Re: Quality Plan Template or Example Needed
We are ISO 9001 and ISO 13485 certified. One of our customers wanted us to have a Quality Plan as a High level document.
Ask the customer WHY????. Send them a copy of your certification certificate and that should be enough. I ,truly, do not understand why a CUSTOMER would want OR need another company's Quality Plan (if such a thing existed). If they insist then send them a copy of your
Quality Manual and Policy. These are the per-eminent documents in your Quality System and spell out how you go about your business. If they persist then get them to show you a copy of THEIR quality Plan.
PS: If you get it, then please post it here (minus their name) so I can dissect it.
Added a little later
5.4 Perform Quality Planning
5.4.1 Define company
Quality Objectives (aka Business KPIs)
Measurable Targets and Objectives must be defined:
1. For each part of your Quality Policy.
2. For each functional area in your company.
3. To help with product realization.
4. At each of the company's organizational levels.
5.4.2 Plan Quality Management System
. (aka 'Management Review Meetings')
1. QMS implementation must be planned and implemented, if it is not already in place.
2. QMS improvements must be planned and implemented over time, as necessary.
IF they really, really really want a plan then give them a copy of your 'Management Review Schedule and an agenda'
(Here is my procedure for it)