Restricted Scope of ISO 13485 Certification

#1
Hey all - long-time lurker, first-time poster. I'm in the process of getting my IVD company ISO 13485 certified under MDSAP. We passed our Stage 1 with flying colors. Now it's crunch time for our Stage 2. We are considering restricting our scope to drop production for the time being. Here's the question I'm trying to answer:

When does a company *really* need their production certified? Is it:
-Prior to producing clinical study devices? (Or are those part of Design and Development?)
-Prior to first 510k and concurrent FDA registration (or is a Design and Development scoped cert sufficient for this)
-Prior to producing the first medical devices that will be sold?

Thanks in advance!
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
First off, separate FDA, IVDR, MDSAP, and 13485. While there's overlap, there are distinct differences.

FDA doesn't require 13485 certification. To enable distribution in the US, you only require clearance through the 510(k). They *may* accept the MDSAP audit results in lieu of doing an inspection (it's by no means a guarantee). FDA also requires that you register as a device manufacturer.

IVDR doesn't exactly require the company's QMS to be certified to 13485 - but it's the easiest route. To enable distribution in the EU, your product needs to be CE marked. That's a process of demonstrating compliance to the IVDR (and in which one element is that your quality system meets requirements - which is generally demonstrated by certification).

Premarket clinical studies are kind of odd ducks. I believe it's typical for those to be governed by an external body (e.g., IRB) and they may require specific safety or performance requirements be demonstrated prior to initiating the trial.

Circling back to your question: why would you want to exclude production "for the time being?" Expanding scope later just means additional audits.
 
#3
Circling back to your question: why would you want to exclude production "for the time being?" Expanding scope later just means additional audits.
All very good points, and helpful. We are considering excluding it because we are concerned we won't have sufficient evidence to audit by our audit date. For example, we won't have process or software tool validations complete. Functionally, for our medical devices, we will be in a design and development state until about our first surveillance audit a year from now. At which time, we could expand scope concurrent to the surveillance audit. (Perhaps of note - we have non-medical devices in production now, and are in the process of implementing our newly developed ISO compliant SOPs onto those products, but the process is taking longer than anticipated)

So if I'm reading your reply correctly, there is no specific regulatory requirement for timing of ISO 13485 cert with full scope, but it is helpful (perhaps very helpful) to have in place prior to FDA registration and CE mark. And may also be helpful for premarket clinicals depending on IRB, protocol, etc. Is that a fair assessment?
 

yodon

Staff member
Super Moderator
#4
FDA doesn't consider 13485 certification. Your 510(k) has to have data which demonstrates substantial equivalence to the predicate. You do have to have a Quality System but you have to address the FDA requirements (which should have been covered in the MDSAP audit), not 13485.

For CE marking, having 13485 certification is, indeed, the easiest path.

I would talk to your ISO registrar about scope and timing. If you have a plan for completing those activities, they *may* accept. It's typical that not everything is fully in place (e.g., postmarket surveillance - actually implementing it - you do need the procedures). If you're not planning on marketing in the EU for over a year, you may want to postpone the Stage II (although they may require that the stage I be re-done). Definitely worth a call.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#5
We are considering restricting our scope to drop production for the time being.
I think the question you should ask yourself is: What would an ISO 13485 certificate WITHOUT PRODUCTION offer you? How would that benefit you? The CB is expected to scrutinize the scope of certification very carefully, as required in the IAF MD9 Document where it reads:

"...The CAB shall precisely document the scope of certification. The CAB shall not exclude part of processes, products or services (unless allowed by regulatory authorities) from the scope of certification when those processes, products or services have an influence on the safety and quality of products ..."
 
#6
I think the question you should ask yourself is: What would an ISO 13485 certificate WITHOUT PRODUCTION offer you? How would that benefit you?
Good question - our goals include demonstrating the ability to meet the requirements to various stakeholders, internal and external; performing design and development under the standard (which admittedly could be done without a cert, but the cert ensures it is truly compliant, with less risk of "rework" or "back-fill" work generating the DHF after the fact); and laying the groundwork for a quick turnaround on transfer to manufacturing / saleable product when the development work is complete.

Open to feedback on the strategy if you or anyone has any thoughts to share
 
#7
Good question - our goals include demonstrating the ability to meet the requirements to various stakeholders, internal and external; performing design and development under the standard (which admittedly could be done without a cert, but the cert ensures it is truly compliant, with less risk of "rework" or "back-fill" work generating the DHF after the fact); and laying the groundwork for a quick turnaround on transfer to manufacturing / saleable product when the development work is complete.

Open to feedback on the strategy if you or anyone has any thoughts to share
I should also add - we have other processes in place with evidence - e.g., management reviews, internal auditing, purchasing with supplier controls, CAPA, non-conforming material handling, incoming inspections, training, etc.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#8
but the cert ensures it is truly compliant,
I don't agree with the premise here. If you are interested in degree of conformity of the existing processes against ISO 13485, I would go with an assessment route. An audit just like a "certification audit" without the pressure, limitations and constraints of a certification audit.

Certificates with serious scope limitations almost always sound as a marketing ploy. Companies issue press releases boasting about their certificates, but NEVER mention that the certificates have limitations.

