Dual ISO 9001 and ISO 13485 Certification for Company with different Product Lines

#1
My company has two business lines, both of which are currently certified to ISO 9001:2008. In one business line (custom), we manufacture solely custom materials for research applications. In the other (contract), we manufacture components to regulated medical devices / medical device manufacturers. We are in the process of building out a separate facility to separate the custom and contract processes adequately. When doing so, we would like to move the contract business to ISO 13485, with the intention of developing and marketing IVDs in addition to the IVD components we already manufacture.

We want to take the approach of leaving the custom business line certified to ISO 9001, while achieving ISO 13485 certification for the "contract" business line. I have a few questions related to this:

1. Can we maintain a single documentation system that houses both ISO 9001 and ISO 13485 documents? I believe the answer to this question is yes.

2. Can we have documents in common between the two business lines. For example, we would like to share the Quality Manual and high level SOPs between the two systems. Documents, of course, would be shared only where documents are required by both systems. Documents unique to a particular standard would not be shared.

3. If we are able to share high level documents between the two systems, how does one harmonize a Quality Policy to meet the requirements of both ISO 9001 and ISO 13485? I'm having particular difficulty because ISO 9001 requires "continual improvement of..." and ISO 13485 requires "maintaining the effectiveness of..." the Quality Management System.

Your thoughts are appreciated on this topic.

Thanks!
 
Elsmar Forum Sponsor

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#2
Re: Dual ISO 9001 and ISO 13485 Certification

My company has two business lines, both of which are currently certified to ISO 9001:2008. In one business line (custom), we manufacture solely custom materials for research applications. In the other (contract), we manufacture components to regulated medical devices / medical device manufacturers. We are in the process of building out a separate facility to separate the custom and contract processes adequately. When doing so, we would like to move the contract business to ISO 13485, with the intention of developing and marketing IVDs in addition to the IVD components we already manufacture.

We want to take the approach of leaving the custom business line certified to ISO 9001, while achieving ISO 13485 certification for the "contract" business line. I have a few questions related to this:

1. Can we maintain a single documentation system that houses both ISO 9001 and ISO 13485 documents? I believe the answer to this question is yes.

2. Can we have documents in common between the two business lines. For example, we would like to share the Quality Manual and high level SOPs between the two systems. Documents, of course, would be shared only where documents are required by both systems. Documents unique to a particular standard would not be shared.

3. If we are able to share high level documents between the two systems, how does one harmonize a Quality Policy to meet the requirements of both ISO 9001 and ISO 13485? I'm having particular difficulty because ISO 9001 requires "continual improvement of..." and ISO 13485 requires "maintaining the effectiveness of..." the Quality Management System.

Your thoughts are appreciated on this topic.

Thanks!
In my opinion:

Yes

Yes

and Yes
 

GStough

Staff member
Super Moderator
#3
Re: Dual ISO 9001 and ISO 13485 Certification

I agree with Coury. My current company is registered to these same ISO standards, as well, and we use one QMS for both. As for the Quality Policy, yes, as long as it meets the intents of both standards and you can demonstrate that it is effective, there shouldn't be any problems.
 
N

Nort1

#4
Re: Dual ISO 9001 and ISO 13485 Certification

I agree with the triple "Yes".
ISO 9001 is the base document and ISO 13485:2003 has the additional requirements you need to incorporate.
It would be helpful to have an automated documentation control system and the Quality Manual and Procedures as the top level documents. This top level documentation has to address the ISO 13485 requirements with exceptions pointing to areas that are ISO9001. Then you can divide the areas and write 'Work-Instructions' as your 'SOP's' for the different areas.
I suggest maintaining at least a common CAPA system, document control and incoming inspection. However, this should be arranged based on your internal structure.
 
#5
Re: Dual ISO 9001 and ISO 13485 Certification

I agree with the triple "Yes".
ISO 9001 is the base document and ISO 13485:2003 has the additional requirements you need to incorporate.
It would be helpful to have an automated documentation control system and the Quality Manual and Procedures as the top level documents. This top level documentation has to address the ISO 13485 requirements with exceptions pointing to areas that are ISO9001. Then you can divide the areas and write 'Work-Instructions' as your 'SOP's' for the different areas.
I suggest maintaining at least a common CAPA system, document control and incoming inspection. However, this should be arranged based on your internal structure.
Thanks to everyone for the prompt responses!

This was my feeling, as well. I suppose my concern relates to the language difference between ISO 9001 and 13485 with respect to the Quality Policy requirements. Do we explicitly need to state in the Quality Policy that we (1) continually improve the effectiveness and (2) maintain the effectiveness of the Quality Management System?

I am concerned that including language about continual improvement will not sit well with an ISO 13485 auditor, while including language about maintaining the effectiveness will not sit well with an ISO 9001 auditor. Thoughts?
 

GStough

Staff member
Super Moderator
#6
Re: Dual ISO 9001 and ISO 13485 Certification

Thanks to everyone for the prompt responses!

This was my feeling, as well. I suppose my concern relates to the language difference between ISO 9001 and 13485 with respect to the Quality Policy requirements. Do we explicitly need to state in the Quality Policy that we (1) continually improve the effectiveness and (2) maintain the effectiveness of the Quality Management System?

I am concerned that including language about continual improvement will not sit well with an ISO 13485 auditor, while including language about maintaining the effectiveness will not sit well with an ISO 9001 auditor. Thoughts?
Typically, if you use the same registrar for both 9001 and 13485, you will have auditors trained in both standards so they will look at the whole policy in terms of meeting both requirements simultaneously.
 
