Quality Plan for ISO 9001 and ISO 13485 - Template or Example Needed

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Coury Ferguson

Moderator here to help
Staff member
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#2
Re: Quality Plan template

Qualityalways said:
Hi all,

I searched through the Cove for a good Quality Plan but could not find one. Can some one share ?

You will need to be more specific on your request. Quality Plan is pretty general.
 

Ajit Basrur

Staff member
Admin
#3
Re: Quality Plan Template or Example Needed

Hi,

No I tried different search words but didnot come across a good template for Quality Plan in the Cove. When I searched the internet for quality plans, came across Batch History records.

Are Batch History records similar to Quality plans. If yes, what is the difference between Batch History Record, Device History Record and Quality plan ?
 
F

favqty

#4
Re: Quality Plan Template or Example Needed

Quality plan should be generated as a sum of all the control plans defined to assure customers satisfaction.
It is usefull to define control plans for each process you think are critical to satisfy your customers, them you relates, sequentially, all of them and woila, you get your quality plan.
It is some easy and accurate way to generate it. There may be some other ways. This is the method I would like to recommend. I hope helps you.

Have a good one!!
 
G

Greg B

#8
Re: Quality Plan Template or Example Needed

Hi all,

I searched through the Cove for a good Quality Plan but could not find one. Can some one share ?
Why do you want a Quality Plan??? Where does it say in the Standard that you require one? If your registrar asks for one tell them that you don't require one!!!!

Does your company have a business plan? Do they use a balanced Score card? Do they have business KPI's? This is the information that runs your business. This is the information that will make or break your business! These are the integral parts of your, so called, Quality Plan. It is your Business Plan! Don't try and bend your business systems to the standard ,rather, build your quality system around your business.
 

Ajit Basrur

Staff member
Admin
#9
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.
 
G

Greg B

#10
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. :D

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)
 
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