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ISO 9001 initial audit 2
- Thread starter boilerman
- Start date
- Staff
- #2
A visitor posted a response to this question:<br>
<br>
What ISO checks for in an audit, is to see that you (your company) is doing things they way that they have specified that they are, or that the do. They are just simply checking to see if you are following your own spec.<br>
<br>
Hunter<br>
Staff<br>
<br>
<br>
What ISO checks for in an audit, is to see that you (your company) is doing things they way that they have specified that they are, or that the do. They are just simply checking to see if you are following your own spec.<br>
<br>
Hunter<br>
Staff<br>
<br>
- Thread starter
- #3
Our company is going through ISO 9000 training at present and we plan to implement our quality system by the end of Dec. 1999. Our initial audit is scheduled for April 2000, I will be happy to share our experience. I was given this advice from someone who's company went through QS9000 in six months(HQ mandate); find out all you can about your auditor in advance. Anyone have a comment about that advice?
- Thread starter
- #5
Yes... the big thing to remember with the whole QM thing is that no-one knows your business as well as you do, and that any audit will not consist of an auditor telling you that you are doing things wrongly.<br>
If you are not doing what you SAID you do (back when you documented your procedures) EITHER you should change what you are doing to match the written version, OR, you should change the written version to match what you do.<br>
In reality, you will probably need to do both to some extent to get the system to a meaningful state..<br>
Good luck, stay cool, and ask yourself: "are we doing what we say we do?"<br>
<br>
Bill Rule <br>
Quality Assurance Officer,<br>
Auspep P/L
If you are not doing what you SAID you do (back when you documented your procedures) EITHER you should change what you are doing to match the written version, OR, you should change the written version to match what you do.<br>
In reality, you will probably need to do both to some extent to get the system to a meaningful state..<br>
Good luck, stay cool, and ask yourself: "are we doing what we say we do?"<br>
<br>
Bill Rule <br>
Quality Assurance Officer,<br>
Auspep P/L
- Thread starter
- #7
Thanks Rag: Sounds like good sound advice, I've got it locked up in my memory banks. I don't know how one can gather, organize and expedite things now a days without computers ( when they're working properly ) I will keep everybody posted as things develop.<br>
<br>
Regards,<br>
<br>
Boilerman
<br>
Regards,<br>
<br>
Boilerman
Dear Boilerman:
We have been ISO 9001:1994 since November of 1996. There are two main area's you need to control. 1) Do as you say, and say as you do ~~ This is your company and you write the rules of how you do your job!! Yes, you have the guidelines written by ISO but!!! 2) Do not!!!! make your written procedures overly burdensome. ~~ Keep it simple or your QA person will go nut's on what you say you do. Remember that in the end it (ISO) just makes good business sense.
P.S. Breath
We have been ISO 9001:1994 since November of 1996. There are two main area's you need to control. 1) Do as you say, and say as you do ~~ This is your company and you write the rules of how you do your job!! Yes, you have the guidelines written by ISO but!!! 2) Do not!!!! make your written procedures overly burdensome. ~~ Keep it simple or your QA person will go nut's on what you say you do. Remember that in the end it (ISO) just makes good business sense.
P.S. Breath
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1
- #9
rajivkrishen
Electrical
Dear boilerman and everyone!
We were accredited to ISO 9001 in 1994. Initially, the apparent enormity of paperwork was overwhelming. But we soon realised, and it was corroborated by our accrediting agency too, that there is absolutely no necessity of bulky procedures and paperwork. A tip: go through and understand ISO 9004 (on how to imlplement ISO 9001). It is one of the the best guides. I once happened to be on the auditors' panel for a manufacturing company. It was a revelation to see that they had a sum total of 12 procedures, each running into just one A4 size sheet! And the supporting documentation was minimal. It is actually a misconception that you need lots of paper to live with ISO 9000 systems. Some experiences, including the ones we had during the initial audit are:
-Do not be afraid to question the auditor's interpretation.
-Keep your QA system very simple right from the initial stages, where you now are. It will save you trouble later. mlt6b is right!
-Write you procedures exactly as the way you perform. Not as what you want to perform. (Caution: some changes may be necessary to make the procedures fall in line with the ISO code requirements). Very thoughtfully pointed out by Rag in his post. If an activity, defined in the code, is not an activity of your company, say so in the quality manual. You do not have to have a procedure for such activity.
-Do not forget to include the internal audit of internal audits in your quality system.
I hope our first hand experiences are of use to you.
rajeev krishan
We were accredited to ISO 9001 in 1994. Initially, the apparent enormity of paperwork was overwhelming. But we soon realised, and it was corroborated by our accrediting agency too, that there is absolutely no necessity of bulky procedures and paperwork. A tip: go through and understand ISO 9004 (on how to imlplement ISO 9001). It is one of the the best guides. I once happened to be on the auditors' panel for a manufacturing company. It was a revelation to see that they had a sum total of 12 procedures, each running into just one A4 size sheet! And the supporting documentation was minimal. It is actually a misconception that you need lots of paper to live with ISO 9000 systems. Some experiences, including the ones we had during the initial audit are:
-Do not be afraid to question the auditor's interpretation.
-Keep your QA system very simple right from the initial stages, where you now are. It will save you trouble later. mlt6b is right!
