During the five-month voting period on the ISO/DIS 13485:2014 closed on July 20, 2014, the ISO/TC 210 Technical Committee had received around 800 comments. Around 400 of these comments were addressed at the first meeting of the TC 210; the remaining comments will be considered at the next meeting.
Due to the large number of comments, the work performed in the working groups is expected to result in a new Draft International Standard ISO/DIS 13485:2015.
Because of the link between the ISO 13485 standard and the regulatory requirements, the standard’s structure – which comprises eight sections – is expected to remain unchanged. The standard-setters want to avoid manufacturers having to restructure their entire quality management system documentation.
A cross-reference table that links the requirements of the future ISO 13485:2015 with those of the ISO 9001:2015 will be prepared.
The ISO 13485:2003 is a quality management system standard specifically designed for Medical Device manufacturers. It covers the requirements of the ISO 9001:2000 standard, complemented by additional requirements for process control, control of design and development, document retention, traceability, market surveillance, reporting to authorities, etc.
Typical ISO 9001:2000 requirements, including customer satisfaction and continual improvement, are not primary goals for ensuring regulatory compliance and were thus rephrased in ISO 13485.
ISO 9001: Final Draft International Standard (FDIS) expected
The working draft ISO/DIS 9001:2015 was distributed for review on May 8, 2014.The Committee Draft (CD) published in the run-up to this draft received around 3,000 comments and was approved by 80% of the countries in a preliminary vote. The international community was invited to submit their comments on this interim working draft by July 2014. Publication of the official Draft International Standard (DIS) followed on July 25, 2014.
After the commenting period, the Final Draft International Standard (FDIS) will then be passed before its presentation. Publication of the final ISO 9001:2015 standard is expected for September 2015. What is already certain is that the structure will change and the “high level structure” will be introduced. The Draft is structured according to the ISO Directive, Annex SL 2013, to ensure that all sections of management system standards share the same section headings and core texts.