Scope & Criteria

Scope

All audits are supposed to have a defined scope. Defined simply, this is the “extent and boundaries of an audit”. Technically this is “what” is being audited, the addresses or virtual locations, processes, and dates of when the audit activities will take place.

Scope is often confused with criteria. It is an all too common occurance to hear that the ‘scope’ of an audit is the MDR, or QSR, or just plain ISO in reference to ISO 13485:2016.

Depending on the size of your organization, the scope of your audit will be different. If you have multiple locations it may be necessary to conduct multiple audits with each geographical location as the specific scope of each audit.

Criteria

The criteria of an audit is what your processes and quality system will be compared to for conformity. This could be internal procedures, regulations such as;

• 21 CFR 820
• Regulation (EU) 2017/745
• ISO 13485:2016
• CMDR SOR98-282

Relating this to your program

Audit programs should scale with your organization. If you are a small start-up company bringing a single device to a single market, then your program should equally be small, focused, and simple. Each audit has a scope, but so does your program. Your audit program should define the entire scope of your Quality System activities, and then utilize audits to evaluate that.

The small single device, single market organization may be able to audit the full scope of their quality system in a single audit. A larger company may have to utilie multiple partial audits to cover that same system scope.

Hopefully the progression of the audit program in relation to your company operations was clear. The change in the depth of art styles was also intended to represent that growth as well. I doodled the first picture with a free app on my phone, it was simple and met my very basic needs. Because my needs grew, so did the art I needed to make my point. The larger audit program is now multiple pictures, a mix of water colors drawn by Alysha Chesser, and my best attempt at making a 3-D book with depth and shadowing, and a coffee stain on a gnarled and torn cover.

First establish the scope and criteria of your Audit Program, and then plan your audits throughout the year to meet those requirements.