ISO/IEC 17025 COURSES
Training Programmes
Click on Icons to download Programme Brochures (where applicable)
ISO/IEC 17025 DECISION RULE
Duration: 1 day
Course Content
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Introduction to Decision Rule
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Interpretation and Application of Clause 7.8.6.1
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Definition of terms
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Risk in conformity assessment
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Probability distribution relating to decision making
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Statement of conformity
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Compiling a Report on Decision Rule
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Workshop: Practical examples
This course provides guidance on how to select the appropriate decision rules and specifically guidance on how the required elements of a decision rule can be compiled when no standard published rules are available.
ISO/IEC 17025:2017 RISK & OPPORTUNITY
Duration: 1 day
Course Content
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What is risk?
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Risk based thinking
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Overview of ISO 31000 Guidelines
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The requirements of ISO/IEC 17025:2017
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How to assess risks in the laboratory?
Risk Identification
Tools & Methods
Mitigate / reduce the risks
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When are risk assessments carried out?
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Risk assessment & opportunities identification procedures
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Resolving risks
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Identification of ongoing risks
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Monitoring plan
UNDERSTANDING & INTERPRETING THE ISO/IEC 17025:2017 STANDARD
Duration: 2 days
Course Content
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Overview of major changes in ISO/IEC 17025
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The new structure
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Risk-based approach
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Clauses and requirements
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Terms & definitions
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General requirements
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Structural requirements
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Resource requirements
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Process requirements
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Management System requirements
ISO/IEC 17025 QUALITY AWARENESS
Duration: 1 day
Course Content
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Interpreting and understanding the ISO/IEC 17025 Standard
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Structure of quality system documentation
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The Eight Management principles and its applications to the management of the Laboratory
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Laboratory Accreditation Process – process, requirements, benefits and implications
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Development and implementation of an effective quality management systems
Gain basic knowledge of the ISO/IEC 17025 standard. Only for in-house training.
ISO/IEC 17025:2017 INTERNAL QUALITY AUDIT
Duration: 2 days
Course Content
Overview of the ISO/IEC 17025:2017 Standard
Roles & Responsibilities of Auditors
Planning Audit schedule
Planning, preparation, conducting and documenting internal audits
The audit process & findings
Generating audit checklists
Identifying and dealing with nonconformities
Interview techniques and social competence
Workshop: Simulation Audit (Actual laboratory audit can be conducted for in-house training)
This course is designed to develop participants understanding of auditing techniques against the ISO/IEC 17025:2017 requirements., and to initiate the sequence of activities involved in scheduling, planning, conducting, reporting on and closing out internal quality audits. Participants will be able to employ effective techniques of auditing and the ability to develop the auditing procedures, scheduling and recording systems needed to sustain the program.
ISO/IEC 17025 QUALITY MANUAL WRITING
Duration: 2 days
Course Content
An overview of the ISO/IEC 17025 Standard
Guideline on Laboratory Quality Manual Writing
Documenting the Management & Technical Requirements
Produce your own Quality Manual
This course will cover interpretation of the new standard elements; effective methodology of writing a quality manual to comply with the new standard.
ISO/IEC 17025 DOCUMENTATION & IMPLEMENTATION
Duration: 2 days
Course Content
The principles behind ISO 17025
Documenting laboratory competence and its implementation
Continual improvement of the laboratory
This course gives participants the knowledge to establish a program for a laboratory management system that is in compliance with ISO/IEC 17025 and suitable for their laboratories size, workload, and that will meet their customer needs.
This course highlights specific documentation requirements of a laboratory quality system and help them to encounter situation/problem of a particular requirement when implementation is in progress.
ISO/IEC 17025:2017 LEAD ASSESSORS (MRCA ACCREDITED: TCP 2001)
Duration: 5 days
Course Content
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Quality concepts for the laboratory
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Risk Based thinking
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Process approach
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Impartiality and confidentiality
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Understanding the ISO/IEC 17025:2017 Standard
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Test Methods and their Validation
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Quality Control and Proficiency Testing
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Learning effective auditing techniques
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Protocol for Open Meeting and Exit Meeting
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Assessment Reporting
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Handling of non-conformance – Identification and classification
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Corrective Action monitoring
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Accreditation and follow-up assessment
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Use and abuse of accreditation status
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Interview techniques and social competence
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Interactive workshops, role play and simulation audit
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Examination
The course covers analysis of the ISO/IEC 17025:2017 standard elements, effective and useful assessment techniques including questioning skills, VAK Practices, transactional analysis, etc. which are equally important to equip all participants with the necessary leadership for assessment. The course will prepare participants to meet technical demands of the assessment while providing practical exercises to aid comprehension.
