Component Molding Controls and Certification to ISO 13485 - Contract Manufacturer

V

Viki N.

#1
Hi All,

We are a contract manufacturer that molds plastic components for use in a finished device that we also assemble to customer's specifications and send to the OEM. We do not do design.

Currently, our Assembly areas are certified to ISO 13485, but our molding areas are certified to ISO 9001. We want to go ISO 13485 across the board, but are unsure what kind of controls for the molding areas we really need vs. what we already do for device assembly. Surely, molding the components can't be held as stringently. Off the top on my head, I would think more controls in the following would be required: Work Environment, Supplier Control, Risk Mgmt., Product Contamination Control, Batch Records, Identification & Traceability & Status, Non-conforming Product Control, and Complaint/Corrective Action.

Has anyone had experience with external auditing of component molding and what areas of the ISO 13485 Standard was concentrated on?

Thanks for any feedback,
Viki
 
Elsmar Forum Sponsor
P

Phil Fields

#2
Hi Viki,
Why is your assembly area ISO 13485 registered, is this a customer requirement?

Phil
 
V

Viki N.

#3
Phil,

Our assembly areas make finished devices for one thing and yes, most of our customers have required this. Now...they want our molding areas also ISO 13485 and 21 CFR 820 as well, and usually try and audit us to those standards (the molding areas). We usually end up with quite a few findings even though we try to remind them that the molding areas are not ISO 13485.

Viki
 
P

Phil Fields

#4
Viki,
Check you ISO 13485 Standard (2nd ed, 2003-07-15), Annex B. Annex B describes the differences between 13485 and 9001.

I hope this is a help,
Phil
 
V

Viki N.

#5
Thanks, Phil!

I will just really need to review our molding areas to make sure we meet the requirements as needed.

Viki
 

somashekar

Staff member
Super Moderator
#6
Phil,

Our assembly areas make finished devices for one thing and yes, most of our customers have required this. Now...they want our molding areas also ISO 13485 and 21 CFR 820 as well, and usually try and audit us to those standards (the molding areas). We usually end up with quite a few findings even though we try to remind them that the molding areas are not ISO 13485.

Viki
Care to tell us the findings per 13485 in your molding area ... ?
My Option: If you also mold plastic parts that are general engineering plastic parts for other customers, then during your audit cycle of 13485, the molding area can be under the 9001 scope and your CB can very well handle this and issue both 13485 and 9001 seperately with scope clearly stated.

If you are molding some plastic parts here for your medical assembly which you would have otherwise outsourced, you would exercise all controls in the molding area as you would when outsourced. Your medical devise risk management will address the molding process also. These are very well the backbone of the 9001. If your 9001 implementation is to good depth, I see no reason why you seek 13485 for the molding area. Your 13485 scope would never say anything about your molding activity.
 
V

Viki N.

#7
Hi,

I guess the bottom line is that our customers are the real culprits as supplier auditing has hit an all-time high. We have no problems with our CB. We have separate quality manuals and most procedures are different and clearly identified.

I would say that for molded components, some of our customers and/or protential expect to see DHR-type records. We have all the required records, define retention periods, have lot identification and traceability as required but they seem to want it like we keep our device lot records. They also write findings for not having a specific procedure when the 9001 Standard does not require it. Another one is environmental type controls that are only required in ISO 13485. Our molding facilities are very clean and if required by a customer, we will use a clean tent to further control the environment. Another good one was we didn't "trend" our mice traps or bait stations and another customer actually wrote we didn't have enough of them inside or out. We pay an outside service for pest control. Or...no "cleaning validations" for our molds. All of our medical component tooling gets a "medical grade" cleaning with approved medical grade lubricants/cleaning agents only.

IMHO, the pettiness of some of the write-ups is ridiculous, but the customer is always "right" and a company jumps through hoops to get or keep the business. The C/A responses, changing/adding procedures/forms, etc. bury us at times in paperwork especially those employees assigned to them. :frust: Anyway...we will have to look more into this. Thanks for your feedback.
 
R

Roland Cooke

#8
Care to tell us the findings per 13485 in your molding area ... ?
My Option: If you also mold plastic parts that are general engineering plastic parts for other customers, then during your audit cycle of 13485, the molding area can be under the 9001 scope and your CB can very well handle this and issue both 13485 and 9001 seperately with scope clearly stated.

If you are molding some plastic parts here for your medical assembly which you would have otherwise outsourced, you would exercise all controls in the molding area as you would when outsourced. Your medical devise risk management will address the molding process also. These are very well the backbone of the 9001. If your 9001 implementation is to good depth, I see no reason why you seek 13485 for the molding area. Your 13485 scope would never say anything about your molding activity.
There's a whole bunch of reasons why you might want to include your molding operations under ISO13485.

The most obvious one is, if you already have ISO13485 for some aspects of your business for medical device customers, why would you not have all of your (relevant) operations similarly covered?
Do your customers KNOW that your molding operations are not under ISO13485? That's a hell of a risk to run. :mg:


In practical terms, there are the more stringent requirements that might be applicable, batch records, etc.

Plastic molding for medical devices is often done in cleanrooms, even if not, usually under stronger environmental controls - no use of mold release agents etc.


Finally it is incorrect to indicate that their scope would not reference plastic molding activities. As long as it is legitimate and comprehensive, in concert with their Registrar of course, their scope can say whatever they want it to say. [Edited] For example (only): Plastic molding and contract assembly for the medical device industry; control of outsourced molding and assembly operations for the medical device industry.


