Lab Requirement 4.10.7

P

Patti

#1
I have been tasked with bringing our labs on site up to speed to the QS-9000 requirements. The internal qualifications are not a problem, the problems lie in accreditation of labs we use in addition to our own. If you could please answer the following questions or direct me to where I could find additional information I would be very grateful.
If I have this correct, QS-9000 requires that all external labs used for analysis and calibration must be Guide 17025 certified or equivalent.
What other National Equivalents. Would EPA, FDA certification be ok?
What can a company do if the external labs they are currently using are not 17025 certified and:
Is the only lab that can perform the required analysis
Is the closest lab to the company and provides the best turnaround time to meet internal/external customer needs
Is the most cost effective choice for the company
What is the protocol for non-certified labs?
Can we perform an audit on their quality systems and approve them for use?
If so, is there a guideline/checklist that we can use that will satisfied QS9000 requirements?
Can we request our customers to waive the accreditation requirement?
Does this include everything sent outside the company or can we define what is required to be sent to accredited labs?
Thanks
 
Elsmar Forum Sponsor
A

Al Dyer

#2
Originally posted by Patti:
I have been tasked with bringing our labs on site up to speed to the QS-9000 requirements. The internal qualifications are not a problem, the problems lie in accreditation of labs we use in addition to our own. If you could please answer the following questions or direct me to where I could find additional information I would be very grateful.

If I have this correct, QS-9000 requires that all external labs used for analysis and calibration must be Guide 17025 certified or equivalent.

-Yes

What other National Equivalents. Would EPA, FDA certification be ok?

-Do you want the FDA/EPA to calibrate your CMM?

What can a company do if the external labs they are currently using are not 17025 certified and:
Is the only lab that can perform the required analysis

-Don't use them. Tough road, why aren't they certified. You can use the gage supplier to calibrate your gages, under circumstancs outlined in QS-9000 3rd edition.


Is the closest lab to the company and provides the best turnaround time to meet internal/external customer needs Is the most cost effective choice for the company

-Do you think the customer (SQA) really cares cares about your cost?


What is the protocol for non-certified labs?

-Don't use them.


Can we perform an audit on their quality systems and approve them for use?

- Sure, will your customer buy in?????


If so, is there a guideline/checklist that we can use that will satisfied QS9000 requirements?

-Not to my knowledge, try A2LA.

Can we request our customers to waive the accreditation requirement?

-Yes, will you get it? I dont know, I'd like my customer to waive the QS-9000 requirements for customer satisfaction. QS is a set of standards with very few "outs".


Does this include everything sent outside the company or can we define what is required to be sent to accredited labs?

-Why would you (your company) put youself in a position where you are using labs that might not be up to snuff?


Cost?

Thanks
ASD...
 
P

Patti

#3
FDA / EPA certifications would only be used for our chemical analysis. Just wanted to know if a registrar would accept these accreditation.
 
