ISO 9001 review
At the end of September 2015 the time had come: the latest version of ISO 9001, ISO 9001: 2015 was published. Since 2011, experts from different countries have been involved in writing and restructuring the ISO 9001 standard. The new ISO 9001: 2015 standard is structured according to the High Level Structure (HLS)
and this involves quite a few changes ..
The starting point of ISO 9001: 2015
Perhaps the most important change is the change inspirit"Of the ISO, the starting point from which the standard starts. The old ISO 9001: 2008 standard was pretty prescriptive. A quality manual was mandatory and the emphasis was on process descriptions. The new ISO 9001 standard has made a considerable change in this and is no longer a series of requirements, but a strategic tool.
The ISO 9001: 2015 asks you to look at who you are as an organization, in which market are you and what role do you play in this (context), what added value do you deliver and do you meet customer requirements? What risks are lurking and how do you deal with this and how do you prevent errors? continuously improved? The ISO demands much less mandatory processes and procedures in this regard, but requires that documented information (records) demonstrates how you as an organization meet the requirements of the standard. For small organizations, this can result in few process descriptions, while large, complex organizations need it. It is important that the whole comes together in a system.
The changes to ISO 9001: 2015 in a row;
• Introduction of the
HLS
: the new ISO 9001 standard is constructed according to the HLS. The new standard therefore uses the same structure as known standards such as ISO 14001, ISO 27001 and 45001
• Introduction of the context analysis: the most radical change from ISO 9001: 2015. In which context does your organization function? Who are you?
stakeholders
and what are the risks?
• Documented information: a new term in the ISO standards. No more mandatory procedures are required, but documented information is required.
• More emphasis on
leadership
: the new ISO 9001 standard requires clear involvement of the management in the quality management system.