The ISO9001 scope can be more general, if they are in non-medical markets as well.
 
Last edited by a moderator:
V

Viki N.

#9
Roland,

You have some good points, thanks. Note: We do let our customer know that our molding is under 9001; however, they choose to audit to 13485 anyway. I think with a little focused effort, we could meet the requirements of 13485 in our molding areas and be done with it.

Viki
 
Thread starter Similar threads Forum Replies Date
F Component Molding and Over-molding - Handling Resin Inventory Manufacturing and Related Processes 2
Ajit Basrur Molding Validation procedure - New medical component ISO 13485:2016 - Medical Device Quality Management Systems 1
F Component maintenance qualification - Regulation (EU) No 1321/2014 Article 5 EASA and JAA Aviation Standards and Requirements 6
D SINGLE FAULT CONDITION, short circuit and open circuit of any component (IEC 60601-1 3.1) IEC 60601 - Medical Electrical Equipment Safety Standards Series 9
K Regulatory requirement of SaMD with machine learning component IEC 62304 - Medical Device Software Life Cycle Processes 3
D Relabelling a component that will be sold as a spare part - Do I become legal manufacturer? EU Medical Device Regulations 2
Anonymous16-2 Dietary Supplement Raw Material/Component Storage and Production Manufacturing and Related Processes 1
S PSW - Requirements for "off-the shelf" component that has multiply manufacturing locations Off the Shelf Item Manufacturing and Related Processes 1
V Process, component or full product re-qualification: leaded to unleaded solder Qualification and Validation (including 21 CFR Part 11) 8
J Traceability of component parts - Bolts, screws and washers ISO 13485:2016 - Medical Device Quality Management Systems 3
R When does the FDA consider a component a medical device? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 17
G Control Plan - Include the processes for each sub component? APQP and PPAP 2
J What is the minimum standard for automotive component traceability? Manufacturing and Related Processes 2
M Informational US FDA – URGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certain Medical Dev Medical Device and FDA Regulations and Standards News 0
D Standard guide for shelf life determination of non sterile component with degradation materials Reliability Analysis - Predictions, Testing and Standards 1
S REF and CE mark symbols on multi-component device EU Medical Device Regulations 3
J EC REP information and CE Mark - Component of a system that is not a medical device EU Medical Device Regulations 2
A Domain of the component (EASA CM No.: CM-SWCEH-001 Issue 01 Revision 02) Point 9.3.3 (Usage domain aspects) EASA and JAA Aviation Standards and Requirements 0
R IMDS for double sourced component RoHS, REACH, ELV, IMDS and Restricted Substances 3
C PCBA Hardware Component different failure types - How to rate detection? FMEA and Control Plans 8
N FDA Traceability Requirements - Component lots ISO 13485:2016 - Medical Device Quality Management Systems 2
P Electronic component failure analysis turnaround time Reliability Analysis - Predictions, Testing and Standards 0
S Medical Device Supplier Component Qualification Service Industry Specific Topics 0
A Is a Manufacturing Process Sheet required for each Component? Manufacturing and Related Processes 4
R 21 CFR Part 820 Contract Manufacturer of Medical Device Component 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
D Design FMEA for a component - Should I make the following assumptions? FMEA and Control Plans 7
I Medical device manufacturer and component supplier miscommunication Other Medical Device Related Standards 5
M Methods of reducing/eliminating the systematic component of error General Measurement Device and Calibration Topics 0
B Non Applications in ISO 13485:2016 for component contract manufacturers ISO 13485:2016 - Medical Device Quality Management Systems 3
S The difference between a Medical Device Accessory and Component Canada Medical Device Regulations 2
R Determining Sample Size for Medical Device Component Validation Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
K Biocompatibility Testing - Component Level or Assembled Medical Device? ISO 13485:2016 - Medical Device Quality Management Systems 7
S Who compiles the Critical Component List, Insulation Diagram etc.? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
MDD_QNA What is the function of the Critical Component List? ISO 14971 - Medical Device Risk Management 2
M Cleanliness and Contamination question (Medical Device Component Manufacturer) ISO 13485:2016 - Medical Device Quality Management Systems 2
M Component Manufacturer of Food Stuffs Mfg. Equipment Parts - Eat Drink Policy ISO 13485:2016 - Medical Device Quality Management Systems 1
E Updating DHF (Design History File) to include Alternative Component 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S ISO 13485 Definitions - Medical Device Component Supplier ISO 13485:2016 - Medical Device Quality Management Systems 4
M ISO 13485:2016 - IQ/OQ Requirements applicable to Electronic Component Suppliers ISO 13485:2016 - Medical Device Quality Management Systems 4
MDD_QNA Medical Device PCB component change IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
R Is pre-conditioning supplier component before incoming inspection tests allowed? Quality Manager and Management Related Issues 16
M Component Lot Number Traceability - Class I reusable and "resposable" Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 10
R USB power between Medical Device Data Collection Device Component IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
O What is the definition of d.c component in standard IEC 60601-2-10? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Who's name should be on component certification? Other ISO and International Standards and European Regulations 2
R RoHS Compliance Problem with One Component RoHS, REACH, ELV, IMDS and Restricted Substances 5
J Biocompatibility Evaluation component other than Testing Other Medical Device Regulations World-Wide 1
alonFAI Component Failure (Relay) during ICT Testing after Surface Mount Assembly Manufacturing and Related Processes 5
V AQL for Component Level and Assembled Finished Product AQL - Acceptable Quality Level 1
alonFAI Solderability test and component's life expectency Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4

Similar threads

Top Bottom