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ISO 13485:2016 Documentation Requirements

Have you ever been in this situation where you have to create the ISO 13485 procedures (or SOPs – Standard Operating Procedures) and don’t know where to start?

Or even more. Do you struggle finding which mandatory procedures you have to create for your ISO 13485 Quality Management System (QMS)?


Ok, ok. Calm down.

You are at the right place to master yourself at writing procedures. So no worry and keep reading.

I will provide you with all the package you need to write procedures for a Medical Device company (Free Procedure writing template).

As a Bonus, I will also provide you with my list of Mandatory Procedures for ISO 13485:2016.

Read More on ISO 13485:2016

  • I created an FAQ for questions on ISO 13485:2016
  • This will provide you a better understanding of ISO 13485
  • If you want another question and answer to be include, please put that on comment
FAQ ISO 13485 question


Recently there was an update on the Standards ISO 13485 with the release of the 2016 version that should be transitioned to by March 2019.

Have you already reviewed it? Did you notice a change?

When I started to work with ISO 13485 it was with version 2003. It was more than 10 years ago but I remember like it was yesterday. I was working on a Dental Company in France and my Manager initiated me to the way to read this standard.

He explained me how this should work in terms of processes with inputs and output.

“Imagine a process like a car. Your procedure will be helping the person driving this process by providing a guidance. If you give some gaz to the car, the mechanism will make it move to the direction you want. And the people driving a car using the same procedure should normally drive similarly.”

He also teached me that every word in a standard are important.

A couple of words were even more important as these words would give you guidance on which are the mandatory procedures  to implement on you Quality Management System.

But before, let’s explain first what is ISO 13485 and also review the document structure of your Quality Management System (QMS).

What is ISO 13485?

ISO 13485 is “THE” Standard for Medical Device Companies. If you have one to know it should be this one.

The name of this standard is

Medical devices — Quality management systems — Requirements for regulatory purposes

To be able to sell your medical devices in Europe, you need 2 things:

  • A Quality System and here is why we need ISO 13485 2016
  • CE mark and there we’ll need to comply to MDR 2017/745 by May 2020.

If you have those 2 elements certified by a Notified Body then you are good to go.

If you didn’t have a chance to learn more about ISO 13485, the first thing is to buy it. Below is an affiliate link from BSI to get a copy of ISO 13485:2016.

Learn more on the history of ISO 13485

Video: What is ISO 13485:2016?

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Where can I find the medical device standard ISO 13485?

Easy Medical Device ISO 13485:2016 buy a copy

Do you have your copy?

This is the internationally recognized quality management system (QMS) ISO standard for the medical device industry.
BSI is one of the company that is licensed to sell standards copies.

Below is an affiliate link so you can grab a copy.

Documentation Structure

But First, what was really the basis to understand is the Document Structure. We usually describe it as a pyramid. At the top of the pyramid we always have the Quality Manual, then the procedures, then documents and then records. This is the way I simplify it. 

Have a look at the figure below to see how this is described in general.

ISO 13485 2016 document pyramid structure

But within your Quality System there is maybe another structure with more layers like:

  • Quality Manual (Read my post on how to create the best Quality Manual)
  • Policy
  • Procedures/SOP
  • Work Instructions
  • Guidance
  • Documents and records

So only you can decide. But one of the rule that I would like you to respect is the fact that any document should be at one point linked to the Quality Manual.

What does it mean?

Let’s talk about an example. You have the Internal audit process. So when you issue an internal audit, there is the audit report (Record). This is linked to a procedure telling how to realize this internal audit. This main procedure is listed on the Quality Manual.

So then the Record is linked to the Quality Manual.

If you create a record which is not linked to a procedure, then there is a breakage on the pyramid. If at one point we are trying to find this record and how to use it it will be difficult.

Look at the figure below where I describe documents linked from the top of the pyramid to the bottom.

As soon as your ISO 13485 Manual and procedures are linked, then you have a good structure.

Easy Medical Device ISO 13485 2016 Document Pyramid link

Easy Medical Device - Free Mini-Course MDR 2017/745Do you know anything about the new Medical Device Regulation EU?

If you answer NO, then this Mini-Course is for you.

It’s a free 6 days challenge with a Certificate of completion.

You’ll learn basic information about what is coming to you with the new requirements of MDR 2017/745

You need to try it

Process vs Procedure vs Work Instruction

I know this question is somehow a struggle for you. So I will try to clarify it.

Those 3 things are really different but some can mix them.

