URDANETA DISTRICT HOSPITAL

PROCEDURAL MANUAL
CONTROL OF MAINTAINED DOCUMENTED INFORMANTION
Document Code: UDH-PM-CMDI Effectivity Date: October 20, 2020 Revision: 00

APPROVAL SHEET

This is to certify that this quality procedure on CONTROL OF MAINTAINED

DOCUMENTED INFORMATION had been reviewed and found to be operationally adequate
for use in the Quality Management System of the Urdaneta District Hospital.

This quality procedure is hereby approved for distribution, use and implementation.

Prepared by: Approved by:

MARY ELEANOR B .MAYO,RN, MAN PABLITO G. BANTA, MD, DPCP

Document Controller Quality Management Representative

REVISION HISTORY

Revision Description of Document Authored by Reviewed by Effectivity

No. Change Creation / Date
Change
Form No.

MARY ELEANOR B. PABLITO G. BANTA, OCTOBER

00 Initial Release N/A
MAYO, RN, MAN MD, DPCP 20, 2020

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 URDANETA DISTRICT HOSPITAL
PROCEDURAL MANUAL
CONTROL OF MAINTAINED DOCUMENTED INFORMANTION
Document Code: UDH-PM-CMDI Effectivity Date: October 20, 2020 Revision: 00

1.0 OBJECTIVE

The objective of this procedure is to ensure that all maintained documented

information related to the Quality Management System procedures on Urdaneta District
Hospital are properly documented, controlled and available as per requirement of ISO
9001:2015 standards. Specifically, it defines controls for the following:

1.1 Establishment of system for the creation and revision of documents;

1.2 Review and approval for adequacy of document content and forms prior to
implementation;
1.3 Traceability of changes or revisions in a document;
1.4 Proper legibility and identification of documents through the use of a coding
system;
1.5 Distribution and availability of documents at the point of use;
1.6 Prevention of unintended use of obsolete documents;
1.7 Storage, archival and disposal of obsolete documents; and
1.8 Management of external documents.

2.0 SCOPE

This procedure defines the life cycle of a document from creation to disposition
and the controls undertaken to preserve its integrity. It lays down activities in the
creation, identification, approval, distribution, modification, storage and disposal of
documents within the Quality Management System (QMS).

3.0 DEFINITION OF TERMS

3.1 Maintained Documented Information - This refers to written materials that

provide guidance in the execution of a process. This includes quality manual,
procedures, work instructions, guidelines, plans, user manuals, checklists,
contracts, and other documents.

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 URDANETA DISTRICT HOSPITAL
PROCEDURAL MANUAL
CONTROL OF MAINTAINED DOCUMENTED INFORMANTION
Document Code: UDH-PM-CMDI Effectivity Date: October 20, 2020 Revision: 00

3.2 Forms – These refer to printed formats or electronically stored templates, which
are meant to collect information in a structured and systematic way. Forms do
not exist by themselves. They are annexes to procedures or other documents that
give the form a context for their usage. Thus, a form without entries is a
considered document, whereas a filled-up form becomes a record.

3.3 Document Controller – This refers to the person responsible in setting up and
administering the system for document control. He is the custodian of the master
copies of all QMS documents.

3.4 Controlled Documents – These refer to documents that are coded, registered
and listed in the Masterlist of Controlled Documents, with specified locations for
storage, and circulation controlled by the Document Controller. These are those
which requirements have been specified for its development, approval, issue,
revision, distribution, maintenance, use, storage, security, obsolescence and
disposal.

3.5 Uncontrolled Document – This refers to any document that is unregistered and
excluded in the Masterlist of Controlled Documents, for the reason that it is not
directly used in the execution of the QMS.

3.6 Controlled Copy – This refers to controlled documents printed, covered by a

distribution list and may not be photocopied or printed out without the
permission of the DQMR and/or the Document Controller.

3.7 Uncontrolled Copy – This refers to copies of controlled documents, printed out
or photocopied, which is used for training, reference by persons outside of the
distribution list. (E.g. Quality Manual, Procedural Manual)

3.8 Document Creation/Change – This refers to the process of creation, revision or

deletion of documents, using the Document Creation and Change Form.

