Trainings and consulting services

Our most requested competence training for Industry guidelines, methods and international management system standards.

Our Exemplar Global certified training courses on ISO 9001, IATF 16949, etc. are modular and may be booked according to personal needs.

Module 1 (2 days): Understanding the standard

Module 2 (advanced, 2 days): Qualification as internal auditor

Module 3 (advanced, 1 day): Qualification as Lead or Supplier auditor

ALL AUDITOR CERTIFICATION TRAININGS ALIGN WITH THE REQUIREMENTS OF ISO 19011.

Understanding and Certification Series:

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. Best practices and techniques for leading audit teams will also be discussed.

Target audience:

All modules can be valuable for Quality Assurance Managers, ISO 9001 implementation and transition team members, management representatives, and all others who would like to develop competency in ISO 9001 and the auditing process for first, second, and third-party auditing.

Training structure:

Module 1

  • Understanding the requirements of the QMS standard
  • Application of quality management principles in the context of ISO 9001
  • Relation of the quality management system to the organizational products, services, and operational processes
  • Organization’s context and interested party needs and expectations related to the planning and implementation of a quality management system

Module 2

  • Application of the principles, procedures and techniques of auditing
  • Personal attributes necessary for the effective and efficient conduct of an audit
  • How to establish, plan and task the activities of an audit team
  • Effective communication with the auditee and audit client
  • Organization and direction of audit team members
  • How to prevent and resolve conflicts with the auditee or within the audit team
  • Preparation and completion of the audit findings and writing non-conformities

Module 3

  • Guiding the audit team to successful conclusion of the audit objectives
  • Prevent and resolve conflict with the auditee and/or within the audit team
  • Prepare and complete the audit report

Implementing the ISO 14001 Environmental Management System (EMS) standard is an important step towards sound environmental practices. The management system that is implemented helps install a basic framework for environmental performance.

Customer demand is what is driving organizations worldwide to adopt and implement EMS. Large organizations in different industries such as GE, Toyota and Nestlé are driving EMS implementations internally and in many cases with their supply base.

Target audience:

This seminar is primarily designed for internal or third party auditor candidates, but can also be valuable for Environmental Compliance Managers, ISO 14001:2015 implementation and transition team members, management representatives, and all others who would like to develop competency in ISO 14001:2015 and the auditing process for first, second and third-party audits.

Seminar structure

Module 1:

  • Application of environmental management principles in the context of ISO 14001:2015.
  • Relation of the environmental management system to the organizational products, services, activities and operational processes
  • Organization’s context and interested party needs and expectations related to the planning and implementation of an environmental management system
  • Risk assessment of significant environmental impacts, activities and its aspects
  • Effectiveness assessment of methodologies to control environmental hazards
  • Assessment the EMS roles and responsibilities within the context of the organization
  • Adequacy and effectiveness of the EMS
  • Application of the principles, procedures, best practices and techniques for auditing

Module 2:

  • Conducting an EMS effective audit
  • Application of the regulations, and other considerations that are relevant to the management system, and the conduct of the audit
  • Personal attributes necessary for the effective and efficient conduct of a management system audit
  • Planning activities of an audit team
  • Effective communication with the auditee, the audit team and audit client
  • Organization and direction of audit team members

Module 3:

  • Preparation and completion of the audit report
  • Review of audit processes and audit management strategies
  • Conflict prevention and resolution with the auditee or within the audit team
  • Practical application of audit principles

This seminar covers the requirements of ISO 45001:2018, which is the international standard for Occupational Health and Safety Management Systems. Auditing topics from ISO 19011 such as 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 are also covered with a focus on ISO 45001:2018 managements system requirements. Auditing case studies to develop skills for identifying nonconformities will be used. Techniques for leading auditing teams will also be discussed.

Target audience:

This seminar is designed for Health & Safety Compliance Managers, ISO 45001:2018 Implementation Team Members, Management Representatives, and ISO 45001:2018 Auditors and Lead Auditors.

