The demand for high-quality reference materials (RMs) has never been greater, particularly within industries that require precise measurement and testing. As these materials are crucial for validating measurement processes, ensuring their accuracy and reliability is vital. The LICQual ISO 17034:2016 Competence of Reference Material Producers Lead Auditor course provides professionals with the knowledge and skills required to audit reference material producers effectively. This certification is key for ensuring the highest standards in reference material production and the competence of organisations in this critical field.
The LICQual ISO 17034:2016 Competence of Reference Material Producers Lead Auditor course is a comprehensive programme aimed at professionals who wish to specialise in auditing reference material producers in line with international standards. This course covers the entire framework of ISO 17034:2016, with a focus on developing the skills needed to lead audits effectively and manage the auditing process from start to finish.
The LICQual ISO 17034:2016 Competence of Reference Material Producers Lead Auditor course offers a unique opportunity for professionals looking to enhance their expertise in reference material production auditing. With this qualification, participants are equipped with the skills to support the accreditation and continuous improvement of reference material producers, ensuring their operations meet the highest standards of quality and competence.
All About LICQual ISO 17034:2016 Competence of Reference Material Producers Lead Auditor
Course Overview
ISO 17034:2016 specifies the requirements for the competence of reference material producers. It establishes the criteria for producing certified reference materials (CRMs) and provides guidelines to ensure their consistent quality and accuracy. This standard covers the entire process, from production to certification, ensuring that reference materials meet the highest international standards and can be relied upon in testing and calibration activities.
ISO 17034:2016 is crucial in industries such as pharmaceuticals, healthcare, manufacturing, and environmental sciences, where precise measurements are integral to product development, quality control, and regulatory compliance.
Study Units
- Introduction to ISO 17034:2016 and Reference Material Production
- Auditing Principles and Techniques
- Competence Requirements for Reference Material Producers
- Planning and Conducting Reference Material Producer Audits
- Non-Conformities, Corrective Actions, and Risk Management
- Audit Reporting, Follow-Up, and Continuous Improvement
To ensure participants are adequately prepared for the LICQual ISO 17034:2016 Competence of Reference Material Producers Lead Auditor course, the following entry requirements apply:
Minimum Age
Participants must be at least 21 years of age at the time of enrolment.
Educational Background
A minimum of a Level 3 qualification (such as A-levels or an equivalent recognised qualification) is required. A background in science, engineering, quality management, or a related technical field is preferred.
Work Experience
Candidates should have a minimum of two years of relevant professional experience in laboratory operations, quality management, auditing, or related activities. Experience in reference material production, testing, calibration, or compliance activities is highly beneficial.
Language Proficiency
As the course is conducted in English, participants must have sufficient proficiency in English to engage in all aspects of the course. Non-native speakers are required to demonstrate an IELTS score of 5.5 or equivalent, or possess comparable qualifications, to ensure effective communication and understanding of the course material.
The LICQual ISO 17034:2016 Competence of Reference Material Producers Lead Auditor course is tailored for professionals involved in quality assurance, auditing, and accreditation within industries that produce and use reference materials. This course is ideal for:
- Internal and External Auditors
Individuals responsible for auditing reference material production processes and ensuring compliance with ISO 17034:2016 standards. - Quality Managers and Coordinators
Professionals overseeing the quality management systems within organisations that produce reference materials. - Compliance and Regulatory Officers
Individuals working to ensure adherence to regulatory standards and accreditation requirements within reference material production facilities. - Technical Experts and Consultants
Those providing consultancy on best practices, accreditation processes, and quality assurance in reference material production. - Accreditation Body Personnel
Professionals working within accreditation organisations who assess the competence of reference material producers. - Laboratory Managers and Supervisors
Those in charge of managing laboratory operations where reference materials are critical for testing, calibration, and measurement processes.
This course is also suitable for individuals seeking to advance their career in the auditing and quality assurance sectors, particularly in industries where accuracy, reliability, and compliance in reference material production are essential.
Learning Outcomes
Introduction to ISO 17034:2016 and Reference Material Production
- Understand the scope and key principles of ISO 17034:2016 for reference material producers
- Identify the critical processes involved in the production of reference materials
- Recognise the significance of reference materials in ensuring measurement accuracy and consistency
- Comprehend the regulatory framework and global requirements for reference material production
Auditing Principles and Techniques
- Apply core auditing principles and techniques within the context of reference material production
- Understand the roles of auditors and the ethical standards required during audits
- Develop skills to effectively assess management systems and operational procedures during audits
- Learn to use audit tools and techniques to evaluate compliance with ISO 17034:2016
Competence Requirements for Reference Material Producers
- Identify the specific competence requirements for reference material producers as outlined in ISO 17034:2016
- Understand the importance of technical competence in producing certified reference materials
- Assess the capability of reference material producers to meet the technical and operational requirements of the standard
- Evaluate the effectiveness of quality management systems in supporting the competence of reference material producers
Planning and Conducting Reference Material Producer Audits
- Develop effective audit plans tailored to the specific needs of reference material producers
- Understand how to define audit criteria, scope, and objectives for auditing reference material production processes
- Gain practical experience in conducting audits, from opening meetings to closing the audit
- Learn how to gather evidence, assess records, and interview personnel to evaluate conformity with ISO 17034:2016
Non-Conformities, Corrective Actions, and Risk Management
- Identify and classify non-conformities within the context of reference material production audits
- Evaluate the impact of non-conformities and recommend appropriate corrective actions
- Develop risk management strategies for mitigating issues identified during audits
- Understand the importance of root cause analysis and its role in corrective actions
Audit Reporting, Follow-Up, and Continuous Improvement
- Learn how to prepare clear, structured, and comprehensive audit reports
- Understand the importance of presenting audit findings to stakeholders in a professional manner
- Develop strategies for following up on corrective actions and ensuring compliance post-audit
- Gain insight into continuous improvement processes and how to support them within reference material production facilities
FAQs LICQual ISO 17034:2016 Competence of Reference Material Producers Lead Auditor
