Human rights regulations and transparency requirements continue to be an emerging regulatory trend worldwide. Legal advice is needed to identify areas of responsible sourcing and to build risk mitigation strategies. Continue reading
ISO 9001:2015 auditability is a key concern for all CB’s over the next five years. So, what does auditability really mean? It first starts with the quality of the risk auditors. Continue reading
As most of you know, ISO 13485–Quality Management Systems—Requirements for Regulatory Purposes is being revised. ISO 13485:201X, as the final revision is being referred to, is expected to be available in late 2015 or early 2016. Understandably, this is causing anxiety for medical device manufacturers, many of whom are still struggling to conform to the current version of the standard. With this in mind, let’s review the basics of the ISO: 13485. In future posts, we’ll examine why the standard is being updated, and the most significant changes you can expect to see. Continue reading
Maybe “Greed is Good” but with a 300% increase in Shareholder Value Berkshire Hathaway proves Ethics pays better! But if Ethics pays, the traditional “zero tolerance” preach & penalize awareness training approach won’t get you there, nuturing will. Continue reading