Quality Management System requirement documentation as per ISO 9001:2015 Standard means activity or process to document that contains sufficient information for effective implementation of processes and be retained to provide evidence that activities were performed.
The new ISO 9001:2015 standard includes three basic core concepts :
a.) process approach
b.) plan-do-check act methodology, and
c.) which is new in the 2015 version is risk based thinking
New structure of ISO 9001:2015 standard has aligned with the common 10-clause to ensure greater harmonization among its many different management system standards. The new revision to ISO 14001:2015will also adopt this same structure, which is built around the Plan-Do-Check-Act sequence. This will help organizations to integrate the requirements of more than one ISO Management System Standard.
ISO 9001:2015 version further require that organization 'determines' processes needed for quality management system and identify all the processes that include Actions to Address Risks and Opportunities.
Risk Based Thinking is a new and welcome addition to ISO 9001:2015 standard requirement
How will the organisation prevent, or reduce, undesired effects? How will the organisation ensure that it can achieve its intended outcomes and continual improvement? One big plus is that preventive action does not now appear. The assumption is that the risk management process has features which creates inherent preventive actions via the improvement cycle.
Highlights to ISO 9001:2015 free download are available on URS website, and 2015 version reference for issues that means 'an actual or potential threat' for effective implementation and control of activities that affect client's ability to supply products or services to meet customer requirements.
A structured approach to risk assessment for a quality management system requirement can describe a process, an actual or potential threats and decision on whether to accept, mitigate, eliminate or transfer the risk, and identify the controls needed to ensure the effectiveness of the processes. By including 'potential' threats, organization can put in place preventive actions.
Quality objective as per ISO 9001:2015 Certification are seen as those that have a direct impact on customer requirements, have a direct impact of the efficiency of the client's business, which means an improvement in the quality system processes. ISO 9001:2015 standard requires quality objectives to be measurable which means that targets have to be set.
The requirements around the ISO 9001:2015 objectives have also been made more detailed. They are to be consistent with the ISO 9001:2015 quality policy, measurable (if practicable), monitored, communicated, and updated as appropriate. They have to be established at relevant functions and levels. Now planning how to achieve its quality objectives is introduced in the new version of ISO 9001:2015 standard.
The main differences in content between the old and new version of ISO 9001 standard?
The adoption of the high level structure as set out in Annex SL of ISO Directives Part 1
An explicit requirement for risk-based thinking to support and improve the understanding and application of the process approach
Fewer prescriptive requirements
More flexibility regarding documentation
Improved applicability for services
A requirement to define the boundaries of the QMS
Increased emphasis on organizational context
Increased leadership requirements
Greater emphasis on achieving desired process results to improve customer satisfaction
Transition means extra paperwork? No! New ISO 9001:2015 standard requires an organization to document a number of things but, these are relatively less as compare to previous version of standard, new standard gives you flexibility to document system (Except mandatory requirement) without unnecessary paperwork. You may refer clause by clause changes in the below guidance note.
ISO 9001:2015 Standard further requires performance management - for more details firstname.lastname@example.org . URS is organizing Transition course for 2015 version of ISO 9001 Standard in India in all major cities- for schedule in your City of India, please visit the Calendar at www.ursindia.com/training.aspx.
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