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ISO 9001:2015, ISO 13485:2016, ISO 17025:2017 QMS/Medical Lead Auditor

Learning Program Details
Price: $1,350.00 AUD
CODE: ISO-QMSLAB

Overview: The Quality Assurance, Medical and Laboratories Management Systems Lead Auditor Program provides learning in Quality Management Medical Devices and Laboratory Systems and Auditing of Management Systems and leading an audit team. The Candidate will be trained to confidently and professionally conduct a Stage 1 and Stage 2 audit on either a newly established Business System or within an established system thoroughly checking and auditing existing documentation plus all of the organisations Management Programmes and Processes. By the completion of learning the candidate will have ensured that they have a comprehensive understanding of Quality Management Systems, Auditing of Management Systems and be Training to Lead an Audit Team ready for preparation for a Third Party Audit (Certification Audit).

Standards Referenced: ISO 9001:2015, 13485:2016, 17025:2017, 15189:2009, 31000:2018, 19011:2018, ISO 17021:2015 plus local, national, statutory rules and regulations and sector specific standards covering country of origin.

Resources: Extensive e-campus library with access to all applicable Standards plus a comprehensive list of course notes and reference material.

Length of program: Minimum 260 hrs in a medical laboratory or similar, no set time limit is imposed, time taken is dependent on Candidates and or organisational time commitments and resources.

Approval Numbers: ISO-QMS, ISO-MED, ISO-LAB, ISO-AUD, ISO-LA, ACI-ACD and ACI-PBD.

Prerequisites: A Basic understanding of Quality Management Systems and their evaluation plus a minimum of 40 hrs. Laboratories experience.

Facilitator: All ACI Global Facilitators are Certified Business Professionals specializing in the specific scope being facilitated and have been assessed as competent in International Facilitation (ISO-FL), Attitude and Cultural Diversity (ACI-ACD) and have undertaken the Hogan Leadership Profile.

Special Needs: - If you have any special needs or requirements that your Facilitator needs to be aware of please Contact Us to discuss this in confidence.

Refund Policy: - No refund upon completion of registration and enrollment process.

 
Member Registration

ISO Personal Certification Outcomes

  • Issued with a Diploma valid for three years covering ISO 9001:2015, ISO 31000:2009, ISO 13485:2016, ISO 17025:2017, ISO 19011:2011 and ISO 17021:2011;
  • Issued with a Personal ISO Certification Card for Auditing Quality Management and Medical laboratories as a Lead Auditor valid for three years;
  • Provided a three years Triennial Personal ISO Certification program with ongoing assessment to verify competency (VOC);
  • Supported by a three year continuous professional development agreement to support the triennial personal ISO Certification program providing unlimited access to the ACI Global secure e-Campus for all resource and personal development needs.
  • Approved Recognition of Prior Learning pathway to ISO Personal Certification Lead Auditor capable of performing audits for a Certification Assessment Body (CAB) or Registrar.

ISO Personal Certification Learning Tasks

  • Learn how a Quality Management System in Conformance to ISO 9001:2015 will add value to an Organisation
  • Understand the meaning of Business Acumen together with Risk Based Thinking and be able to determine the key drivers for Business or Organisational Success.
  • Learn the principles and guidelines for auditing management systems to International (ISO) and National Standards for an Organisation.
  • Demonstrate the application of "Knowledge, Attitude, Cultural Diversity and Personal Disciplines" necessary to lead an Audit Team in undertaking a Stage 1 and Stage 2 Audit during an "Observational Event" under visual observation (Video).
  • Ongoing Assessments to ensure the candidates competencies are maintained in accordance with the candidates 3 year CPD agreement

ISO Personal Certification Career Benefits

  • ISO Certified Business Professionals receive higher returns for services provided and greater chances of employment and or contracts
  • Three Year Continuous Professional Leadership Development Guarantee CPD for the period of ISO Certification (3 yrs).
  • Entry into the ACI Global Professionals' Register.
  • At the successful completion of the programme candidates are able to apply for Registration with Third Party Certification Bodies (CB's). Please note conditions do apply for example industry experience, necessary auditor codes plus auditor experience are all considered essential requirements performing third party audits for further details please refer to your preferred Certification Body for further details.

