Where in the quality manual do I put our Quality Objectives and our Quality Policy
- Thread starter kerris
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Re: Where in the quality manual do I put our Quality Objectives and our Quality Polic
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.
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.
Re: Where in the quality manual do I put our Quality Objectives and our Quality Polic
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.
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.
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.
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.
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.
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.
