CONTROL OF DOCUMENT
SCHOOL OF MEDICAL SCIENCES
UNIVERSITI SAINS MALAYSIA
MS ISO 9001:2015
CONTROL OF DOCUMENT
(PPSP/QMS/CD)
Edition : 2
Revision no.: 0
Effective date: 1 June 2022
CONTENT
1. Aim
2. Scope
3. References
4. Definitions
5. Abbreviations
6. Procedure
7. Flow Chart
8. Records
9. Appendices
10. Amendment Records
1. AIM
To control all document related to Quality Management System involving their preparation, approval, amendment, retention and disposal.
2. SCOPE
This procedure is to be applied to all Quality Management System in PPSP which involves all documents related to MS ISO 9001:2015.
3. REFERENCE
3.1 Malaysian Standard ISO 9001:2015 Quality Management Systems-requirements (PPSP/QMS/CD/ER1).
3.2 Quality Manual of PPSP (PPSP/QMS/QM)
4. DEFINITIONS
4.1 Core Document: Include Quality Manual, Quality Procedures, and Departmental Core Procedures.
4.2 Other Documents: Include Work Instruction, Internal References, and External References that used in the department for Quality Management System.
4.3 Internal References: These are Guidelines, Policies, and References that are prepared and compiled by the management or committee of USM.
4.4 External References: These are Guidelines, Policies, and References that are prepared and compiled by external sources which are used in our QMS.
4.5 Controlled Document: They are documents which have been controlled during its preparation, approval, amendment, distribution and disposal. They are current issues/copies approved for use in our QMS.
4.6 Uncontrolled Document: Document issued for reference purposes, not to be considered for revision and not to be used in any procedure which effect quality.
4.7 Obsolete Document: These are old documents which no longer effective.
4.8 Management Procedures: Procedures which are compulsory and in accordance with MS ISO 9001:2015 standards.
4.9 Quality Procedures: These are procedures which are used and applied in all processes of the QMS.
4.10 Author: The person who prepares the document prior to its approval.
5. ABBREVIATION
5.1 CDC : Chief Document Controller
5.2 DCDC : Deputy Chief Document Controller
5.3 DC : Department Document Controller
5.4 CP : Core Procedure
5.5 QM : Quality Manual of PPSP
5.6 QMS : Quality Management System
5.7 MR : Management Representative
5.8 AcP : Academic Programme
5.9 HOD : Head of Department
5.10 PPSP : Pusat Pengajian Sains Perubatan
5.11 USM : Universiti Sains Malaysia
5.12 PF : Phase coordinator
5.13 PC : Programme Chairman
5.14 IR : Internal Reference
5.15 ER : External Reference
5.16 R : Record
5.17 L : Appendix
6. PROCEDURE
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ACTIVITY |
RESPONSIBILITY |
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6.1 |
Document Identification |
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6.1.1 |
PPSP/QMS/ <name of document> QM for Quality Manual, CD for Control of Document, CR for Control of Record, IA for Internal Audit, NCP for Nonconforming Product, CA for Corrective Action, RM for Risk Management and LAT for Training and Competency. |
CDC/DCDC |
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6.1.2 Departmental core procedures (CP) involved in academic programme |
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a. |
PPSP/< AcP>/<dept/unit>/CP<no> |
CDC/DCDC/ DC |
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6.1.3 Departmental core procedures (CP) not involved in academic programme. |
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a. |
PPSP/<dept/unit>/CP<no>. |
CDC/DCDC/ DC |
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Note: Documents already identified under other quality management systems can also be used where applicable. |
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6.2 |
Prepare and approve documented procedure |
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6.2.1 |
Prepare document procedure (hard and soft copy). |
Author |
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6.2.2 |
Forward the document procedure to the respective person as stated in Table 2 of The Quality Manual for approval. |
Author |
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6.2.3 |
Forward the approved document procedure (hard and soft copy) and DDN to CDC/Deputy CDC. |
Author |
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6.2.4 |
Officially stamp the approved hard copy as `controlled` document to be kept as record according to QMS guidelines. |
CDC/DCDC |
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6.2.5 |
Upload onto the web site. |
CDC/DCDC |
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6.3 |
Review and amend document |
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a. Core Procedure/Document (Note: Revision is when the document is review or amended. Documents must be reviewed in at least once every 5 years. Edition is when 30% of the document is amended or major structure changes to the document or 10 times of revision. |
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6.3.1 |
Review document |
Author |
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6.3.2 |
Forward the document to the respective person as stated in Table 2 of The Quality Manual for approval. |
Author |
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6.3.3 |
Forward the approved document together with AFA to CDC/DCDC |
Author |
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6.3.4 |
Issue a copy of the AFA to the respective DC. |
CDC/DCDC |
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6.3.5 |
Officially stamp the approved hard copy as `controlled` document to keep as record. |
CDC/DCDC |
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6.3.6 |
Upload the latest edition onto the web site. |
CDC/DCDC |
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b. Other Documents |
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6.3.1 |
Review document according to departmental guidelines or respectively. |
Author /DC |
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6.3.2 |
Forward the document to the head of the department for approval. |
DC |
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6.3.3 |
Officially stamp the approved hard copy as `controlled` document to keep as record. |
DC |
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|
ACTIVITY |
RESPONSIBILITY |
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6.4
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Register and record approved |
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6.4.1 |
Register/update all documents in a master list of document |
CDC/DCDC/DC |
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6.4.2 |
Send a copy of the master list of document to CDC/DCDC. |
DC |
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6.5
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Retention Period |
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6.5.1 |
Keep the controlled documents until the procedure is reviewed. |
CDC/DCDC/DC |
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6.5.2 |
The `obsolete` document is retained until it is been replace by a new obsolete document of the same procedure. |
CDC/DCDC/DC |
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6.6
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Disposal of obsolete document |
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a. Core Document |
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6.6.1 |
Disposal of core documents shall be done following the approval from MR. |
CDC/DCDC |
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6.6.2 |
Disposal of other obsolete documents shall be done following approval from the respective head. |
DC |
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7. FLOWCHART
8. RECORDS
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Registration no |
Storage |
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Duration |
Location |
Responsibility |
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Master list of document |
PPSP/QMS/CD/R1 |
5 yrs |
dept. |
CDC/DCDC/DC |
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Application for amendment (AFA) |
PPSP/QMS/CD/R2 |
5 yrs |
dept |
CDC/DCDC/DC |
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Document delivery note (DDN) |
PPSP/QMS/CD/R3 |
5 yrs |
dept |
CDC/DCDC/DC |
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List of registered internal reference |
PPSP/QMS/CD/R4 |
5 yrs |
dept |
CDC/DCDC/DC |
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List of registered external reference |
PPSP/QMS/CD/R5 |
5 yrs |
dept |
CDC/DCDC/DC |
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Borang Semakan Pengurusan Dokumen |
PPSP/QMS/CD/R6 |
5 yrs |
dept |
CDC/DCDC |
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Borang Permohonan Pelupusan Dokumen |
PPSP/QMS/CD/R7 |
5 yrs |
dept |
CDC/DCDC |
9. APPENDICES
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No. |
List of Appendices |
Reference No. |
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9.1 |
Application Form for Amendment (AFA) |
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9.2 |
Document Delivery Note (DDN) |
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9.3 |
Borang Permohonan Pelupusan Dokumen |