The 6 documented procedures required by ISO 9001:2008

B

brahmaiah

Some of the posts have missed objectivity and become personal.
V.J.Brahmaiah
 

Marc

Fully vaccinated are you?
Leader
Some of the posts have missed objectivity and become personal.
V.J.Brahmaiah
I have watched closely. The posts in this thread are not personal. They are respectful responses. This is an internet forum so you will have to expect people to disagree from time to time.

As to objectivity, there may be a language issue but the responses in this thread are sincere and without bias. I am not sure why you feel the responses are not objective (neutral).

But - That is off topic. Let us please get back to the thread topic.
 
S

Shearwater

This is a very timely thread for me.

We are a manufacturing company with 5 employees.

I have been reviewing our ISO 9001 document and I have to say that I am disappointed. I expected this to be a document that we could use to communicate the company's quality vision with the information needed to implement it.

Instead I have found a document written in bureaucratize. I looked at a few paragraphs at random. On the third page I looked at, I found a paragraph with 45 words and 101 syllables in the first two sentences.

Am I the only one who thinks that trying to use this type of document in a production environment is madness. I can barely understand it and I deal with dense documents all the time. I suspect that for some of our valuable employees, it might as well be written in Latin.

So.... How aggressively can I wield the editors marker? I would like to cut this down to the six required clauses, the detailed work instructions, and clear instructions on how to comply with our quality and test expectations.

Do we really need paragraphs like this in the document?

"8.5.1 Continual improvement
8.5.1.1 XXXXX continually improves the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.
8.5.1.2 Internal audit results and quality performance data are analyzed by management review to assess the effectiveness of the quality system and current organizational performance. Opportunities and priorities for improvement are identified by comparing present quality performance to goals and aspirations defined in the quality policy. This process is defined in Operational Procedure QOP-56-01 Management Review.
8.5.1.3 Improvement projects are defined either as corrective and preventive actions or as quality objectives. These processes are defined in Operational Procedures QOP-85-03 Corrective and Preventive Actions, and QOP-56-01 Management Review, respectively."

Would we still be compliant if we were to substitute something more along the lines of this:
"Our goal is to produce quality products and back them with the customer service that people want. In addition, we want those products, and that service to get better.

In order to do that, we use a process of auditing and measurement to assess our quality, and then use the information collected to improve our performance.

Two tools that we use assess quality are audits and non-conformance records. Management reviews these records and then uses it to direct corrective action."

I would love to hear comments on this before I spend days wasting my time.
 
Last edited by a moderator:
D

DrM2u

(...)So.... How aggressively can I wield the editors marker? I would like to cut this down to the six required clauses, the detailed work instructions, and clear instructions on how to comply with our quality and test expectations.(...)
Well, as long as the quality manual satisfies the requirements of the standard you can have everything from one sheet of paper to the 'traditional' copy of the standard with company's name instead of "the organization". What does make a difference is what the quality manual means to the organization. Of course, there is a lot of discussion around what documentation is needed and how much is appropriate, and what format, and ... the list goes on.

To get to the point and answer your question, I would like to stir your attention to my favorite formats for documentation. So, go to the top of the page and follow the 'Post Attachments List' link. In there search for two documents: 'Sample Quality Manual' and 'Improvement Actions' (or 'Change Control'). The first is self-explanatory, the second and third are sample procedures. I am not claiming that these documents are the best, or that they will work for you, or that this is the way to go. All I am saying is that they are simple, they meet the requirements of ISO 9001 and they offer another example of how documentation requirements can be addressed. There are a lot of other examples to look at and consider as well.

Now pull out your editor's marker and taylor a quality system and documentation that is effective for YOUR organization.:agree1:
 
S

Shearwater

I am missing something. I have spent the last half hour trying to find something called a 'Post Attachments List' link.

I have also searched the web and this site for 'Sample Quality Manual' and 'Improvement Actions' (or 'Change Control') in various combination.

Where exactly would I find this link/manual.

Any help would be appreciated.
 

Marc

Fully vaccinated are you?
Leader
Well, you probably need to brush up on some search techniques. I have added two searches for you in links in my post above.
 
C

Chance

I think it would be better if those paragraphs are reduced into a clear and Lean based kind of working instruction.
 
Top Bottom