Regulatory Open Forum

HI, 
We are currently pursuing our ISO certification. Could someone help point me in the right direction on how this is written? is there a guidance document that would help with this? If anyone has had experience in writing the scope on the cert how did you go about it?

Thanks,

Rafael

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Rafael Bonilla
Quality and Regulatory Officer
Cleveland OH
United States
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Hi Rafael,

There is a guide, for what I am assuming you are trying to get is ISO 13485:2016 certified. It's the "ISO 13485:2016 – Medical devices – A practical guide
Advice from ISO/TC 210"

For scope that just depends on what stage you think you will be at when you go for your certification. You should be able to work that out through your notified body. I currently work for a company that has a design and development scope, we did have one for full manufacturing and such, but had to scale the scope back.

Thanks,

Erin

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Erin Nicklaw
Quality Analyst
Grass Lake MI
United States
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Original Message:
Sent: 30-Jan-2020 09:41
From: Rafael Bonilla
Subject: Scope for ISO cetification

HI,
We are currently pursuing our ISO certification. Could someone help point me in the right direction on how this is written? is there a guidance document that would help with this? If anyone has had experience in writing the scope on the cert how did you go about it?

Thanks,

Rafael

------------------------------
Rafael Bonilla
Quality and Regulatory Officer
Cleveland OH
United States
------------------------------

Original Message------

Hi Rafael,

There is a guide, for what I am assuming you are trying to get is ISO 13485:2016 certified. It's the "ISO 13485:2016 – Medical devices – A practical guide
Advice from ISO/TC 210"

For scope that just depends on what stage you think you will be at when you go for your certification. You should be able to work that out through your notified body. I currently work for a company that has a design and development scope, we did have one for full manufacturing and such, but had to scale the scope back.

Thanks,

Erin

------------------------------
Erin Nicklaw
Quality Analyst
Grass Lake MI
United States
------------------------------

Rafael,

I also like to use Health Canada's guidance document for creation of quality system scope.  Certainly the auditing companies for CMDCAS (in the past) used this guidance document to ensure the scope statement on the CMDCAS certificates were proper.  The guidance is here: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/quality-systems-13485/guidance-document-gd207-guidance-content-13485-quality-management-system-certificates-issued.html.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 30-Jan-2020 11:03
From: Rafael Bonilla
Subject: Scope for ISO cetification

Hi Erin,

Thanks for the insight. 

Original Message------

Hi Rafael,

There is a guide, for what I am assuming you are trying to get is ISO 13485:2016 certified. It's the "ISO 13485:2016 – Medical devices – A practical guide
Advice from ISO/TC 210"

For scope that just depends on what stage you think you will be at when you go for your certification. You should be able to work that out through your notified body. I currently work for a company that has a design and development scope, we did have one for full manufacturing and such, but had to scale the scope back.

Thanks,

Erin

------------------------------
Erin Nicklaw
Quality Analyst
Grass Lake MI
United States
------------------------------

Scope can include: "Design, development, manufacturing, distribution," etc. and then you also want to describe your product and specifically what you do with it.  Do you design and develop it or just distribute it and some contract manufacture designs, develops and manufactures it.  The scope should be specific for your devices and if different devices in your portfolio of devices that will be in your scope are different be really clear.  It it really critical to do this.

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Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------

Original Message:
Sent: 30-Jan-2020 09:41
From: Rafael Bonilla
Subject: Scope for ISO cetification

HI,
We are currently pursuing our ISO certification. Could someone help point me in the right direction on how this is written? is there a guidance document that would help with this? If anyone has had experience in writing the scope on the cert how did you go about it?

Thanks,

Rafael

------------------------------
Rafael Bonilla
Quality and Regulatory Officer
Cleveland OH
United States
------------------------------