In recent years many in the compliance industry have observed a shift in regulation from prescriptive to performance and outcome-based designs. What we are s...

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 Dame Judith Hackitt f...

Focusing on non-conformance is the first level of compliance. This involves meeting the prescriptive part of a regulation or industry standard. However, stan...

To effectively meet compliance obligations, it is essential to differentiate regulatory and compliance demand according to their designs. Regulations and sta...

The purpose of a quality program is fundamentally to improve the quality of something. However, with today's focus on quality systems and conformance to stan...

Like other sectors, health care also requires innovation. Current models are based on a reactive and transactional approach to how health care is delivered. ...

Harvard Business School's Michael E. Porter introduced the concept of a value chain in his book, "Competitive Advantage: Creating and Sustaining Superior Per...

Companies often say that compliance is a "necessary evil." They feel that they are forced to comply with arbitrary rules that have little correlation with th...

More companies are becoming aware that they are too reactive when it comes to compliance. In my previous blog, I discussed four misuses of audits that result...

Audits were first adopted by financial institutions to identify and prevent fraud. Their focus was to test the integrity of accounting procedures and financi...

"It is impossible to design a system so perfect that no one needs to be good." – T.S. Eliot Technology is advancing faster and further than our ability to ke...

Risk scores are commonly used to support risk-based decisions and are usually derived from a semi-quantitative analysis of the underlying risk factors to pro...

Many companies are in the midst of adopting changes introduced by ISO 9001:2015. One of the most significant of these, is incorporating "Risk-based Thinking....

Recent revisions to compliance standards and regulations have introduced changes to the way we think about and manage risk. You can look at: ISO 9001:2015, I...

Every company currently certified for ISO 9001 will need to re-certify against 9001:2015 by the end of 2018. This transition brings along with it more than j...

In a world of competing and overlapping compliance demands, siloed departments, and numerous stakeholders the role of an architect is needed more than ever. ...

In a world that values specialists, individual workmanship and personal accountability the LEAN culture can seem foreign, threatening and perhaps even wrong....

The need to comply with regulations and standards is a necessary part of every business. In fact, companies need to comply with several regulations and stand...