Ok, once again, please forgive my ignorance, I'm learning...
I know it's not really advisable to copy the Standard verbatim, but when I touch on each of the elements as I put my QM on a diet, do I need to mention all of the points listed in the standard? Or can I just state that we've established a procedure to meet the requirements of the Standard?
For example.
I now have:
"5.6 MANAGEMENT REVIEW
5.6.1 GENERAL
5.6.1.1 Management reviews of the QMS are conducted bi-annually, in order to ensure the continuing suitability, adequacy and effectiveness of the QMS in accordance with QSP 5.6 – Management Review of the Quality Management System. Records of management reviews shall be maintained per § 4.2.4 Control of Records.
5.6.2 MANAGEMENT REVIEW INPUT
5.6.2.1 The purpose of Management Review is to evaluated collected data from the following sources:
o Results of audits
o Customer feedback
o QSP, SP & WI performance and product conformity
o Status of Corrective and Preventive Actions
o Follow-up actions from previous management reviews
o Changes that could affect the QMS
o Recommendations for improvement
5.6.3 MANAGEMENT REVIEW OUTPUT
5.6.3.1 The output from Management Review includes decisions and actions relating to:
o Improvement of the effectiveness of the QMS and its processes
o Improvement of product related to customer requirements;
o Resource needs
Could I change it to the following statement and then get into the details of how we meet the requirements in the actual procedure?
"5.6 MANAGEMENT REVIEW
5.6.1 GENERAL
5.6.1.1 Management reviews of the QMS are conducted biannually, in order to ensure the continuing suitability, adequacy and effectiveness of the QMS in accordance with QSP 5.6 – Management Review of the Quality Management System. Records of management reviews shall be maintained per § 4.2.4 Control of Records."
As Somashekar pointed out, there is no need to have that level of detail in your quality manual. You do not have to show how you are going to address every "shall" of the standard in the quality manual, or in your procedures either for that matter.
Your quality manual needs three things (see element 4.2.2)
1) A scope statement including justification for any exclusions.
2) Your written procedures, or reference them.
3) A description of the interaction between your processes.
Focus on the second part. Your quality manual does not need to include your written procedures as long as you reference them. That could simply be a copy of a table of contents for your written procedures. Those written procedures do not need to include how you address every "shall". The written procedures need to include the six topics that the standard says need to be documented (control of documents, control of records, internal audit, control of nonconforming product, corrective actions, and preventive actions). You may determine that you want more, and whatever you determine has to be documented.
Some companies decide to include the procedures in their quality manual. Some decide to reference them. Some do provide a somewhat paraphrased version of the standard in the quality manual and then have written procedures as well. My general attitude is why duplicate that stuff. Forget about paraphrasing the standard and just write the procedures. When your quality manual and procedure manual overlaps, you end up on an easter egg hunt when trying to determine where you need to look.
So my preferred method is to have a combined manual. Include your written procedures, but forget about paraphrasing the standard.
Do what works for you.
