Adding ISO 13485 to an AS9100 QMS

O

outdoorsNW

Quite Involved in Discussions
#1
#1
Management at my AS9100D certified company has asked about adding ISO13485 certification.​

The guides I can find online, including Elsmar, are either for older revisions, are broken links, or are focused on going from ISO13485 to 9100 or ISO9001 to 13485 rather than AS9100 to ISO13485. (I know AS9100 is all of 9001, but the added 9100 requirements may cover 13485 requirements 9001 does not.)​

We are a contract manufacturer of electronics and do not do design. Most of our current customers are aerospace, so we are used to aerospace FOD controls, product preservation, etc.​

We will avoid sterile products except possibly if the customer will take all responsibility for getting the product from commercially clean to sterile.​

Labeling, if any, would be as required by the customer. Medical products would not be sold under our name.​

Having taken a quick look at the latest rev of 13485 including Appendix B, I don’t immediately see any big changes required.​

How practical are combined AS9100-ISO13485 audits?​

How many more days would typically be added for a 100 person company?​

Does anyone know of an up to date guide for adding 13485 to an established AS9100 quality system?​

I would like to hear from people what areas we would likely have to update and what pitfalls we may encounter.

​
 
Quickly Organize an Intelligent TDP from DISCUS
Elsmar Forum Sponsor
Sidney Vianna

Sidney Vianna

Post Responsibly
Staff member
Admin
#2
#2
outdoorsNW said:
How practical are combined AS9100-ISO13485 audits?
Click to expand...
From a CB audit team perspective it is highly unlikely that your current CB auditors would be deemed competent for ISO 13485, so chances are you will have new auditors assessing your system against a new standard and the possibility for conflict of interpretational issues.

Becoming part of the medical device supply chain will also make your organization a potential "target" of the FDA oversight system, just like being part of the Aerospace supply chain makes you a potential recipient of a FAA audit, too.
 
shimonv

shimonv

Trusted Information Resource
#3
#3
Combining in the full sense of the word is not a good idea.
I worked once with such a contract manufacturer. He had a designated area for medical device manufacturing and some specific SOPs for medical. Not all SOPs can be adapted in an effective way. I remember they had a CAPA SOP and Medical CAPA SOP, and so on. It's a big job.

And continuing with what Sidney wrote, you will also need an additional internal audit to cover the Medical part of your QMS.

Shimon
 
O

outdoorsNW

Quite Involved in Discussions
#4
#4
Thanks Sydney and Shimonov.​

Good to know that a single auditor for both standards is unlikely.​

I don’t see a clause that allows a contract manufacture to exclude parts of 4.2.3 that are handled by the customer or OEM.​

Looking at the 13485 requirements for the medical device file (4.2.3) the section says "shall include" the items in subsections a to f. However as a contract manufacturer of only part of the device, selling only to the product OEM or other subcontractors working for the OEM, parts of section 4.2.3 may be difficult to comply with. Will we be allowed to simply put in the file whatever the customer tells us and not have to fight them to give us information to comply with every clause?​
 
D

DannyK

Trusted Information Resource
#5
#5
I am qualified to audit both AS9100 as an AEA and as a lead auditor for ISO 13485:2016.
As a consultant, I have also been involved in helping several contract manufacturers get certified to both. I am able to do an integrated internal audit since I know both standards quite well.

Regarding the comment about 4.2.3 from outdoorsNW, if you are a manufacturer of part of the device, that means you are manufacturing the assembly and not the final device. Auditors cannot expect you to have the full contents of clause 4.2.3.
 
S

sandra2014

Involved In Discussions
#6
#6
DannyK said:
I am qualified to audit both AS9100 as an AEA and as a lead auditor for ISO 13485:2016.
As a consultant, I have also been involved in helping several contract manufacturers get certified to both. I am able to do an integrated internal audit since I know both standards quite well.

Regarding the comment about 4.2.3 from outdoorsNW, if you are a manufacturer of part of the device, that means you are manufacturing the assembly and not the final device. Auditors cannot expect you to have the full contents of clause 4.2.3.
Click to expand...
Hello,
 
S

sandra2014

Involved In Discussions
#7
#7
We are certified to both AS9100D and ISO 13485:2016, we are a contract manufacturer of components for medical device clients. We do not design or manufacturer the 'medical device'. Our CB auditors have never addressed this issue with us, we currently have ISO 13485:2016 4.2.3 as in compliance, and we would like to revise our QA Manual to deem ISO 13485:2016 clause 4.2.3 as 'non applicable', since we are not the medical device manufacturer (our client is). Would this be an acceptable action?
 
Sidney Vianna

Sidney Vianna

Post Responsibly
Staff member
Admin
#8
#8
sandra2014 said:
Would this be an acceptable action?
Click to expand...
Since the file requires production and testing procedures, you would be expected to support the design responsible/legal manufacturer with part of the files, so I don't think you could/should claim full exemption to it.
 
