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ISO 9001:2015 Lead Auditor for Quality Management Systems
Hear directly from our star instructors!
This course also features a 30-minute session with our star instructors, Dan Reid and William Kovacich who will share insights on the standard and key industry updates.
ISO 9001 Lead Auditor Training & Certification
Course Duration: 5 Days - 8 Hours/day
Omnex is an Exemplar Global Certified TPECS provider for Exemplar Global QM, AU and TL Competency Units. This five-day ISO 9001 training course has been developed to satisfy the Exemplar Global QM and AU Examination Profiles and, as such, all attendees who successfully pass the exams during this course will achieve a Certificate of Attainment for the following competency units:
- Exemplar Global-QM
- Exemplar Global-AU
- Exemplar Global-TL
This course was developed to cover all requirements of the ISO 9001:2015 standard. Group exercises and case studies will be used to develop the required skills. Other topics covered are from ISO 19011 and include the auditing process and methodologies, e. g. planning and conducting an audit, writing nonconformity statements, preparing an audit summary and report, and verifying corrective actions. Auditing case studies to develop skills for identifying nonconformities will be used. Techniques for leading audit teams will also be discussed.
Note: Successful completion of this course will fulfill the training requirement necessary for all Exemplar Global certified TPECS auditors to meet the knowledge requirements of the new ISO 9001 quality management systems standard.
Learning Objectives
- Understand the application of quality management principles in the context of ISO 9001
- Relate the quality management system to the organizational products, services, activities and operational processes.
- Relate organization’s context and interested party needs and expectations to the planning and implementation of an organization’s quality management system.
- Understand the application of the principles, procedures and techniques of auditing.
- Understand the conduct of an effective audit in the context of the auditee’s organizational situation.
- Understand the application of the regulations, and other considerations that are relevant to the management system, and the conduct of the audit.
- Practice personal attributes necessary for the effective and efficient conduct of a management system audit.
- Establish, plan and task the activities of an audit team.
- Communicate effectively with the auditee and audit client.
- Organize and direct audit team members.
- Prevent and resolve conflict with the auditee and/or within the audit team.
- Prepare and complete the audit report.
Course Outline
Day One
- Introduction and Welcome
- The ISO Standard Explained
- Introduction to ISO 9001
- ISO 9001 Requirements
- Group Exercise: Context of the Organization
- Group Exercise: Interested Parties
- Group Exercise: Audit Scenarios
Day Two
- Overview of ISO 9001 Requirements (cont’d)
- Group Exercises: Audit Scenarios (cont’d)
- Independent QMS Written Exercise
- Introduction to Turtle Diagrams and Audit Trails
- Management of Audit Programs
- Audit Planning and Preparation
- Breakout Exercise 1: Writing an Objective and Scope Statement
- Breakout Exercise 2: Documentation Review
- Breakout Exercise 3: Creating an Audit Plan
Day Three
- Performing the Audit
- Breakout Exercise 4: Performing an Audit
- Writing Nonconformity Statements
- Breakout Exercise 5: Writing Nonconformity Statements
- Closing Meeting
- Completing the Audit Report
- Corrective Action and Closeout
- Management Systems Auditing Written Exercise
Day Four
- Leading Audit Teams
- Customer-Specific Requirements
- Management System Certification Scheme and Auditor Qualifications
- Leading Management Systems Audit Teams Written Exercise
Day Five
- Review of Audit Process and Audit Management Strategies
- Leading Management Systems Audit Teams Mock Audit Case Study
- Practical Application of Audit Principles and Instructor Interviews
Who Should Attend
This course is primarily designed for internal or third party auditor candidates, but can also be valuable for Quality Assurance Managers, ISO 9001Implementation and/or Transition Team Members, Management Representatives, and all others who would like to develop competency in ISO 9001and the auditing process for first, second and third party auditing.
Course Materials
Each participant will receive a seminar manual and a breakout workbook that includes auditing case studies.
Note: Omnex does not provide copies of standard(s) during training courses, but clients are encouraged to have their own copy.
