ISO 13485 Requirements versus FDA product classification and GMP exemptions - Audits

pbojsen

Involved In Discussions
#1
I work for a manufacturer of FDA regulated products, but some of them are FDA classified as Class I, GMP exempt. That means I am only required to keep records and complaints. No design files are required, no medical device file, etc.

However, ISO 13485 says I do have to have design files, medical device files, and all the other applicable documents in the standard.

The question is, does the FDA requirement trump the ISO standard, or am I required to have what the standard calls for regardless of FDA product classification?
 
Elsmar Forum Sponsor

William55401

Quite Involved in Discussions
#2
It really depends. Where do you distribute your product? For the USA, class I GMP exempt is an express lane. The bar may be higher in other geographies where 13485 is must
 

Gisly

Starting to get Involved
#3
The scope of your ISO13485 certificate should be clear on this. Ex.- exlude Design and Development, or be specific on which product(-lines) is covered by the certificate.
 

Billy Milly

Involved In Discussions
#6
As already explained above, if your product (device family...) is listed on the certificate scope, 13485 requirements apply to this product in full. If certificate states any exclusions/omissions, you can omit those chapters in the QMS (e.g exclusion of R&D).
If it is a MD or not is actually irrelevant, your certificate scope determines what you need to do and have. Silly example, if you include "production of paper clips" into your scope, 13485 requirements apply to them, because you decided so by including them in the scope.

Maybe a solution would be to define different product codes for different jurisdictions: Product 1 for US/FDA - no design files. Product 2 for EEC (listed on the certificate) - full QMS per 13485.
 
