What are statutory and regulatory requirements?

ISO 13485 specifies requirements for a quality management system where an organization

  • needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and
  • aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements

Whatever the type, size and nature of your organization be, ISO 13485 requirements are applicable because they are generic in nature.  Any such requirements that cannot be applied due to the nature of work of the organization, then that requirement can be considered for exclusion. The effect of any such exclusion made should not affect the organization’s ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.

Implementation of applicable statutory and regulatory requirements is one of the main benefits of ISO quality management system in addition to better management control and improving the effectiveness of processes/products/services. Read more about the overall benefits of ISO 13485:2016.

Why is compliance to statutory and regulatory requirements important?

Meeting the applicable statutory and regulatory requirements in addition to the customer requirements is the first step towards customer focus for any organization. If there are some statutory and regulatory requirements which do not interfere with the organization’s services or products if not complied with, then only such requirements can be excluded with proper justification.

When a customer buys a product or a service from an organization, he seeks a sustaining relation and a long-term association with the organization. If for any reason, the regulatory requirements are not met, then it results in the loss of the existing customers as well as potential customers. The company brand image will be tarnished, company credibility will be at stake and share value will decrease as a consequence. This is especially important when it comes to other related standards like medical and environmental safety standards etc. There are some customers who will require their suppliers to be ethical in all their dealings and in effect conserve the environment. Such regulatory breaches distract the company from their focus of customer satisfaction.

How is the compliance to the statutory requirements demonstrated?

The general perception about any organization is that it exists and operates for profit. Organizations are profit focused and not customer focused. But profits should be the result of our activities and should not be the reason of our existence as a company. Profits are no doubt important – we need them to pay employee salaries, pay off any loans, expansions, investing in new technologies, training and development of competencies etc. But focusing on the profit should not be the company’s motto- rather the decisions of the company should be based on customer satisfaction and product/service quality.

It is the responsibility of the top management to examine its work culture and see that the employees operate not under fear but under excellence. The customer requirements have to be met, in addition to the regulatory requirements, of course in a profitable way. In case the business cannot operate in a profitable way to satisfy a customer, there has to be opportunities identified to operate profitably through other transactions so that the loss can be recovered. A clear understanding of the customer and regulatory requirements has to be established and this should be communicated through the company sales force. They should not make promises to the customers that the company cannot honor. This way the management requires a re-alignment of their priorities and the way they operate in the market.


Our All-in-One Certification Package is a proven, efficient system. It gives you all you need to prepare for registration – in one simple to use package.

Customer Review:

"I have just passed my ISO Audit with zero non-conformances for the second year in a row using your ISO products to write my entire QMS. Thank you for producing documents of this quality"

Bettye Patrick

Buy the Standard

13485 Store Logo ISO 13485