Certificate of Calibration Suppliers for an ISO 9001 company

[potato124]

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

 

[Stijloor]

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]

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...

 

[potato124]

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]

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]

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]

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.

 

[AndyN]

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]

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]

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? Please advise.
Thank you very in advance for the usual prompt attention you will give in this request.
Best regards,
Raffy

Stijloor.[/QUOTE]