This course is an ISO accredited course from Malaysia Register of Certificated Auditors (MRCA). MRCA is the Governing Body for the National Registration Scheme for assessor or Auditors of Quality System and Training Course Providers.
DOCUMENT CONTROL SYSTEM
Duration: 1 day
Course Content
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Concepts of Document Control
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Difference between “controlled copy” & non-controlled copy”
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Document review including revision number, issue number, approved date, etc.
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Document distribution, updates, storage, retention & disposal
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Extracts from controlled copies
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Methodology for easy retrieval of document
The intent of document control is to ensure that all documents are properly identify, index, file, maintain, update, store and dispose systematically as to prevent unintended use of obsolete document.
UNCERTAINTY OF MEASUREMENT
Duration: 3 days
Course Content
Estimating Measurement Uncertainty
SI System of Units
Statistical Techniques Commonly Use in Estimating Measurement Uncertainty
Fitted Curves for Some Calibration works
Partial Differentiation
ISO Guide to the Expression of Uncertainty of Measurement (GUM)
Applying the ISO Guide to Uncertainty Calculation
Practical Guidance on Evaluating Uncertainty Components
Control Charting
This course intended to develop an understanding of uncertainty in measurements & calibrations. It helps attendee to receive an idea of evaluating and calculating uncertainty for laboratories.
UNCERTAINTY OF MEASUREMENT IN MICROBIOLOGY
Duration: 2 days
Course Content
Principles of estimating the uncertainty
- Type A and Type B estimation of uncertainty
- Calculating the combined uncertainty
- Uncertainty in Analytical MeasurementMetrological characteristics of microbiological cultural methods
- Common basic equations
- The one-plate instrument
- The multiple-plate instrument
- The one-dilution MPN instrument
- The multiple-dilution MPN instrumentEstimation of the components of uncertainty
Mathematical models of microbiological test results and uncertainties
Systematic corrections and uncertainties
Practical workshops
This course is designed to help laboratories engaged in routine microbiological analysis to calculate uncertainties of their test or measurement results. The workshops take participants through the process of evaluating uncertainty in microbiology with hands-on formulae (APLAC method) being provided as well as an appreciation of a European method which follows closely the generic GUM.
METHOD VALIDATION FOR ANALYTICAL LABORATORY
Duration: 3 days
Course Content
Why method validation is necessary?
Overview of the validation process
Statistics for method validation
Validation parameters
Key performance characteristics
Verification of standard methods
Using method validation data
Method validation is the process that provides evidence that a given analytical method, when correctly applied, produces results that are fit for purpose. It is essential to understand method validation if you want to make sure that your analytical results are accurate. This course explains the general principles of method validation and demonstrates some practical techniques that can be applied in the analytical laboratory.
INTRODUCTION TO GOOD LABORATORY PRACTICE
Duration: 1 day
Course Content
What is OECD Good Laboratory Practice (GLP)?
History of GLP & regulation
GLP in Malaysia
The OECD Principles of Good Laboratory Practice
Elements of GLP
General good testing conduct
The OECD Principles of Good Laboratory Practice (GLP) is a quality system deals with the organization, process and conditions under which laboratory studies are planned, performed, monitored, recorded and reported. This course provides training in the principles of good laboratory practice for personnel of laboratories who wish to demonstrate that they produce test results that are fit for the purpose and can therefore be relied upon when making risk/safety assessments.
LABORATORY SKILLS
Duration: 2 days
Course Content
Essential health and safety information that analysts should be familiar with to enable them to work safely in the laboratory
Method & equipment selection
The importance of Standard Operating Procedures
Sample handling and storage
Key laboratory skills that analysts need in order to be able to carry out analytical work with the required level of accuracy
Quality assurance and quality control
Data handling and reporting of results
The course consists of taught and practical elements that focus on laboratory safety, basic lab equipment maintenance and use, basic laboratory techniques, laboratory calculations, buffer preparation, and recording of experimental results. This is to build on analysts’ experience of day to day work practices in a laboratory.