D

DannyK

Trusted Information Resource
#10
#10
Sandra, I agree with Sidney's answer. The legal manufacturer is responsible for the medical device files in 4.2.3. In your quality manual you can state that you will maintain the files as per the contractual requirements with the legal manufacturer. Some of my clients were building circuit card assemblies and were not informed about where the assembly was being used.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
K Adding a New Site to Our ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 9
R Considering adding ISO 13485 certification - Your thoughts? ISO 13485:2016 - Medical Device Quality Management Systems 4
4 Adding a new Company - ISO 9001 Design Exclusion Design and Development of Products and Processes 1
D Adding PPAP forms to the ISO procedures Document Control Systems, Procedures, Forms and Templates 2
M Adding AS9100C Lead Auditor Certification to an IRCA ISO 9001 LA Certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
F Implementing ISO 11135 - Facilities Conditions - Adding ETO Sterilization Other Medical Device Related Standards 4
A ISO 9001 company now adding Welding to the Scope - What needs to change? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
F Adding a New Office Location to an ISO 9001 Certificate (Scope of Registration) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
B ISO 14971 DFU IFU Warning Adding Accessory ISO 14971 - Medical Device Risk Management 1
M Adding More Procedures than are Required by ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
G Adding AS9100 to a ISO/TS 16949 QOS (Quality Operating System) Document Control Systems, Procedures, Forms and Templates 4
J Adding AS9000 to ISO 9001 and QS9000 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
U Adding another Subcontractor EU Medical Device Regulations 3
N Adding unclassified product to the medical device registration US Food and Drug Administration (FDA) 1
S Complexity Rating - CB adding another audit day for "high complexity" AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
E Adding models to an approved Russian Registration Certificate Other Medical Device Regulations World-Wide 1
gunnyshore Adding a new facility - do I need to submit an amendment to the MDL or MDEL, or both? Canada Medical Device Regulations 3
D Adding a Class I to a sample box Canada Medical Device Regulations 5
K Adding the Notified Body Number CE Marking (Conformité Européene) / CB Scheme 2
P Adding "new" medical device to existing CER - under MDD CE Marking (Conformité Européene) / CB Scheme 1
F Adding a medical device in another medical device package EU Medical Device Regulations 2
K Relabeling or Not Relabeling - Adding our internal Part Number barcode label 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A Adding Remote Site to Current IATF 16949 Certification IATF 16949 - Automotive Quality Systems Standard 2
S Adding Value prior to signing EASA Form 1 EASA and JAA Aviation Standards and Requirements 5
D Adding a new site to 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 4
S Adding claims on medical device labelling 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Adding a UDI Compliant Label to previously manufactured devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
P Adding an additional distributor to a current Mexico Medical Device Registration Other Medical Device Regulations World-Wide 0
L IATF 16949: Adding a Remote Location between certifications IATF 16949 - Automotive Quality Systems Standard 2
T Adding an adapter to a Torque Meter to change the Range Capability, Accuracy and Stability - Processes, Machines, etc. 6
R Coexisting Investigational Use and CE-Mark - Adding a new Indication EU Medical Device Regulations 4
C Adding information to Labels - Class II Medical Devices US Food and Drug Administration (FDA) 1
K Medical device procedure tray - Adding products in Custom packs Other Medical Device and Orthopedic Related Topics 3
D Adding an extra Label on an Ethylene Oxide Sterilized Box ISO 13485:2016 - Medical Device Quality Management Systems 3
E Adding a "Scope Statement " to my Quality Policy ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
W Quality for value adding or certification? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
somashekar Adding an other process into the system - Authorised Economic Operator (AEO) Scheme ISO 13485:2016 - Medical Device Quality Management Systems 4
Z Adding 1% error to data in a column in Minitab Using Minitab Software 3
M Is 510k Required for Adding a section on use of Disinfectants to Product Manual? US Food and Drug Administration (FDA) 3
S FDA CDRH Premarket Review Submission Cover Sheet - adding more products 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
B What to do when adding new Proprietary name under same 510(k) Other US Medical Device Regulations 2
M PPAP requirements when adding Part Transfer Robots between Machines APQP and PPAP 1
B Need help in adding second location to FDA Registration Other US Medical Device Regulations 4
K Adding a Disclaimer on an FMEA FMEA and Control Plans 4
M Adding Bizminer's Industry Financial data to my Peer Company Comparison Manufacturing and Related Processes 0
D Rounding Numbers - Adding numbers in Excel - I want the average Excel .xls Spreadsheet Templates and Tools 3
Q Adding to our A2LA Scope of Accreditation General Measurement Device and Calibration Topics 2
marmotte Adding a Funct. Earth. to a class II / BF device...retest needed? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
M Document Changes not affecting the process - Adding Logos, etc. Document Control Systems, Procedures, Forms and Templates 8
V Option for adding date-time to the copies printed from Adobe Acrobat (pdf) Quality Assurance and Compliance Software Tools and Solutions 1

Similar threads

Top Bottom