Certificate of Calibration Suppliers for an ISO 9001 company

P

potato124

#1
Hello,

I am working with a company that is ISO 9001 certified. One of the calibration suppliers they use calibrates equipment to NIST standards, but is not ISO 17025 certified. Does ISO 9001 require that calibration suppliers be ISO 17025 certified? Any reference or direction on this issue would be greatly appreciated...

Thanks,
potato
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
Re: Cert of Calibration Suppliers for an ISO 9001 company

Hello,

I am working with a company that is ISO 9001 certified. One of the calibration suppliers they use calibrates equipment to NIST standards, but is not ISO 17025 certified. Does ISO 9001 require that calibration suppliers be ISO 17025 certified? Any reference or direction on this issue would be greatly appreciated...

Thanks,
potato
No, ISO 9001:2000 does not require that calibration services providers are ISO/IEC 17025 accredited.

Stijloor.
 

howste

Thaumaturge
Super Moderator
#3
Re: Cert of Calibration Suppliers for an ISO 9001 company

The requirement is that calibrations be done with standards traceable to national or international standards (ISO 9001 clause 7.6a). There is no requirement for the lab to be accredited to anything.

Having said that, I think that the accreditation process speaks to the competence of the organization. There is a 3rd party verification that they meet the requirements for laboratories.

By the way, the automotive standard ISO/TS 16949 does require outside labs, including calibration labs, to be ISO 17025 accredited. This may be what you were thinking of...
 
P

potato124

#4
Re: Cert of Calibration Suppliers for an ISO 9001 company

THANKS! I am mistaken about their certificaiton...The plant I am working with is ISO 13485, does that require calibration providers to be 17025?
 

howste

Thaumaturge
Super Moderator
#5
Re: Cert of Calibration Suppliers for an ISO 9001 company

There's no requirement there either. The requirements in ISO 13485 clause 7.6a are word-for-word identical to ISO 9001.
 

howste

Thaumaturge
Super Moderator
#6
Re: Cert of Calibration Suppliers for an ISO 9001 company

Before you ask, I should probably add, the FDA requirements don't either:
820.72 Inspection, measuring, and test equipment.
(a) Control of inspection, measuring, and test equipment.
Each manufacturer shall ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results. Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained. The procedures shall include provisions for handling, preservation, and storage of equipment, so that its accuracy and fitness for use are maintained. These activities shall be documented.
(b) Calibration. Calibration procedures shall include specific directions and limits for accuracy and precision. When accuracy and precision limits are not met, there shall be provisions for remedial action to reestablish the limits and to evaluate whether there was any adverse effect on the device's quality. These activities shall be documented.
(1) Calibration standards. Calibration standards used for inspection, measuring, and test equipment shall be traceable to national or international standards. If national or international standards are not practical or available, the manufacturer shall use an independent reproducible standard. If no applicable standard exists, the manufacturer shall establish and maintain an in-house standard.
(2) Calibration records. The equipment identification, calibration dates, the individual performing each calibration, and the next calibration date shall be documented. These records shall be displayed on or near each piece of equipment or shall be readily available to the personnel using such equipment and to the individuals responsible for calibrating the equipment.
 

Stijloor

Staff member
Super Moderator
#7
Re: Cert of Calibration Suppliers for an ISO 9001 company

By the way, the automotive standard ISO/TS 16949 does require outside labs, including calibration labs, to be ISO 17025 accredited. This may be what you were thinking of...
Here is what ISO/TS 16949:2002 states:

7.6.3.2 External laboratory

External/commercial/independent laboratory facilities used for inspection, test or calibration services by the organization shall have a defined laboratory scope that includes the capability to perform the required inspection, test or calibration, and either

 there shall be evidence that the external laboratory is acceptable to the customer, or

 the laboratory shall be accredited to ISO/IEC 17025 or national equivalent.

NOTE 1 Such evidence may be demonstrated by customer assessment, for example, or by customer-approved second-party assessment that the laboratory meets the intent of ISO/IEC 17025 or national equivalent.

NOTE 2 When a qualified laboratory is not available for a given piece of equipment, calibration services may be performed by the equipment manufacturer. In such cases, the organization should ensure that the requirements listed in 7.6.3.1 have been met.
Stijloor.
 
#8
Re: Cert of Calibration Suppliers for an ISO 9001 company

The requirement is that calibrations be done with standards traceable to national or international standards (ISO 9001 clause 7.6a).
Not strictly - there are many standards for which traceability to a known 'master' in this sense is not available. The organization must be able to demonstrate the calibration provisions for that equipment.......
 

howste

Thaumaturge
Super Moderator
#9
Re: Cert of Calibration Suppliers for an ISO 9001 company

Not strictly - there are many standards for which traceability to a known 'master' in this sense is not available. The organization must be able to demonstrate the calibration provisions for that equipment.......
True. I didn't mention it because I believe it's a tangent from what Potato124 was asking about. I do run across that situation now and then, but it's a very small percentage of the time.
 