-Write you procedures exactly as the way you perform. Not as what you want to perform. (Caution: some changes may be necessary to make the procedures fall in line with the ISO code requirements). Very thoughtfully pointed out by Rag in his post. If an activity, defined in the code, is not an activity of your company, say so in the quality manual. You do not have to have a procedure for such activity.
-Do not forget to include the internal audit of internal audits in your quality system.
I hope our first hand experiences are of use to you.
rajeev krishan
hi rajiv,
We are a construction company. We are going to be audited for ISO in coming month. Information provided by you is helpful but if you could provide some sort of questionnaire it would be great great help, especially for Management representative (MR).
thanks in advance,
imtiyaz
We are a construction company. We are going to be audited for ISO in coming month. Information provided by you is helpful but if you could provide some sort of questionnaire it would be great great help, especially for Management representative (MR).
thanks in advance,
imtiyaz
rajivkrishen
Electrical
Hi imtiyaz
I, unfortunately, could not respond to your request. I am not sure whether a 'questionnaire' will help now (it probably is too late) as the audit for your company must be over?
rajeev krishan rajeev krishan
I, unfortunately, could not respond to your request. I am not sure whether a 'questionnaire' will help now (it probably is too late) as the audit for your company must be over?
rajeev krishan rajeev krishan
My company just got certified ISO9001 last month, and we are soon to get a "check-up" this December. I just started here a few weeks ago, and I am shocked to read through their Quality Manual. I am wondering how the check-up will be compared to the initial certification? I mean... if they got certified, what's the chances of them losing it?
I came from a medical device manufacturer that had a 4" binder to cover all of their SOP/DOP and this company only has about 25 proceedures. I'm just a bit nervous. "Happy the Hare at morning for she is ignorant to the Hunter's waking thoughts."
I came from a medical device manufacturer that had a 4" binder to cover all of their SOP/DOP and this company only has about 25 proceedures. I'm just a bit nervous. "Happy the Hare at morning for she is ignorant to the Hunter's waking thoughts."
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1
- #13
Boilerman/madmango,as a lead auditor and a QA manager,when i am auditing companies,my basic simplified premise is to see that 1, people know what their job functions and descriptions are,2 they are aware of the plans and procedures and know where to find them and 3, that these plans and procedures are being implemented and complied with and that conforming product is being produced.
Auditors should not be there to find fault or to attach blame, they are supposed to be independent, unbiased and honest and the main purpose of the audit is to give the degree of assurance that, if plans and procedures are properly implemented then conforming product should be produced.
The opening meeting should give assurance to the people in the company that it is the plans and procedures that are being audited, not the individual.The closing meeting should give you an opportunity to discuss any non conformances/non compliances that have occurred as generally speaking people comply,products conform.
The follow up, normally after the initial certification or audit would be in some cases to close out any NCR,s that may have been written or to audit another section or discipline,or to audit same sections again.
I have some generic training manuals (although somewhat lengthy) that i developed for auditors/auditees to give them a brief insight into auditing, what is expected of auditors and what is expected of auditees and would be glad to let you have a copy if you are still in need of them.
Auditors should not be there to find fault or to attach blame, they are supposed to be independent, unbiased and honest and the main purpose of the audit is to give the degree of assurance that, if plans and procedures are properly implemented then conforming product should be produced.
The opening meeting should give assurance to the people in the company that it is the plans and procedures that are being audited, not the individual.The closing meeting should give you an opportunity to discuss any non conformances/non compliances that have occurred as generally speaking people comply,products conform.
The follow up, normally after the initial certification or audit would be in some cases to close out any NCR,s that may have been written or to audit another section or discipline,or to audit same sections again.
I have some generic training manuals (although somewhat lengthy) that i developed for auditors/auditees to give them a brief insight into auditing, what is expected of auditors and what is expected of auditees and would be glad to let you have a copy if you are still in need of them.
I create my internal audit forms from my quality manuals. I go through the process-related procedures for the planned audit & highlighted areas that would be covered in an audit - particularly those that required a record to be kept.
When I conduct an audit, I try to avoid questions with YES/NO answers. I like to ask how & then I tell 'em I had ancestors from Missouri, so show me:
How do you do this process?
What tells you how to do this process?
How do you know you have the most recent version of this process?
Would you show me the records?
ISO9001 quite simply is basically, as mentioned earlier:
Document what you do
Do what you document
Keep records to prove it
As for having only 25 procedures, ISO9001:2000 only requires only 6 documented procedures:
1. Document Control
2. Records Control
3. Internal Audits
4. Nonconformance Control
5. Corrective Action
6. Preventative Action
When I conduct an audit, I try to avoid questions with YES/NO answers. I like to ask how & then I tell 'em I had ancestors from Missouri, so show me:
How do you do this process?
What tells you how to do this process?
How do you know you have the most recent version of this process?
Would you show me the records?
ISO9001 quite simply is basically, as mentioned earlier:
Document what you do
Do what you document
Keep records to prove it
As for having only 25 procedures, ISO9001:2000 only requires only 6 documented procedures:
1. Document Control
2. Records Control
3. Internal Audits
4. Nonconformance Control
5. Corrective Action
6. Preventative Action
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