N

Nort1

#8
Re: Dual ISO 9001 and ISO 13485 Certification

It make sense to have the same registrar. Thats what we did to have ISO13485:2003 and ISO 9001:2008.
Good Luck.
Norbert
 

Le Chiffre

Quite Involved in Discussions
#9
Re: Dual ISO 9001 and ISO 13485 Certification

In my small company, the 9001 certification came for free with the 13485. That is when I got quotes for 13485 registration then asked for 9001 as well, the estimate didn't change.
 
O

ontheopenroad

#10
Re: Dual ISO 9001 and ISO 13485 Certification

I just went through this exact same dual-certification process (adding 13485 certificate to an existing 9001 certificate). I agree with the earlier posters. I maintain one QMS, and just added the extra clauses where appropriate.

As someone said earlier, make sure that your quality policy includes "a commitment to comply with requirements". Also, apparently the people who wrote 13485 don't care about continual improvement, but want to see that you "maintain the effectiveness" of your QMS. This one cracks me up. It's like saying "don't get any better, just remain effective".

Also, if you haven't done so already, to comply with ISO 13485, Section 7.1, you will need to implement ISO 14971 Risk Management Standard.
 
Thread starter Similar threads Forum Replies Date
N Dual ISO 9001 (Manufacturing) and ISO 13485 (Design Control) for same product line ISO 13485:2016 - Medical Device Quality Management Systems 3
G Implementing Dual Standards in a Company - ISO 9001 & AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
C AS9100 and ISO 9001 - Dual Certifications Suggested at AS9100 Internal Auditor class AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13
A Maintaining Dual Standards ISO 9001 and ISO 13485 - Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 9
G Experience with APIQR dual registration to ISO 9001/API Q1 Oil and Gas Industry Standards and Regulations 10
M Scope of ISO Certification - Dual Certificates for different Products? Quality Manager and Management Related Issues 3
S Dual MDD and MDR certification EU Medical Device Regulations 7
pcoltsqe Dual AS9100 and AS9110 certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Ron Rompen Dual level holes - Measurement method suggestions wanted General Measurement Device and Calibration Topics 9
K Holding Dual Certifications - for AS9100 and AS9110 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
D Dual Lot Manufacturing requirements for Clinical Customers Manufacturing and Related Processes 3
B Registration Certificate Dual Accreditation Marks (UKAS and ANAB) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
W AS9100C/ISO9001:2008 Dual Certification (to both standards) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
I Dual Acceptance Criteria: Cpk and Individual Values Statistical Analysis Tools, Techniques and SPC 3
F How to set-up a Dual Company QMS (Quality Management System) Quality Manager and Management Related Issues 2
T Dual Reporting Responsibilities in a Company Quality Manager and Management Related Issues 3
W Can a company have a dual QMS, part AS9100 and ISO9001 the rest? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 18
J Dual degree MSQA - CSU online program (MSQA) and continuing a Masters in Biotech Professional Certifications and Degrees 2
T ASME NQA-1-1994 Standard Supplement 17S-1: Dual Storage Various Other Specifications, Standards, and related Requirements 5
U New fuel injection system - Nissan Dual Injector System World News 1
W Is a dual ISO9001 AND AS9100 QMS Feasible? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 28
J Dual Quality Systems? Pharmaceuticals and Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 8
BradM Running two monitors on one computer - Dual View After Work and Weekend Discussion Topics 9
P A standard method of Dual Dimensioning drawings (Inch/Metric) Manufacturing and Related Processes 5
GStough Dual cert (9001 & 13485) - How to audit the 1 medical device we manufacture? ISO 13485:2016 - Medical Device Quality Management Systems 6
P SUPPLIER OR CUSTOMER? - Dual role quandary Service Industry Specific Topics 6
Marc Advanced Micro Devices' new dual-core processors prices revealed After Work and Weekend Discussion Topics 2
B Dual Role Question - Metrologist AND Quality Manager - Conflict of Interest? Career and Occupation Discussions 14
M Some people here at the Cove are often brutally honest - Dual/Secret Identities? Coffee Break and Water Cooler Discussions 43
M Dual Role - Quality and Production ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
chris1price Archiving of paper records - ISO 9001 7.5.3.1b Records and Data - Quality, Legal and Other Evidence 3
M Transferring ISO 17025 from one company to another ISO 17025 related Discussions 1
D Common practices in ISO 9001 deployment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
Q ISO 9001-2015 Internal audit finding Internal Auditing 12
B ISO 17025:2017 risk management Risk Management Principles and Generic Guidelines 0
P Audit check for IT company (ISO 9001) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Label Making & Printing Standards ISO / ASTM ISO 13485:2016 - Medical Device Quality Management Systems 5
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance standard to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Ed Panek ISO 13485:2016 Section 5.5.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
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
S ISO 2768-mk print call out Other ISO and International Standards and European Regulations 11
T ISO 17024, clauses 4.3.8. and 5.1.1. Other ISO and International Standards and European Regulations 4
C ISO 14001:2015 6.1.3 Compliance Obligations - Legal requirements monitoring ISO 14001:2015 Specific Discussions 0
C Requirement to link Quality Manual to ISO 9001 clause numbers? ISO 13485:2016 - Medical Device Quality Management Systems 13
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 9
W First time being audited (ISO 9001), asking for advice ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
John C. Abnet ISO 26262 ISO 26262 - Road vehicles – Functional safety 3
Marc ISO 26262- Road vehicles – Functional safety ISO 26262 - Road vehicles – Functional safety 0
John C. Abnet ISO 26262 IATF 16949 - Automotive Quality Systems Standard 0

Similar threads

Top Bottom