Seminar structure

Module 1:

  • Understanding the requirements of the OHSMS standard
  • OHS hazards that are reasonably expected to occur for that business type or industry
  • Risk assessment of identified hazards in the context of the organization’s OHS management system
  • Assessment methodologies to control OHS hazards, aspects and impact
  • Assessment the EMS roles and responsibilities within the context of the organization
  • Adequacy and effectiveness of the OHS system

Module 2:

  • Application of the principles, procedures and techniques for auditing and conducting an effective audit
  • Application of the regulations, and other considerations that are relevant to the management system, and the conduct of the audit
  • Personal attributes necessary for the effective and efficient conduct of a management system audit
  • Activities of an audit team: establish, plan and task
  • Effective communication with the auditee and audit client
  • Organization and direction of audit team members
  • Conflict prevention and resolution with the auditee or within the audit team

Module 3:

  • Preparation and completion of the audit report
  • Review of audit process and audit management strategies
  • Practical application of audit principles

Corporate sustainability and social responsibility are the ways in which business creates integrated value in society through economic development, good governance, stakeholder responsiveness and environmental improvement. There are many global standards that address these issues today, including ISO 14001 (environment), ISO 26000 (social responsibility) and ISO 50001 (energy).

Our approach at Omnex is to create Integrated Value (IV) by helping companies to understand the changing business and societal context, assess stakeholder needs and expectations, align leadership goals and metrics, analyse risks and opportunities across key business processes and integrate the management systems for quality, health & safety, environment and social responsibility.

Register with Omnex to learn best practices leading to the integration of ISO 26000 with the organizations management system and other standards such 9K 14K 45K and 27K.

Omnex offers auditor certification training for auditing integrated management systems.

This is an IRCA certified training course and meets the training requirements for the Lead QMS Auditor grade or lower. This seminar covers the requirements of ISO 17025:2017 the standard for Laboratory management systems Topics include the audit program and its systems, the auditing process and audit instruments; the documentation process, conducting an audit, writing the audit report, and taking corrective action. Auditing case studies to develop skills for identifying nonconformities will be used. Techniques for leading audit teams will also be discussed.

Attendees who successfully pass the final exam and continual assessments will receive an IRCA certificate of successful completion.

Target audience:

This seminar is designed for Management Representatives, ISO 17025 Implementation Teams, Internal Auditors and others who would like to develop judgment and decision-making in ISO 17025 and learn the auditing process for first, second, and third party auditors.

Seminar structure

Module 1:

  • Application of quality management principles in the context of ISO 17025
  • Relation of the quality management system to the lab services, and operational processes including the context of the lab, risk assessment and risk-based thinking specific to lab

Module 2:

  • Application of the principles, procedures and techniques of auditing
  • Conduct of an effective audit in the context of the auditee’s organizational situation
  • Application of the regulations, and other considerations that are relevant to the management system, and the conduct of the audit
  • Personal attributes necessary for the effective and efficient conduct of a management system audit
  • Activities of an audit team: establish, plan and task
  • Effective communication with the auditee and audit client
  • Organization and direction of audit team members
  • Conflict prevention and solution with the auditee or within the audit team

Module 3:

  • Preparation and completion of the audit report
  • Review of audit process and audit management strategies
  • Practical application of audit principles

Note – IRCA Certificates are only valid for three years from the last day of the course, with recertification required after that.

Although the ISO 9001 requirements have been removed from IATF 16949:2016 Automotive Quality Management System requirements and are published as a separate ISO standard, IATF 16949 is not a stand-alone standard and must be used in conjunction with ISO 9001.

This course was developed to cover all requirements of both the ISO 9001:2015 and IATF 16949:2016 standards, including the new IATF 16949 requirements for Internal and Second Party Auditors regarding Core Tools and Customer Specific Requirements. Audits conducted to ISO 19011.

Target audience:

All modules can be valuable for Quality Assurance Managers, IATF 16949:2016 implementation and transition team members, management representatives, and all others who would like to develop competency in IATF 16949:2016 and the auditing process for first, second and, third party auditing.

Training structure:

Module 1

  • Application of quality management principles in the context of ISO 9001:2015 and IATF 16949:2016.
  • Relation of the quality management system to the organizational products, services, and operational processes.
  • Organization’s context and interested party needs and expectations related to the planning and implementation of a quality management system.
  • Application of the principles, procedures and techniques of auditing.

