What systems are in place to manage and control quality?
Identifying the systems used to control and manage the quality of a service or product is a key function of the auditing process. One of the principal considerations is what accreditation or compliance (e.g., ISO, GLP or cGMP) the provider claims for the service; for example, service providers that say they comply with cGMP should be in possession of the relevant licences and, if applicable, a letter of inspection and support from the Medicines and Healthcare Products Regulatory Agency. When selecting a provider, the first stage is usually to establish the existence of a quality system and any third party inspection bodies, such as the UK Accreditation Service, that are useful for calibration services. A quality management system should contain, as a minimum: • Quality Manual. This is a high-level policy document that describes the management’s commitment to quality. • Standard Operational Procedures. These documents follow on from the Quality Manual and describe how the policies descr
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