3.9 Document Code/Number – This refers to a series of numbers and letters that
are intended to identify a particular document from others in a systematic
manner. They are used for easy control and reference

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 URDANETA DISTRICT HOSPITAL
PROCEDURAL MANUAL
CONTROL OF MAINTAINED DOCUMENTED INFORMANTION
Document Code: UDH-PM-CMDI Effectivity Date: October 20, 2020 Revision: 00
3.10 Masthead – this refers to the header per document.

3.11 Effectivity Date – This refers to the start of implementation of a particular

document following approval of distribution and use.

3.12 Revision Number (Rev.xx)– This refers to the revision status of a document or
the number of times a document have been modified. Revision 00 is assigned or
newly-created documents, while Revision 1 is for the first revised copy and so
on.

3.13 Masterlist of Maintained Documented Information– This refers to the list

where all documents approved for use in the QMS are registered.

3.14 Document/Record Distribution List – This contains the name of recipients and
serves as acknowledgement receipt.

3.15 Internal Documents- These are documents developed and approved by the
organization’s authorized personnel

3.16 External Documents- These are documents used in the QMS generated outside
the organization.

3.17 Master Copy- This is the original document signed by the authorized personnel
of the QMS. It should bear with printed blue ink “MASTER COPY”.

3.18 Obsolete Document-This refers to a document that has been superseded.

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 URDANETA DISTRICT HOSPITAL
PROCEDURAL MANUAL
CONTROL OF MAINTAINED DOCUMENTED INFORMANTION
Document Code: UDH-PM-CMDI Effectivity Date: October 20, 2020 Revision: 00

4.0 DOCUMENTED INFORMATIONCONTROL TEAM ORGANIZATIONAL

CHART

Document Controller
Mary Eleanor B. Mayo

Assistant Document
Controller
Jan V. Rilloma

Document Custodian Document Custodian

Maria Theresa T. Casanova Mildred Dela Cruz

Document Custodian Document Custodian

Ana Margarita R. Lapena Nelman Xenia C. Baltazar

Document Custodian
Krisanta Mae P. Banda

5.0 SELECTION OF DOCUMENTED INFORMATION CONTROL TEAM

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 URDANETA DISTRICT HOSPITAL
PROCEDURAL MANUAL
CONTROL OF MAINTAINED DOCUMENTED INFORMANTION
Document Code: UDH-PM-CMDI Effectivity Date: October 20, 2020 Revision: 00
The Quality Management Representative selects and appoints the members of the
Documented Information Control Team composed of the Document Controller and
Assistant Document Controller and Document Custodians from the offices. They are
selected based on the following qualifications:

5.1 College Graduate;

5.2 Knowledgeable on ISO 9001:2015 standards, UDH QMS and governing statutory and
regulatory requirements.

5.3 Practical computer application knowledge in Microsoft Word, Microsoft Excel

5.4 High level of accuracy and diligence

5.5 Transfer of knowledge through coaching and re-echo of an ISO 9001:2015 standards
of Documented Information personnel.

6.0 DOCUMENTED INFORMATION CONTROL TEAM SERVICES

6.1 Maintains and updates documents and records of ISO 9001:2015 requirements and
UDH’s requirements.

6.2 Distributes controlled documented information

6.3 Performs monthly checks to ensure up-to-date documents are readily available

6.4 Ensures removal of irrelevant/obsolete documents.

6.5 Responsible for documented information storage, document archive and electronic
archive.

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 URDANETA DISTRICT HOSPITAL
PROCEDURAL MANUAL
CONTROL OF MAINTAINED DOCUMENTED INFORMANTION
Document Code: UDH-PM-CMDI Effectivity Date: October 20, 2020 Revision: 00

7.0 PROCEDURE OUTLINE

Responsibility Input Process / Activity Output

Process owners, -Feedbacks Review Document

-IQA Report Determine need for
Auditors,
-Management Review document creation or
Top Management, Internal Minutes
Customers, External document revision.
-CAR
Customers

