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Q# ISO 9001:2015 Clause Audit Question Audit Evidence: 7.5 Documented Information

This document contains audit questions related to ISO 9001:2015 requirements for documented information. It asks how the organization determines internal and external communications relevant to the quality management system. It also asks what documented information is required by the standard and what additional information the organization determines is necessary. Finally, it addresses requirements for creating, updating, controlling, and protecting documented information to ensure it is available and suitable for its intended uses.

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187 views1 page

Q# ISO 9001:2015 Clause Audit Question Audit Evidence: 7.5 Documented Information

This document contains audit questions related to ISO 9001:2015 requirements for documented information. It asks how the organization determines internal and external communications relevant to the quality management system. It also asks what documented information is required by the standard and what additional information the organization determines is necessary. Finally, it addresses requirements for creating, updating, controlling, and protecting documented information to ensure it is available and suitable for its intended uses.

Uploaded by

Hosay
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Q# ISO 9001:2015 Clause Audit Question Audit Evidence

7.4q1 The organization shall determine the internal and How do you determine internal and external
external communications relevant to the quality communications relevant to the QMS?
management system including: How do you determine:
a) on what it will communicate; What?
When?
b) when to communicate; With Whom?
c) with whom to communicate; How?
d) how to communicate.
7.5 Documented information
7.5.1 General
7.5.1q1 The organization’s quality management system What documented information do you Documented information required by this standard.
shall include: have as required by this standard? Documented information necessary for the effectiveness of
a) documented information required by this What documented information do you the QMS.
International Standard; have as being necessary for the
b) documented information determined by the effectiveness of your QMS?
organization as being necessary for the
effectiveness of the quality management system.
NOTE The extent of documented information for a quality management system can differ from one
organization to another due to:
a) the size of organization and its type of activities, processes, products and services;
b) the complexity of processes and their interactions;
c) the competence of persons.

7.5.2 Creating and updating


7.5.2q1 When creating and updating documented Show me that your documented Documented information (in various media) needs
information the organization shall ensure information contains: identification, description.
appropriate: Identification; Review / approval process?
a) identification and description (e.g. a title, date, Description;
author, or reference number); In what media format?
b) format (e.g. language, software version, Show me how the documented information
graphics) and media (e.g. paper, electronic); is reviewed and approved for suitability and
c) review and approval for suitability and adequacy. adequacy.
7.5.3 Control of documented information
7.5.3.1
7.5.3.1q Documented information required by the quality Show me how you control documented Control of documented information.
1 management system and by this International information. Suitability and availability for use.
Standard shall be controlled to ensure: Show me how you make it available and How is it protected?
a) it is available and suitable for use, where and suitable for use.
when it is needed; How do you protect your documented
b) it is adequately protected (e.g. from loss of information?
confidentiality, improper use, or loss of integrity).
7.5.3.2

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