ISO 13485:2016 is based on the ISO 9001 process model approach and is a management systems standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonized medical device regulatory requirements.

ISO 13485 baseras på ISO 9001 och är en standard för kvalitetsledning avsedd för medicinteknisk verksamhet, där vissa krav är skärpta. Det finns också ett ökat 

A summary of the changes incorporated into this edition compared with the previous edition is given in Annex A. ISO 13485 is an industry-specific interpretation of ISO 9001 with a focus on the medical device industry. While the ISO 9001 quality regulations are meant to apply to organizations across industries, ISO 13485 provide specialized guidance in the form of quality system regulations that are specific to the medical device industry. There are many similarities and differences between ISO 9001 2015 & ISO 13485, and many organizations want to know what they are. These two are the biggest quality standards, (ISO 9001 2015) goes to a new high level pattern, not similar to (ISO 13485 2016), making the two standards split, going on their own way. While ISO 13485:2016 maintains the same structure of its prior version (based on ISO 9001:2008), the new structure of ISO 9001:2015 has an entirely fresh look and feel. ISO 9001:2015 is based on Annex SL, which is intended to provide a uniform frame for writers to use when developing or revising standards.

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ISO 13485 calls for risk management to be in place for all stages of In the case of ISO 13485, it isn’t so much a management system in its own right; rather, it’s based on the core principles of ISO 9001 for quality management, applied in the context of medical devices manufacturing. ISO management systems share a common high-level structure known as Annex L. 2019-06-17 · ISO 13485 is a patient-focused and risk-based quality standard designed specifically for the high-risk medical device industry. The ISO 13485 standard grew out of the more generic ISO 9001 standard — which provides a general framework to ensure quality and enhance customer satisfaction across a wide range of industries. Se hela listan på svenskcertifiering.se Se hela listan på 13485store.com Now, both ISO 9001 and ISO 13485 have been revised, with publication of the fifth edition of ISO 9001 in September 2015 and publication of the third edition of ISO 13485 in March 2016. These two standards have always been very closely aligned, as the 1996 and 2003 versions of ISO 13485 were directly based on ISO 9001 (1994/2000).

Why Integrate ISO 9001 and ISO 13485? There are many situations that may benefit from certifying to multiple quality management standards, for example: Organizations that have an existing commercial customers who require broader quality standard (such as ISO 9001) and need to prove certification to the medical device market with a narrower standard (such as ISO 13485).

ISO 13485 is based on the ISO 9001 format with additional requirements relating to design, special processes, environmental control, traceability, documentation records, and regulatory actions. This is an outcome of the primary objective for the creation of ISO 13485, which was to facilitate standardized medical device regulatory requirements for quality management systems. On Demand Training for ISO 9001, ISO 14001, ISO 19011, ISO 13485, AS9100D, GMP, GLP, HACCP.

2020-08-02

ISO 9001 has changed this requirement and is  同時，ISO 13485是產品取得CE驗證的必要條件。 13485：2016並無採用ISO 9001：2015之高階管理架構(High Level Structure, HLS) ，因ISO/TC 210認為  ISO 9001.

A principal difference, however, is that ISO 9001 requires the organization to demonstrate continual improvement , whereas ISO 13485 requires only that the certified organization demonstrate the quality system is effectively implemented and maintained.
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Quality management  ISO 13485 is a standalone standard.

ISO 13485 certification is a valuable credential put in place to keep professionals and customers safe in clinics, hospitals and other medical settings. ISO 13485:2016 is based on the ISO 9001 process model approach and is a management systems standard specifically developed for the manufacture of medical devices.
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迄今全球已有超過150 萬個組織，我國亦有超過20,000個組織通過ISO 9001驗證 13485 醫療器材業品質管理系統; IATF 16949 汽車業品質管理系統; FSSC / ISO 

ISO 13485 for medical device quality management shares many similarities with ISO 9001, the leading global quality management standard with more than 1.1 million certificates worldwide. While most standard revisions now follow ISO 9001’s new high-level structure, ISO 13485 does not, even though it was released after ISO 9001. Comparing ISO 9001 and ISO 13485 While ISO 13485 is based on ISO 9001, there are some key differences and additional requirements, in addition to product-specific demands and more stringent documentation requirements.