CONTROL OF RECORD (rev: 00)

1.         PURPOSE

1.1        To define the procedure for the identification, storage, protection, retrieval, retention, and dispose of records.

2.             SCOPE

2.1  This procedure shall apply to all records pertaining to the QMS of ABC, including the following:

a.     Product-related to purchasing records.

b.    Training records, internal audit logs and reports, maintenance records.

c.     All records defined in the Service Flow Chart.

3.         REFERENCE

           

3.1          ISO 13485:2012 - Quality Management Systems Requirements

3.2          QM – 001                      - Quality Manual

4.             DEFINITION

4.1        QMS                             - Quality Management System

4.2      QM                          - Quality Manual

5.             PROCEDURES

5.1          Identification and traceability

5.1.1     All records shall be filed in sequence and dated accordingly to allow easy identification and retrieval.

5.1.2     QMR shall be responsible to maintain the Records Master List. If any change to the list of their records, the list shall be updated accordingly.

5.1.3     Records should be kept at the designated location to ensure the traceability and easy reference to the person in charge.

5.3          Storage, protection and retention

5.3.1     All records shall be stored and maintained and retrievable by the respective authorized department.

5.3.2     Records shall be stored in hard copy and/or soft copy as appropriate. For non-critical records, storage in normal file cabinet is sufficient. For critical records, if any, the records shall be protected from potential fire, theft, unauthorized removal and other damages.

5.3.3     Also, critical records on electronic media shall be secured from accidental deletion, computer viruses and corruption of files.  Hard copies shall be produced and kept at a different location / area.

5.3.4     Records on soft copy shall be backed-up.  Back-up records shall be protected accordingly from damage or loss.

5.3.5     All records must be retained for a minimum period as specified in the Records Master List.

5.4          Retrieval and Disposal

5.5.1     All records shall be made available for inspection by management or as requested by the authorized parties.

5.5.2     The records shall be stored in such a way that they are readily retrievable for review.

5.5.3     Records only can be disposed once approval is obtained from QMR or higher authority.

5.5.5     Records shall be disposed by any suitable mean.  Confidential records must be disposed by shredding.

6.         RECORDS

The following records shall be maintained :-

No.	Name of Record	Document No.	Responsibility
1.	Records Master List	L-002	QMR