We all have a lot of experience of the new normal. We have the experience of washing our hands, keeping our distance, being at home, living with partners remote working, children experiencing remote learning, and, yes, remote working ourselves. It's not a huge leap to realize that pretty much everything has been delivered remotely and that includes ISO auditing. This means it's crucial to update the approach, content, and delivery of ISO lead auditor training.
Businesses that proactively and effectively implement ISO standards and maintain certifications specific to their industries end up reaping benefits that go far beyond simply checking the box on a mandatory standard. The business benefits of ISO are twofold. First, the actual implementation of processes, documentation, and quality standards provide important frameworks for improvement across many aspects of a business. And, second, being officially certified in standards like AS9100 for...
The FDA is presently working on transitioning their QSR requirements to ISO 13485. The intent is to coalesce 21 CFR Part 820 with ISO 13485:2016 to harmonize requirements while revamping the regulation, which hasn’t been updated in more than 20 years. As medical device companies increasingly distribute globally, they have had to comply with both requirements, as well as other international requirements. Since international medical device regulators (including the ones in EU, Canada, Australia,...
Root Cause Analysis (RCA) is a problem-solving technique targeted at identifying the actual root cause, or the reason for a nonconformity. A root cause is just what it sounds like: the “root” of the problem. The need for RCA stems from the fact that the elimination of the symptoms of the problems is not alone sufficient to address the problem, it must be addressed at the source. If you solve a problem at this root level, it is highly probable that you can prevent its recurrence.
Even before the 2020 pandemic, Cavendish Scott was performing some internal auditing services remotely. But since the first lockdowns, remote and hybrid audits have represented an increasing portion of the firm’s business.
Clients sometimes ask Cavendish Scott for advice on the best software for ISO. They generally seem to be hoping for a package that will provide the architecture for their standards, so they can simply follow all the prompts, check all the boxes, and thereby pass all their audits.
Cavendish Scott auditors eat, breathe, and sleep ISO standards. When they’re not traveling to multiple client sites to conduct internal audits, they’re consulting about auditing and training auditors. All of this adds up to a tremendous benefit to clients.