Documented Information Guidance Sample ISO 9001
Documented Information Guidance Sample ISO 9001
Documented Information Guidance Sample ISO 9001
uk
Documented
Information
Guidance
ISO 9001:2015
Documented Information Guidance
ISO 9001:2015
Table of Contents
Introduction ......................................................................................................................................................... 2
Step 1: Determine how QMS documentation can be integrated into existing documents..................................... 4
Step 2: Tailor the documentation to your organization’s needs ........................................................................................ 4
Step 3: Determine a standard format for all documents ....................................................................................................... 4
Step 4: Determine what records are required ............................................................................................................................ 5
Step 5: Prototype each new document......................................................................................................................................... 5
Step 6: What to maintain as documented information .......................................................................................................... 6
Step 7: What to retain as documented information ................................................................................................................ 6
QMS Documentation Worksheet .................................................................................................................................................... 8
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Documented Information Guidance
ISO 9001:2015
Introduction
A robust document control process invariably lies at the heart of any compliant quality management system
(QMS); almost every aspect of auditing and compliance verification is determined through the scrutiny of
documented evidence. With this in mind, it becomes apparent that the on-going maintenance of an efficient
document management system must not be overlooked.
Your organization must control the documentation required by the QMS and ensure that a suitable process is
implemented to define the controls needed to; approve, review, update, identify changes, identify revision
status and provide access. The document control procedure that is included with this document will help you
to define the scope, purpose, method and responsibilities required to implement these parameters.
The procedure also defines the controls needed for the identification, storage, protection, retrieval, retention
and disposition of records and ensuring that they remain legible and identifiable throughout their retention
period. This is because records are an important organizational asset; as they provide the primary route for
evidence based verification and traceability since they demonstrate compliance with customer and regulatory
requirements. Records will prove the efficacy of your QMS:
Of course, you are free to keep more records than those listed in this document, if you feel that your
business needs them, but as we always preach; keep your system simple. The fewer documents and records
you keep, the fewer things that will be audited, and the more time you will have to actually run your business.
Keep in mind that you are free to combine some of these records where it makes sense, for example, you
could combine the corrective and preventive action request log with a simple checkbox to note which one it
is. You could also combine both corrective and preventive action requests onto one form, again with a simple
check box to designate its purpose.
You need to restructure your management system to follow the sequence of and titles of the requirements.
Providing all of the requirements contained in ISO 9001:2015 are met, your organization’s quality
management system will be compliant.
1. If your system manual fits your business and your customers require it, keep it!
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Documented Information Guidance
ISO 9001:2015
2. If your procedures are effective and define how your key processes operate, keep them!
3. If the quality policy and related objectives align with business strategy, and they are communicated
and adding value, keep those too!
You do not need to renumber your existing documentation to correspond to the new clauses. It is down to
each organization to determine whether the benefits gained from renumbering will exceed the effort
involved.
The type and extent of documented information that your organization should retain and maintain, in order
to be compliant with ISO 9001:2015, clearly depends on the nature of your organization’s products and
processes. The following criteria can be used to assess the different types of documentation and information
that your organization should retain and maintain as documented information by determining whether the
information:
If you don’t want to control external documents, you must specifically state this in the procedure and on the
documents themselves, which are ‘For Reference Only’ and are not updated. For multi-site/corporate
certifications the auditor will expect to see that system documentation and changes are centrally managed
(usually performed at the headquarters location) with further control of documents at the local level, as
applicable.
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