ISO Learning and Certification Needs Analysis

Recognition of Prior Learning - ISO-RPL/RCC

Recognition of Prior Learning, Current Competence, Special Needs and Commitment to agreed Learning Outcomes and Continuous Professional Development is examined through:

  • Assessment of Industry Experience against required Learning Outcomes;
  • Assessment of Prior Learning against required Learning Outcomes;
  • Assessment of Current Competence against required Learning Outcomes;
  • Assessment of Special Needs if applicable;
  • Commitment to undertake and achieve learning outcomes;
  • Commitment to Continuous Professional Development.

ISO Course Curriculum

Curriculum and Learning Outcomes have been developed, implemented and undergo continuous improvement through input from Industry, ISO Technical Committees, independent third party audits and conform to the International ISO 17024 Conformity Assessment Standard - General requirements for bodies operating certification of persons with the following levels of Competency "Competent" (C) or "Not yet Competent" (NYC). If a candidate is assessed as (NYC) they are provided an additional attempt and are able to redo the assessment with additional mentoring and resources provided where necessary. There is no set number of additional attempts provided as this is determined between the candidate and their assigned facilitator.

Business Acumen and Risk Based Thinking - ACI-BAC and ISO-RM.

  • Competency Unit: Assess an organisations business Acumen in line with an organisations strategic objectives.
  • Competency Unit: Understand Risk Based thinking and how it will apply to all organisational processes.

Quality Management Systems - ISO-QMS, ISO-RM, ISO-MED, ISO-LAB.

  • Competency Unit: Understand the meaning and intent of each clause and sub clause of ISO 9001:2015 and 13485/17025.
  • Competency Unit: Understand the application of Quality Management Principles in the context of ISO 9001:2015 and ISO/IEC 17025:2005.
  • Competency Unit: Relate the QMS to Organisations Products including services and operational process.
  • Competency Unit: Relate the Management System for quality, administration and technical operations to Laboratory customers, regulatory authorities and accreditation bodies.
  • Competency Unit: Demonstrate an understanding of the processes needed to ensure competence of testing and calibration of Laboratories including its sub contractors where applicable.

ISO Auditor - ISO-AUD.

  • Competency Unit: Understand the application of the principles, procedures and techniques of auditing
  • Competency Unit: Understand the conduct of an effective audit in the context of the auditees organisational situation
  • Competency Unit: Understand the application of the regulations, and other considerations that are relevant to the audit management system, and the conduct of the audit.
  • Competency Unit: Be able to demonstrate through "Observational Means" how the internal audit program addresses both elements of the management system and "Risk to the Organisation, including the testing and or calibration activities of a known organisation.

ISO Lead Auditor - ISO-LA.

  • Competency Unit: Establish, plan and task the activities of an audit team.
  • Competency Unit: Communicate effectively with the auditee and audit client.
  • Competency Unit: Organise and Direct audit team members.
  • Competency Unit: Prevent and resolve conflict with the auditee and/or within the audit team.
  • Competency Unit: Prepare and complete the audit report.

Attitude and Cultural Diversity - ACI-ACD.

  • Competency Unit: Understand and be able to demonstrate attitude and cultural diversity disciplines necessary for the effective and efficient conducting of a management system audit.

Personal Behaviour Disciplines - ACI-PBD (Hogan Leadership Profile).

  • Competency Unit: Understand and be able to practice personal behaviour disciplines necessary for the effective and efficient conducting of a management system audit.

ISO Key Learning Objectives:

  • International Standards covered ISO 17025, ISO 9001, 9004, 19011 and 17021.
  • Relevant Legislation, Statutory Laws and the Eight Quality Management Principles.
  • Key Quality Policies, Objectives, Impacts and Key Performance Indicators (KPI's).
  • Evaluating to ensure Conformance to both ISO 17025 and ISO 9001:2015.
  • Evaluating the developed QMS and its Laboratory documents and related records.
  • Audit Definitions, Principles and Categories.
  • Audit Sampling, Calibration's, Traceability.
  • Stages of an Audit and followup activities.
  • Attitude and Cultural diversity;
  • Personal Behaviour Disciplines - Hogan Leadership Profile;
  • Perform an audit on an organisations management system;

ISO Key Learning Outcomes:

Achieve Competence in ISO 17025 and Quality Management Systems in line with the following Key Evidence Criteria:

