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Documented Information Procedure

This document outlines the procedure for controlling the identification, distribution, and management of documents related to the quality management system. It specifies the responsibilities of top management, quality coordinators, and other personnel, as well as requirements for document approval, storage, and revision. Additionally, it includes guidelines for document permissions and internal audit requirements to ensure compliance and traceability.

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3 views3 pages

Documented Information Procedure

This document outlines the procedure for controlling the identification, distribution, and management of documents related to the quality management system. It specifies the responsibilities of top management, quality coordinators, and other personnel, as well as requirements for document approval, storage, and revision. Additionally, it includes guidelines for document permissions and internal audit requirements to ensure compliance and traceability.

Uploaded by

raviajudiya
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Published By: Published Date: Doc Version: Page #:

1 1 of 3
Document ID:
Documented Information ISO-PRO-7500

1 PURPOSE
This procedure has been established to control the identification, distribution, and control of
documents required by the quality management system.
2 SCOPE
The scope of this this procedure applies to all documents that directly affect product quality
including documents of external origin.
3 RESPONSIBILITY
a) Top Management – ultimately responsible for compliance, communication,
implementation, budget, allocation of personnel and resources as required by legal
and contractual requirements
b) Quality Coordinator – create Quality documentation, maintain records,
communicate QMS to company personnel, consult with top management regarding
revisions and approvals of documentation
c) Admin – adhere to policies, procedures, and SOPs as applicable, notify supervisors
and managers of incidents and nonconformances, actively participate in trainings as
required
d) Supervisors – accountable for operations & technicians, enforce Quality policy,
generate NCR, CAR, and other feedback to management, maintain accurate accounts
of production and services
e) Operations & Technicians – adhere to policies, procedures, and SOPs as
applicable, notify supervisors and managers of incidents and nonconformances,
actively participate in trainings as required
4 REFERENCE DOCUMENTS
a) ISO 9001 Clause 7.5
5 DEFINITIONS AND ABBREVIATIONS
a) Document – meaningful data that controlled and maintained and the medium on
which it is contained
a) Record – a specific type of document that cannot be changed, provides traceability,
states a result achieved or information received, and shall be maintained as evidence
in pursuance of legal obligations or in the transaction of business
b) Template – a specific type of document with pre-selected formatting that is used to
create other documents in a similar style
c) Obsolete document – previous version of a document that must be controlled,
removed from circulation, and is not suitable for use
d) Document Permissions:
1) Full Access – Can approve, modify, create, edit, delete, view, and download
documents and authorize others as required
2) Edit – can edit, delete, view, and download documents
3) Read – can view and download documents
4) View – can view documents
6 PROCEDURE
6.1 Control of Documented Information
6.1.1 General Requirements
All Documents shall:
a) Shall be stored in the appropriate library and/or list in the QMS system
a) Be reviewed and approved for adequacy prior to issue and use
b) Identify the authors and date of creation
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Documented Information ISO-PRO-7500

c) Identify the approver and date of approval


d) Identify when revisions are made
e) Remain legible and readily identifiable
f) Be available where the activity is being performed
g) Shall be protected from unintended modification or removal.
All Records
a) Shall be stored in the appropriate library and/or list in the QMS system
b) Shall be protected from unintended modification or removal
c) Shall include those originating from outsourced activities
d) Shall provide evidence of conformity to the QMS
e) Shall be retained for a minimum of 5 years as required by customer, legal, and other
applicable requirements, whichever is longer
Obsolete Documents:
a) Shall be marked as obsolete via a watermark
b) Shall be labeled with the phrase “Obsolete: Do Not Use” in the file folder and/or in
the description
6.1.2 Document Revisions and Modifications
a) Documents may be modified and or updated as needed. All document revisions
shall:
1) receive the next revision number in both the document and in the file name, i.e.,
revision 2 becomes revision 3. (*It is the responsibility of the approver to ensure
these revision numbers match)
2) shall be approved via the approval process
b) Templates may also be revised and modified as needed and shall follow the approval
process.
1) Documents created from older revisions of a template are not required to be
retroactively updated
2) Should be modified sparingly to achieve a uniform style but may be customized
as needed.
3) Approval of the modified template certifies that the new form of the document is
acceptable for use in the Quality system.
6.1.3 Document Permissions
To ensure documents are both accessible and access is adequately controlled, document
permissions shall be restricted according to the following:
a) The Quality Coordinator and Top Management shall have “full access” to the
documents
b) Supervisors and management shall have “edit” level permission as applicable based
on department and job responsibility
c) Employees shall have “read” level permission as a default unless further authorized
d) Guests shall have “view” level permissions of non-confidential information if deemed
necessary by a user with full access
6.1.4 Approval Process for Documents
All documents shall be approved by an authorized employee who is not the author prior to
distribution according to the following:
a) Approval of policies and manuals are authorized to the Quality Coordinator and Top
Management
b) Approval of technical documents are authorized to the process owner or technical
leader
c) Unapproved Documents shall not be accessible to users with “read” or “view” level
access
d) Form FT.015 shall be updated to include the revised document, signed by the QMS
representative and confirmation of destroyed/obsolete documents shall be verified
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Document ID:
Documented Information ISO-PRO-7500

6.2 Internal Audit Requirements


Documents shall be reviewed at a minimum annually during the scheduled QMS Internal
Audit and shall include:
a) review document versions
b) a formal report of the audit retained as a record

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