TESTING AND CALIBRATION LABORATORIES

ISO/IEC 17025:2017
GENERAL REQUIREMENTS FOR THE COMPETENCE OF TESTING AND
CALIBRATION LABORATORIES

RISK BASED APPROACH

 WHAT IS RISK-BASED THINKING?

 Risk-based thinking is something we all do automatically and often sub-consciously

to get the best result

 The concept of risk has always been implicit in ISO 17025 – this edition makes it
more explicit and builds it into the whole management system

 Risk-based thinking ensures risk is considered from the beginning and throughout

 Risk-based thinking makes preventive action part of strategic and operational

planning

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 RISK-BASED THINKING IS IN:

 Introduction - the concept of risk-based thinking is explained

 Clause 4 – Impartiality
 4.1.4 The laboratory shall identify risks to its impartiality on an on-going basis
 4.1.5 If a risk to impartiality is identified, the laboratory shall be able to demonstrate how it eliminates or minimizes such risk

 Clause 7
 For a statement of conformity to a specification or standard is
7.8.6 Reporting statements of conformity :
provided, the laboratory shall document the decision rule employed, taking into account the
level of risk (such as false accept and false reject and statistical assumptions) associated
with the decision rule employed and apply the decision rule.
 7.10 Nonconforming work :
 b) actions (including halting or repeating of work and withholding of reports, as necessary) are based upon the risk levels established
by the laboratory

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 RISK-BASED THINKING IS IN:

 8.5 Actions to address risks and opportunities

 The laboratory shall consider the risks and opportunities associated with the laboratory activities .
 The laboratory shall plan a) actions to address these risks and opportunities
 Actions taken to address risks and opportunities shall be proportional to the potential impact on the
portant : validity of laboratory results .

There is no requirement for formal methods for risk management or a documented

risk management Important process

The laboratory is responsible for deciding which risks and opportunities need to be
addressed
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 RISK-BASED THINKING IS IN:

8.7 Corrective action

 e) update risks and opportunities determined during planning, if necessary;

8.9 Management reviews (MR)

 Inputs for MR : m) results of risk identification;

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 HOW DO I DO IT ?

 Identify what the risks are – it depends on context

 Use risk-based thinking to prioritize the way processes are managed

 ISO 17025 :2017 does not require formal risk management

 ISO 31000 Risk Management — Principles and guidelines may be a

useful reference for organizations that want or need a more formal
approach to risk (but its use is not obligatory)
RISK MANAGEMENT PROCESS
RISK MANAGEMENT WORKSHEETS
 WORK SHEET

Section: …. Risk Assessment Date: …. Activity: …… Assessment Done By:

…….
Sl. Identified Rating Rating Significan Risk assessment Mitigation Action
 No Risk
.
Risk
Severity
Risk
Frequency
ce / Risk
Index
Low= 1 - 5 Action Type Reference
Significant = 6- 9 (Scale 1- 5) Number
( Scale 1 – (Scale 1 –
 4) 4)
S*F=
(Scale1-
High= 10 - 16

 16)
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 WORK SHEET
MITIGATION ACTION WORK SHEET :

Action Risk Action Description of Person Due Date Action Taken Remarks
Reference Level Type Action Responsible ( dd/mm/yy) Date (Sign)
Number (dd/mm/yy)

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