So a Procedure is a high-level SOP and a work instruction is more for deep dive. Both are controlled documents. So the difference between a procedure and work instruction is not so big. 

And a Process is included on both documents. It’s a step-by-step description that can be described on a High-level basis or with more deep dive.

Technical Documentation Templates

GSPR Template MDR 2017/745
  • Template compliant to requirements of MDR 2017/745 Annex II and III.
  • Formatted with the chapters already defined.
  • Guidance provided to help you identify the content to include
  • General Safety and Performance Requirements compliant to Annex I.
  • Include guidance to prove evidence to the requirements.

How to find ISO 13485:2016 mandatory procedures?

It’s not easy to find ISO 13485 procedures but there are some tricks to find them in your Standard. I usually look for some words that are explicit on the fact that you should create a procedure. You’ll see it’s simple.

But first, “Why required or mandatory”.

Because on the standard it is explicitly said that you need to create a procedure. So no choice. You have to have it or this is an observation during an audit.

Same when we ask to have a record. It’s explicitly marked that you need to have a record about this or this.

Ok, I am sure you are impatient to know the magic words?

These words are “Shall document” and “Procedure”.

Easy no?

So here is my technique. I am using the search function on the document and I look for the word “Procedure”.

Wherever this word pop-up I look if they ask to create a procedure and for which topic they need this procedure.

When it comes to records, it’s the same. I just look for all sentences with the word “Record” and then define if it makes sense to create a record.

It helps for the most obvious ones. Then there are some procedures that should be created but not clearly identified. This is where I use the words “Shall document”.

If you have the most obvious ones, these will be the main focus of your Notified Body when it will come to you certification. So be really committed to have all these procedures available for their review.

To help you, I’ve made my own review of the procedure and what can be considered as the main procedures to create.

I also created a pdf where I list from my research which Procedure, Documents and Records should be created to have a complete Quality Management System.

These are my own research so please don’t hesitate to contact me if you think I forgot something.

Gift for you

To help you, I’ve made my own review of the procedure and what can be considered as the required procedures to create.

I created an excel sheet where I give you an sop list from my research with which Procedures, Documents and Records should be created to have a complete Quality Management System.

These are my own research so please don’t hesitate to contact me if you think I forgot something.

Mandatory procedures

Below are listed the mandatory procedures that I did find on the ISO 13485:2016 standard.

These are my own interpretation. I suppose that you can also estimate that other procedures are mandatory for you.

  • Validation of the application of computer software used in the quality management system (4.1.6).
  • Control of documents (4.2.4)
  • Control of records (4.2.5)
  • Management Review (5.6.1)
  • Training (6.2)
  • Requirements for infrastructure and maintenance activities (6.3)
  • Monitor and control the work environment (6.4.1)
  • Arrangements to control of contaminated or potentially contaminated product (6.4.2)
  • Design and Development (7.3.1)
  • Transfer of design and development output (7.3.8)
  • Control design and development changes (7.3.9)
  • Purchasing process (7.4.1)
  • Servicing procedure (7.5.4)
  • Validation of processes (7.5.6)
    • Validation of the application of computer software used in production and services provision (7.5.6)
    • sterilization and sterile barrier systems (7.5.7)
  • Identification & Traceability (7.5.8 &
  • Preservation of product (7.5.11)
  • Control of Monitoring and measuring equipment (7.6)
  • Validation of the application of computer software used for the monitoring and measurment of requirements (7.6)
  • Feedback process (8.2.1)
  • Complaint handling (8.2.2)
  • Reporting to regulatory authorities (8.2.3)
  • Internal Audit (8.2.4)
  • Control of non-conforming product (8.3.1)
  • Advisory notices in accordance with applicable regulatory requirements (8.3.3)
  • Rework (8.3.4)
  • Analysis of data (8.4)
  • Corrective Action (8.5.2)
  • Preventive Action (8.5.3)

Now that you know which procedure you should create. Let’s help you to create them by providing some guidance and even a template.

How to write procedures

A procedure is a controlled document. This means that this is a document that has a reference, a version, a date of release…

I propose you to see what are the things that should be inside.

A procedure is normally always with the same chapters. The structure that will follow is a proposal and not something that is mandatory.

So you can be creative on the format but regarding the content we are proposing, it is in general what is expected by the auditors.

