The latest revision to the ISO 9001—the leading quality management standard—has introduced numerous important changes to improve the standard and streamline its implementation.
· The adoption of a 10-clause structure and core text consistent with all other ISO management systems.
· Better compatibility with the service sector and non-manufacturing users;
· A need to clearly understand the organization and its context to avoid a “one size fits all†approach to QMS application and implementation;
· The recognition that while preventive action was implicit throughout the standard, there was need to make it more explicit through the application of risk-based thinking, i.e. the identification and associated mitigation, both at the strategic and operational levels.
· The need to consider additional factors in determining the boundaries and applicability of the QMS to establish its scope.
·
Improving the understanding and application of
the process approach through the application of risk-based thinking in
conjunction with the context of the organization;
·
Greater emphasis on achieving desired process
results to improve customer satisfaction;
·
A somewhat contentious change to the use of the
term “documented information†from the terms “documents†and “recordsâ€; and
secondly providing greater flexibility in the need for providing documented
information;
·
A change in terminology from the use of the
terms “purchasing†and “outsourcing†to the term “externally provided products
and servicesâ€;
·
A wider scope has been put on seeking
opportunities for improvement. While continual improvement still remains a
requirement at the operational level to enhance customer satisfaction, the need
for strategic improvements through break-through change, innovation, use of new
technologies, reorganization and other means to significantly improve products,
performance and customer satisfaction, has been added;
·
The wording of Leadership requirements have been
beefed up to put more specificity and emphasis on leadership requirements;
· Less prescriptive, but with greater focus on achieving conforming products and services
· More user friendly for service and knowledge-based organizations
· Greater leadership engagement
· More structured planning for setting objectives
· Management review is better aligned to organizational results
· The opportunity for more flexible documented information
· Addresses organizational risks and opportunities in a more structured manner
· Addresses supply chain management more effectively
· Opportunity for an integrated management system that addresses other elements such as environment, health & safety, business continuity, etc.
·
More emphasis on change management throughout
the standard;
·
The need to establish and maintain the
continuity of organizational knowledge;
·
More specificity in requirements related to
post-delivery activities;
· The scope of requirements to analyze and evaluate the data and information gathered from monitoring and measurement, while not widened, has been made more specific;
· The need to track trends in operational performance and customer satisfaction for management review;
·
Further
dampening down of manufacturing sector terminology for greater application and
acceptability by the services and non-manufacturing sectors.
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