Do they have to? Is it a requirement? I have never seen anything in ISO 9001 which says a user has too...
Interesting Discussion Potential Issues for Auditing ISO 9001:2015
- Thread starter Colin
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Do they have to? Is it a requirement? I have never seen anything in ISO 9001 which says a user has too...
Y
Yukon
Jen,
It's pretty obvious isn't it? If there's no issue/date/revision on the document hen it can't be traced to,the current version. The document is to be considered un-controlled. That being said it would appear that some of our more enlightened colleagues don't think control is required ?
It says we are required to have version control. I am merely asking what that looks like when version number is not made apparent to the user on the document.
It looks like only what Andy says it looks like, as I was not there; I am relying on what Andy tells me. That is why I keep asking the question. I am wondering when I will get an answer to my very simple question.
If the organization has deemed a quality manual to be important enough to write and show the auditor, I suppose it is (7.5.1b) documented information determined by the organization as being necessary for the effectiveness of the quality management system. That would subject it to the requirements of the rest of the clause.
Y
Yukon
Documented information refers to records.
Retained documented information is about records, mentioned in 7.5.3.2.... 7.5.1b does not differentiate.
Please read the standard. All of it. You keep misquoting.
Annex A (in the back of the standard) Clarification of new structure, terminology and concepts. (emphasis on terminology) A.6 Documented information. I suggest you read all of A.6 but I'm going to pull out the pertinent parts.
"documented information" is used for all document requirements.
Where ISO 9001:2008 used specific terminology such as "document" or "documented procedures", "quality manual", or "quality plan" this edition of this International Standard defines requirements to "maintain documented information". (so maintaining documented information refers to having what was known before as documents)
Where ISO 9001:2008 used the term "records" to denote documents needed to provide evidence of conformity with requirements, this is now express as a requirement to "retain documented information". (so what was known before as records are now referred to a retained documented information.
Let's look in the main body of the standard now for some examples. By my count there are nine places where it says that it is necessary to maintain documented information. Some of them require both maintain and retain. Some of them are to the extent necessary or as applicable.
- 4.3 Maintain DI of Scope
- 4.4.2 Maintain DI to support operation of processes
- 5.2.2a Maintain DI of Quality Policy
- 6.2.1 Maintain DI of Quality Objectives
- 8.1e1) Operation planning includes determining, maintaining, and retaining DI to the extent necessary for confidence that processes have been carried out as planned
- 8.1e2) Operation planning includes determining, maintaining, and retaining DI to the extent necessary to demonstrate conformity of products
- 8.2.4 relevant DI is amended when product requirements are changed
- 8.5.1 As applicable, availability of DI that defines characteristics of products or services to be provided that ensure production under controlled conditions
- 8.5.1 As applicable, availability of DI that defines results to be achieved to ensure production under controlled conditions
By my count there are 30 places where the standard calls for retained documented information. Some of them also say to maintain. Some are also as appropriate or something similar.
Retain (Record Retention) – Some of these may contain weasel words such as “as applicable” or “as necessary”. Refer to the full text of the ISO 9001:2015 Standard.
- 4.4.2 Retain DI to provide confidence that the processes are being carried out as planned
- 7.1.5.1 Retain DI as evidence of calibrated equipment fitness for purpose
- 7.5.1.2 Retain DI for how to calibrate equipment that cannot be traced to standards
- 7.2 Retain DI as evidence of competence
- 8.1e1) Operation planning includes determining, maintaining, and retaining DI for confidence that processes have been carried out as planned
- 8.1e2) Operation planning includes determining, maintaining, and retaining DI to demonstrate conformity of products
- 8.2.3.2a Retain DI to show results of contract review
- 8.2.3.2b Retain DI on product new requirements
- 8.3.2 Determine DI [retaining]needed to demonstrate design requirements have been met
- 8.3.3 Retain DI of design inputs
- 8.3.4 Retain DI of design control activities (reviews, verification, validation, actions taken)
- 8.3.5 Retain DI of design outputs
- 8.3.6 Retain DI of design changes
- 8.3.6 Retain DI of results of reviews that ensure that changes has no adverse effects
- 8.4.1 Retain DI of external providers approval activities and actions
- 8.5.2 Retain DI necessary to enable traceability
- 8.5.3 Retain DI of reports to customers or external suppliers when their property is lost, damaged, or otherwise found to be unsuitable for use
- 8.5.6 Retain DI of results of reviews of production changes
- 8.6 Retain DI of evidence of conformity of products (inspection results)
- 8.6 Retain DI showing who authorized release of product
- 8.7.2 Retain DI that describes product nonconformity
- 8.7.2 Retain DI that describes action taken concerning product nonconformity
- 8.7.2 Retain DI that describes any concessions obtained for nonconforming product
- 8.7.2 Retain DI that identifies the authority deciding the action in respect to the nonconformity
- 9.1.1 Retain DI that provides evidence of monitoring, measuring, analysis, and evaluation results
- 9.2.2 Retain DI as evidence of implementation of the internal audit program
- 9.2.2 Retain DI of internal audit results
- 9.3.3 Retain DI as evidence of management review
- 10.2.2 Retain DI of the nature of nonconformities and any subsequent actions taken
- 10.2.2 Retain DI of the results of any corrective actions
Please read 7.5.3.2 c
For the control of documented information, the organization shall address the following activities, as applicable . . . control of changes (e.g. version control) . . .
Whoa! Thanks for the effort Big Jim.
I hope Yukon read this.
