My solo consultancy is geared towards startup medical device companies preparing for quality system lift-off.
ISO 13485:2016 has a broader view of risk management than in the past.
Does your organization’s Quality Policy inspire you, or tire you? First, let’s review US FDA and ISO 13485 requirements and ISO 14969 guidance. After that, I am sharing my current “state of the art” model for a Quality Policy and corresponding Quality Objectives. Quality Policy Definitions ISO 9000:2005 – Overall intentions and direction of anContinue reading “Quality Policy and Objectives”
Before you read the vocabulary definitions in ISO 9000:2015 you need to know what the “small words” mean.
Accelerated Aging is utilized to establish the shelf life of a product relatively quickly.
I can think of 3 options when engineering specification (design verification spec) is not met.
Unfortunately, there is currently no centralized database to search Notified Bodies and their Client companies. Here are some ideas for how to go about this.
I am not a microbiologist but I play one on TV!
Independence is the basis for judicial systems and sporting matches. And for quality systems, it is generally accepted that personnel who are independent of an activity are more objective (impartial) than persons who are directly responsible for the success of the work.