ISO 13485:2016 is a standard and not a regulation. And only Accredited Certification Bodies for this standard are eligible to certify you. So the accreditation verification is important.
But it is the same for your CE certification. The Notified Body that you’ll select should also be accredited for this legislation.
I know what is your next question.
How do I know if a Certification body is accredited for ISO 13485 or for CE Certification?
I have the answers to that.
First I will show you a Step-By-Step process to verify if a Certification Body is accredited for a standard. And then I will show you how to check if a Notified Body is accredited for CE certification.
For both situations, the Certification Body should be inspected by an accreditation body.
ISO Accreditation
To find the approved certified bodies for ISO certificates, you can go to the IAF website (International Accreditation Forum).
This is an international organization where the accredited bodies are registered. This organization ensures that its accreditation body members are doing the right job. They should only accredit bodies that are competent for the defined standards.
So you have here 3 levels for Standard to arrive to the Inspection Body:
- Level 1: IAF (International Accreditation Forum)
- Level 2: Accreditation body
- Level 3: Certification companies (or laboratories)
As an example, we’ll see how we can find about an English Inspection Body that is accredited for ISO 13485.
Notified Body Accreditation
I will also explain you the same process for the accreditation of Notified Bodies for CE marking. In this case, you should look at the NANDO database.
This is a gold mine for you to find your Notified Body but first, you need to understand how this is working.
I created a Video for that as this is easier to understand. I will show you live from the google search to the navigation on the website how to investigate on a Notified Body. I hope you’ll enjoy it.
Index
- ISO Accreditation
- Step 1: Visit the International Accreditation Forum website
- Step 2: Check the Accredited Body Website
- Step 3: Verify the ISO Certification Body Accreditation
- Change your Certification Body
- Video - How to find a Notified Body for CE certification?
- Notified Body crisis
- How many times should I check this?
- How to write this procedure?
- Strategy to choose your Certified Body
- Next step for you
ISO Accreditation
Step 1: Visit the International Accreditation Forum website
So we start with the IAF website. Below is the homepage. You can have access to a lot of information on how this organization is working and also on their members.
Now let’s look for an accredited body located in UK. We first go to the section IAF MEMBERS AND SIGNATORIES
Then you choose the country where you want to see the accredited body.
One important thing. The accreditation body is not looking for the Medical Device Regulation. So if you have already chosen a notified body and want to verify that this one is accredited for ISO 13485, you need to select the country of the notified body. For TUV SÜD it will be Germany, for GMED or LNE it will be France, and for BSI it will be UK.
So let’s say that you are looking for BSI as your notified body (This is maybe a bad example because of BREXIT but lets use it only as example)
So we choose United Kingdom as a country to look for the accredited body. And the result is “United Kingdom Accreditation Service (UKAS)”
ISO 13485 Gap Assessment Tool
You need a ready to use tool to make a Gap Assessment for the implementation of an ISO 13485 standard. Click on the link below to see the offer
Step 2: Check the Accredited Body Website
So now you can go and visit the website of UKAS (Link). Now we will try to look for the Inspection Body that is accredited for ISO 13485. As we are already looking for BSI, we hope that this one will be on the list.
Look for the Search section on this page. It should be on the upper right side. You should see a magnifier.
When you’ll click on it the search field will expend. Now write on it “13485”.
Here is the result when you are specifically looking for “ORGANISATIONS” (Look on the upper menu bar to select it)
When you are selecting on the left sidebar “Category” tick the box for Medical Devices Quality Management Systems (ISO 13485). This will filter those specific organizations.
Or in the case, you know the name of the organization just put on the search box for example “bsi“
Step 3: Verify the ISO Certification Body Accreditation
Alleluyah!! BSI is on the list. So now you can check more deeply what is BSI accredited for.
Click on BSI Assurance UK limited.
A PDF file is opening to show you all the details on the accreditation. You first have all the contact information for this organization and the date when this accreditation was issued or updated. And also all the addresses of the offices that are under this accreditation.
On the header the first thing you find on the left side is the fact that this organization is allowed to provide you a Quality Management System Certification (ISO/IEC 17021-1)
Move forward on the document and you’ll see for which standard you can select this inspection body.
Let’s go directly to the page for ISO 13485
One of the requirements for the regulation is to select a body specialized on your field.
For example, if you are manufacturing “Device for imaging” you should find this information on this document. If you don’t find it this means that this is not the right inspection body for you.
If we go further, it will also tell you for what kind of sterilization method this body is accredited. If you are using Ethylene Oxyd as your sterilization method you should find it written on this document.
In the case this inspection body is not accredited for this Sterilization method, you should not choose it.
Let’s check for BSI.
Ok, they are allowed to accreditate you for the EO sterilization.
Last but not least. If you are located in another country, you should verify that this country accept accreditation for the UKAS. At the end of the Accreditation documents. It lists all the countries for which BSI can provide a certification.
So if your company is not located in one of these countries, you should not choose BSI as your Inspection body.
