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.
Now is the time to get the 13485 monkey off your back.
Does your organization’s Quality Policy inspire you, or tire you? Are you Quality Objectives follow a framework established by the Policy statement?
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.