You will be surprised how far
we'll go for you !

How to Define the Applicable Statutory & Regulatory Requirements ?
(by Choong Ewe Lee)


We found that the aspects/scope of "Applicable Statutory & Regulatory Requirements” in the ISO 9001:2015 is not that well defined. This may cause some arguments between the clients and Certification Body (CB) auditors.

The critical argument here is, whether the Environmental Quality Act, 1974 and Occupational Safety & Health, 1994 are applicable. If they are, then the auditor may have to audit the scope of the Environmental Management System (ISO 14001), and OSH Management System (OHSAS 18001) which may be required by the said legal requirements as above which is not directly quality related.

After having a thorough discussion among our consulting team, we have decided to declare only the applicable statutory & regulatory requirements that will affect the intended results of Quality Management System only, else they will be considered as “Not Applicable”.

For example, we have a client of multi-level marketing, Direct Sales Act, 1993 will be applicable to them. If a Manufacturer/Supplier uses or supply any Group A or Group B poison, then Poison Act, 1952 is applicable to them. 

As summary, as long as the legal requirements are to state the specification or requirements for the products or services provided, then the said requirements shall be applicable.

For our existing client, if we have any new articles published, we will inform you all through our usual Brain Performance – ISO 9001 Wassap Group.

Should you have any comments/inputs/topics that wish us to put in this Sharing Session, please feel free to drop us an email.

For more information, please visit our Services Package in Upgrading ISO 9001:2015, ISO 9001:2015 QMS Conversion & Documentation Training, Risks & Opportunities Analysis Training, Our Articles, Photo Gallery, or our website @


Please feel free to forward the above articles to whoever that may find it useful. If they have any enquiries on ISO 9001:2015 upgrading, they are most welcome to email for further clarification.

  Copyright © 2011. Brain Performance Consultants Sdn Bhd (853925-W). All Rights Reserved.