1.

0 Purpose:
To determine the risk and opportunities related to QMS, issues identified in context of the organization and plan actions to
address these risks and opportunities to achieve intended outcomes.

2.0 Scope:
This procedure includes, determination of risk and opportunities related to QMS and planning actions to address the risk
and opportunities.

3.0 Reference Clause & Element:

ISO 17025:2017, Clause: 8.5

4.0 Responsibility
Head of Laboratory

5.0 Procedure
5.1 Risk & Opportunities Assessment
The Head of Laboratory in consultation with Quality Manager carries out risk and opportunities assessment based on the
following inputs:
a) Identified Internal and External Issues related to MSM.
b) Requirements of Customers.
5.2 Actions to Address risk and Opportunities
Based on the risk and opportunities identified, HODs plan to take actions to address the identified risks to mitigate the risk
or enhance the opportunities.
For each risk and opportunities, existing controls are reviewed and risk rating is classified as explained below:
a) No control: High Risk
b) Control not effective: Medium Risk
c) Effective Control: Low Risk
For all high and medium risks, actions are planned by either or all of the following:
a) Establishing objectives, targets and programs;
b) Develop and implement process controls (monitoring and measurement) in accordance with operating criteria
c) Providing resources such as people (including training), infrastructure and work environment.
The actions as above are implemented and verified for effectiveness of the actions taken.
The details of the actions planned as above for each risk and opportunity is updated in Risk and Opportunities action
register.
Existing Risk
S. Control Rating (High / Monitoring and
Issue Risk / Opportunity Implentation
No. (Full / Partial / Medium / Measurement
No Control) Low)
No immediate measure
Impartiality (Testing) Pressure on employee Partial Low Mitigate
required.
1.
Impartiality (Personnel Relationship of laboratory Undertaking from laboratory
Full Control Low Mitigate
Interests) personal with customer personnel
Risk- Sharing information to
Competitor Laboratory. Signing confidentiality
2. Confidentiality (Lab Visitors) Partial Low Mitigate
Opportunity- Indirect agreement with visitor
Marketing to relevant customers
Staff have right skills and Risk- Lack of qualification, Education & competency
3 Full High Mitigate
regular updating of their skills knowledge and experience lead requirement defined
to be in line with the latest to inconsistency in laboratory
trends activities
Training calendar prepared
Influence on routine laboratory
Training Full Medium and execution monitored on Mitigate
activities
routine basis
Authorization and Communication of
Influence on routine laboratory
responsibilities of laboratory Full Medium authorization and Mitigate
activities
personnel responsibilities