Good luck.
 
Thread starter Similar threads Forum Replies Date
J Restricted device vs. prescription device Medical Device and FDA Regulations and Standards News 1
Q Restricted Substance in my Product - How to declare problem? RoHS, REACH, ELV, IMDS and Restricted Substances 3
F Statistical Models (Sigma - Restricted Vs Over- parameterized parameterisation) Statistical Analysis Tools, Techniques and SPC 2
Kales Veggie Ford RSMS (Restricted Substance Management System) 2008 released / GADSL categories RoHS, REACH, ELV, IMDS and Restricted Substances 16
M Restricted Plastic Material in the manufacturing of automotive parts? Customer and Company Specific Requirements 3
S Is Toluene (Methylbenzene) a banned or restricted substance Miscellaneous Environmental Standards and EMS Related Discussions 4
D GM's GMW 3059 - Restricted and Reportable Materials For Parts Specification Customer and Company Specific Requirements 4
P PSW (Part sample Warrant) - Restricted or reportable substances APQP and PPAP 13
S Recycling codes on PSW - Restricted or reportable substances APQP and PPAP 4
I IATF Lab Scope Testing Qualification and Competency Documentation IATF 16949 - Automotive Quality Systems Standard 3
Crimpshrine13 Laboratory Scope - Calibration vs. Test Methods - IATF 16949 IATF 16949 - Automotive Quality Systems Standard 3
silentmonkey Are risks in supply chain and development activities within scope of MDD? EU Medical Device Regulations 3
D Limited Scope for second site Question? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J Scope of ISO 9001 clause 10.2 in the product life cycle ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A IATF 16949 4.3.1 - Determining the scope of the quality management system - supplemental IATF 16949 - Automotive Quality Systems Standard 9
hockeyhead Existing process never included in AS9100 scope of certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
G APQP Scope and scale tool APQP and PPAP 2
R NRTL - Scope Question - Off-the-Shelf Plug In IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
D ISO 9001:2015 4.3 Determining the Scope of the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Scope of Combined ISO 9001 and IATF 16949 QMS - Non-automotive customers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
O MDSAP Reduction in Scope Other Medical Device Related Standards 0
D Do non-IATF customers need to be included in audit scope? IATF 16949 - Automotive Quality Systems Standard 23
C IATF 16949 - Scope or not? IATF 16949 - Automotive Quality Systems Standard 2
S Similar scope medical products connected by WIFI US Food and Drug Administration (FDA) 2
N IATF 16949:2016 7.1.5.3.2 External Laboratory - How to approve the Testing Laboratory without accreditation scope IATF 16949 - Automotive Quality Systems Standard 2
qualprod To raise a NC beyond the audit scope? Two signatures were missing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
D CE Marking Requirements MDD & MDR - new product development covered under same scope EU Medical Device Regulations 1
P Scope of application for IEC 60601-1-11 Medical electrical equipment — Part 1-11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M ISO 27001 ISMS scope for companies with subsidiaries IEC 27001 - Information Security Management Systems (ISMS) 0
T AS9100D - Scope of QMS for New Company - Only Choosing a Function Subset Due to Management AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
R Scope of ISO 13485 certification ISO 13485:2016 - Medical Device Quality Management Systems 6
D Scope of Facility - Our auditor asked us last week for our "Scope of the Facility" AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
L Dying a slow SCOPE death - NEW ISO APG Paper on Scope and Applicability May 2020. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
P Dropping ISO 9001 limits the scope of the ISO 13485 audit? ISO 13485:2016 - Medical Device Quality Management Systems 6
W Scope of MRB (Material Review Board) Responsibilities Misc. Quality Assurance and Business Systems Related Topics 5
P ISO 80369-7 standard - Interpreting which Parts should be in scope Other Medical Device Related Standards 7
I Sales Documents in scope for ISO-9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
V Exclusion of 'Design and Development' from scope of certification ISO 13485:2016 - Medical Device Quality Management Systems 9
S ISO 13485 scope of certification - We are a virtual manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 1
F API Spec Q1 Scope - Limiting the scope of certification Oil and Gas Industry Standards and Regulations 3
M How To Define ISMS (information Security Management System) Scope IEC 27001 - Information Security Management Systems (ISMS) 9
qualprod ISO 9001:2015 8.5.1 f - Scope with customer special process requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
M Determining number of employees within the "Scope" of the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
M Informational Scope of BSI for the MDR – Regulation (EU) 2017/745 on medical devices Medical Device and FDA Regulations and Standards News 0
M Medical Device News TGA Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia Medical Device and FDA Regulations and Standards News 0
Q Calibration laboratory scope - Include software such as Gagetrak or Mini tab used? General Measurement Device and Calibration Topics 3
A Determining the Scope of the QMS during Stage 1? Registrars and Notified Bodies 11
F Information Technology in IATF 16949 audit scope IATF 16949 - Automotive Quality Systems Standard 12
S MDSAP Scope ISO 13485:2016 - Medical Device Quality Management Systems 1
W Minor Audit Nonconformance Against Determining the scope of QMS IATF 16949 - Automotive Quality Systems Standard 12

Similar threads

Top Bottom