ISO 9001:2015 was published in September 2015. The updated quality standard reinforces the process approach and introduces risk based thinking. In addition, the new standard conforms with the common higher level structure for ISO management systems. The 2015 revision to ISO 9001 includes significant changes and additions to terminology that will affect the way organizations think, work and perform, notably at senior management level.
Organizations have until September 2018 to complete the transition from ISO 9001:2008 to ISO 9001:2015. The 2008 version of the standard will not be recognised after September 2018 for certification purposes.
With the above in mind, two of the most significant changes are “Leadership” replacing “Management Responsibility” in the 2008 version and “Risk based thinking”.
Organizations that have applied ISO 9001:2008 well will find the transition to ISO 9001:2015 relatively straight forward while those who have simply sustained a certificate on the wall could struggle.
ISO 9001:2015 requires top management to demonstrate leadership and to be accountable for the effectiveness of their quality management system leading and ensuring that the process approach achieves required results.
Top Management are required to lead their organizations establishing a process approach, risk based thinking and a continual improvement culture ingrained in everyday work activities. By adopting this approach from the top of the organisation, measurable benefits can be achieved:
ü Better internal and external communication
ü Increased repeat business
ü Increased levels of new business
ü Improved organisational effectiveness
ü Increased bottom line
ü Reduced waste
ü Risk Management
The addition of Risk Management into the ISO 9001 revision emphasises the importance of establishing a philosophy of risk based thinking throughout the organization. Identification and control of risk has been given a higher priority in the revised standard. Resources need to be provided to make this effective at all levels.
Risk management of process will consider the wider risks from external factors such as environmental impacts, breakdown of supply chains, industrial action or customer changes, as well as the internal risks and constraints within the organization.
Other notable clauses
Context of organization – The revision requires organisations to identify factors that could affect operations, for example regulation, governance and stakeholders.
Needs and expectations of stakeholders – This would include; customers, competitors, trade bodies, regulators, shareholders and board members.
Organizational Knowledge – Examples include; employee knowledge, intellectual property owned, and information stored.
What should we do next?
DAT Performance consultancy packages can help your organization with the implementation or transition to the new quality system standard.
Contact us at DAT to learn more.