Register approved document for

Document Controller -Approved existing
document control and verify entry date in the -Controlled Document
-Updated Masterlist of masterlist. Update Masterlist of -Maintained Documented
Maintained Maintained Documented Information Information
Documented
Information

-Process owners Store Retrieve copies Updated Masterlist of

-Document and documents in of revised Maintained Documented
Records Control Team MASTER COPY
specified document Information
location. Page 7 of 16
 URDANETA DISTRICT HOSPITAL
PROCEDURAL MANUAL
CONTROL
Folders andOF MAINTAINED DOCUMENTED INFORMANTION
Filing
Cabinet
Document Code: UDH-PM-CMDI Effectivity Date: October 20, 2020 Revision: 00

Dispose Updated Masterlist of

-Filing Cabinets obsolete Maintained Documented
-Document Controller Information
-Disposal Tool documents as
-Archive
prescribed.

8.0 PROCEDURE DETAILS

8.1 Determining the Need for Document Creation or Revision

8.1.1 The need for document creation or revision shall be identified, but not
limited through the following venues:
 Regular review or inspection by the DQMR
 Audit findings and observations
 Management Review
 Recommendations from Top Management
 Suggestions from employees

8.1.2 A document creation or change shall be deemed necessary under the

following instances:

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PROCEDURAL MANUAL
CONTROL OF MAINTAINED DOCUMENTED INFORMANTION
Document Code: UDH-PM-CMDI Effectivity Date: October 20, 2020 Revision: 00
 When there is a need to create a new document to cover areas or
aspects not previously touched by existing documents;
 When there is a need to change the way a process is executed; and
 When there is a need to streamline or simplify a process in order to
achieve efficiency.

8.1.3 The Head of Department shall be primarily responsible in ensuring that all
document changes necessary for effective and efficient operations are
identified and executed.

8.1.4 The process owners may recommend a need for document change
authorized by the concerned Head of Department.

8.1.5 Document changes can be initiated by anyone in the organization who can
demonstrate the value and need for such a change. As such, DQMRs shall
also provide opportunities for other employees including internal
customers and staff to recommend changes. The Head of Department may
also initiate document creation or change to be approved by the top
management.

8.2 Creating or Revising a Document

8.2.1 Once a need is identified, the process owner shall prepare the proposed
document change by creating a new document or revising an existing
document.

8.2.2 The Process Owner shall accomplish the Document Creation and Change
Form (DCCF) and submit it together with the created or revised document
hard copy or soft copy to the Head of Department for review, checking
and approval.

8.2.3 The Process Owner shall submit the created or revised document to
Document Controller who shall use the appropriate code.

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 URDANETA DISTRICT HOSPITAL
PROCEDURAL MANUAL
CONTROL OF MAINTAINED DOCUMENTED INFORMANTION
Document Code: UDH-PM-CMDI Effectivity Date: October 20, 2020 Revision: 00
8.2.4 The Document Controller shall include Revision History, if the document
change involves revision of the Quality Manual, mandatory and quality
procedures, guidelines or work instruction. The Revision History shall
follow the Approval Sheet. It shall be in the following form:

REVISION HISTORY
Document Page Revision Details of Authored Reviewed
Date
Code Number Number Revision by: by:

8.2.5 Forms are normally part of a procedure as annexes. Nonetheless, even if

the body of the procedure changes, if the form, including annexes remains
the same, the form or the annexes will not require a change in the revision
number and issue date or vice-versa.

8.2.6 TRANSITORY NOTE:

All documents bearing REV 00 and with October 20, 2020 as effective
date shall not require a Document Creation and Change Form (DCCF).

All documents and forms, whether new or revised & with effectivity date
October 20, 2020, will all assume REV 00 upon effectivity of the QMS. To
synchronize revision number between mother documents and its attached
forms, old forms (existing prior to effectivity of QMS) once changed, shall
assume REV number of its mother document.

