SBS - The best value in QMS software

ISO 13485 QMS certification as a Supplier

#1
Hi everyone,
Whilst there is a lot of content regarding manufacturer's evaluation, control and so on over suppliers, is there a way to find content from the Supplier's perspective and what their obligations (and exemptions) are when becoming certified under the ISO 13485 standard? How to best adapt the QMS to reflect supplier status?
 
Elsmar Forum Sponsor

William55401

Involved In Discussions
#2
Welcome to the Cove! Please tell us more. What sort of supplier are you? Components? Services? This information may help you get a better response.
 
#3
Thanks so much for the welcome and happy holidays!
So we are a supplier of non-critical components and already have our QMS ISO 13485 certified however we must now address the non-conformities that were brought about by our lack of knowledge regarding what applies or what doesn't apply to us in having supplier status as opposed to manufacturer. Funnily enough it is proving more difficult to know what to exclude rather than know that we must cover all of the requirements.
 

Tagin

Trusted Information Resource
#4
So we are a supplier of non-critical components and already have our QMS ISO 13485 certified however we must now address the non-conformities that were brought about by our lack of knowledge regarding what applies or what doesn't apply to us in having supplier status as opposed to manufacturer.
Can you provide the text of the NCs?
 

Tagin

Trusted Information Resource
#6
Frustratingly so it very broadly only states that we should 'carefully read the standard' and assess its applicability to us as a supplier
Hmm, that doesn't sound like a proper NC. It should be specific and it should reference the exact clause that the NC is against.
 

William55401

Involved In Discussions
#7
Here's a start. You can justify not following requirements for sections 6, 7, and 8. However, you must explicitly address requirements from sections 1 to 5. One more. You say your firm makes non-critical components. Be careful with this language. Your customer, not you, is responsible for intended use and overall Risk Mgmt File per EN14971. For you to be a good supplier (and partner) and to follow the intent of the 13485:2016, risk management is important. If you implement your QMS correctly (IMHO), you take great care with your customer's highest risk features (important to quality / safety / process / function) and take action in a commensurate way. What does this mean? A critical feature (per your customer) that is nonconforming should have the proportionate level of handling to disposition that NC. What if your customer does not identify critical features? I would make this a part of contract review (yes, a dated term) to ensure your org knows what is important about each and every item you make.

I agree with prior responders that the NC from your Notified Body sounds broad.

HTH. Have fun. Enjoy the ride.
 
#8
Here's a start. You can justify not following requirements for sections 6, 7, and 8. However, you must explicitly address requirements from sections 1 to 5. One more. You say your firm makes non-critical components. Be careful with this language. Your customer, not you, is responsible for intended use and overall Risk Mgmt File per EN14971. For you to be a good supplier (and partner) and to follow the intent of the 13485:2016, risk management is important. If you implement your QMS correctly (IMHO), you take great care with your customer's highest risk features (important to quality / safety / process / function) and take action in a commensurate way. What does this mean? A critical feature (per your customer) that is nonconforming should have the proportionate level of handling to disposition that NC. What if your customer does not identify critical features? I would make this a part of contract review (yes, a dated term) to ensure your org knows what is important about each and every item you make.

I agree with prior responders that the NC from your Notified Body sounds broad.

HTH. Have fun. Enjoy the ride.
This is quite helpful advice and insight, thank you so much.
 

chris1price

Trusted Information Resource
#9
I would suggest the most important point is to identify what your customer wants from you. Certification to ISO13485 is the first step. How and when you communicate change controls and how you respond to complaints and CAPAs tend to be the more important quality related issues. Get these right and you'll have a good relationship.
 
