Quality

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Overview of IS EN IEC 60812:2018 Failure Modes and Effects Analysis (FMEA and FMECA)

IS EN IEC 60812:2018, Failure Modes and Effects Analysis (FMEA and FMECA) was published in October 2018 and replaces the 2006 version of the standard. The standard describes how to perform a systematic failure modes and effects analysis (FMEA). An analysis of this kind establishes how a product or process might fail to perform its …

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Risk management in ISO 9001:2015 and other management system standards

ISO 9001:2015 establishes a systematic approach to risk. The previous versions treated it as a single component of a QMS.  ISO 14001 and ISO 45001 have added an enterprise risk element to the existing environmental and safety risk assessments. A risk-based approach embeds an assurance and prevention strategy into the whole system. Organisations can increase …

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