Statistical Methods in Quality Assurance - AQL According to ISO 2859‑1 and ISO 3951‑1
This course provides a clear and practice oriented introduction to statistical sampling methods in quality assurance, focusing on AQL based inspection according to ISO 2859 1 (attribute sampling) and ISO 3951 1 (variable sampling).
Participants gain the knowledge required to design, evaluate, and implement sampling plans that balance risk, efficiency, and compliance. Through hands on exercises and practical examples, the training equips professionals to build or optimize sampling inspection systems aligned with industry expectations and international standards.
Course Outline
- Introduction to AQL and statistical sampling principles
- Attribute sampling according to ISO 2859 1
- Variable sampling according to ISO 3951 1
- Risk based sampling strategies and sample size determination
- Integration of sampling methods into ISO 13485 compliant QMS
- Practical exercises using sampling tables, switching rules, and decision charts
- Development of a compliant sampling inspection system
- Understand what auditors expect and how to implement sampling plans that stand up to regulatory scrutiny.
Learning Outcomes
- Clear introduction to AQL and statistical sampling principles
- Attribute sampling according to ISO 2859‑1
- Variable sampling according to ISO 3951‑1
- Risk‑based sampling strategies
- Sample size determination
- Integration into an ISO 13485‑compliant QMS
- Practical workshops with sampling tables, switching rules, and decision diagrams
- Building a consistent and compliant sampling inspection system
Who Should Attend
- Medical device manufacturers
- Auditors and PRRCs
- Production and operations teams
- R&D personnel
Why You Should Attend
This course is ideal for professionals seeking a solid, applicable understanding of AQL based sampling and its role in quality assurance. It enables participants to reduce inspection effort, manage risk effectively, and ensure compliance with key international standards. The combination of theory and hands on workshops enables immediate application in day to day quality activities and supports the development of robust, compliant sampling systems.
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