Unpacking Calibration
Background
Measuring and monitoring devices, in the language of ISO 9001, are typically instruments or devices which are used to control processes or verify performance or products against specifications.
Every organisation is different, and the equipment used varies widely, both in its type and application. So knowing what needs to be done in this area of the standard can be tricky, and there are often a range of approaches that can achieve the same result, at (sometimes) widely differing costs.
The examples in this article will help you understand what the Standard asks for and the type of evidence that is needed, so you can make the best decision.
Audit Approach
Auditors conduct audits using a risk based approach and the systems and processes related to calibration are often identified as high risk. This element of the Standard is one that may take more time to audit, depending on the types of equipment involved. Our experience is that this is not always well managed by clients and contracted services (Calibration Services Provider or CSP).
Verification is generally done through sighting:
- A planned/preventive maintenance schedule that shows equipment required to be calibrated, contracts with suppliers to conduct calibrations, and reports from companies;
- Calibration certificates for equipment used by contractors;
- Reports provided by companies of measurement and testing conducted. There is wide variation in the content of these reports between companies;
- Evidence of review of these, with appropriate action.
Issues Affecting Calibration Audit
- Conducting procedures using highly technical equipment
- Not being provided with calibration certificates from contracted service providers
- Contractors recording in reports the identity of a calibration device and the date of the last calibration
- Reports from contracted services not containing measurable parameters, and actual measurement at testing
- Ensuring measurement traceability
- Information being provided related to design and development of equipment that has a self calibration function i.e. calibration may not be necessary
Acceptable documentation from Calibration service providers
The main issue is to clarify what the necessary evidence is to demonstrate traceability.
What is meant by "traceability to national measurement standards" is that the equipment has been compared to a 'chain' of equipment which eventually traces to a known relationship against a known measurement standard. This chain of equipment may include "master" equipment held by the organisation which is then checked by the calibration service provider's equipment. This in turn is checked by them against their master equipment or against known standards of measurement. This should be done by the calibration provider under a certified management system, preferably NATA laboratory registration, but some believe ISO 9001 is also acceptable.
The Standards of measurement can also be known scientific quantities such as standard solutions made up by a qualified chemist, telephone time (within +/- 1second), the frequency of the AC electrical supply is 50Hz, water boils at 100C and freezes at 0C (at sea level) etc.
In Summary…
Still baffled by the requirements, especially if you outsource your calibration? The reference guide below may assist. Remember, though, that each circumstance is different, and the intent of ISO 9001 is, as described above, to ensure that when measurements are taken, you can rely on the results.
Key: |
Green OK |
Orange – possibly OK |
Red – probably not OK |
Calibration report |
Supporting information |
|
1. Internal record Indicates item ID and ID of master equipment, as well as measurements before and after calibration. Calibration sticker on instrument showing status (i.e. next date due)
|
Calibration certificate for master equipment from NATA CSP (calibration service provider) as well as NATA (system) certificate and scope of CSP |
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2. External (CSP) report indicates item ID and ID of master equipment, as well as measurements before and after calibration and includes NATA Logo. Also includes a sentence – i.e. Pass or Fail. Indication on report that organisation has reviewed sentence and taken any action necessary. Calibration sticker.
|
NATA (system) certificate and scope of CSP |
|
3. External (CSP) report indicates item ID and includes NATA Logo. Also includes a sentence – i.e. Pass or Fail. Indication on report that organisation has reviewed sentence and taken any action necessary. Calibration sticker.
|
NATA (system) certificate and scope of CSP |
| 4. External (CSP) report Indicates item ID. Calibration sticker. | NATA (system) certificate and scope of CSP |
| 5. External (CSP) report Indicates item ID. Calibration sticker. | NATA (system) certificate and scope of CSP |
| 6. External (CSP) report Indicates item ID. Also includes a sentence – i.e. Pass or Fail. Indication on report that organisation has reviewed sentence and taken any action necessary. Calibration sticker. | ISO 9001 certificate and scope of CSP which includes calibration or servicing NOTE – cannot issue a certificate of test with ISO 9001 logo or JAS-ANZ, as classed as a product!! |
|
7. External (CSP) report Indicates item ID. Also includes a sentence – i.e. Pass or Fail. Indication on report that organisation has reviewed sentence and taken any action necessary. Calibration sticker.
|
ISO 9001 certificate and scope of CSP which does not include calibration or servicing |
| 8. No calibration report, but item has automatic self calibration function. | Evidence from technical specialist that self calibration is valid. |
| 9. Record of dates of calibration, but item has user initiated self calibration function. | Evidence from technical specialist that self calibration is valid. |
|
10. External (CSP) report Indicates item ID and ID of reference equipment. Also includes a sentence – i.e. Pass or Fail. Indication on report that organisation has reviewed sentence and taken any action necessary. Calibration sticker.
|
CSP not certified, but has supplied NATA calibration certificate for reference equipment |
| 11. No Record of dates of calibration, but item has user initiated self calibration function. | Evidence from technical specialist that self calibration is valid. |
| 12. External (CSP) Service report Indicates item ID. Also includes a sentence – i.e. Pass or Fail. | ISO 9001 certificate and scope of CSP which does not include calibration or servicing |
| 13. External (CSP) Service report Indicates item ID. | ISO 9001 certificate and scope of CSP which does not include calibration or servicing |
| 14. No calibration report, but item has automatic self calibration function. | No Evidence from technical specialist that self calibration is valid. |
| 15. Record of dates of calibration, but item has user initiated self calibration function. | No Evidence from technical specialist that self calibration is valid. |
|
16. External (CSP) report Indicates item ID and ID of reference equipment, as well as measurements before and after calibration. Also includes a sentence – i.e. Pass or Fail. Indication on report that organisation has reviewed sentence and taken any action necessary. Calibration sticker.
|
CSP not certified |
|
17. External (CSP) report Indicates item ID and ID of reference equipment. Indication on report that organisation has reviewed sentence and taken any action necessary. Calibration sticker.
|
CSP not certified |
|
18. External (CSP) report Indicates item ID Also includes a sentence – i.e. Pass or Fail. Calibration sticker.
|
CSP not certified |
Quality Award Partners® has ASQ Certified Quality Engineers on staff, who can help you bring reliability to measurement and meet the requirements of ISO 9001. Call us with your questions. We will be pleased to help you.