For any major standard change, you’ll need to redo the exercise to find if your Inspection Body has updated his certification.
Is this process only for ISO 13485?
What you learned now is not only applicable to ISO 13485. This process can be done for other standards.
For laboratories that you are using for calibration, analyze of your products or tools you’ll have to make this exercise and check if they are accredited for ISO 17025.
If you are using a laboratory to make microbiology test following a certain standard, you’ll to verify if the laboratory you’ve chosen is capable to do that.
On the document that will pop-up, you’ll be able to verify all the activities they can do.
Change your Certification Body
There are some situation where a manufacturer wants to change his certification body. And for that there is also some good guidance on the IAF website.
The transfer of certificates between certification bodies is described also on the ISO/IEC 17021-1:2015 clause 9.5.2.
To have a better understanding of this process, you should read the “IAF Mandatory Document for the Transfer of Accredited Certification of Management Systems”.
In case this document is updated, you can check the new version on the webpage.
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Video - How to find a Notified Body for CE Certification?
On this video, I will give you the step-by-step process not to check for ISO accreditation but for the EU Legislation accreditation. A Notified Body for CE mark, for CE Certification.
I will explain to you how to find a Notified Body on the NANDO database.
The NANDO database will have no more secret for you after that. You will be able to find a notified body with its name, its ID number or on the Free Search.
And more than that, you will also be able to check for what kind of product and which conformity assessment they are accredited.
Some of the Notified Bodies that we will highlight are BSI (0086), TUV (0123) or SGS.
Recently we have been informed that BSI located in the UK is now accredited for the New Medical Device Regulation MDR 2017/745 but what will happen after the Brexit (They are moving their Headquarter to the Netherlands).
And I will show you where to find it on this database.
Notified Body for Medical Devices is critical so choose them well. And this video will help you for that.
Oh my god, no more secret for you.
The Notified Body Crisis
While I am writing these lines, there is a crisis happening. Some Notified Bodies decide to “Lay Down Service” and do not want to follow the pathway to get MDR or IVDR accredited.
We discuss about that on an episode of my Podcast with Erik Vollebregt from Axon Lawyers.
Notified bodies are really a critical piece of the CE mark process for Medical Devices. So less Notified Bodies we have, longer can be the certification process.
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How many times should I check this?
This should be done regularly as this can change without notice. Some laboratories are not informing you that their accreditation change and continue to perform tests for you.
If a Certification Body is discovering that you are claiming the use of a certain standard but the laboratory is not anymore accredited for that, this can lead to an observation.
Solution:
- Implement a regular check of the accreditation certificate.
- At the reception of the lab report, check if the accreditation is still valid.
The only thing is that this process of accreditation check should be written somewhere. So you have to create a procedure to describe how you are doing this check.
It can also be interesting to check that for your Notified Body for CE marking on the NANDO database. Maybe less often as this is not something that changes too much and also because you have an audit every year with them. But why not verifying if they are still accredited for your products.
Can you check other Notified Bodies?
Give me the answer
How to write this procedure?
The procedure is up to you. But one thing is important.
During an audit, there is always a need of an objective evidence that this action is performed. So following the method you decided to use there can be many ways to prove that this action is done.
If you are mentioning that a check of the accreditation will be done Quarterly for example, then you need to create a form to prove that you have done this action.
If you don’t have a lot of accredited laboratories, you can say that this check will be done for each report received. And you can create a specific stamp for this to prove that you have done it.
But you can be more creative and include also on your contract with the laboratory that he should inform you of any change in their accreditation. This can be dangerous if he is not doing it.
Leave me a comment with another method that you recommend.
Gift
Template
- I created a Procedure Template to help you write the best procedure
List of Mandatory procedures
- Here is the list of the mandatory procedures for ISO 13485:2016
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Strategy to choose your Certified Body
If you are asking me which one to choose, as always the answer is “it depends”.
I will list you some cases:
Europe only
You are selling only in Europe and do not plan to sell your products outside.
If you are located in France for example, you should look for a certified body in France accredited for both CE marking and ISO 13485. Same for other countries. This is the most simple case.
Canada
If you are selling in any other country and also Canada, select a Certified Body accredited for ISO 13485, CE marking and MDSAP.
Canada accept only MDSAP certified companies. So check my article and video on MDSAP to know more.
MDSAP
If you are selling in Europe and in more than one of these countries, the MDSAP program is for you:
- USA
- Canada
- Australia
- Brazil
- Japan
So same as before, you should select a certified body that his ISO 13485, CE marking and MDSAP certified.
Let me know if you have other cases.
Next step for you
Now that you learned this process, I want you to do something.
You are not all coming from the UK so can you please check this process for your country notified bodies or laboratories.
When you checked it, tell me if you were able to find the accreditation certificate for your laboratory or certification body.
If you identify some problems, I will contact the different website and ask them to correct the issues.
This is important to keep compliance with our systems.
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.
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