Pre-Requisite
An understanding of the ISO 9001requirements and/or work experience in applying ISO 9001 is recommended.
ISO 9001 Lead Auditor Training & Certification Program is available in multiple locations globally, including the USA, Canada, Mexico, India, Europe, Thailand, Singapore, Middle East and China.
MICHAEL DOWN
315 E. Eisenhower Parkway, Suite 300, Ann Arbor, Michigan - 48108, USATel: (734) 761-4940
Fax: (734) 761-4966
Michael Down is a Senior Consultant with extensive Engineering, Quality and Reliability experience. Whether it may be in Product Development, Manufacturing, or Quality Management Systems, his greatest desires are to improve clients understanding and improving system to provide optimum performance, quality and durability of the product or process design. He also well understands the need for reducing costs while continually improving quality & compliance/conformance.
Mr. Down has extensive experience working in the automotive industry from manufacturing and assembly to vehicle design development and software/hardware Reliability, DMFEA and PFMEAs. He spent over 32 years working for GM in the quality engineering, statistical problem solving and continuous improvement and teaching. Have taught thousands of employees over the years in relation to FMEA, Probability and Statistics, SPC, System Thinking, Deming, Reliability, and statistical problem solving. Used SPC principles to manufacturing processes at GM, increasing line efficiency and reducing cost, saving GM millions of dollars. Applied DOE to advanced design and process development, identifying critical variables and optimizing process performance. Statistically solved process and product issues in relation to casting, metal fabrication, electronics, injection molding and SMC plastics. Also, statistically solved issues in relation to stamping, heat treating, paint, and in relation to issues with oxygen sensors.
In addition, he was instrumental in the development of the GM Powertrain PFMEA guidelines. Managed quality engineers in manufacturing and assembling. Was a part of the leadership group that directed the Statistical Network within GM (assisted in facilitating Deming seminars and assisted in the training of his courses and seminar) Mike also represented GM at both SAE and AIAG, providing extensive guidance and input to the development of Global Automotive Standards reference documents on Quality and Core tools, including PFMEA, APQP/CP, PPAP, SPC, MSA, and DRBFM reference documents. Mike has been involved with FMEA standards and including developing and teaching FMEAs since the 1990s. Today, Mike is actively working on the SAE J1739 committee updating the FMEA standard to reflect AIAG-VDA FMEA.
Specialties: Training and support the development of DFMEAs and PFMEAs for FMEA 4th edition and AIAG-VDA FMEA. Lead for PQMS training development, IQFMEA tech expert, taught and developed DFA and Robust engineering courses. Deming expert, facilitation and application, DOE trainer and implementer, Represent GM at SAE and at AIAG. Expert in the area of AIAG-VDA FMEA, SPC, MSA, FMEA 4th edition, and DRBFM
EDUCATION
Bachelor of Science, Electrical Engineering, MTU, Bachelor Industrial Management in Electronic Engineering Technology from Baker College, and a Master Degree in Applied Statistics from Oakland University
GREG GRUSKA
315 E. Eisenhower Parkway, Suite 300, Ann Arbor, Michigan - 48108, USATel: (734) 761-4940
Fax: (734) 761-4966
Greg Gruska is the Omnex Champion for APQP, PPAP, FMEA, ISO 26262, Lean Six Sigma and a Fellow of the American Society for Quality (ASQ). His strength in ISO 26262 is a strong understanding and experience in systems engineering and reliability/safety analysis in both hardware and software development. Greg managed the Quality Engineering Activity at Chevrolet. This group provided benchmarking, quality engineering and statistical support to all divisional and corporate activities and their suppliers. Besides the application of statistics within the design, manufacturing, and support environments, this group was active in the development of new technologies and training in these areas. Greg additional served as a Divisional and Corporate consultant in Statistical Engineering and Management. He has traveled extensively in assisting engineering, financial, and support staffs and manufacturing plants in the investigation and solution of problems affecting quality, new product development, product failures and customer satisfaction.
