New standard ISO 9001 2015 has been published with many core changes. Few new requirements have been introduced that was not there in ISO 9001:2008 standard.
Some major changes are as follows:
Structural changes – The old standard (ISO 9001:2008) had 5 main sections / clauses (i.e. Clause 4 to clause 8) while in new standard (ISO 9001:2015) there are main 7 sections i.e. Clause 4 to clause 10). The new standard is more prepared for integration.
Context – Now while establishing your quality management system, you have to decide context of your organization. Now you have to focus on needs & expectations of interested parties. The new standard ISO 9001:2015 wants you to consider external & internal issues which are relevant to your QMS.
In new standard ISO 9001:2015 it is not mandatory to have documented procedures or a quality manual. Unlike old standard terms ‘document’& ‘Records has been eliminated & now both are known as ‘documented information’ Risk Based emphasis - The new standard ISO 9001:2015 wants you to identify & address risks & opportunities that can affect your product & service compliances which will result into increased customer satisfaction.
EXCLUSIONS & REQUIREMENTS
In old standard ISO 9001:2008 exclusion was limited to clause / section 7 only but now in ISO 9001:2015 the same concept can be applied to any clause / section if it is justified.
Objects, Outputs, Products and Services – ‘Object’ is a new term in ISO 9001:2015 which means anything conceivable or perceivable. What was used to be called ‘product ‘in old standard (ISO 9001:2008) is now called ‘Output ‘in the new standard. Now both product & services are thought of as ‘outputs’.