Reference Material Producers
The LICQual ISO 17034:2016 Competence of Reference Material Producers Foundation Course provides learners with a comprehensive understanding of reference material production based on the ISO 17034:2016 standard. This foundation course covers the key principles, requirements, and frameworks for producing high-quality reference materials, enabling learners to understand how organizations maintain accuracy, reliability, and compliance in laboratory settings.
Learners will explore critical topics such as production processes, validation, quality management, traceability, and documentation practices. The ISO 17034 Foundation Training emphasizes practical application, equipping learners with the knowledge to implement effective production procedures, ensure compliance with international standards, and maintain consistency in reference material quality.
Through this LICQual ISO 17034 online course, learners gain foundational knowledge on reference material competence, laboratory quality assurance, and evaluation techniques. The course equips learners with the skills to interpret ISO 17034:2016 requirements and apply best practices, supporting reliable, compliant, and high-quality reference material production in professional laboratories.
Course Overview
Qualification Title
LICQual ISO 17034:2016 Competence of Reference Material Producers Foundation Course
Total Units
6
Total Credits
40
GLH
120
Qualification #
LICQ2201348
Qualification Specification
To enroll in the LICQual ISO 17034:2016 Competence of Reference Material Producers Foundation Course applicants must meet the following criteria:
|
Qualification# |
Unit Title |
Credits |
GLH |
|---|---|---|---|
|
LICQ2201348-1 |
Introduction to ISO 17034:2016 and the Role of Reference Material Production |
8 |
24 |
|
LICQ2201348-2 |
General and Structural Requirements for Reference Material Producers |
8 |
24 |
|
LICQ2201348-3 |
Resource and Personnel Competence Requirements |
6 |
18 |
|
LICQ2201348-4 |
Production Planning and Control Processes |
6 |
18 |
|
LICQ2201348-5 |
Homogeneity, Stability, and Characterisation Requirements |
6 |
18 |
|
LICQ2201348-6 |
Management System Requirements and Continual Improvement |
6 |
18 |
By the end of this course, Applicants will be able to:
Introduction to ISO 17034:2016 and the Role of Reference Material Production
- Understand the scope and purpose of ISO 17034 as the international standard for reference material producer competence.
- Explain the critical role of reference materials and certified reference materials in supporting accurate laboratory measurements.
- Identify the relationship between ISO 17034 and its predecessor ISO Guide 34 within the conformity assessment framework.
- Recognize the importance of metrological traceability and its dependence on quality reference materials.
- Distinguish between reference materials and certified reference materials based on their production and characterization requirements.
General and Structural Requirements for Reference Material Producers
- Describe the legal and organizational structure requirements for operating as a competent reference material producer.
- Explain the impartiality mechanisms necessary for ensuring objective and unbiased production activities.
- Identify the confidentiality obligations protecting sensitive information related to materials and clients.
- Understand the documentation requirements for establishing policies, procedures, and organizational oversight.
- Outline the contractual arrangements governing relationships between producers and their stakeholders.
Resource and Personnel Competence Requirements
- Identify the personnel competence criteria for staff involved in production, characterization, and certification activities.
- Describe the qualification, training, and professional development processes for maintaining technical expertise.
- Explain the facility and environmental conditions necessary for preserving material integrity during processing.
- Understand the equipment requirements including calibration, maintenance, and performance verification protocols.
- Recognize the provisions for managing external resources and subcontractors involved in production activities.
Production Planning and Control Processes
- Describe the processes for designing and developing reference material production programs.
- Explain the selection criteria for appropriate materials and production methodologies.
- Identify the procedures for managing production campaigns with consistency and reproducibility.
- Understand the material processing requirements including purification, synthesis, and formulation techniques.
- Outline the packaging, labelling, and preservation protocols for maintaining material stability throughout distribution.
Homogeneity, Stability, and Characterisation Requirements
- Explain the homogeneity assessment methodologies including sampling plans and statistical evaluation.
- Describe the stability testing requirements for short-term transport conditions and long-term shelf life.
- Identify the characterisation methodologies for assigning property values to reference materials.
- Understand the establishment of metrological traceability for certified values and their supporting evidence.
- Recognize the approaches for calculating and expressing measurement uncertainty associated with assigned properties.
Management System Requirements and Continual Improvement
- Describe the management system options available to reference material producers for demonstrating consistent operation.
- Explain the documentation hierarchy including quality manuals, policies, and supporting procedures.
- Identify the internal audit processes for monitoring system effectiveness and identifying improvement opportunities.
- Understand the management review requirements for evaluating producer performance and resource adequacy.
- Outline the corrective action and preventive action procedures for addressing nonconformities and mitigating risks.
This course is ideal for:
- Reference material producers seeking to formalize their understanding of ISO 17034 requirements for competent operations.
- Laboratory managers responsible for sourcing and using certified reference materials in quality assurance programs.
- Quality assurance personnel in reference material producing organizations managing compliance with international standards.
- Accreditation body assessors who evaluate reference material producers against ISO 17034 competence criteria.
- Metrologists and measurement scientists involved in establishing metrological traceability for reference materials.
- Analytical chemists who develop and characterize reference materials for specific analytical applications.
- Production staff involved in processing, packaging, and preserving reference materials for distribution.
- Technical coordinators managing reference material production campaigns and ensuring consistency across batches.
- Data analysts responsible for evaluating homogeneity, stability, and characterization study results.
- Document control specialists maintaining the technical documentation and certificates accompanying reference materials.
- Regulatory authorities overseeing reference material quality in regulated sectors including pharmaceuticals and environmental monitoring.
- Consultants advising organizations on establishing reference material production capabilities aligned with ISO 17034.
- Recent graduates in chemistry, metrology, or materials science aiming to specialize in reference material production.
- Training providers developing educational programs about reference material requirements and applications.
- Procurement professionals evaluating reference material supplier competence and certificate authenticity.
Assessment and Verification
All units within this qualification are subject to internal assessment by the approved centre and external verification by LICQual. The qualification follows a criterion-referenced assessment approach, ensuring that learners meet all specified learning outcomes.
To achieve a ‘Pass’ in any unit, learners must provide valid, sufficient, and authentic evidence demonstrating their attainment of all learning outcomes and compliance with the prescribed assessment criteria. The Assessor is responsible for evaluating the evidence and determining whether the learner has successfully met the required standards.
Assessors must maintain a clear and comprehensive audit trail, documenting the basis for their assessment decisions to ensure transparency, consistency, and compliance with quality assurance requirements.