8.3 Reviewing and Approving New or Revised Documents

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 URDANETA DISTRICT HOSPITAL
PROCEDURAL MANUAL
CONTROL OF MAINTAINED DOCUMENTED INFORMANTION
Document Code: UDH-PM-CMDI Effectivity Date: October 20, 2020 Revision: 00
8.3.1 The process owner shall draft the required document to be created or
revised. The created or revised document shall be reviewed, checked and
approved by the Head of Department. The approved created or revised
document shall then be forwarded to the Document Controller for
checking of the following:
 If the DCCF is properly signed, authentic and is legible;
 If the coding used conform to the established standards

8.3.2 The Document Controller and the Assistant Document Controller shall
cascade information on changes to all concerned to ensure efficiency and
effectiveness in the implementation of said amendment.

8.4 Registering the Document for Control

8.4.1 The Document Controller shall require the following:

 Approved DCCF
 For creation, copy of the final version of the new document hard or
soft copy; for revision, turnover of existing document and the
submission of the revised document
 Signed Approval Sheet.
 Existing Masterlist of Controlled Documents and updated
Masterfile of Masterlist of Controlled Documents

8.4.2 The Document Controller shall register the approved documents by:
 Ensuring that every page new or revised document has the correct
coding and printed.
 Updating of the Masterlist of Controlled Documents one day after
receipt of created/revised document
 The Head of the Department shall verify if the created/revised
document had been posted/updated in the Masterlist of Controlled
Documents.

8.4.3 All documents within the Quality Management System are considered
controlled documents. Control of these documents comes in the form of
coding, approval, registration, safekeeping and proper disposal. The
Master List of Controlled Documents shall be accomplished by each

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 URDANETA DISTRICT HOSPITAL
PROCEDURAL MANUAL
CONTROL OF MAINTAINED DOCUMENTED INFORMANTION
Document Code: UDH-PM-CMDI Effectivity Date: October 20, 2020 Revision: 00
office. However, Printing are done on selected document types to ensure
that the sensitive information they contain are prevented from any
unauthorized modification, to wit:

 Quality Manual
 Procedures
 Work Instructions
 Guidelines
 Other documents which may later be declared by the QMR as
CONTROLLED documents

8.5 Reproducing, Distributing New/Revised Documents and Retrieving Existing

Documents

8.5.1 The Document Controller/Asst. Document Controller shall be responsible

in the reproduction and distribution of documents like User Manual,
Procedure Manuals, etc.

8.5.2 The Document Controller/Asst. Document Controller distributes the

documents based on the Document/Record Distribution List to control
circulation and establish receipt. As he/she distributes revised documents,
he/she must retrieve at the same time all existing pertinent documents and
disposed as prescribe, to ensure that they are replaced by the latest
revision and to prevent unintended use.

8.5.3 The Document Controller shall store and distribute all controlled
documents of the QMS electronically in PDF format and shall be available
to all for viewing only. DQMRs or Head of Department are not allowed to
keep non-PDF files with them, except electronic templates or forms in
non-PDF format to be used in accomplishing their reports.

8.5.4 They may request for non-PDF file of their documents from the Document
Controller for document change purposes only.

8.5.5 Controlled copies cannot be reproduced without authorization from the

assigned record custodian or document controller. For request of

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PROCEDURAL MANUAL
CONTROL OF MAINTAINED DOCUMENTED INFORMANTION
Document Code: UDH-PM-CMDI Effectivity Date: October 20, 2020 Revision: 00
additional copy of any document printed, the requisitioning person shall
inform the Document Controller for the needed action. The latter may
photocopy or print a copy from the computer and mark it as
UNCONTROLLED COPY. Before issuance, the Document Controller
shall let the requisitioning party log his/name in a record book/logbook as
evidence of receipt.

8.6 Storing and Protecting Documents

8.6.1 The Document Controller shall keep original copies of registered

documents in a secure filing cabinet.

Document Custodians per office shall likewise store copies of registered

documents relevant to their office services.

8.6.2 All employees who are part of the distribution list for a particular
document shall be accountable for its safekeeping and protection.

