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Three basic questions about ISO 9001:2015

#1
1-what is the diffrences between
refrences document and record
2-choose
we can exclude from iso9001:2015
a)clause 4.2
b)some of requirments of clause 7
c)clause5.3
d)allof the above
3-true or false
1-wi describe the busniess process
2-qms should include porceduer for nonconformity
 

dsanabria

Quite Involved in Discussions
#2
1.
A.6 Documented information

As part of the alignment with other management system standards, a common clause on “documented information” has been adopted without significant change or addition (see 7.5). Where appropriate, text elsewhere in this International Standard has been aligned with its requirements. Consequently, “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”.

Where ISO 9001:2008 used the term “records” to denote documents needed to provide evidence of conformity with requirements, this is now expressed as a requirement to “retain documented information”. The organization is responsible for determining what documented information needs to be retained, the period of time for which it is to be retained and the media to be used for its retention.

A requirement to “maintain” documented information does not exclude the possibility that the organization might also need to “retain” that same documented information for a particular purpose, e.g. to retain previous versions of it.

Where this International Standard refers to “information” rather than “documented information” (e.g. in
4.1: “The organization shall monitor and review the information about these external and internal issues”),
there is no requirement that this information is to be documented. In such situations, the organization
can decide whether or not it is necessary or appropriate to maintain documented information.


2.
The organization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its quality management system.

The scope of the organization’s quality management system shall be available and be maintained as documented information. The scope shall state the types of products and services covered, and provide justification for any requirement of this International Standard that the organization determines is not applicable to the scope of its quality management system.

Conformity to this International Standard may only be claimed if the requirements determined as not being applicable do not affect the organization’s ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction.
 

tony s

Information Seeker
Trusted
#3
1-what is the diffrences between
refrences document and record


reference documents serve as specified way to carry out the activities within a process​
record serves as evidence that the activities and their expected results happened​

2-choose
we can exclude from iso9001:2015
a)clause 4.2
b)some of requirments of clause 7
c)clause5.3
d)allof the above


7.1.5.2 can be excluded for a service oriented organization e.g. banking, schools, etc.​

3-true or false
1-wi describe the busniess process
2-qms should include porceduer for nonconformity


1 - true​
2 - true​
 

yodon

Staff member
Super Moderator
#4
I hesitated to answer initially - these are kind of trick[y] questions, IMO.

I've seen companies where "reference" documents are considered uncontrolled; i.e., just for reference and not relied on for decisions / directions. I'd like to first see what the OP's definition of "reference" document is.

May be a bit pedantic but "exclusions" are passe. I believe you need to cite such as non-applicable.

Regarding the T/F question of WIs describing business processes, it may also be pedantic but there's no requirement for Work Instructions, just "documented information." WIs certainly CAN describe a "business process" but not all "business processes" require a WI (or documented information).
 
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