CONTROL OF DOCUMENT (Rev: 00)

1.         PURPOSE

1.1        To define the procedure for the control, maintenance, retrieval and storage of QMS documents used within ABC.

2.             SCOPE

2.1  This procedure shall apply to documentation related to the QMS, including :-

i.           Quality Manual

ii.          Quality Procedures

iii.         Process Mapping Interaction

iv.        Work Instruction (where applicable)

v.         Process flow chart

vi.       Relevant external documents (such as standards, regulatory requirements, etc related to the quality system or product specification)

vii.       Forms

viii.      Back-up of electronic versions of quality system documents and data.

3.         REFERENCE

           

3.1          ISO 13485:2016      - Quality Management Systems Requirements

3.2          QM – 001                - Quality Manual

4.             DEFINITION

4.1        QMS                 -           Quality Management System

4.2        QM                   -           Quality Manual

4.3        DRL                  -           Distribution / Retrieval List

4.4        DCN                 -           Document Change Notice

5.             PROCEDURES

5.1. New Document

5.1.1.             For any new document proposal, DCN must be raised.  The use of DCN is only applicable after the QMS has been fully implemented.

5.1.2.          For any new proposal of document other than Quality Manual, Procedure, Service Flow Chart and Work Instruction, no DCN need to be issued, alas QMR need to present evidence that the document are being reviewed and approved accordingly.

5.1.3.             DCN after it has been filled-in by initiator, has to be submitted to QMR for review.

5.1.4.             QMR has to review the DCN. Subsequently QMR needs to generate a unique reference number should the proposal is accepted.

5.1.5.             DCN is then forwarded to MD for approval.

5.1.6.             It will then be dispatched to the respective section after approved.

5.1.7.             To track the changes,  the changes need to be recorded at the Distribution/ Retrieval List/ Revision History (SM-F-002) and placed it in front of Quality Manual and Procedures page.

5.2. Generation of document numbering

5.2.1.             The Quality Manual is to be numbered as follows;

                  QM – Sequential Number (001 to 020)

5.2.2.             The Quality System procedures are to be numbered as follows:-

SM-D - Sequential Number (001-999)

5.2.3.             The form type code shall be as follows;

SM-F – Sequential Number (001-999)

5.2.4.             List of item or documents;

                  L  –  Sequential Number (001-999)

5.2.5.             The other type of document than above the code shall be as follows;

                  DOC – Sequential Number (001-999)

5.2.6.             If there is any document without the document number, the document is classified as an old document generated before the establishment of company QMS. The QMR will decide the generation of numbering depends on it impact to QMS implementation.

5.3. Revise Document

5.3.1.             Any proposal of revision to the existing document must use Document Change Notice (DCN).

5.3.2.             Any proposal of changes the existing document other than Quality Manual and Procedure, no DCN will be  issued but it  needs to be reviewed and approved accordingly by the QMR.

5.3.3.             Any proposal as per 5.3.1, DCN must be filled-in and submit to QMR for review.

5.3.4.             QMR has to review the DCN periodically. He/She has to generate revision number in running order if the changes are accepted.

5.3.5.             DCN is then forwarded to MD for approval.

5.3.6.             For those changes made in accordance with the 5.3.2, old version of document need to be cleared first before use of revised document. Where applicable, QMR has to authorize to cease using old document if it adversely affected the quality service conformity.

5.3.7.             As an additional control for revision of Quality Manual and procedure, QMR has to:

a)             Print the whole sets of document if any newly introduce revision to the quality manual effect the structure or sequence of the pages. (Revision number to be updated for each of pages)

b)            Print the respective page only if the change does not affect other pages of document structure and/or content. (Revision number to be updated for respective pages only)

c)             Revision history will be updated after changes of Quality Manual and/or Procedures after it has been made.

5.4. To observe and maintain the integrity of document, the followings have to be strictly followed:

5.4.1.             Copy of document shall be in printed version.

5.4.2.             Soft copy can only be kept by the QMR for reference or for amendments.

5.4.3.             Any soft copy (if applicable), the document must be formatted as PDF file or in protected MS Word file format.

5.4.4.             Maintenance of soft copy should be done accordingly and back-up system should be activated.

5.4.5.             Master copy of document must be indicated with MASTER in red on the first page of document.

5.4.6.             If requires an extra copy, QMR will justify the method of distribution and DRL will be update

5.4.7.             Distributed copies shall be indicated with CONTROLLED in red on the first page of documents. MASTER indication shall be remained but font to be set in black color.

5.4.8.             Distribution of document should be completed by filling the DRL

5.4.9.             Any controlled document distributed to the third party shall be approved by QMR and indicated with UNCONTROLLED.

5.5. Control of External Document

5.5.1.             External document can be described as any document originated by the external parties which may reflected to the product conformity and/or QMS implementation effectiveness.

5.5.2.             At the moment no external document is kept by the company.

5.5.3.             Control of the external document shall be in accordance to 5.4

5.6. Control of Obsolete Document

5.6.1.             After process as per described in the 5.3.5 is completed or any existing document is no longer to be used, the document should be disposed to prevent unintended of use.

5.6.2.             Obsolete document should be crossed and can be used as a recycled paper.

5.6.3.             Master copy of obsolete document can be retained as for reference and indicated by OBSOLETE at each pages for identification.

5.6.4.             The soft copy of obsolete document must be kept by QMR only.

5.7. Document should remain legible and readily identifiable

5.7.1.             All documents must be readable and given the clear direction in meeting the intent of its establishment.

5.7.2.             No any duplication of document prior approval as described in 5.1 or 5.3.

5.7.3.             Any establishment or re-establishment of document which are not following as described in 5.1 or 5.3, the document is consider invalid.

6.             FOLLOWING RECORDS SHALL BE MAINTAINED

No.	Name of  Record	Form No	Responsibility
1.	Distribution / Retrieval List/ Revision History  (DRL)	SM-F-002	QMR
2.	Document Change Notice (DCN)	SM-F-007	QMR
3.	Document  Master List	SM-F-003	QMR