7.6.3.2 External Lab - HELP!!

D

davidsb

#1
New to TS; received third party non-conformance during surveillance audit because Lab we used to calibrate and did not have ISO17025 accreditation. As I dug into answering NC, I determined the following facts:

- External lab was the OEM of the equipment;
- No other lab could be found to do same calibration;
- Receive approval from all customers to use lab for calibration;
- External lab does not have a lab scope;
- All information required in a lab scope was found on calibration report

Short term, root cause, long term was approved by third party but rejected my objective evidence because they the calibration report I submitted in lieu of a lab scope was not a "controlled lab scope".

I really have no idea what to do next. The essence of what is required has been answered and put into place. Any suggestions on a direction would be most appreciated.

Thanks, Dave
 
Elsmar Forum Sponsor

Jen Kirley

Quality and Auditing Expert
Leader
Admin
#2
Welcome to the Cove, congratulations on your first post!

Note 2 of TS 16949:2009, 7.6.3.2 says calibration services "may be" performed by OEM when no other accredited lab is able to do the work. The sub element goes on to say the 7.6.3.1 requirements "should" be met in this case.

Have you asked the OEM for documentation that would support this issue? I wonder if they have confronted such a request before.
 

Chennaiite

Never-say-die
Trusted Information Resource
#3
New to TS; received third party non-conformance during surveillance audit because Lab we used to calibrate and did not have ISO17025 accreditation. As I dug into answering NC, I determined the following facts:

- External lab was the OEM of the equipment;
- No other lab could be found to do same calibration;
- Receive approval from all customers to use lab for calibration;
- External lab does not have a lab scope;
- All information required in a lab scope was found on calibration report

Short term, root cause, long term was approved by third party but rejected my objective evidence because they the calibration report I submitted in lieu of a lab scope was not a "controlled lab scope".

I really have no idea what to do next. The essence of what is required has been answered and put into place. Any suggestions on a direction would be most appreciated.

Thanks, Dave
I would suggest to make a visit to this Laboratory and audit them as per 7.6.3.1 and keep your records. Monopolies generally do not offer so much liberty to their Clients and therefore it might require quite an effort to make a visit or even to get them submit their documents. Also, I think your idea of receiving approvals from all Customers goes down well with ISO/TS requirement. If that be the case, I think the Auditor shall be contented with the evidence of approvals from Customer.
 
D

davidsb

#4
Welcome to the Cove, congratulations on your first post!

Note 2 of TS 16949:2009, 7.6.3.2 says calibration services "may be" performed by OEM when no other accredited lab is able to do the work. The sub element goes on to say the 7.6.3.1 requirements "should" be met in this case.

Have you asked the OEM for documentation that would support this issue? I wonder if they have confronted such a request before.
Thank you for your response. I have been lurking on here for years and it only took me eight years to post. :D

I have asked the OEM, both by phone and e-mail and acted as if they had no clue was a Lab Scope was.
 
D

davidsb

#5
I would suggest to make a visit to this Laboratory and audit them as per 7.6.3.1 and keep your records. Monopolies generally do not offer so much liberty to their Clients and therefore it might require quite an effort to make a visit or even to get them submit their documents. Also, I think your idea of receiving approvals from all Customers goes down well with ISO/TS requirement. If that be the case, I think the Auditor shall be contented with the evidence of approvals from Customer.
Thank you for your input, it is appreciated.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
#6
Thank you for your response. I have been lurking on here for years and it only took me eight years to post. :D

I have asked the OEM, both by phone and e-mail and acted as if they had no clue was a Lab Scope was.
You are so welcome.

I wonder if the person you talked to knows what this means? Examples include:

Salflex

Champion

Albar

I am not affiliated with any of the above.
 