8.6.3 The Document Controller shall ensure that all QMS documents and
original copies of vital documents shall have back-up files as
follows:
 Computer hard disk of Document Controller
 CD or Flash Drive or External Hard Drive

8.6.4 The Document Controller shall apply appropriate controls to back up files
like virus protection, proper handling and storage.

8.6.5 The Documented Information Control Team and respective process

owners shall retain all QMS documents and determine their duration and
manner of retention through archiving until their designated disposal
following the policies under the National Archives of the Philippines.

8.6.6 The Documented Information Control Team, DQMRs and process owners
shall ensure the availability of QMS documents as deemed needed during
review or other purposes.

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PROCEDURAL MANUAL
CONTROL OF MAINTAINED DOCUMENTED INFORMANTION
Document Code: UDH-PM-CMDI Effectivity Date: October 20, 2020 Revision: 00
8.6.7 The Documented Information Control Team, DQMRs and process owners
shall ensure the adequate protection of confidential documents from
unauthorized access or loss.

8.6.8 The Documented Information Control Team and process owners shall
maintain a Borrower’s Logbook where all those who want to borrow
documents shall log their respective names, date borrowed, date returned
and the particular document borrowed.

8.6.9 In general, original copies of external documents like service agreements

shall be controlled by Document Controller, except for confidential
documents, or those that need to be kept by the DQMR for operational
reasons. Control of external documents shall include, among other, proper
filing, protection from unauthorized access, etc.

8.7 Disposal

8.7.1 The Document Controller shall maintain physical copies of all QMS
documents up to their 2nd mode of revision (current and most previous
revision).

8.7.2 To illustrate using a situation where the current version is Revision 3:

Rev 00 Rev 01 Rev 02 Rev 03

In this example, issuance of Revision 01 will render Revision 00 as

obsolete but not yet for disposal. When Revision 02 is issued, both
Revision 0 and 1
are rendered obsolete; Revision 01 shall be retained while Revision 00
shall be disposed. Disposal of Revision 01 shall happen upon issuance of
Revision 03.

Thus, as a rule, only two versions, current and most previous, shall be
retained physically at any given time, and all other previous versions shall
be disposed as scheduled. Nonetheless, obsolete copies may still be kept in

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 URDANETA DISTRICT HOSPITAL
PROCEDURAL MANUAL
CONTROL OF MAINTAINED DOCUMENTED INFORMANTION
Document Code: UDH-PM-CMDI Effectivity Date: October 20, 2020 Revision: 00
electronic format or CD only, except the latest revision which shall be
kept in hard copy in a binder for obsolete documents.

8.7.3 Once a document is rendered obsolete, the Document Controller shall

retrieve all copies of the obsolete documents. Obsolete documents shall be
kept in electronic format or CD only, except the latest revision which shall
be kept in hard copy in a binder for obsolete documents.

8.7.4 Lost documents that cannot be retrieved or disposed shall be the

accountability of the custodian of such document. The loss shall be
reported to and noted by the Document Controller.

8.7.5 The Document Controller shall schedule disposal of obsolete documents

using appropriate methods.

8.7.6 Document Controller shall update MMDI, both soft and hard copies.

9.0 FORMS/RECORDS

As illustrated in the attached Annexes, all forms to be used in the conduct of this
procedure can be obtained from the Lead Document Controller as well as the Document
custodians under each member-office of the Support group. Each office shall design their
own forms relative to their ISO-aligned processes and services.

9.1Annex 1 :Master List of Maintained Documented Information

9.2Annex 2 :Master List of External Documents
9.3 Annex 3 :Document/Record Distribution List
9.4 Annex 4 :Document Creation and Change Form (DCCF)

10.0 REFERENCES
10.1 Quality Manual

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 URDANETA DISTRICT HOSPITAL
PROCEDURAL MANUAL
CONTROL OF MAINTAINED DOCUMENTED INFORMANTION
Document Code: UDH-PM-CMDI Effectivity Date: October 20, 2020 Revision: 00

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