Thread starter Similar threads Forum Replies Date
Q Is there a recommended lab layout for a ISO TS requirement? General Measurement Device and Calibration Topics 3
T Lab Accreditation Requirement QS-9000 - American Automotive Manufacturers Standard 1
H Can a calibration lab still use ISO 6789:2003 as guide for torque calibrations Other ISO and International Standards and European Regulations 1
F Position of Quality Manager - Can the organization's Quality Lead be shown as Quality Manager of the lab as well? ISO 17025 related Discussions 5
W My company is looking to start a materials testing lab that conforms to ISO17025:2017 ISO 17025 related Discussions 3
P Testing lab in India IEC 60601-2-25 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
M Microbiological Testing Lab - Layout & Standards Other Medical Device Regulations World-Wide 0
D USFDA vs NRTL/IEC 17025 Differences - Compliance testing lab ISO 17025 related Discussions 0
D USFDA vs NRTL/IEC 17025 Differences - Compliance testing lab US Food and Drug Administration (FDA) 6
S How many of you are using Robotic process automation for calibration lab management? ISO 17025 related Discussions 0
C Must your reference standard provider be ISO17034 certified to meet your testing lab's ISO 17025 certification requirements? Other ISO and International Standards and European Regulations 2
S The procedure for replicate check in calibration lab as per ISO 17025 General Measurement Device and Calibration Topics 2
M Arguing with the test lab about failing in an EMC test IEC 60601 - Medical Electrical Equipment Safety Standards Series 12
D Help identify a Nationally Recognized Testing Laboratory (NRTL) (UL) certified lab General Measurement Device and Calibration Topics 3
I FAR Part 43 and Application to 17025 Accredited Cal Lab Federal Aviation Administration (FAA) Standards and Requirements 2
S Is it mandatory for a Calibration Lab to be ISO 17025 accredited? General Measurement Device and Calibration Topics 7
G Setting Up a Basic Quality Lab for a small manufacturing company General Measurement Device and Calibration Topics 2
C MSA for Non Manufacturing - Design Validation, Characterization and Qualification Lab Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
D 7.6.3.2 External Lab - HELP!! IATF 16949 - Automotive Quality Systems Standard 5
J ISO 17025 testing laboratory - Receiving lab supplies - What really needs a C of A? ISO 17025 related Discussions 2
R (OOT) Measurement Equipment after the calibration at a third Party lab General Measurement Device and Calibration Topics 3
M Auditor has requested that the granite table in the lab be Calibrated Calibration and Metrology Software and Hardware 19
P Data Collection - R&D / Lab Notebooks Document Control Systems, Procedures, Forms and Templates 5
M How to perform Chelex DNA Method Verification in the lab General Measurement Device and Calibration Topics 2
G Temperature Requirements for a Manufacturing Inspection Lab General Measurement Device and Calibration Topics 5
S IEC 60601-1 Cl. 14 - Report changes in Software after Testing to Test Lab? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
G TS 16949 External Lab for Raw Material Certs for PPAPs IATF 16949 - Automotive Quality Systems Standard 26
Ron Rompen Seeking Test Lab which can do 1440 Hour Accelerated Weathering Characteristics Misc. Quality Assurance and Business Systems Related Topics 1
V Qualification & Management Of Contract Quality Control Lab - Formats & Templates US Food and Drug Administration (FDA) 0
S Does anyone use a FRACAS system to track lab equipment issues? Calibration and Metrology Software and Hardware 1
F Biocompatibility study conducted in the GLP lab outside Japan Japan Medical Device Regulations 2
SATHYABALARAMAN Calibration Laboratory vs. Standards Lab Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
D PCBA Lab Temperature & Humidity Requirements - Advice needed Manufacturing and Related Processes 7
N Calibration Lab unable to issue Accredited Certificate when error is too high? General Measurement Device and Calibration Topics 3
S Are you struggling with your IEC 60601-1 3rd edition testing lab? IEC 60601 - Medical Electrical Equipment Safety Standards Series 16
V Test Lab for JIS T 1501 (Performance of Ultrasonic Pulse-Echo Diagnostic Equipment) Japan Medical Device Regulations 1
V GM Lab Packages - Submitting Lab Packages to Lear for Material Laboratory Approval APQP and PPAP 3
S Searching for a Lab to test Patient Safety for Product used in Mouth CE Marking (Conformité Européene) / CB Scheme 2
P FDA Approved API (Active Pharmaceutical Listing) Bioequivalence Study Lab for India Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
K Calibration & Testing Lab here in the States - RA Audit - Wow! General Measurement Device and Calibration Topics 8
C Do we have to use an FDA recognized lab for Biocompatibility testing of 510k devices? Other US Medical Device Regulations 1
J Reputable Third Party Inspection (Metrology Lab) In USA? Cam Profile Measurement General Measurement Device and Calibration Topics 5
J Is it possible to train our lab technician to perform balance calibrations? General Measurement Device and Calibration Topics 2
I Need help finding an Accredited Lab that can Calibrate Brunson 76-RH Survey Transits General Measurement Device and Calibration Topics 5
M Key Performance Indicators (KPI) specific for the LAB Manufacturing and Related Processes 4
B Service Contract for VMP for our failure analysis and material science lab question US Food and Drug Administration (FDA) 1
S Setting up a Scale Calibration Service lab - Where to start? General Measurement Device and Calibration Topics 7
AnaMariaVR2 Link between failure to comply w/ Lab PPE standards & ISO9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
V Mechanical Testing Lab - PT vs. QC questions General Measurement Device and Calibration Topics 4
R ISO 17025 for our CMM LAB HAVE A FEW QUESTIONS! ISO 17025 related Discussions 2
Similar threads


















































Top Bottom