Raffy

Quite Involved in Discussions
#10
Re: Cert of Calibration Suppliers for an ISO 9001 company

Hi Stijloor,
Some concerns that comes into my mind with regard to the requirements of ISO/TS16949:
1) What if we cannot find any lab accredited to ISO17025 for a certain equipment. Will our Certifying Body will issue an NC if the said equipment was not calibrated to an ISO17025 accredited? Please advise.
2. What must be done to provide compliance to the requirements aside from an ISO17025 accredited?
3. What if the said equipment was calibrated by an authorized Calibration Service Providers, e.g. the OEM authorized ABC Company to be their calibration Service Provider for all equipment they manufacture. Will it be against the requirements of Note 2 of Clause 7.6.3.2 of ISO/TS16949? Please advise. :frustrated:
4. Is it acceptable that the equipment will only give an ANSI Z540 certification with NIST traceability and uncertainty.? Instead of ISO17025? Please comment.
5. Can we provide a provision in our procedure that since we cannot find an Accredited ISO17025 Laboratory locally, is it possible to accept those Calibration Service Provider that are not ISO17025, i.e. Z540, ISO9001:2000? Is this acceptable? If not, what we should do?:confused: Please advise.
Thank you very in advance for the usual prompt attention you will give in this request.
Best regards,
Raffy :cool:

Stijloor.[/QUOTE]
 
Thread starter Similar threads Forum Replies Date
L A certificate of conformance used to support a calibration General Measurement Device and Calibration Topics 6
M Storing Calibration Certificate Document Control Systems, Procedures, Forms and Templates 7
M Calibration Certificate Result issued by an accredited external laboratory General Measurement Device and Calibration Topics 9
F Calibration certificate content - Average Value and True Value ISO 17025 related Discussions 6
M How to read a calibration certificate for thermo hygrometer General Measurement Device and Calibration Topics 2
V Calibration certificate verification Qualification and Validation (including 21 CFR Part 11) 3
A Calibration Certificate Results General Measurement Device and Calibration Topics 3
E Calibration Certificate Content Requirements General Measurement Device and Calibration Topics 3
M Accredited Calibration Sevice Provider using computerized system to issue calibration certificate Qualification and Validation (including 21 CFR Part 11) 3
M Accredited Calibration Sevice Provider using computerized system to issue calibration certificate General Measurement Device and Calibration Topics 2
G Is the calibration due date of equipment used to be on calibration certificate ISO 17025 related Discussions 38
G Calibration Certificate, fancy paper or not? General Measurement Device and Calibration Topics 9
Crusader Certificate of calibration from Manufacturer allowed? General Measurement Device and Calibration Topics 14
T Calibration Certificate Readings After Adjustment General Measurement Device and Calibration Topics 5
C Calibration Certificate "As Found" condition - TS16949 Section 7.6.2 General Measurement Device and Calibration Topics 7
M ILAC Regulations - Expression of Units on the Calibration Certificate General Measurement Device and Calibration Topics 6
A Coverage factor in calibration certificate for a multimeter General Measurement Device and Calibration Topics 4
N Client Request for Reference Equipment Calibration Certificate General Measurement Device and Calibration Topics 3
T Microsoft Access Database to create a Simple Calibration Certificate General Measurement Device and Calibration Topics 6
V How to use a Calibration Certificate in Uncertainty Calculation for a Test Measure Measurement Uncertainty (MU) 13
T Uncertainty in Hygrometer Calibration Certificate General Measurement Device and Calibration Topics 4
O How can I use reading from calibration certificate in measurement Calibration Frequency (Interval) 7
K New Gauges calibration certificate shows deviations from the measurement uncertainty IATF 16949 - Automotive Quality Systems Standard 5
Q Can we go by different Calibration Frequency vs. What's on the Certificate ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
R Torque Tester Calibration Traceability and Certificate question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S No Calibration Due Date on a Calibration Certificate unless requested by a customer? Calibration Frequency (Interval) 9
P Rounding Uncertainty to Zero on a Calibration Certificate Measurement Uncertainty (MU) 7
N Calibration Lab unable to issue Accredited Certificate when error is too high? General Measurement Device and Calibration Topics 3
S How to Evaluate a Calibration Report Certificate General Measurement Device and Calibration Topics 8
R LCP 01201P and ICPF2P Calibration Methods Stated in Calibration Certificate General Measurement Device and Calibration Topics 2
M ILAC p14:12/2010 - Accredited Calibration Certificate Uncertainty General Measurement Device and Calibration Topics 2
A Can any organization issue a Calibration Certificate? General Measurement Device and Calibration Topics 5
A No Uncertainty Listed on Calibration Certificate: Is it traceable calibration? General Measurement Device and Calibration Topics 8
M External Calibration Certificate Review ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
N Calibration Certificate Requirements for Pressure Gauges General Measurement Device and Calibration Topics 9
A Fluke Digital MultiMeter Calibration Traceability and Certificate General Measurement Device and Calibration Topics 11
S Reference to original Calibration Certificate - ISO 17025 Section 5.10.9 ISO 17025 related Discussions 4
howste Calibration Certificate Contents: How to report Measurement Uncertainty? Measurement Uncertainty (MU) 18
C Accredited Calibration Certificate Content - ISO 17025 Section 5.10.4.2 Question ISO 17025 related Discussions 7
D Calibration Certificate - 'test report shall not be reproduced except in full' General Measurement Device and Calibration Topics 2
howste Condition of Item Calibrated - ISO 17025 Clause 5.10.2f - Calibration Certificate ISO 17025 related Discussions 13
C Interpreting Outside Laboratory Calibration Certificate Measurement Uncertainty (MU) 3
A Calibration Certificate content for New Equipment General Measurement Device and Calibration Topics 8
R What to do after I receive a calibration certificate General Measurement Device and Calibration Topics 4
E Calibration - Manufacturer's Calibration Certificate Date ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
S Verification of calibration certificate Miscellaneous Environmental Standards and EMS Related Discussions 1
B ISO 17025 logo & ISO 9001 logo on calibration certificate/report ISO 17025 related Discussions 7
S Validity of 7 Year Old Calibration Certificate General Measurement Device and Calibration Topics 19
BradM Certificate for In-House Calibration General Measurement Device and Calibration Topics 25
Wayne Never put an Expiration (Due) Date on a Calibration Certificate Calibration Frequency (Interval) 41

Similar threads

Top Bottom