One Time Service Supplier - Temperature and Humidity Testing Service

Carol2015

Starting to get Involved
#1
Here's an interesting question. We're trying to establish our operating conditions specs for temperature and humidity. To this end, we're going to test our device at specific temperature and humidity ranges using a third party's chamber. The question came up whether we need to "qualify" the company supplying the chamber in the same manner we do our other suppliers. Ours is a risk-based supplier program, with those suppliers providing critical components or services, considered as "level 1 suppliers," which are subject to surveys, periodic on-site audits, and for which we have quality agreements.

On the one hand, I would think that using equipment to establish our operating conditions specs is critical, since this will be part of our labeling and the performance of the device (like any other) would be affected if used outside the specified temperature and humidity parameters. On the other hand, it seems to me 'silly' to go through the pain and aggravation of including this one-time service company in our supplier program and start generating surveys, quality agreements, conducting audits, etc. Especially, considering they are an accredited facility holding UL and ISTA certifications. I'm leaning towards not auditing them and not including them in our supplier program. Thoughts?
 
Last edited:
Elsmar Forum Sponsor

levatorsuperioris

Involved In Discussions
#2
the compliant answer may be different than the practical answer. I don't think you will find anyone who can tell you it's compliant not to include them in your supplier program.

But what goes on a corporate credit card for a test may be different, from a practical perspective I would document why they are acceptable, ie UL certified, ISO 17025 for whatever test etc... a assessor for the testing probably only cares about the validity of the test. In this case you would be burying a skeleton in the closet so to speak, but its not too likely to get caught - you have to weigh it against your organizations risk tolerance. If your organization is extremely risk averse, I would sign them up as a new supplier, if you work for a free wheeling new company that has risk appetite I would say hope that it doesn't get caught in an audit.
 

Carol2015

Starting to get Involved
#3
I would say the compliant part is that I checked their certifications and they have the right accreditations. The company providing the chamber is reputable and fairly well-known in our industry.

After reading your answer, I'm leaning towards adding them to the supplier program. Per our SOP, level 2 suppliers are defined as providers of non-critical components or materials that become part of the final product or directly impact product quality; or a supplier of critical components in which product quality is verified by company; or service providers that could have an impact on product quality or quality system compliance. These vendors don't need to be audited. You're right, better be safe than sorry. Thanks so much for your input!
 

William55401

Involved In Discussions
#4
One more thought to think about. In travels (many med device QMS's audited and improved), I have observed some suppliers with a "one time" channel established in their supplier controls program. It defines what is needed for one time and the trigger (a third use?) pushes them into full controls. I know it takes effort to revise procedures but lightning will strike again and your team will have a future need for a "one time" supplier.
 

Carol2015

Starting to get Involved
#5
One more thought to think about. In travels (many med device QMS's audited and improved), I have observed some suppliers with a "one time" channel established in their supplier controls program. It defines what is needed for one time and the trigger (a third use?) pushes them into full controls. I know it takes effort to revise procedures but lightning will strike again and your team will have a future need for a "one time" supplier.
That makes sense, William, and it's something I had not previously considered. Thanks!
 

yodon

Staff member
Super Moderator
#6
Sounds like you have yourself painted into a bit of a corner with your categorization approach. There are frequently suppliers (especially test service providers) and commercial component providers that get qualified and approved to provide service in the life of a device. Doing an onsite audit is probably unlikely and surveys are likely to not be returned (and may not fit well for such providers anyway). You're right in that the certification (ensure through an accredited source!!) is probably the best way to qualify and approve. I agree with @William55401 that you should probably open up your process a bit to give more flexibility for such providers.
 