Greg is also an active/writing member of the MSA, SPC, FMEA, and EFMEA Manual subcommittees of the American Automotive industry�s Supplier Quality Requirements Task Force which is part of the international task force governing TS-16949. Greg is an adjunct professor at Madonna University. He has advanced degrees in mathematics and engineering from the University of Detroit, Michigan State University and Wayne State University. He was the Deming Memorial Lecturer at the Sheffield Hallam University for the year 2000.
Greg is a charter member of the Greater Detroit Deming Study Group and the W. E. Deming Institute. He is an ASQ certified Quality Engineer, a licensed Professional Engineer (CA - Quality) and a member of the Board of Examiners of and Judge for the Michigan Quality Leadership Award (1994-2011). Greg is on the writing committee of AIAG on FMEA, a member of the SAE Functional Safety Committee (J2980) and is considered one of the foremost authorities on risk management in the world. He has considerable hardware and software experience in Automotive applications.
MARY E. ROWZEE, ASQ FELLOW
315 E. Eisenhower Parkway, Suite 300, Ann Arbor, Michigan - 48108, USATel: (734) 761-4940
Fax: (734) 761-4966
Mary Rowzee is an Omnex consultant with extensive experience and achievements in Quality Systems development, implementation and auditing to ISO 9000 series and IATF 16949 standards; Six Sigma Black Belt Problem Solving and Advance Quality Tools including: Design and Process FMEA, Design and Process Verification and Test Planning, Complex Statistical Analyses and Reliability Prediction, Modelling and Risk Reduction. Mary is a writing member of AIAG-VDA FMEA 1st edition and the Core Tools Guidelines: SPC 2nd edition, MSA 4th edition, EFMEA 1st edition, PPAP 4th edition and APQP 2nd edition.
Mary has been actively leading industry practices and application of ISO 26262 Functional Safety Standard for Electrical/ Electronic Products; Software FMEAs, ASPICE, CMMI and Quality; Supplemental Monitoring and Systems Response (MSR) FMEAs; Safety of the Intended Functionality (SOTIF) ISO 21448 and use of Safety Engineering tools (Reliability Block Diagrams, Hazard and Risk Analyses, Addressing ASIL rated risks) in Advanced Driver Assistance Systems (ADAS). She also served as GM Global representative on AIAG-VDA and SAE Quality Standards development teams.
Mary has worked for Daimler Chrysler Fiat, TRW and recently GM working as a Senior Engineer ADAS Electrical sub-systems quality for Autonomous Vehicles. She was the Quality and Reliability Resource on ADAS Electrical Sub-systems teams, used in Autonomous Vehicles. For GM she worked with internal and first tier supplier teams to develop Safety Analyses and Design FMEAs on Electrical, Mechanical and Software products in support of ISO 26262 requirements. Mary also assisted in the establishment and implementation of an aggressive Advanced Product Quality Process within GM and Supply Base. Additionally, at GM, she served as in-house consultant and coach to more than 5,000 product engineers in Six Sigma project development and implementation. Mary was an Operational Excellence Master for the GM Quality organization, leading and facilitating the highest impact, most financially significant corporate projects, in addition to teaching many courses on Six Sigma tools and techniques. Also at GM, Mary served as the Senior Leader for Global Design and Process FMEA. In this she revitalized the use of FMEAS within General Motors by developing and teaching all live and web based FMEA classes in North America and developing criteria and assessment processes for Global FMEA software selection.
While at Daimler Chrysler Fiat she served as the manager of Product and Process Integrity. In this position she supported interior and electrical product development (SMTs) areas in writing technical specifications, developing reliability requirements, constructing and executing designed experiments, developing FMEAs and Validation plans.
EDUCATION
Mary has Bachelor of Arts (BA), Psychology and Human Factors from University of Delaware, Newark, DE. She also has a Master of Science (MS), Industrial Psychology and Applied Statistics from University of Akron, Akron, OH. Mary hold numerous certifications including: Certified Reliability Engineer CRE, Certified Manager of Quality and Organizational Excellence CQM/OE, Certified Quality Engineer CQE, Certified Quality Auditor CQA, Registrar Accreditation Board Quality Auditor.