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)?
So I hear you screaming “HOW TO WRITE A PROCEDURE ?” or “HOW TO DOCUMENT PROCEDURES ?”
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
Background
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?
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.
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.
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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.
Let’s start first with the biggest Encyclopedia Wikipedia. If we ask Wikipedia what will be their definition for a process?
A process is a set of activities that interact to produce a result.
So for example for your industry, your process can be, for example, the way you need to package your product.
- Step 1: I take the product after the inspection process is complete
- Step 2: I put it on the Box ref: 12345
- Step 3: I check that this looks identical to picture ref 6789
- Step 4: Close the box
- Step 5: Put in place the label on the outside box
So these are a set of activities that interact to package a product.
This can be made orally or documented on an official document.
Keep reading to see how this interacts with the 2 others words
First, a procedure can have many names. In our industry, it is also called SOP or Standard Operating Procedure.
Same, let’s read again Wikipedia.
Standard operating procedure, a step-by-step instruction to achieve some result, used in industry and military
If you read it like that you think, this is the same as process, but the difference is the fact that an SOP is a controlled document.
An SOP has a certain format. You can check my free Procedure Writing Template.
So first I can say that a Process is describing specifically a set of activities when a procedure is a formatted container for this process.
Usually, the process is described inside a procedure or work instruction.
Surprisingly, at the time I looked at Wikipedia, there was no definition for “Work Instruction” so if you want to write it.
When you ask me the difference between Procedure vs Work Instruction, here is my answer.
For me, Work Instructions and procedures are nearly similar. The only difference is first:
- Procedures are higher than Work instruction
- Work instruction is like sub-procedures
In my practice, I use work instruction when I want to deep dive on a procedure.
For example, you can write a procedure on CAPA. This is a high-level procedure showing the big process.
And then I use procedures, to give more detail. I include screenshots with arrows showing on wish button to click.
For example, if you look at my article “How to verify your Certification Body accreditation?“.
This is an article I created to create a step by step process with a deep dive. I put screenshots, I include examples, links…
This is what I would consider a Work Instruction.
When if I wanted to create a procedure, I would create one on “Control of accreditations”. And inside it, I would mention a lot of other accreditations process that I should check. And one of them would be one on my Certification body one.
Let me know if this is clear for you.
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
- 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 & 7.5.9.1)
- 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.
- First we have
- the Title
- the Reference
- the Version
- the Date of release. The format of the date should be approved on your Document Control Procedure.
- Always include the page numbers. This is a Good Document Practice.
- Use the headers and footers so these information appear on each pages of your procedures.
- Approval: You should have a place where we see who did create, review and approve the document.
- History: List the different changes from Version 1. You will need also to describe the changes that you performed at each version. This is important to track when something new was implemented.
- Goals and objectives: To make this procedure understandable by everyone, we dedicate a chapter to the Goal. It should define the objective of it.
- The scope of the procedure is also important to know where this should apply. It can list the different places, offices, plants where this is applicable.
- Process Owner: One element that is important is to dedicate a chapter to who is the owner of this procedure. Why is this important? Because if you want to change it or ask question about it you can then know who to contact.
- KPI: Another possible chapter is the KPI (Key Performance Indicator). This can tell how you are measuring the effectiveness of this procedure. LISTEN to Episode 7 of the Medical Device made Easy Podcast to learn more about KPIs.
- Definitions and Abbreviations: Sometime, people when they create a procedure, they use difficult words or abbreviations, so we should dedicate a chapter to Definitions and Abbreviations.
- Standards: A good practice is also to define which standard you are using to use this procedure. Like for the risk management procedure, I would maybe list the ISO 14971. But there are also technical standards that can be listed in case it is a specialized topic.
- Related documents: As you can see on the Document Structure, the procedure is usually the main document after the Quality Manual. But under the procedure there can be other documents. First transversally, a procedure can relate to another procedure. Second the procedure can also need some forms or other documents to put it in practice. So we dedicate a special chapter to list all these documents. We should always have a link between the Quality Manual and any document of the pyramide. If a link is missing then your system is not working well. Look at the figure below to see an illustartion of documents that are linked from top to down.
- Process description: After all this you can start to describe your process. You can use only text but for a better reading and understanding, I recommend the usage of images, figures, flowcharts. Anything that visually help the reader to not get lost.
Podcast Episode 7 - Make your KPIs green again
If you have some comments on this episode, please write them on the Episode webpage (https://podcast.easymedicaldevice.com/7)
Free Document Package
I offer you 2 documents so you can start to create your procedures (Procedure writting template...) Look below for more detail
First 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
As 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.
Why?
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.
TATOO THIS QUOTE ON YOUR ARM
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.
Handbook of technical writing
Gerald J. Alread, Charles T. Brusaw and Walter E. Oliu
Technical Writing 101: A real-world guide to planning and writing technical content
Alan S. Pringle and Sarah S. O’Keefe
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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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 info@easymedicaldevice.com or +41799036836
My objective is to share my knowledge and experience with the community of people working in the Medical Device field.
