What certification is required of whom? Multiple Locations and Testing Laboratory

J

jawatts - 2009

#1
I imagine there is an existing thread dealing with this issue, but I couldnt locate it.The company I work for has two manufacturing locations, A and B. Location B is the corporate site and also the location of the corporate testing lab which is used by both locations. All maufacturing in location B is heavy truck with no customers requirng TS certification. Location A, on the other hand manufactures for most tier 1 automotive manufacturers and is required by their customers to be TS certified. Location A uses the corporate testing lab in location B.
My question is....
Is location B, the non-automotive manufacturing site, required to be TS certified due to the testing lab and/or the corporate site being located there? Im confused. Like I mentioned, location B is all large truck and has no customers requiring TS certification. Both locations are currently QS certified.
Thanks in advance for any information.
 
Elsmar Forum Sponsor
K

Kevin H

#3
You could approach testing lab certification in one of 2 ways to meet TS requirements:
1. Consider it to be an external supplier, and have it certified to ISO Guide 17025 by an acceptable accreditation body such as LAB, A2LA, NAVLAP, etc. Then by using an ISO Guide 17025 certified lab you meet the requirements of TS.

2. Include it within the scope of registration of location A's TS certification. The fact that it is not at location A doesn't matter. You'll have to pay an extra fee to have the site reviewed as far as your TS quality system is concerned, but it may or may not be less expensive than ISO Guide 17025 registration.
For example, our design location is Sweden, our manufacturing plant is in Western PA. The design location, which is currently ISO 9001 & QS 9000 had to be audited to the TS requirements during their last surveillance so we could keep our TS certificate.

Hope the opinions help.

IMO, I'd choose the ISO Guide 17025 route. I ran a testing lab in a steel mill and felt that our A2LA certification and the reviews required to gain it actually made our lab a little better than we would have been without having sought and gained them.
 
Last edited by a moderator:
V

vanputten

#4
Check the IAOB

Hello Jawatts:

Check the IAOB website for Rules 2nd Edition FAQ's. Item #7 may relate to your question. The FAQ's were hard for me to understand but they might help you in understanding what your choices are for the lab at location B. Also, surf the website to see if there is other information pertaining to your question.

http://www.iaob.org/sanctioned.html

Regards, Dirk
 

Hershal

Metrologist-Auditor
Trusted Information Resource
#5
Kevin H said:
...certified to ISO Guide 17025 by an acceptable accreditation body such as LAB, A2LA, NAVLAP, etc.
Side notes here.....in North America, the recognized accrediting bodies are: IAS, NVLAP, A2LA, L-A-B, ACLASS, SCC (Canada), and EMA (Mexico).

ANSI/ISO/IEC 17025 is not a guide, it is a standard that a laboratory can be accredited to.

Hershal
 
M

Matt Swartwood

#6
Are both A & B under the same certification umbrella? If so, you can state procedurally (in lab and certification scope) that the testing is performed at a different facility. However, if you do this, you will be required to audit (internal audit) and 3rd party audit the lab in facility B.

We do some testing inside and because our lab scope is very specific about the methods of testing, procedures, contingency plans, measurements devices, etc, the auditors had no problem with our system and our lab is not required to be 17025 certified.

Hope this helps.
 
R

rjkozak

#7
TS rules 2.3 remote location

The support site will have to be audited for the lab & any other support functions, per the TS rules. See TS rules 2.3 remote support locations. The headcount for that support location should only be for those that support your mfg site. It keeps the cost of certification lower. Talk to your registar about this point because headcount drives cost / audit days. TS rules are tricky in this regard.

You should check with your customer in case they would require ISO 17025, as some commodities are required by OEM customers to have internal labs accredited to ISO17025. ( not common, but i have seen this required for some material suppliers).

Also it will be less costly than lab accreditation thru A2la or other . Your labs will be covered under your TS lab scope, and the remote location will have to have support functions audited for TS prior to the mfg. site , per TS rules.

Both your sites will have a lab scope that covers test & cal capabilities, see definition of lab scope in TS definitions. And external cal & test labs will need to meet external lab requirements for TS.
 
M

Matt Swartwood

#8
^^^^Exactly^^^^^

Your first plan of action should be to review the end user's supplier requirements and speak with your SDM (supplier quality rep). You should ensure there are no customer specific requirements that would tie you down. If there is nothing in writing, it wouldn't hurt to request approval from the customer.
 
K

Kevin H

#9
Hershal, you're absolutely correct on ISO 17025. Most of my active experience with it was with its predecessor - ISO Guide 25, (we were just beginning to upgrade to 17025 from guide 25 when I changed employers) and I inadvertently add guide whenever I think of it - just 1 of those little mental hickups :eek: Hopefully I'll eliminate guide from any future references I make to ISO 17025.
 
