ISO 37301 is the new compliance management standard, published in April 2021 to replace ISO 19600:2014. It provides guidelines for companies to establish, develop, implement, evaluate, maintain, and continually improve their compliance management system (CMS).
The new standard reflects a shift towards a comprehensive approach to compliance across all sectors, regardless of the organisation’s activity, size, or complexity.
Whereas its predecessor was only considered a recommendation, ISO 37301 is a so-called Type A management system standard and is therefore certifiable. Organisations can become certified by undergoing a conformity assessment via an independent third party.
The standard is 90% the same as its predecessor, so companies that have already aligned themselves with ISO 19600 will not need to change too much. The most significant change is the shift towards looking at compliance as a central part of an organisation’s overall culture, rather than the responsibility of one small team working in isolation. As such, the new standard represents a significant opportunity for organisations to gain accreditation and demonstrate the strength of their compliance culture.
Our article covers everything you need to know about ISO 37301, helping you align your compliance strategy and achieve accreditation.
Principles
ISO 37301 is based upon several general principles of compliance management systems:
- Integrity
- Proportionality
- Transparency
- Accountability
- Good governance
- Sustainability
Benefits of implementing ISO 37301 in an organisation
The benefits of implementing ISO 37301 extend beyond reducing the cost of non-compliance. Enhanced credibility and reputability offer exponential benefits to organisations, providing enhanced confidence to clients and stakeholders.
Implementing ISO 37301 will help your organisation to:
- Create and sustain a positive culture of compliance
- Address compliance concerns effectively
- Develop positive relationships with regulators
- Build customer trust and loyalty
- Improve business opportunities
- Protect your reputation and safeguard integrity by detecting and preventing unethical conduct
- Increase third party confidence in the organisation
Building and maintaining a culture of compliance
The most significant shift in focus of the new standard is the stronger emphasis given to how a company manages its compliance culture. Although compliance departments should maintain control of the system’s overall management, the new standard asserts that the responsibility for making a compliance system run effectively belongs to every department.
This amendment to the standard reflects the broader change that competitive organisations are already making. Despite the superior experience compliance professionals have, it is impossible for them to always be on the frontline to help staff make correct decisions should a compliance issue arise.
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What does ISO 37301 mean for your organisation?
Historically, many companies aimed their CMS wholly at risk avoidance strategies and individual goals. The publication of ISO 37301’s predecessor, ISO 19600, meant that organisations were able to follow and maintain a uniform standard for the first time.
Embedding this approach to compliance with a traditional, manual approach can be time-consuming, costly and resource-intensive for quality and compliance teams.
By aligning your CMS with ISO 37301 to obtain - and then promote - the third-party certification, your organisation can gain a competitive advantage.
More and more organisations are turning to tools like quality management software to:
- Simplify compliance with multiple simultaneous standards
- Embed compliant processes more easily into the day-to-day
- Give themselves the control and visibility of their compliance landscape to drive continuous improvement and unlock new standards.
Ideagen’s Q-Pulse system equips you with the tools you need to achieve accreditation more quickly and easily than ever before, helping you:
- Map any kind of business process to create powerful workflows, including CAPA close-out and document approval
- Maintain complete traceability with audit-trailed and time-stamped actions for airtight compliance
- Foster a culture of compliance with a single source of truth to ensure everyone remains connected to your compliance agenda and on the same page.
Learn more about how Q-Pulse can support your compliance agenda with our standard-specific toolkits.
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Sophie Willink
As Ideagen’s Content Marketing Executive, Sophie produces informative content to provide customers with digestible insights into the world of quality, audit, risk and compliance.
With a background in psychology, Sophie is passionate about understanding human behaviour and the role technology can play in measuring, reporting and improving behaviours to create higher quality business environments.