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    ISO 9001 Training from IQC

    products-servicesIrish Quality Centre Ltd
    March 19th 2024

    Irish Quality Centre (IQC) has become a European leader in offering ISO 9001 training programs that take life sciences professionals from basic familiarity to full Internal Auditor and Lead Auditor competence to conduct audits, assess remedial actions and ensure the effectiveness of all core business processes.

    Its range of ISO 9001 learning and training programs are approved by Exemplar Global, the CQI Chartered Quality Institute and IRCA International Register of Certificated Auditors.

    Its distance learning and virtual classroom moderated internal Auditor and Lead Auditor Training courses equip life sciences companies to ensure their QMS Quality Management Systems are fully developed and functional to ensure ISO 9001 compliance at external audit stage.

    About ISO 9001

    The International Standards Organisation (ISO) is the global leader in setting, maintaining and validating industry-based quality standards, with ISO 9001 as a globally recognized benchmark for quality management systems (QMS) to deliverance of quality products and services.

    The ISO 9001:2015 standard for QMS describes a process-based approach focused on enhancing customer satisfaction by meeting customer expectations. The ISO standards require organisations to determine the effectiveness of their quality management systems annually through external audits, followed by an ISO Certified Body led re-certification audit every third year, to ensure compliance. The annual external audit is hugely important to organisations, making it critical to develop internal audit skills.

    Lead Auditors have similar responsibilities, usually for both internal and supplier auditees, but with a greater emphasis on leading audits.

    IQC’s main offerings for ISO 9001 training are graduated in duration and complexity from basic familiarity to full Auditor expertise.

    ISO 9001 Fundamentals E-Learning Course

    A highly affordable self-directed and self-paced distance learning program that uses interactive online e-learning design and methodology to familiarize the learner with the main elements of the ISO 9001 Standard for Quality Management and what is required for compliance. The e-learning course provides an excellent introduction to the ISO 9001:2015 standard, equipping learners to proceed onto the IQC Foundation course, followed by the accredited Internal and Lead Auditor training where appropriate.

    The course is designed to meet the needs of anyone whose role involves the design, development, implementation, and auditing of quality management system, including operational staff who implement or maintain QMS systems, QM and QC professionals, managers and supervisors with existing basic knowledge of quality management concepts but who are new to ISO 9001. Its learning objectives include ability to identify and recall the purposes of QMS and ISO 9001 Standards, the principal requirements of ISO 9001:2015, how to use “risk based” thinking”, process approach and process management, the PDCA (Plan Do Check Act) methodology, and the relationship between ISO management standards and Annex SL.

    ISO 9001 Foundation Training

    Facilitated by experts working in the Quality Management field for many years, this one-day online ‘virtual classroom’ course Is designed to meet the needs of quality personnel, managers, supervisors and anyone responsible for QMS design, development, implementation, and auditing. It is highly useful for those who are new to ISO 9001 or are scheduled to attend IQC IRCA approved Internal Auditor and Lead Auditor training courses.

    The course aims to provide learners with of with more detailed understanding of the ISO 9001 standard and its implementation/maintenance in life sciences contexts. It evaluates and focuses on the standard’s requirements against the learner’s own organizational services and products. that provides learners with excellent opportunities to become fully versed with the ISO 9001 requirements ahead of their upcoming Internal Auditor or Lead Auditor training.

    ISO 9001:2015 Internal Auditor Training

    This course is conducted over two day-long sessions, either via Virtual Classroom online or hosted onsite where requested. It includes physical training materials, pre-course study materials, registration with accreditation body, certification, and refreshments where applicable. This course will assist auditors, particularly Quality Managers and others expected to conduct QEHS internal audits of their structured management systems, to do so in an organised and systematic way that can identify any improvements needed.

    The training program assumes prior learner knowledge of quality management principles and concepts, and the basic requirements of ISO 9001. IQC provides a “Pre-course” pack to all delegates approximately one week before the training commences.

    Overall Learning Objectives include being able to describe the purpose of a quality management system, list the key structural elements and requirements of ISO 9001:2015, place the role of the internal auditor in QMS maintenance and improvement, list different types of audits and set out a step-by-step plan for conducting an audit in accordance with ISO 19011, demonstrating ability to plan and prepare effectively.  The first day session is essentially dedicated to auditing concepts and methodology, while Day 2 goes through the various steps required to conduct an audit, including teamwork, collecting information, communicating audit findings, and evaluating QMS effectiveness. Learners are given an opportunity to demonstrate their new knowledge in role-playing scenarios, with all key learnings confirmed by final examination to qualify for CQI or IRCA auditor certification.

    ISO 9001 Lead Auditor Training

    The Lead Auditor role is key to the efficient and effective audit process, with ultimate responsibility for the audit. Lead Auditors must be fully versed in the ISO 9001 Quality Standards requirements to manage QMS audits effectively and liaise appropriately with external bodies or regulatory auditors/inspectors, as well as represent the organisation externally when auditing suppliers.

    IQC’s five-day Lead Auditor training program is designed to equip participants with best-in-class audit practice to master the audit skills required to manage and lead an entire ISO 9001 audit process from audit planning, resource allocation, team management and to final closing meeting where the audit results are presented to management.

    The intensive IQC ISO 9001:2015 Lead Auditor course is delivered over five days via Virtual Classroom or on client site with all physical materials required delivered in advance. The course focuses on best-in-class auditing practice and detailed aspects of ISO 9001 compliance, teaching learners how to perform fully effective internal, supplier and third-party QMS audits, with full grasp of the detailed learning objectives confirmed by final examination and continuous assessment to qualify for CQI/IRCA auditor or lead auditor certificate of achievement.


    Click on IQC ISO 9001 Auditor Training for further information.
    Click on Introduction to IQC to watch video.


    Training for Pharmaceutical Quality Systems


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