Thread starter Similar threads Forum Replies Date
B IATF 16949 Clause 8.4.1.2 - Supplier Selection Process - Service Providers IATF 16949 - Automotive Quality Systems Standard 11
B Supplier Approval of electronic document storage service ISO 13485:2016 - Medical Device Quality Management Systems 8
S Supplier/ Service Provider Accreditation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
T Do Machine Service Contractors Need to be an Approved Supplier? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Crusader Service-Type Supplier Evaluation Exclusion? Supplier Quality Assurance and other Supplier Issues 12
V Supplier Service Level Agreements (Supplier Quality Development) APQP and PPAP 2
T Supplier Scorecards - Service/Parts (Diesel trucks and engines) Supplier Quality Assurance and other Supplier Issues 1
A Supplier Quality Plan for Service Providers - Assistance and advice wanted Supplier Quality Assurance and other Supplier Issues 2
I Service Supplier Rating where Objective Pass/Fail Data is not Available Service Industry Specific Topics 7
D What knowledge should supplier and buyers of computers (public service agency) share? Supplier Quality Assurance and other Supplier Issues 1
B Evaluation of Service Supplier - Third party audit NC against clause 7.4.1 General Auditing Discussions 6
A Vendor (Supplier) Evaluation of Service Providers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S Service Quality at its best? Telephone line supplier Coffee Break and Water Cooler Discussions 3
Q "Service" Vendor (Supplier) Evaluation - How are you evaluating suppliers? Supplier Quality Assurance and other Supplier Issues 5
D Supplier Evaluation and Selection in the ?Service? industry Supplier Quality Assurance and other Supplier Issues 2
J Service Supplier Evaluations - Criteria for evaluation and control of registrars Supplier Quality Assurance and other Supplier Issues 7
L AS9100 - Product and Service Provision 8.5.1q AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
JoCam Rental, service & installation - regulatory requirements EU Medical Device Regulations 2
E Qualification for non gmp service providers Supplier Quality Assurance and other Supplier Issues 1
I Equipment service dates ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
H Operational planning and product and service provision when things happen so fast ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
D IEC 60601-1 - Service life testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
D Device functionality over service life - Objective evidence required? Design and Development of Products and Processes 10
Q ISO 9001 8.5.1 - Control of production and service performance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
L Design & Development of a SERVICE Service Industry Specific Topics 13
N Evaluation of service providers Supplier Quality Assurance and other Supplier Issues 2
N "Placing on the market" & "putting into service"- one time regulatory event or Continual supply event? EU Medical Device Regulations 2
samarth IVD manufacturer and service provider ISO 14971 - Medical Device Risk Management 2
C Quality Manager vs Warranty (service) Manager - Authorities & Responsibilities Customer Complaints 2
J Product Service after CE Certification expiration CE Marking (Conformité Européene) / CB Scheme 1
T Nonconforming product at customer detected by a routine inspection by field service Nonconformance and Corrective Action 9
S Service record requirements for Non-Serviceable Medical Devices CE Marking (Conformité Européene) / CB Scheme 1
C Quality at Logistical Service Provider Service Industry Specific Topics 0
M Standards Subscription Service and Standards Tracking Service Pros and Cons? Other US Medical Device Regulations 3
J NHS exemption - Benefits versus expectations in UK NHS service EU Medical Device Regulations 0
C ISO 9001:2015 Monitoring and measuring resources. Application a service industry ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
K Packaging and Damaged Parts returned from a Service Provider (Anodize) - Who is Responsible? Manufacturing and Related Processes 20
F 21 CFR Part 11 - Implicit requirements - Validation plan for a Software as a Service Other US Medical Device Regulations 1
M Informational From RAPS – Prep for Brexit: UK Seeks £25M Freight Service to Deliver Medicines, Devices Medical Device and FDA Regulations and Standards News 0
C Determining if Maintenance Contractor is an External Service subject to ISO 9001 Clause 8.4 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 43
W Customer Signature / Acceptance Service Reports Service Industry Specific Topics 2
T Is anyone working with N299.1 (Supply/service to nuclear power plants)? Various Other Specifications, Standards, and related Requirements 0
Ed Panek Ideas to keep quotes for consulting service accurate on not inflated Consultants and Consulting 11
M Informational New Notified Body designated under the MDR – TÜV SÜD Product Service GmbH Zertifizierstellen Medical Device and FDA Regulations and Standards News 1
V Replaced part affecting service life? IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
A Defining Expected Service Life in Risk Management File Reliability Analysis - Predictions, Testing and Standards 5
T Transportation - External Service Provider ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
B Will you please help me with my academic project? Repair & calibration service for test equipment ISO 17025 related Discussions 0
S Product registration platforms - A service called Licensale by Arazy Group Medical Information Technology, Medical Software and Health Informatics 0
K How to define Expected life service life of medical device Other Medical Device Related Standards 4

Similar threads

Top Bottom