The revised ISO 9001 has now been published following several years of work by the TC176 technical committee. The updated quality standard reinforces the process approach and introduces risk based thinking. In addition the new quality management system standard conforms with annex SL, 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 organisations think, work and perform particularly at senior management level.
Organisations have three years to complete the transition from ISO 9001:2008 to ISO 9001:2015; full implementation will be required by September 2018. The 2008 version of the standard will not be recognised after this date.
ISO 9001:2015 provides a quality management system requirements based on the process approach and risk based thinking. With a focus on performance and risk the revised quality management standard is more about managing process and less about documentation.
With this in mind, two of the most significant changes are “Leadership” replacing “Management Responsibility” in the 2008 version and “Risk based thinking”.
Organisations that have effectively applied ISO 9001:2008 will find the transition to ISO 9001:2015 relatively straight forward while those who have relied on merely sustaining a certificate on the wall may struggle.
The updated ISO 9001 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 organisations 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:
- Better internal and external communication
- Increased repeat business
- Increased levels of new business
- Improved organisational effectivness
- Increased bottom line
- Reduced waste
The addition of Risk Management into the ISO 9001 revision emphasises the importance of establishing a philosophy of risk based thinking throughout the organisation. 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 organisation.
Other new clauses
Context of organisation – 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.
Organisational Knowledge – Examples include; employee knowledge, intellectual property owned and information stored.
What can I do next?
DAT Performance consultancy packages can help your organisation with the implementation or transition to the new quality system standard.
Contact us at DAT to learn more.