Thread starter Similar threads Forum Replies Date
V ISO 9001 or ISO 17065 required for an organization issuing 5 star rating certification of digital experience? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M Quality management certification required by Health Canada Canada Medical Device Regulations 3
M CE/FCC/Industry Canada - Standards required for Certification for a Bluetooth Device CE Marking (Conformité Européene) / CB Scheme 6
Marc IAF Mandatory Documents (MD Series) - Required to be used by certification bodies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
K ISO 14001:2015 certification for two locations required? ISO 14001:2015 Specific Discussions 3
D Distributor of Medical Devices - Is ISO certification required? ISO 13485:2016 - Medical Device Quality Management Systems 1
Wayne Is a Manufacturer's Certification good enough or is ISO 17025 Certification required ISO 17025 related Discussions 8
S Is ANVISA site certification not required for Class I and II devices ? Other Medical Device Regulations World-Wide 1
M ISO 13485 Certification - Internal Audit Program Required ISO 13485:2016 - Medical Device Quality Management Systems 12
R ISO 13485 vs FDA Requirement question about when ISO 13485 Certification is Required ISO 13485:2016 - Medical Device Quality Management Systems 4
A Microbiological Audits Required by CB under ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 9
J Required Audit Days for TS 16949 Initial Certification Audit IATF 16949 - Automotive Quality Systems Standard 1
V Is there a Heat Treat certification that is required at PPAP? APQP and PPAP 4
S Is a Stage 1 Audit required for ISO 50001 Certification? Sustainability, Green Initiatives and Ecology 1
D Moving Manufacturing Equipment from USA to Europe - Is CE certification required?? CE Marking (Conformité Européene) / CB Scheme 12
P New Certification Body Recommendations Required Registrars and Notified Bodies 25
Ajit Basrur Is ISO 13485 certification required for distribution company ? ISO 13485:2016 - Medical Device Quality Management Systems 5
M Corrective Action Report (CAR) for CB (Certification Body) required? Registrars and Notified Bodies 8
T Is Material Certification Required for Incoming Material (Receiving) Inspection? Supplier Quality Assurance and other Supplier Issues 10
M Consultant required for applying an ISO14001-2004 certification. ISO 14001:2015 Specific Discussions 14
Brizilla The Paper Chain of Certification - Supplier Certification Required? IATF 16949 - Automotive Quality Systems Standard 8
B CQI-14 (Consumer-Centric Warranty Management) certification required in the future? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 7
D TS 16949 In-House Calibration Requirements - Certification Required? IATF 16949 - Automotive Quality Systems Standard 26
I Is ISO 14971 certification required for IEC 62304? IEC 62304 - Medical Device Software Life Cycle Processes 11
J What certification is Required to Sell medical devices in the UK EU Medical Device Regulations 3
M ISO 17025 Certification required by which standards? ISO 17025 related Discussions 13
R Documents required for certification process - AS/EN/JISQ9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
L Canadian Certification Required for a USA-Based Class I Medical Device? ISO 13485:2016 - Medical Device Quality Management Systems 2
A How much objective evidence is required for ISO9000 certification? Records and Data - Quality, Legal and Other Evidence 8
N Non UKAS certification bodies - reasons for their avoidance required... Registrars and Notified Bodies 41
R Internal Audit and Management Review before Certification: Is it a required? Management Review Meetings and related Processes 3
J Demonstrate 12 months performance data for TS 16949 Certification - Required? IATF 16949 - Automotive Quality Systems Standard 5
J Is 1 year worth of audits required for TS Certification? IATF 16949 - Automotive Quality Systems Standard 6
A List of documents to prepare for Re-certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
F Attendance possibility for a certification audit ISO 13485:2016 - Medical Device Quality Management Systems 7
V ADDING NEW MEDICAL DEVICE / Product, WHEATHER THIS AFFECTS EXISTING ISO 13485 CERTIFICATION? ISO 13485:2016 - Medical Device Quality Management Systems 4
K SGS Certification - Advice on their Performance Service Industry Specific Topics 9
P How to keep a ISO 9001:2015 certification when a company is sold ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Scope of ISO 13485 certification as legal manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
J CMO in Canada do they need MDSAP/13485 certification? ISO 13485:2016 - Medical Device Quality Management Systems 1
R ISO 13485 certification scope ISO 13485:2016 - Medical Device Quality Management Systems 5
A AS9100D new certification cost?? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
N ISCC Plus - The international Sustainability Carbon Certification Sustainability, Green Initiatives and Ecology 2
S Which certification to get? Professional Certifications and Degrees 3
J Implementation, establishment and certification of IATF 16949. IATF 16949 - Automotive Quality Systems Standard 6
D Regulatory Affairs Certification (RAC) Devices Exam - Autumn 2022 study Professional Certifications and Degrees 2
A MDR Article 16 Certification of Distributors by a Notified Body? EU Medical Device Regulations 8
T NDT/NDE Level 2 Technicians Certification Oil and Gas Industry Standards and Regulations 20
M PSE Certification Japan Medical Device Regulations 5
C IATF16949 certification eligibility IATF 16949 - Automotive Quality Systems Standard 6

Similar threads

Top Bottom