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Chapter: 8 Introduction to quality assurance of measurements
    Section: 8.7 Auditing, Certification and Accreditation

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Updated: 28 October 2011
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8.7 Auditing, Certification and Accreditation

Quality audits entail onsite assessment of the quality system and its operation. Internal audits are an essential aspect of every formal quality system and must be carried out at regular intervals. Practice varies as to whether advance warning of an audit inspection should be given. In all cases, however, it is desirable for the auditor(s) to be independent of the day-to-day operations of the unit being audited. The audit may be conducted as a senior management function but many larger organisations have a designated quality manager or quality audit unit. Whatever the approach, the auditor must have a good knowledge of quality assurance principles and adequate scientific knowledge to understand the work being undertaken. It is important to appreciate, however, that a conventional quality audit is assessing the system and not correcting any scientific failings in the measurements. In some organisations the audit is also used to assess technical performance although the depth of this assessment varies widely.

External auditing is also widely used to supplement the internal procedures. Its value lies in the provision of a completely independent assessment to interested parties such as senior management, customers or regulatory authorities. In order to provide maximum consistency and transparency for such assessments it is desirable that the audits take place within recognized accreditation or certification schemes. These generally entail the implementation of quality systems in accordance with a national or international standard and auditing against these standards by officially approved organisations. These laboratory accreditation bodies participate in the Mutual Recognition Arrangement operated by the International Laboratory Accreditation Cooperation (ILAC) to promote the acceptance of technical test results and calibration data. The widely accepted international standard for quality system accreditation of measurement laboratories is ISO/IEC 17025:2005, which describes general requirements for the competence of testing and calibration laboratories. The standard itself does not set out the level of technical capability required since it is generic and clearly this varies widely with application area. It does, however, specify the aspects of the measurement process where a technical assessment should be made against the requirements of the measurement service provided by the laboratory.

Where it is intended to submit the quality system for certification instead of or in addition to accreditation, it should be implemented in accordance with the ISO 9000 series of standards of which the most important is ISO 9001:2008. This sets out requirements for a quality management system, regardless of what the organization does, its size, or whether it is in the private or public sector.

M. Sargent

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