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

Learning Program Details
Price: $1,090.00 AUD
CODE: ISO-QMSIAL

Overview: The Quality Assurance, Medical and Laboratories Management Systems Auditor Program provides learning in Quality Management Medical Devices and Laboratory Systems and Auditing of Management Systems. The Candidate will be trained to confidently and professionally conduct a Stage 1 or Desk Top 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 and Auditing of Management Systems.

Standards Referenced: ISO 9001:2015, 13485:2016, 17025:2017, 31000:2018, 15189:2009, 19011:2018 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 60 hrs 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, ACI-ACD and ACI-PBD.

Prerequisites: Basic understanding of Quality Management Systems and evaluations and have a minimum 200 hrs experience working in a Medical environment or Laboratory.

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 and ISO 19011:2018;
  • Issued with a Personal ISO Certification Card for Auditing Quality Management and Medical laboratories as an 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.
  • The Organisation that the candidate has worked with to demonstrate and have verified through an observational activity that they are competent is issued with a Certificate of Sustainability covering the nominated ISO or Industry Standard/s and Statutory Rules and Regulations.

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 perform audits during an "Observational Event" under visual observation (Video) on either a newly established Business Management System or within an established system thoroughly checking and auditing existing documentation plus all of the organisations Management Programmes.
  • 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 ISO/IEC 17025:2005.
  • 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 auditeeÓ³ 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.

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 Behavioural 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 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;
  • Be able to perform an opening and closing meeting;

E-Campus Enrolment

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