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 |
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