Professional Documents
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Q MS – P ro c ed u re M a n u al CONTROL STATUS
CONTROLLED COPY
QMS
QP/MSA/10 Manual No. Issue No 01
9001:2015
ORIGINAL ISSUE REV. LEVEL / Prepared & Approved
CLAUSE No. DATE PAGE
DATE Reviewed By By
Change History
1. Scope
2. Purpose
The purpose of this procedure is to define methods for managing changes to processes and other aspect
of management system in a controlled manner so as to maintain integrity of QMS & organizations ability
to continue to deliver product and services of optimum quality during the change
3. Responsibility
MSA & HOD’s of all departments are responsible for effective implementation of this procedure
4. Procedure
4.2 In such cases, the process must be change in controlled manner to ensure proper authorization and
implementation of the changes
4.3 Formal change to the process output will be used when the change is significant. Minor changes can
be made without formal control, however the decision on what constitute significant vs minor change must
be agreed by those involved in the change. If customer indicates a change is significant it will overrule any
internal decision.
The request for process change shall be documented typically in a Change Request. Justification for
change shall be recorded
Management shall evaluate the merits of the proposed change and determine the actions necessary to
address and implement the intended change
CONTROLLED COPY
QMS
QP/MSA/10 Manual No. Issue No 01
9001:2015
ORIGINAL ISSUE REV. LEVEL / Prepared & Approved
CLAUSE No. DATE PAGE
DATE Reviewed By By
Change History
4.5 Before authorizing the implementation of changes, below mentioned points must be thoroughly
verified:
All necessary technical, safety, security and environmental reviews are completed
Risks and consequences identified are addressed to utmost satisfaction
Proposed changes comply with regulatory and legal requirements
Necessary approvals are taken from regulatory and / or legal authority wherever required
All affected personnel are informed of changes and are adequately trained where necessary.
Documentation related to changes and review is complete
4.6 The change shall be reviewed by appropriate management including the HOD responsible for the
process. Change must be approved by Top Management
5. Records