![Advisera Mark Hammar](jpg/markhammar-2.jpg)
February 14, 2017
One of the requirements that are embedded within ISO 9001:2015 is the necessity to understand and include statutory and regulatory requirements within the Quality Management System (QMS); however, many people have difficulty with understanding how to do this. To help understand this process, there are three main questions to answer: what are these requirements, what does ISO 9001:2015 require, and how can I best include the requirements?
By definition, “statutory” refers anything relating to a decree or act, and “regulatory” is related to state, national, or international laws and regulations – so, requirements of these sorts come from the legal system. These legal requirements are mandates that you need to follow for your products or services in order for them to be made legally available for sale. An example would be the safety requirements for sports helmets; helmets need to meet a certain level of testing to be considered safe for use, and any company that produces helmets needs to make sure their product meets these mandatory requirements.
In ISO 9001:2015, statutory and regulatory requirements are mentioned in conjunction with customer requirements. In all cases, your products and services need to meet customer and applicable statutory and regulatory requirements, and ISO 9001:2015 points out where you need to consider this in your QMS. This comes into consideration when understanding the needs of interested parties, understanding all requirements to ensure customer focus is maintained, determining and reviewing the requirements for your products and services, collecting design and development inputs, what control you will have on external providers, and post-delivery activities.
Of course, before you can include statutory and regulatory requirements in your QMS, you need to identify which are applicable to you, your processes, and your products and services. You need to know what laws and other mandatory requirements you need to meet in order to legally provide your products and services, and ISO 9001:2015 Appendix A.3 is very clear that it is for you to decide if any particular requirement of an interested party is relevant to your QMS. So, you need to have a way to identify the statutory and regulatory requirements that you need to meet, and you then need to ensure that you keep up to date on any changes.
Once you know the requirements you need to meet, you then need to find a way to bring them into your QMS. It does not make sense to try to have a separate method of controlling the activities that your employees need to do to meet statutory and regulatory requirements, so including these requirements in the processes, procedures, and documented information that your employees follow is advisable.
There are basically two main types of statutory and regulatory requirements to consider in your QMS:
The most important thing to remember about statutory and regulatory requirements is that it is your responsibility to identify them and then ensure that they are maintained and included in your QMS as applicable. By including these requirements within the documentation and practices of your QMS, you can better ensure that these important requirements are met and maintained, so that you can continue to legally provide your products and services by meeting all requirements that are applicable. Incorporating these requirements means that they are not easily forgotten.
For a better understanding of ISO 9001:2015 for statutory and regulatory requirements, check out this free online training: ISO 9001:2015 Foundations Course.