ISO Management Systems & Auditing
ISO/IEC 17025:2017 – Laboratory Competence (Requirements, Method Validation, Uncertainty & Internal Audit)
Build and audit a laboratory management system to ISO/IEC 17025:2017. Participants interpret the requirements for impartiality, competence and consistent operation, validate and verify methods, estimate measurement uncertainty, use QC charts to assure results and practise internal audits.
At a glance
Catalog codeC09
Duration
- 5 days
LevelPractitioner
Program typeTechnical
LanguageEnglish / Arabic
DeliveryIn-house · Public · Online
Who it's for
- Laboratory managers & quality managers
- Analysts & technicians in testing and calibration labs
- Internal auditors of laboratories
Learning objectives
- Understand ISO/IEC 17025:2017 requirements for competence, impartiality and consistent operation
- Interpret clauses 4–8
- Validate and verify test methods
- Estimate measurement uncertainty
- Use quality-control charts to ensure validity of results
- Plan and perform internal laboratory audits
Detailed content
- Purpose and scope of ISO/IEC 17025
- Terms and definitions
- Accreditation process and the role of the accreditation body (EGAC)
- Impartiality and confidentiality
- Personnel competence and authorisation
- Facilities and environmental conditions
- Equipment, calibration and metrological traceability
- Externally provided products and services
- Review of requests and contracts
- Method selection, verification and validation
- Sampling and handling of test items
- Technical records
- Reporting results, statements of conformity and decision rules
- GUM approach to uncertainty
- Identifying uncertainty sources
- Type A and Type B evaluation
- Combined and expanded uncertainty with worked examples
- Internal quality control and control charts
- Proficiency testing and interlaboratory comparisons
- Nonconforming work and complaints
- Option A and Option B management systems
- Risks and opportunities
- Internal audits per ISO 19011
- Management review
- Audit exercise
Day-by-day agenda
A typical schedule. In-company versions are tailored to your processes, data and timing.
- Awareness
- General, structural and resource requirements
- Process requirements
- Measurement uncertainty
- Assuring validity of results
- Management system and internal audit
- Case study, action plans and course assessment
Practice, tools and assessment
Hands-on practice
- Audit simulation: plan, interview, sample evidence and write findings
- Gap analysis of your own documents against the clauses
- Write nonconformity statements and review corrective actions
- Mock regulatory inspection of a GMP area
Tools and templates you keep
- Clause-by-clause gap-analysis checklist
- Audit plan, checklist and report templates
- Nonconformity and CAPA log
- Deviation, CAPA and change-control forms
How learning is assessed
- Pre- and post-course knowledge check
- Assessment of practical exercises by the trainer
- Action plan reviewed at the end of the course
Built on these standards and bodies of knowledge
- ISO 9001:2015 + Amd 1:2024
- ISO 19011:2018 (auditing management systems)
- ISO/IEC 17021-1 (certification bodies)
How it is delivered
- Public courses in Cairo, in-company programs and live online training
- Practical exercises, case studies and examples from your sector
- Can also run as Train & Stay in Sharm El Sheikh, Hurghada or Cairo
Part of these career paths
- Pharma, Medical Devices & Food Safety · Practitioner
FAQ
Frequently asked questions
How long is ISO/IEC 17025:2017 – Laboratory Competence (Requirements, Method Validation, Uncertainty & Internal Audit)?
The program runs 5 days. In-company versions can be adapted to your needs.
Is the course taught in Arabic or English?
Sessions are usually delivered in Arabic with English technical terms and materials. Full English delivery is available for in-company groups.
Can you run it inside our company?
Yes. In-company programs use exercises built on your own processes. Tell us the group size and preferred timing and we will send a proposal.
Will I receive a certificate?
Participants who complete the program and its assessment receive a certificate from The Excellence Center, which can be verified online.
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