  • The Intent & Requirement of each clause of ISO 17025 and 9001 is Understood.
  • The Relationship between the 8 QMP and ISO 17025 and 9001 is understood.
  • Mandatory Documents required by ISO 17025 and 9001 is understood.
  • Conformity to the clauses of ISO 17025 and 9001 is understood.
  • Sub Contractor quality systems are evaluated.
  • Equipment maintenance and control is evaluated and understood.
  • Calibration techniques are evaluated and understood.
  • Traceability techniques are evaluated and understood.
  • Test procedures are evaluated and understood.
  • Sample preparation and Non Standard Sampling Techniques are evaluated and understood.
  • Environmental Conditions are evaluated and understood.
  • The Audit Report used uses correct terminology.
  • The Effectiveness of the QMS is evaluated.
  • The Audit Report reflects the specific Business under audit.
  • Difference between Legal Conformance and Conformity to ISO is reported.
  • Product Realization Processes are Evaluated.
  • Audit Evidence Demonstrates Conformance.

Achieve Competence in Auditing in line with the following Key Evidence Criteria:

  • Audit Principles understood and applied.
  • Audit Definitions understood and applied.
  • Audit Criteria understood and applied.
  • Audit Planning understood and applied.
  • Document Review understood and applied.
  • Onsite Audit Activities understood and applied.
  • Audit Reporting understood and applied.
  • Audit Evidence understood and evaluated.
  • Followup Activities understood and applied.
  • The Management System is audited to Criteria, Plan and Reference Standard.
  • Sampling understood and applied.
  • Techniques to establish positive relationships.
  • "Attitude" - Cultural, Language and Ethical Issues.
  • Regulations, Legal Requirements and Codes of Practice.
  • Effective Communications understood and practiced.
  • Personal Attributes and Questioning Techniques understood and practiced.

Achieve Competence in Leading an Audit Team in line with the following Key Evidence Criteria:

  • Understand the Roles and Responsibilities of Audit Team Members.
  • Onsite Team Audit Activities are Planned explained and understood.
  • Feasibility of the Audit is explained and understood.
  • Audit Objectives and Timing are understood.
  • Team Selected According to the Business.
  • Checklist and Appropriate Documents Prepared, explained and understood by all team members.
  • Evidence of Audit Plan Prepared Accurately and all team members involved.
  • Legislation and Standards Addressed.
  • Preparation Prior to an Audit performed.
  • Communication during the Audit performed and understood.
  • Planning an effective closing meeting.
  • Audit outcomes are explained and understood.
  • Ensuring the Audit was effective.
  • Areas of Conflict are addressed and mitigated.
  • Addressing Disagreement with Audit Finding between team members.
  • Addressing Conflict with the Auditee.
  • Communicating the Audit findings.
  • Ensuring Followup actions are agreed and carried out.
  • Closing out an Audit.

Achieve Competence to demonstrate attitude and cultural diversity disciplines in accordance with the following Key Evidence Criteria:

  • Understand and be able to apply cultural diversity in differing situations, locations and roles.

Achieve Competence to practice personal behaviour disciplines in accordance with the following Key Evidence Criteria:

  • Adjustment - The degree to which a person is calm and even tempered or conversely, moody and volatile;
  • Ambition - The degree to which a person seems leader like, seeks status and values achievement;
  • Sociability - The degree to which a person appears talkative and socially self confident.
  • Interpersonal Sensitivity - Reflects social skill, tact and perceptiveness;
  • Prudence - Concerns self control and conscientiousness;
  • Inquisitive - The degree to which a person seems curious, adventurous and imaginative;
  • Learning Approach - The degree to which a person enjoys academic activities and enjoys education as an end in itself.

Achieve Competence by demonstrating under JAS-ANZ Auditor observation guidelines the ability to perform under visual observation the application of Skills applied during an actual audit activity in accordance with the following Key Evidence Criteria:

  • Demonstrate Conformance to ISO 19011 Clause 7 applicability Competency, Awareness and Training;
  • Demonstrate audit planning;
  • Demonstrate the Possession of the necessary Industry Codes:
  • Demonstrate the ability to perform a Stage 1 Audit;
  • Demonstrate the ability to perform a Stage 2 Audit, selected or mandatory clauses only;
  • Be able to perform an opening and closing meeting;

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