Manage Legal Risk with ISO 31022:2020
Earlier this year (May 2020) the International Standards Organization (ISO) published their legal risk management guidelines, ISO...
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Better Compliance Done a Better Way
According to Albert Einstein: Insanity is doing the same thing over and over again and expecting different results. And yet, that is...
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Are You Auditing What Really Matters?
Audits have been used for many years to confirm the integrity of financial statements and that proper accounting procedures have been...
143 views
The Regulatory Tsunami
In recent years many in the compliance industry have observed a shift in regulation from prescriptive to performance and outcome-based...
1,192 views
A Burning Platform of Reactive Compliance
Do we now have a burning platform with respect to reactive compliance? On May 16 2018, a report was published following a review led by...
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Why is focusing on non-conformance missing the point?
Focusing on non-conformance is the first level of compliance. This involves meeting the prescriptive part of a regulation or industry...
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Integrated Regulatory and Compliance Taxonomy
To effectively meet compliance obligations, it is essential to differentiate regulatory and compliance demand according to their designs....
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The Qualitative Nature of Quality
The purpose of a quality program is fundamentally to improve the quality of something. However, with today's focus on quality systems and...
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Leading Health Systems Innovation
Like other sectors, health care also requires innovation. Current models are based on a reactive and transactional approach to how health...
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Compliance Chain Analysis
Harvard Business School's Michael E. Porter introduced the concept of a value chain in his book, "Competitive Advantage: Creating and...
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Tyrannical Compliance
Companies often consider compliance as a "necessary evil" rather than a "necessary good." They sometimes feel they are forced to comply...
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Four Steps to Proactive Compliance
More companies are becoming aware that they are too reactive when it comes to compliance. In my previous blog, I discussed four misuses...
1,399 views
Four Misuses of Audits
Audits were first adopted by financial institutions to identify and prevent fraud. Their focus was to test the integrity of accounting...
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Ethical Compliance
Technology is advancing faster and further than our ability to keep up with the ethical implications. This applies also to the systems using
787 views
Problem with Risk Scores
Risk scores are commonly used to support risk-based decisions and are usually derived from a semi-quantitative analysis of the underlying...
506 views
Risk-Based CAPA?
Many companies are in the midst of adopting changes introduced by ISO 9001:2015. One of the most significant of these, is incorporating...
629 views
5 Ways Risk Management Has Changed
Recent revisions to compliance standards and regulations have introduced changes to the way we think about and manage risk. You can look...
1,437 views
ISO 9001:2015 – More Than Re-writing Procedures
Every company currently certified for ISO 9001 will need to re-certify at some point in time. This is an opportunity to go beyond just...
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Why You Need a Compliance Architect
In a world of competing and overlapping compliance demands, siloed departments, and numerous stakeholders the role of an architect is...
766 views
LEAN Paradox - Specialists versus Generalists
In a world that values specialists, individual workmanship and personal accountability the LEAN culture can seem foreign, threatening and...
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Do You Need A Different System For Each Regulation?
The need to comply with regulations and standards is a necessary part of every business. In fact, companies need to comply with several...
56 views
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