example:

“ Regulation:

• MDD 93/42/EC
• QSR 21 CFR Part 820

Iso 13485 2016 Pdf Free Download

Standards:

• ISO 13485:2016
• ISO 14971:2012”

ISO 13485 Quality Manual Template Free Download

You will receive a Zip file with 4 versions of that document (pdf, docx, open document odt and epub).

I created a Free ISO 13485 Quality Manual Template to help you understand how this should look like.

I used Easy Medical Device as the company which manufactures some medical devices.

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But everything is fiction.

I also included the other things I mentioned but as I told you this is not mandatory. It’s only to put more clarity on some elements.

For those that are interested to get a copy of this free Quality Manual Template to download, Push the below button.

Tips: I see some companies on the internet that are selling a Template of Quality Manual around 100$. I hope this will save you some money and help you to think about the content of your Quality Manual to fit your company.

I described you how I see the perfect Medical Device Quality Manual. I hope this was valuable to you.

Now, I want to hear from you if there are other things that you estimate should be included and why. This can maybe help me to update my post to include it. If you find some mistakes don’t hesitate to contact me on my about me page.

Remember that the Quality System is here to help you provide good products to your customers and not to stop your progression or act as a Police.

Leave me a comment below.

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Medical Device expert. Working since more than 10 years on the area of Quality and Medical Devices. Expert on Quality Management, Regulatory Affairs, Regulatory Compliance and New Technology.

My objective is to share my knowledge and experience with the community of people working on the Medical Device field.

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