Thread starter Similar threads Forum Replies Date
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
DuncanGibbons Clear differences between ISO 13485 and AS 9100D requirements ISO 13485:2016 - Medical Device Quality Management Systems 10
R Approvals on QMS Documents - ISO 13485 Requirements Document Control Systems, Procedures, Forms and Templates 2
C CE marking for general IVD (self-certified) & ISO 13485 QMS requirements - auditing EU Medical Device Regulations 6
F ISO 13485:2016 Quality Policy Requirements Other ISO and International Standards and European Regulations 18
M Does ISO 13485 or MDR require you to state the origins of customer requirements or user needs? Design and Development of Products and Processes 2
D ISO: 13485:2016 Sec. 7.5.2 (C) - Requirements for cleanliness of product or contamination control ISO 13485:2016 - Medical Device Quality Management Systems 2
G ISO 13485:2016 and regulatory requirements - Contract Manufacturing ISO 13485:2016 - Medical Device Quality Management Systems 22
R CNC Software Validation requirements as per ISO 13485:2016 Other ISO and International Standards and European Regulations 8
A ISO 13485:2016 Applicable regulatory requirements ISO 13485:2016 - Medical Device Quality Management Systems 2
D ISO 13485 production cleaning requirements of reusable devices ISO 13485:2016 - Medical Device Quality Management Systems 2
S ISO 13485 Cl. 4.2.5 - Requirements for Control of Records ISO 13485:2016 - Medical Device Quality Management Systems 3
R ISO 13485 - Advisory Notice Requirements ISO 13485:2016 - Medical Device Quality Management Systems 5
Sam Lazzara Medical Device File Requirements (ISO 13485 Cl. 4.2.3) ISO 13485:2016 - Medical Device Quality Management Systems 11
C ISO 13485 Medical Device File requirements for IVD ISO 13485:2016 - Medical Device Quality Management Systems 1
R CAPA Verification - ISO 13485:2016 Requirements and Objective Evidence ISO 13485:2016 - Medical Device Quality Management Systems 2
K Meeting the requirements of ISO 13485:2016 Cl. 4.1.4 within a wiki-based QMS ISO 13485:2016 - Medical Device Quality Management Systems 3
T Product Instructions (IFU) - Placement Requirements - ISO 13485:2003/2016 Other ISO and International Standards and European Regulations 2
GoSpeedRacer ISO 13485:2016 Clause 4.2.5 - Control of Records - HIPAA Requirements ISO 13485:2016 - Medical Device Quality Management Systems 11
N ISO 13485 - Other Documentation specified by Applicable Regulatory Requirements ISO 13485:2016 - Medical Device Quality Management Systems 2
B Risk Requirements to meet the explicit Risk Based Approach of ISO 13485:2016 Examples ISO 13485:2016 - Medical Device Quality Management Systems 21
E ISO 13485 Clause 7.3.2 - Purchased Data Approval and Record Requirements ISO 13485:2016 - Medical Device Quality Management Systems 2
M ISO 13485:2016 - IQ/OQ Requirements applicable to Electronic Component Suppliers ISO 13485:2016 - Medical Device Quality Management Systems 4
J KGMP (Korean GMP requirements) vs. ISO 13485 Other Medical Device Regulations World-Wide 5
Raffy ISO 13485 NIST Traceability requirements for calibration of test equipment ISO 13485:2016 - Medical Device Quality Management Systems 3
K ISO 13485 and DHF (Design History File) requirements ISO 13485:2016 - Medical Device Quality Management Systems 9
R ISO 13485 Validation and CAR Requirements ISO 13485:2016 - Medical Device Quality Management Systems 6
N Do ISO 9001 and ISO 13485 have requirements for Shelf-Life? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
V Differences between ISO 13485 & FDA Requirements ISO 13485:2016 - Medical Device Quality Management Systems 6
M ISO 13485 Audit Questions - Internal Auditor Training and other Requirements ISO 13485:2016 - Medical Device Quality Management Systems 10
T Early Research & Development - ISO 13485:2003 requirements Clarification ISO 13485:2016 - Medical Device Quality Management Systems 34
K ISO 13485 requirements for Stand Alone Medical Device Software (Class II a) ISO 13485:2016 - Medical Device Quality Management Systems 1
S Identifying gaps over ISO 13485 to be compliant to MDD 93/42/EEC requirements EU Medical Device Regulations 5
M ISO 13485 - Supply Chain Requirements ISO 13485:2016 - Medical Device Quality Management Systems 8
J Columbia ISO 13485 Requirements Other Medical Device Regulations World-Wide 1
J Essential Requirements Checklist w/o ISO 13485 CE Marking (Conformité Européene) / CB Scheme 7
C ISO 13485 - Documented Requirements for Risk Management ISO 13485:2016 - Medical Device Quality Management Systems 6
M ISO 13485 Calibration Supplier Evaluation Requirements question Other ISO and International Standards and European Regulations 2
somashekar What are the ISO 13485 documented requirements for Risk Management? ISO 13485:2016 - Medical Device Quality Management Systems 13
R ISO 13485 Software Validation Requirements - Help needed ISO 13485:2016 - Medical Device Quality Management Systems 4
S Packaging and Label Change Requirements - ISO 13485/FDA 21CFR820 ISO 13485:2016 - Medical Device Quality Management Systems 3
M Learning ISO 13485 - Getting a better understanding of the requirements ISO 13485:2016 - Medical Device Quality Management Systems 6
L ISO 13485 Lead Auditor Re-Training Requirements ISO 13485:2016 - Medical Device Quality Management Systems 2
M IAF-MD9 Audit Man-Days Requirements for ISO 13485 Quality Manager and Management Related Issues 30
A ISO 13485 Supplier Monitoring Minimum Requirements Supplier Quality Assurance and other Supplier Issues 3
C Document Numbering and Hierarchy Requirements for ISO 13485 Document Control Systems, Procedures, Forms and Templates 3
F Traceability Requirements for Computer Hardware Equipment under ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 2
T How to manage Suppliers in accordance with ISO 13485 Requirements Supplier Quality Assurance and other Supplier Issues 5
R Training Within Industry modules - JIB's and ISO 13485 Documentation Requirements Lean in Manufacturing and Service Industries 5
C ISO 13485 Class 7 Cleanroom Requirements ISO 13485:2016 - Medical Device Quality Management Systems 7

Similar threads

Top Bottom