![]() (This article is the second installment of a two-part series highlighting 17 key differences between ISO 13485:2003 and ISO 13485:2016. The transition period ends in March 2019, leaving any ISO 13485:2003 certifications invalid. Over half the transition time from the 2003 edition to the new ISO 13485:2016 standard is behind us. With an emphasis on risk management in the quality system process, the changes impact organizations in the medical device supply chain, auditors/certification bodies, training providers, and consultants. For the first time in 13 years, the International Organization for Standardization (ISO) has updated ISO 13485, the medical device industry’s framework for quality management systems (QMS).
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