Quality

ISO 37301:2021 - Compliance Management Systems Requirements with Guidance for Use

 

Mr. Bhupesh Sood CEO, SEC Global Consulting

The word compliance, as per Cambridge Dictionary means the act of obeying an order, rule, or request. Alternatively, as per the same Dictionary it also means - the fact of obeying a particular law or rule, or of acting according to an agreement. As we understand however, there may be a variation in the degree of compliance among the firms measured in terms of requirement of the standard to the quality of implementation. Compliances have been helping the organizations to meet the law of the land and the laws of the country where you want to sell your product. The complex world of medical devices makes it mandatory for manufacturers to follow a definitive route of compliance rather than a haphazard approach which takes more time, more manpower ultimately leading to additional costs which are then indirectly built into the finished goods cost. This makes the manufacturer more in-competitive in the price sensitive markets. Hence a solution for such challenges has been arrived with the launch of ISO 37031 which specifies requirements and provides guidelines for implementing an effective compliance management system within an organization.

This document is applicable to all types of organizations regardless of the size and nature of the activity being performed by them. This is also covering the sectors like public, private or non-profit sector. All requirements specified here to a governing body/top management as the case may be. This document was prepared by Technical Committee ISO/TC 309, Governance of organizations. This first edition of ISO 37301 replaces ISO 19600:2014, which has now been revised.

The top management in the organizations that want to ensure that they are growing and successful in the long term, must establish and maintain a culture of compliance. Compliance is therefore an opportunity, for a long term and sustainable organization. Since compliance is an ongoing process, its made sustainable by embedding it in the culture of the organization. The people need to be trained and their behaviour and attitude must be aligned as per the requirements. Though we need to ensure implementation in the strictest manner, the compliance processes must be integrated with the organization’s routine operational processes and procedures.

Several benefits of implementation of ISO 37301:2021 as per the standard are listed below for a ready reference.

• improving business opportunities and sustainability;
• protecting and enhancing an organization’s reputation and credibility;
• taking into account expectations of interested parties;
• demonstrating an organization’s commitment to managing its compliance risks effectively and efficiently;
• increasing the confidence of third parties in the organization’s capacity to achieve sustained success;
• minimizing the risk of a contravention occurring with the attendant costs and reputational damage.

Since this is a “Certifiable” standard, and both regulators and independent experts may use the standard in assessing an organisation’s compliance management system. Certification enables an organisation to demonstrate its commitment to compliance to all stakeholders and interested parties.

Organisations that align their compliance management system with ISO 37301, and obtain third-party certification, are likely to gain a competitive advantage.

References
a) https://www.iso.org/obp/ui/#iso:std:iso:37301:ed-1:v1:en )
b) https://www2.deloitte.com/au/en/blog/royal-commission/2021/iso-37301-compliance-management-system-opportunity-change.html