Thread starter Similar threads Forum Replies Date
H Regarding external surface temperature limit requirement for lab incubators. CE Marking (Conformité Européene) / CB Scheme 2
D IATF 16949 SI 10, External non-accredited lab IATF 16949 - Automotive Quality Systems Standard 4
G TS 16949 External Lab for Raw Material Certs for PPAPs IATF 16949 - Automotive Quality Systems Standard 26
P How to check the external lab (manufacturer) satisfied 7.6.3.1-testing of the product IATF 16949 - Automotive Quality Systems Standard 2
C Hairsplitter question - Lab classification - 7.6.3.1 Internal or 7.6.3.2 External IATF 16949 - Automotive Quality Systems Standard 7
D 8.5.1.2 Validation and control of special processes requirements for Heat Treat External Processor AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
D IATF16949 external audit plan IATF 16949 - Automotive Quality Systems Standard 3
A How to monitor new versions of external standards in your business Various Other Specifications, Standards, and related Requirements 2
Q Quick question on the sequence of ISO 17025 external audits ISO 17025 related Discussions 14
M IATF external audit NC closure IATF 16949 - Automotive Quality Systems Standard 4
dubrizo Good Documentation Practice (GDP) as it Applies to External Contractors or Vendors Document Control Systems, Procedures, Forms and Templates 4
qualprod External consultant into a QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
W External PSU Providing a MOOP -- Will This Necessitate Conducted Emissions Testing? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
L AS9100 Section 8.4.2 - External provider test reports AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
Mikey324 External calibration - Finding in our 3rd party audit General Measurement Device and Calibration Topics 58
D Help Me. Non conformitty in External Audit IATF 16949 - Automotive Quality Systems Standard 13
P Is the second factor authentication (2FA) required for external users? Qualification and Validation (including 21 CFR Part 11) 1
J State of the Art for Documents of External Origin ISO 13485:2016 - Medical Device Quality Management Systems 17
S Recommended software to send Quality scorecards to suppliers (external providers) Supplier Quality Assurance and other Supplier Issues 3
J External Standard Services Document Control Systems, Procedures, Forms and Templates 12
Ed Panek External Standards List - Should this document include previously revised standards? ISO 13485:2016 - Medical Device Quality Management Systems 4
F Logistic/shipping companies as external providers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
J External third party audits Registrars and Notified Bodies 1
J Help settle a disagreement: Should external providers of preventive maintenance be on your ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
J Requirement for Retention of Records of Withdrawn Documents of External Origin Document Control Systems, Procedures, Forms and Templates 3
M Calibration Certificate Result issued by an accredited external laboratory General Measurement Device and Calibration Topics 9
L IATF external audit virtual (remote) IATF 16949 - Automotive Quality Systems Standard 13
A IEC 62304 safety classification, External Controls and off-label use related risks IEC 62304 - Medical Device Software Life Cycle Processes 5
R External Audit and Certificate prorogation due to the pandemic General Auditing Discussions 10
N Audit non-compliance API Q1 - Use of External Documents 4.4.4 in Product Realization Oil and Gas Industry Standards and Regulations 8
J 510(k) for a control kit for an external IVD test kit 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
R Is it required to have an SOP for external audits? Medical Device and FDA Regulations and Standards News 7
Pmarszal External Standards and Regulations Management Process Document Control Systems, Procedures, Forms and Templates 10
I What kind of wine best complements the Friday that you close out your external audit findings? Opinions are welcome. Coffee Break and Water Cooler Discussions 12
B How to apply external voltage to SIP/SOP IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
P Qualifying commercial off the shelf (COTS) external suppliers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
B Internal and external auditor competency to CSR's IATF 16949 - Automotive Quality Systems Standard 20
N IATF 16949:2016 7.1.5.3.2 External Laboratory - How to approve the Testing Laboratory without accreditation scope IATF 16949 - Automotive Quality Systems Standard 2
A OHSAS 18001 external auditor finding personal interpretation? Occupational Health & Safety Management Standards 5
L External power supplies: How close does the safety report have to match the end-use application? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
D Reduction of software class based on multiple external risk controls IEC 62304 - Medical Device Software Life Cycle Processes 5
C Identifying and Controlling External Documents Document Control Systems, Procedures, Forms and Templates 3
C External Laboratories and OEM Calibration IATF 16949 - Automotive Quality Systems Standard 0
Q AS9120B flow down to external providers: Records Retention AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
Casana IATF 16949 7.1.5.3.2 External Laboratory - On Site Calibration IATF 16949 - Automotive Quality Systems Standard 8
B Using external FDA and ISO 13485 audit as internal audit Internal Auditing 6
C ISO 17025 2017, Requirement 6.6.3 - Communicate requirements to external providers ISO 17025 related Discussions 4
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 44
qualprod The Perfect audit? External Audit causes a significant negative impact in a company General Auditing Discussions 9
K AS9100D 8.4.1.1 external providers question - Walmart, Home Depot, our lawn care team. etc. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 20

Similar threads

Top Bottom