Where in the quality manual do I put our Quality Objectives and our Quality Policy

#1
Could someone please tell me where in the quality manual do i put our Quality Objectives and our Quality Policy? Would it be after the Foreword? Any help would be appreciated.

Thanks!
Kerri
 

AndyN

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#2
Re: Where in the quality manual do I put our Quality Objectives and our Quality Polic

Could someone please tell me where in the quality manual do i put our Quality Objectives and our Quality Policy? Would it be after the Foreword? Any help would be appreciated.

Thanks!
Kerri
Hi Kerry:

Good question! Neither, technically, have to appear IN the Quality manual. Policy can - generally early on. Have you a specific format for your manual? Like, does it follow the ISO requirements?

The objectives IMHO have no place in the manual. Put them in your management review for discussion and review during the course of doing business.
 
#3
Re: Where in the quality manual do I put our Quality Objectives and our Quality Polic

I do follow the ISO requirements. So how do you know what your quality policy and quality objectives are if you do not have them in your quality manual?
 

Eredhel

QA Manager
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#4
Re: Where in the quality manual do I put our Quality Objectives and our Quality Polic

Which standard are you trying to fulfill the requirements of?
 

AndyN

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#5
Re: Where in the quality manual do I put our Quality Objectives and our Quality Polic

I do follow the ISO requirements. So how do you know what your quality policy and quality objectives are if you do not have them in your quality manual?
The quality policy and objectives have to be communicated. Since no-one reads any manual which is formatted on the ISO requirements (including the arcane language the standard uses) - so posting the policy and objectives (on a score card) is a better option, IMHO.
 

DEVigil

Involved In Discussions
#6
Re: Where in the quality manual do I put our Quality Objectives and our Quality Polic

We're a small company, and we structured our Quality Manual similarly to ISO 13485. Section 1 is Purpose and Scope (where we list applicable standards covered, non-applicability, etc.). Section 2 is Company Information (brief overview, high level org charts, etc.) Section 3 is labeled Quality System and that's where we put out Vision statement, Quality Policy, and Quality Objectives (with a table that maps them to the policy and metrics we use to measure performance against our goals). Then the rest of the manual follows the organization of 13485 pretty closely - Section 4 is QMS, Section 5 is Management Responsibility, and so forth.

We also post the Quality Policy itself, signed by the CEO, in various places in our offices - the break room, the developer area, and so forth.
 
#8
Re: Where in the quality manual do I put our Quality Objectives and our Quality Polic

Could someone please tell me where in the quality manual do i put our Quality Objectives and our Quality Policy? Would it be after the Foreword? Any help would be appreciated.

Thanks!
Kerri
Page 1. :)


Stick it wherever you want. But I wouldn't include quality objectives as they are likely to change over time. Would want to have to update a manual every time. Maybe just make an appendix or attachment.
 

EthanLoh

Involved In Discussions
#9
Re: Where in the quality manual do I put our Quality Objectives and our Quality Polic

You can create appendix in the QM.
E.g.
Appendix - I, Quality policy
Appendix - II, Quality objectives

PS: You will need to provide evidence to prove that the policy and objectives are reviewed at least annually. Normally during Management Review meeting.
 

AndyN

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#10
Re: Where in the quality manual do I put our Quality Objectives and our Quality Polic

PS: You will need to provide evidence to prove that the policy and objectives are reviewed at least annually.
Can you point to this requirement? Is it in ISO 9001? Some other QMS requirement? Customer?
 

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