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ISO 10012:2003 is a practical standard for managing calibrations which is available from National Standards Authority of Ireland. It lays down generic requirements and provides guidance for the management of measurement processes and metrological confirmation of measuring equipment used to support Quality, Environmental or Safety compliance.
The standard deals with the issue of influence variables which have tended to be ignored by calibration personnel in the past, and requires that where an uncertainty budget is not estimated, the maximum potential effect of influence variables on tolerances should be allowed for. In practical terms, this means that technical calibration methods should be scientifically validated before use.
Note: This standard is a supplement to general quality standards such as ISO 9001 - it is not a substitute for ISO/IEC 17025 which is mandatory for traceable calibrations.
Traceable calibration of reference standards is critical to process industry. The Irish National Accreditation Board (INAB) is the organisation having national resposibility in Ireland for accreditation of calibration laboratories. View INAB traceability policy.
The international standard for organisations performing traceable calibrations is ISO/IEC 17025, and the schedule of accreditation for all calibration laboratories accredited to ISO/IEC 17025 by INAB can be downloaded in Adobe format from the INAB Directory.
Important: Customers should download and assess the accredited capability of calibration laboratories they propose to use for reference standard calibrations prior to use to verify that the proposed calibration is within the scope of the schedule of accreditation.
Details of the Irish National Standards are provided by NML. Links to international calibration related organisations can be found at the BIPM.
Good calibration practice guidance documents are available from Euramet, European co-operation for Accreditation (EA) (which is made up from nationally recognised accreditation bodies in Europe), OIML and INAB in Ireland. The United Kingdom Accreditation Service (UKAS) also provides a number of useful calibration guides, including LAB-14 "Calibration of Weighing Machines".
The Institute of Measurement and Control has published an excellent code of practice for calibrating industrial process weighing systems, and in conjunction with NPL has produced guides to the measurement of humidity, force, mass and weight, and pressure and vacuum. Useful guides may also be purchased from the Engineering Equipment and Materials Users Association (EEMUA).
The "GAMP Good Practice Guide: Calibration Management", available from ISPE describes the principles of calibration from a pharmaceutical perspective, and provides guidance in setting up a calibration management system, formally assessing criticality, documenting calibrations and carrying out corrective actions. Click here for for further information on the Calibration Management Guide.
The ISO 9001:2008 quality management systems (QMS) standard is available from National Standards Authority of Ireland. The standard which mandates a process approach to business management is viewed as a baseline model for suppliers of services to regulated industries such as pharmaceutical and medical devices manufacturers.
The quality management system standard applicable to all accredited calibration laboratories internationally is ISO/IEC 17025 'General Requirements for the Competence of Testing and Calibration Laboratories' which can be ordered from National Standards Authority of Ireland.
The regulations governing pharmaceutical manufacturing in Europe may be found in Eudralex Volume 4, and for the U.S.A. in Title 21 of the U.S. Code of Federal Regulations, or on the very informative GxP Quality Systems web site.
The Good Automated Manufacturing Practice guide is currently available as GAMP 5 from ISPE. It aims to assist companies in the healthcare industries to achieve validated and compliant automated systems and provides guidance to the suppliers on the necessary documentation to support validation.