Thread starter Similar threads Forum Replies Date
J Implementing an ISO 13485 QMS Software ISO 13485:2016 - Medical Device Quality Management Systems 6
O Adding ISO 13485 to an AS9100 QMS ISO 13485:2016 - Medical Device Quality Management Systems 13
E Sharepoint for ISO 13485 QMS for small IVD company ISO 13485:2016 - Medical Device Quality Management Systems 11
R ISO 13485 QMS Implementation Training ISO 13485:2016 - Medical Device Quality Management Systems 7
R ISO 13485 and QMS related concepts Training - Small medical device startup company ISO 13485:2016 - Medical Device Quality Management Systems 9
R Approvals on QMS Documents - ISO 13485 Requirements Document Control Systems, Procedures, Forms and Templates 2
R ISO 13485 QMS sequence of implementation ISO 13485:2016 - Medical Device Quality Management Systems 4
S Is Annual QMS Training Required? ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
C CE marking for general IVD (self-certified) & ISO 13485 QMS requirements - auditing EU Medical Device Regulations 6
R ISO 13485 purchasing QMS and ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 8
E MDSAP Audit - Our QMS conforms to ISO 13485:2016 and FDA GMP Canada Medical Device Regulations 9
S Saving QMS documents in cloud drive - Compliance with ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 3
J Medical Devices in Japan - Conformity of QMS to ISO 13485 Japan Medical Device Regulations 1
P QMS software recommendations for a small ISO 13485 company Quality Manager and Management Related Issues 5
S ISO 13485 Cl. 6.2 Human Resources - Personnel working within the QMS ISO 13485:2016 - Medical Device Quality Management Systems 4
K EQMS question - Implementing an electronic QMS to support ISO 13485:2016 Quality Assurance and Compliance Software Tools and Solutions 4
A Process Validation of QMS Software ISO 13485: 2016 Cl. 4.1.6 ISO 13485:2016 - Medical Device Quality Management Systems 26
K ISO 13485:2016 Cl. 4.2.3 - Determine QMS Processes, Monitoring, Measuring, etc. ISO 13485:2016 - Medical Device Quality Management Systems 4
A ISO 13485:2016 - Validate our use of software that impacts on the QMS ISO 13485:2016 - Medical Device Quality Management Systems 8
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
A How do we implement a Process Approach ISO 13485:2016 - Existing GMP QMS Other ISO and International Standards and European Regulations 2
J ISO 13485:2016 QMS: Outsourced Processes ISO 13485:2016 - Medical Device Quality Management Systems 11
E ISO 9001 vs ISO 13485 or both? A QMS for a Design and Development Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
L Implementing ISO 13485 with an ISO 9001:2008 QMS ISO 13485:2016 - Medical Device Quality Management Systems 3
N ISO 13485 Certification - Device Technical File in conjunction with QMS development ISO 13485:2016 - Medical Device Quality Management Systems 5
T Quality Compliance Software to meet ISO 13485 QMS and 21 CFR 820 Requirements Quality Assurance and Compliance Software Tools and Solutions 3
Q ISO 13485, ISO 9001 QMS and FDA Requirements - Process vs. Compliance Approach? ISO 13485:2016 - Medical Device Quality Management Systems 4
A LEAN ISO 13485 QMS: How many Level 3 Procedures? ISO 13485:2016 - Medical Device Quality Management Systems 7
M ISO 13485 vs. TS 16949 - One or two QMS in a company ISO 13485:2016 - Medical Device Quality Management Systems 2
Y Training on the Basics of a QMS (Quality Management System) for ISO 13485 Training - Internal, External, Online and Distance Learning 4
A ISO 13485 Internal Audits Must Cover All Elements of QMS? Internal Auditing 13
T ISO 13485 QMS Documentation template wanted ISO 13485:2016 - Medical Device Quality Management Systems 3
A Paperless Compliance - Planning to set up an ISO 13485 compliant QMS ISO 13485:2016 - Medical Device Quality Management Systems 11
W ISO 13485, ISO 9001, and AS9100 Combined QMS Manual Quality Management System (QMS) Manuals 14
T Upgrading of QMS from ISO 9001 to ISO 13485 - Quality Manual Revision ISO 13485:2016 - Medical Device Quality Management Systems 5
P Can I perform an ISO 13485 audit? I'm a registered RABQSA QMS and AS9100 Auditor ISO 13485:2016 - Medical Device Quality Management Systems 3
N Upgrading ISO 13485:2003 QMS to FDA 21 CFR 820 Compliance ISO 13485:2016 - Medical Device Quality Management Systems 1
A How to do Equipment Validation - Establishing our ISO 13485 QMS procedures Qualification and Validation (including 21 CFR Part 11) 26
H cGMP calendar and ISO 13485 - Does ISO 13485 QMS require a cGMP calendar? ISO 13485:2016 - Medical Device Quality Management Systems 10
apestate Job shop seeking QMS intends to manufacture devices, is ISO-13485 appropriate? ISO 13485:2016 - Medical Device Quality Management Systems 11
C ISO 13485:2003 QMS Flow - I have just put together my first draft ISO 13485:2016 - Medical Device Quality Management Systems 15
C Medical Device QMS manual - MDD, AIMD, 21 CFR part 820, CMDCS, and the new ISO 13485 Quality Management System (QMS) Manuals 3
R ISO 13485 Medical Devices QMS - Requirements for Regulatory Purposes Checklist ISO 13485:2016 - Medical Device Quality Management Systems 26
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
M Scope for ISO 13485 Certification of a Translation Service Provider ISO 13485:2016 - Medical Device Quality Management Systems 13
Q ISO 13485 7.5.6 Validation - Off the shelf Software ISO 13485:2016 - Medical Device Quality Management Systems 3
A ISO 13485 Certification for Resin Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
A ISO 13485 Sterilization Clause Applicability ISO 13485:2016 - Medical Device Quality Management Systems 7
K ISO 13485 and compliance of electronic signature ISO 13485:2016 - Medical Device Quality Management Systems 5
T ISO 13485 - Assembly instructions written vs. online ISO 13485:2016 - Medical Device Quality Management Systems 5

Similar threads

Top Bottom