ISO 9001:2000 and 2008 Registrar Audits: What Questions are Being Asked?
- Thread starter Marc
- Start date
L
lissa
auditor from BSI was not happy that our auditors had not been trained to audit to the new standard.As far as he was concerned the way to do it is through turtle diagrams and a process approach. 
Peter Fraser
Trusted Information Resource
Our clients' experiences have been that assessors:
(a) don't understand systems defined as a structured set of process definitions - and are scared to look at them;
(b) want to know how "continual improvement" is achieved - but readily accept that good management of a system defined as above will achieve this [despite the comment in (a)];
(c) are very keen to see measurable objectives defined;
(d) expect to see a silly diagram of the "sequence and interaction of processes";
(e) don't seem to bother with "top management commitment" too much; and
(f) still use the standard as a template for what they expect to see in a management system. When will they learn?!
And no - I won't mention the assessing bodies concerned!
(a) don't understand systems defined as a structured set of process definitions - and are scared to look at them;
(b) want to know how "continual improvement" is achieved - but readily accept that good management of a system defined as above will achieve this [despite the comment in (a)];
(c) are very keen to see measurable objectives defined;
(d) expect to see a silly diagram of the "sequence and interaction of processes";
(e) don't seem to bother with "top management commitment" too much; and
(f) still use the standard as a template for what they expect to see in a management system. When will they learn?!
And no - I won't mention the assessing bodies concerned!
Good point.Randy said:I am continuously identifying people that write/approve document revisions (especially technical and regulatory ones) that have no experience or training in the subject matter.
Thanks! Good summary!gpainter said:Specific subprocesses looked at (schedule) - 5.0, 8.5.1,8.2.1, 4.2.3, 4.2.4, Lunch
Linkage of clauses- each audited process needed to have linkage to 5.4.1, 5.5.1, 4.2.3, 6.2, 5.3, 4.2.4, 4.1(e), 7.2.1, 8.2.1, 4.1(f) and 8.5.1
Checklist was not used.
D
db
Randy said:A question I like to ask is related to the competence of individuals that modify and approve system documents like procedures and work instruction.
I am continuously identifying people that write/approve document revisions (especially technical and regulatory ones) that have no experience or training in the subject matter.
One of the reasons for this is that some organizations want their Document Controller to write and approve the documents. It might be the idea of the process owner, and the DC gets input and actual approval from the process owner, but the DC's name is what shows up on the document.
But, I am amazed at how many companies want me to write their Level II and Level III docs for them. One wanted us to beat a quote from a company out of the Netherlands who would write the II's and III's without talking to the operators, or even visiting the site. The cost was about $13,000, I think. My response was to ask if they wanted someone who knew nothing about them, telling them how to do their business?
E
energy
Create or write
I assume that you don't mean that the clerk/typist who prepared the document? I find it difficult to understand how you measure somebody's competence in a subject to make that statement. Not as much training and experience as who? You? What yardstick are you using? Do they tell you that they don't know how they came up with the document because they don't know enough about it? Just call me curious.
Randy said:A question I like to ask is related to the competence of individuals that modify and approve system documents like procedures and work instruction.
I am continuously identifying people that write/approve document revisions (especially technical and regulatory ones) that have no experience or training in the subject matter.
I assume that you don't mean that the clerk/typist who prepared the document? I find it difficult to understand how you measure somebody's competence in a subject to make that statement. Not as much training and experience as who? You? What yardstick are you using? Do they tell you that they don't know how they came up with the document because they don't know enough about it? Just call me curious.
M
mshell
All of our documents have an author and an approver (different people) but we also route the document to everyone involved in the process so that they can offer any input. If they agree with the contents, I receive a mail form each individual and continue with the process. Even if I receive an approval from the author and the approver before I receive feedback from all involved parties, I do not publish the document. I wait until everyone has responded. This helps us to ensure that our procedures and instructions are accurate. I also believe that this gives the individual employees some sense of ownership.
just my 2 cents worth.
mshell
just my 2 cents worth.
mshell
J
Joe Cruse
Marc,
our auditor spent a lot of time with the "process" idea, making sure we had nailed that approach in our system. His only real beef with us, which he wrote as an OFI, was our process map. He felt it was too general, and should have shown a greater level of detail. He wanted our system to show how each part of our process was interrelated.
This was the main difference I saw, with regards to focus between the 2 standards. Same auditor, by the way.
Joe
our auditor spent a lot of time with the "process" idea, making sure we had nailed that approach in our system. His only real beef with us, which he wrote as an OFI, was our process map. He felt it was too general, and should have shown a greater level of detail. He wanted our system to show how each part of our process was interrelated.
This was the main difference I saw, with regards to focus between the 2 standards. Same auditor, by the way.
Joe
W
wrodnigg
I don't think, that one can state "special questions" according to an upgrade, but there is -of course- a focus on some things.
I would like to see, how the organisation has established the process management, how they plan their quality management [5.4], the customer focus [5.2] communication [7.2.3] satisfaction [8.2.2.], the management reviw [5.6] and derivated actions. Internal Audits, derivated actions and their verification [8.2.2].
Qualifiaction of the emplyess, training plans, -records and -verification is also a hot topic [6.2.2].
I also would state, that "control loops" for several processes [audits, training, production, CAPA] should be operative.
I will try to add some findings to the other thread...
regards~ghw
I would like to see, how the organisation has established the process management, how they plan their quality management [5.4], the customer focus [5.2] communication [7.2.3] satisfaction [8.2.2.], the management reviw [5.6] and derivated actions. Internal Audits, derivated actions and their verification [8.2.2].
Qualifiaction of the emplyess, training plans, -records and -verification is also a hot topic [6.2.2].
I also would state, that "control loops" for several processes [audits, training, production, CAPA] should be operative.
I will try to add some findings to the other thread...
regards~ghw
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