ISO 9001:2015 uses the new structure specified in Annex SL of the ISO/IEC Directives, Part 1, while ISO 13485:2016 continues with the structure developed in the previous versions. The following links below take you a pages where elaborated content of both standards are listed: Meanwhile, the focus of ISO 13485:2016 is primarily driven by the need for regulators to ensure that the medical devices placed on the market by organisations are safe and effective. The general nature of and the industries that use ISO 9001:2015 are driven by customer focus and making the correct risk-based decisions to minimize the risk of customer dissatisfaction. While the differences between the two standards obvious in terms of structure, the similarities that are more prevalent and the value in how these two standards can be used together to provide industry with quality and/or regulatory insight irrespective of business operational activities and corresponding strategic direction are well-established in both standards. With the change of ISO 9001 to the new HLS, the structure of the two standards are now different and this may cause some concern in organizations where both standards are relevant. The content and structural changes of the current version of ISO 13485 is based on the ISO 9001:2008 whereas the ISO 9001:2015 version and other management system standards have adopted the new ISO/IEC high level structure (HLS) that comes from Annex SL of the ISO/IEC Directives, Part 1. In addition, ISO 9001:2008 took on more similarities to ISO 13485:2003. In this second edition of ISO 13485, the identical text was shown in black standard font and different text was provided in black italic font (blue italic font in electronic versions). This was readily apparent in ISO 13485:2003 as much of the text is identical to the text from ISO 9001:2000. These two standards have always been very closely aligned, as the 19 versions of ISO 13485 were directly based on ISO 9001 (1994/2000). For a period these standards stood the test of time in the industries until emphasis on quality and regulatory requirements shifted on "risk-based approach." This compelled the ISO Technical Committees and Working Groups to consider revisions to address concerns in the industries to which the standards are applicable.īoth ISO 9001 and ISO 13485 have now 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. In 2008, ISO 9001 was again revised and brought in many of the requirements of ISO 13485:2003. In 2000, the third edition of ISO 9001 was published and ISO 13485 was revised in 2003 to align with that revision. The first edition of ISO 13485 was published in 1996. ISO 9001 was revised to a second edition in 1994. and other Defence Standards ("MIL SPECS"), and was better suited to manufacturing.
#Quality manual iso 13485 2016 pdf series#
The series of quality management systems depending on the activities of the organization were based on BS 5750 and also influenced by the U.S. ISO 9001 emerged from the ISO 9000 series published in 1987.
The scope of ISO 9001 defines it as a general and generic standard for all quality management systems while the scope of ISO 13485 is specific to the medical device sector and those related services. The two most widely used Quality Management Systems (QMS), namely ISO 9001 and ISO 13485 have gone under the knife recently and much discussion is going on about how the industries operating both systems might manage them considering the way they look now - different.
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