Document Control (QM 10)

QUALITY MANUAL (ISO/IEC 17025 : 2008)

Document ID	:	XXX/QM/10
Title	:	Document Control
Issue No.	:		Issue Date                     :
Revision No.	:		Revision Date                :
Reference ISO Clause	:		Page                               :

4.3.1       General

The laboratory has established and been maintaining procedure ORG/QP/0000 to control all documents that form part of the management system such as regulations, standards, other normative documents, specification, drawing, charts, instructions, manuals, etc., test methods and / or calibration methods.

4.3.2       Document approval and issue

4.3.2.1  All documents prepared and issued to personnel in the laboratory as a part of the management system are reviewed and documents identify the personnel who has prepared and approved, prior to issue. Master copy of documents ORG/QP/0000 is maintained by QAM mentioning the current revision status, issue no. and issue date, to preclude the use of invalid document. Copies for use by its authorized personnel are marked as “CONTROLLED COPY” in blue. QAM ensures use of controlled copies of documents only in each section and ensures that these documents are readily available at place of work to preclude use of invalid / obsolete documents. Distribution of the documents is done by QAM through ORG/QP/0000 as per the distribution list.

4.3.2.2   The procedure ORG/QP/0000, adopted, ensures that

a)     Controlled copies of documents are available at all locations where operations essential to the effective functioning of the laboratory are performed;

b)    Documents are reviewed after every two years or earlier and when necessary, revised to ensure continuing suitability and compliance with applicable requirements;

c)     Invalid documents are promptly removed from all points of use;

d)    When a document is made obsolete, it is stamped as “OBSOLETE COPY” in red. All obsolete copies of the documents are promptly destroyed except one copy of each obsolete document which is preserved by QAM for 3 years for future reference and legal purpose.

4.3.2.3   Management system documents generated by laboratory mention the document ID / section no., issue no, issue date, current revision status, page no. along with personnel who has prepared and approved it. Identification of formats for keeping records are given in the top right corner of the record. Copies for use by its authorized personnel are marked as “CONTROLLED COPY” in blue. Each copy of quality manual and quality procedures has distinct number and designation of the holder to whom issued. External documents like specification, drawing, charts, etc. are marked as “CONTROLLED COPY” in blue to indicate its current status. The preparation and approval of documents are as shown below :

Document	Prepared By	Approved By
Quality Manual (QM)	QAM	TM
Quality Procedures (QP)	QAM	TM
Work Instructions (WI)	Testing personnel / QAM	QAM / TM
Quality Formats (QF)	Testing personnel / QAM	QAM / TM

4.3.3       Document Changes

4.3.3.1   Changes to documents are reviewed and approved by same function as shown above with having access to pertinent background information. (Reference: 4.3.2.3 page No. 1 of 2)

4.3.3.2   The new text after alteration is entered in amendment sheet; document ID ORG/QM/0000 of this manual. Any amendment has to be approved by TM.

4.3.3.3   The document control system of the laboratory does not permit hand written correction. A revised document shall be formally reissued as soon as practicable.

4.3.3.4   The laboratory does not make changes in document in computerized system.