How to create your procedures for ISO 13485:2016
Easy Medical Device ISO 13485 2016 Document Pyramid link

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Free Document Package

I offer you 2 documents so you can start to create your procedures (Procedure writting template...) Look below for more detail

Template QMS procedure ISO 13485First of all, on this package, I prepared a Procedure writing Template in Word. This document combines all the previous advice that I provided.  

You’ll just have to fill the different sections of the document.

I know this is the most difficult part.

For an ISO 13485 Quality Manual example, you’ll have to look here

Document Structure Pyramid for ISO 13485:2016As we were talking about the Document Structure, I told myself, why cannot I go through the standard and propose a generic Document Structure. Then everyone can customize it. 

I wanted to help you understand what is a document structure that you can start with. Then you can make it more in phase with your company.

I listed on an excel sheet the documents that are mentioned on the ISO 13485:2016 standard.

It’s your ISO 13485 documentation to build your own Quality System by yourself.

Consider that as an SOP list that you can start to see if this is applicable to your business.

And I defined if this is something that should be on the Quality Manual, the Mandatory Procedures, some additional procedures to create, the documents or the records.

With this you are ready to start the building of your Quality Management System with the required procedures and documents.

Mindset on how to write an SOP

When you write an SOP (Standard Operating Procedure), you have to have some important mindset.

First, when you write a procedure there is a famous quote saying: “You should write what you do and then do what you write”.

What does it mean?

It means that you should not commit on something in your procedure that you cannot do or cannot sustain. 

I saw so many procedure with activities that people are not doing, but the process owner want them to do that.

Don’t use a procedure to impose something without consultation. Otherwise you will fail.


When the procedure is released, we then identify that nobody is doing this action and as a consequence it leads to an observation during an internal audit or a third party audit.

Other thing is to really use the all the possibilities on the pyramid of documentation and not create a 50 pages procedures that nobody will really read.

If one procedure is too heavy it will be difficult to implement. You should divide it then on smaller ones. 

For example you can create a main procedure linking to smaller ones. 


Easy Medical Device - Quote Write what you do and do what you write

What else should we know to write a procedure?

Let’s talk now about some soft skills that people should have to create a procedure.

There is the format of the document, the structure of the documents and now there is all what is outside.

One other important mindset is to identify for “Who” this procedure will be written.

Is it for Engineers or Machine workers or Logistic people. Each of those people do a have a different experience with procedures.

The language used, the inclusion of pictures is something you need to evaluate for an optimal understanding.

Ok, this one looks obvious but if you are an american company and you open a facility in Germany, don’t expect that all your documents should remain in English.

It’s obvious that they should be understandable locally.

I saw so many companies with documents that have been created more than 5 years ago and without any review.

I know that some people will say it’s normal as nothing changed since then. 

But during an audit, you discover that a small paragraph of the procedure is obsolete. This is an observation that could have been avoided.

My advice, implement a review timeline for each document. It can take no more than 20 minutes. 

And if all is fine, you can move to your next task.

Tips: Ideally the one reviewing the procedure should be the one that is using it.

Something that is also important is to go through your process. 

In japan, they call this “Gemba”. It means that you are going on the shop floor and looking at how people are working.

It will help you to assess if what is on the procedure is what people are doing.

Remember: “Write what you Do and Do what you Write.”

Bonus: Quick powerpoint presentation

Look at this powerpoint presentation to get a quick summary of what is on an ISO 13485 procedure.

You can use it as a reference.

Books to help you improve Technical Writing

To continue your journey to write perfect documents, I selected for you 2 books that you should read.

These books will provide you all the advices that you need to write awesome procedures for your employees.

Have a look at the amazon affiliate links below.

Now it's your turn

I hope you enjoyed this article on best tips to create your procedures with ISO 13485:2016 in mind.

Now I want to hear from you:

What did you prefer on this post and what will you change on the creation of your procedures?

Are you going to use my Motto “Write what you Do and Do what you Write”? Or will you know be sure that all your documents are linked to the Quality Manual?

Let me know by leaving a quick comment.

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Best Tips: ISO 13485 procedures with our free template (Ver 2016)
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Best Tips: ISO 13485 procedures with our free template (Ver 2016)
To write a procedure you should write what you do and then do what you write. Take the template from the website easy medical device dot com
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Easy Medical Device
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Categories: Quality

Monir El Azzouzi

Medical Device expert. Monir founded Easy Medical Device to help Medical Device companies to place compliant products on the market. He proposes his consulting services so don't hesitate to contact him at or +41799036836 My objective is to share my knowledge and experience with the community of people working in the Medical Device field.

UK Representative from January 1st, 2021

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