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,...
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.
Having worked in the ISO industry for over 30 years, at Cavendish Scott we recognize that making a decision about ISO can be a future-altering decision for a company. For many, the future is altered in a good way. For others, the choices made when choosing a consultant can harm a company for years to come. The reality is that when a decision is made correctly the first time, it can pay off dividends down the road.
The International Organization for Standards (ISO) developed ISO 9001 to be an overarching standard focused on quality. Specifically, ISO 9001 gives us the standard that specifies requirements for a quality management system(QMS). It is the most popular standard in the series.
A question we often receive from organizations considering standard adoption is what is the cost? As with any change within a business, when an organization decides to adopt an International Organization for Standardization Standard, there are costs inherent within said adoption. Outside of the monetary expense, there is also time cost and in some cases, organizational structure cost. We will walk through each of these to help explain the different costs of adopting ISO.
In over 35 years of business at Cavendish Scott, one consistent choice we see clients face is whether to develop a stable team of internal auditors or to engage professional auditors on a subcontracted basis to perform internal audits.