All ISO standards are revised every 5 years to keep these current and relevant. The ISO 9001 standard was first published in 1987. Since then it is revised every 6 to 8 years.
The current version of the ISO 9001 is 2008. The next changes to the Quality System Standard ISO 9001 are due for final release in the second half of this year, with these changes being seen as more revolutionary than previous updates. Some of the important differences in the new edition will witness an updated structure to the standard, allowing a more seamless integration with other standards, such as ISO 14001 (environmental management systems).
Changes to the Standard
Some of the proposed changes are as follows, and so ISO9001:2015 will:
Adopt a new standard high level framework and terminology (known as Annex SL). This is a unified guideline which is to be used for the development of all new and revised ISO standards
Be re-worded to increase clarity and accessibility, reducing room for interpretation
Introduce two new clauses relating to the context of the organization, which require the organization to determine the issues and requirements that can impact on the planning of the quality management system and can be used as an input into the development of the quality management system.
Make the adoption of a process approach in the implementation of a quality management system more explicit.
Replace the term ‘products’ with ‘goods and services’, in order to remove the existing bias towards organisations dealing with physical products, and make it clearer that the new standard is applicable for organisations of any kind.
Remove the specific requirement for preventive action as this is the task of the quality management system in its entirety, as opposed to a specific subsection of it.
Reinforce the concept of Risk Based Thinking. Although this requirement has been implicit in the 2008 version, the new standard makes the risk based thinking more explicit.
Not allow the organisation to have exclusions (e.g. design, measuring devices, etc.) if it falls under the scope of its QMS. Also non-applicability is not allowed if that could lead to failure to achieve the conformity or to enhance customer satisfaction.
What you need to do!
If your business is currently using ISO 9001 then these changes will affect you! Whether you are a business owner managing your own system or a quality assurance officer working for an SME it is important you are able to take control of these changes before they affect the compliance and performance of your business.
While organisations are granted a three-year transition period after the revision has been published, you’ll need to allocate significant time and resource to migrate your quality management system to the new edition of the standard.
How EQAS can help
We can remove the stress and confusion you are likely to encounter during your transition, and help you as follows. EQAS can:
Re-assess the status of your QMS, and identify if you have too much documentation. Is your system user friendly? Is it possible to integrate other compliance criteria into one more manageable system?
Train and educate your staff including your internal audit team and those responsible for ensuring the changes are implemented effectively.
Create a transition plan that maps out how you will manage the process to achieve ISO 9001:2015 certification.
Assist you to communicate to interested parties and stakeholders that the changes are occurring and the transition is being managed
Show you how to use your internal audit process to validate changes