Quality System – Where Do We Start? You have decided that you need a new or improved quality system, and now the question is, where do you start? To quote Stephen Covey, begin with the end in mind. Does the organization need or wish to pursue an ISO certification, Nadcap accreditation, or FDA clearance? If
One Quality System, Please The organization should have only one quality system. And, unless there is an overwhelming need, the organization should have one quality system certification or accreditation. For clarity, an overwhelming need would include ISO certification and a regulatory registration (e.g., FDA), not two separate ISO or ISO-equivalent certifications. This is true whether
Part 1: Whose Quality System Is It? Whose quality system is it? Who cares and why? The answer to the first question is, it is your quality system. How do you know it is yours? With no pun intended, the documents probably include your company’s letterhead or logo. And, whether it was developed in-house and
What is quality? Ask different people within your organization and for every person you ask, you will probably get a different answer. So how do most companies make sure they have the right answer to what is quality?