Module 2

  • Conducting of an effective audit in the context of the auditee’s organizational situation
  • Application of regulations, and other considerations relevant to the management system, and the conduct of the audit.
  • Personal attributes necessary for the effective and efficient conduct of an audit.
  • How to establish, plan and task the activities for the audit team; in line with ISO 19011.
  • Effective communication with the auditee and audit client.
  • Organization and direction of audit team members.
  • How to prevent and resolve conflicts with the auditee or within the audit team.
  • Preparation and completion of the audit report.
  • Purpose and application of the core tools
  • Linkage between the core tools and the IATF 16949 requirements
  • Importance of customer specific requirements

Module 3

  • Leading audit teams to ISO 19011
  • Review of audit process and audit management strategies
  • Practical application of principles of leading audit teams and conducting interviews

APQP: Advanced Product Quality Planning | 1 day

The seminar explains the process of Advanced Product Quality Planning (APQP) within an organization. An overview of the five phases of APQP is given, comparing the APQP approach with VDA 6.3, internal management systems and IATF 16949.

Target audience:

Those who have direct responsibility for introducing new products and/or a new manufacturing processes and systems would benefit from this seminar. This includes program/product managers, quality managers, design engineers, manufacturing engineers, APQP team members and others who have direct responsibility for process standardization and improvement.

Training structure:

  • The five phases of APQP and the benefits of the APQP strategy
  • Inputs and outputs of the five phases of APQP
  • Process elements and key requirements of VDA 6.3 in relation to APQP
  • APQP and the specifications for “product realization” according to IATF 16946
  • Connections between APQP, VDA 6.3 and IATF 16949

Special features:

  • The training may include requirements of the company quality management system.

Production Part Approval Process | Production Process Approval | 1 day

The training builds on APQP and provides the participants with comprehensive knowledge of PPAP/PPA which is the final part of the APQP process: basic requirements, documentation, customer specific requirements, evaluation.

Target audience:

Development engineers, quality assurance officers, supplier developers, production engineers, internal Auditors.

Training structure:

  • Introduction and overview to PPA process
  • PPAP within the framework of the operational QMS
  • Management of sampling documents
  • Submission stages
  • Archiving of records and master samples
  • Representative production run
  • PPAP documents for submission
  • Part submission confirmation and status
  • Assessment of PPAP documents

Special features:

  • Customer-specific documents and processes can be included in the training.
  • The training can be aligned to PPAP (AIAG) or PPF (VDA), depending on your needs. In each case, differences and parallels to the other standard are taken into account.

Note: The VDA has announced a revised version of PPF for summer 2020. All changes can be considered at short notice after the document comes into force.

Design FMEA | 1-2-3 days

The seminar enables the participants to work in an FMEA team. The participants learn about the structure and development of a design FMEA, as well as how to use the corresponding tools.

Target audience:

Leaders responsible for design activities, design engineers, NPI development teams, process engineers, quality engineers.

Training structure:

  • System and design FMEA: block diagrams, the use of an interaction matrix to identify the connection between components and higher-level systems
  • Product development and quality
  • Implementation of a design FMEA: Identification of functions, malfunctions, causes as well as avoidance and discovery measures, documentation
  • Implementation of the results of the Design FMEA into a Design Verification Plan (DVP&R)
  • Determination of functional failure modes and errors, and their significance
  • Incorporating Special Characteristics and features in product design
  • Using FMEA risk assessments as the basis for the continuous improvement process

Process FMEA | 2-3 days

The training provides practical knowledge on the development and linking of process flow diagrams, P-FMEA and production control plans in order to improve and standardize processes.

Target audience:

Leader responsible for process design and development and process engineers, APQP team members, manufacturing engineers, quality representatives as well as PPAP coordinators and project managers.

Training structure

  • Performance of a P-FMEA
  • Flowcharts
  • Requirements and special features
  • Risk assessment
  • Types of defects, prevention and detection
  • Production control plan
  • Work instructions

 

Special features: D-FMEA and P-FMEA

  • If desired, the use of the corresponding software can be integrated into the training; the training duration is thus increased by one day.
  • The FMEA training can be conducted according to the specifications of AIAG, VDA or the new harmonized FMEA. Training on the new FMEA necessarily includes software training, as the use of corresponding programs is specified by the standard.

Note: After Daimler has announced that from now on only FMEAs according to the new standard will be accepted, it is expected that the other OEMs will follow suit. It is certainly recommended to train according to the new standard.

For FMEA-experienced employees Omnex also offers trainings that focus on the differences and changes (training material currently in English; German as training language is still possible).

Measurement System Analysis – 2 days

The seminar imparts practical knowledge on test process suitability, MSA objectives, procedure, MS evaluation methods. Course includes the use of the common software for some practical exercises.

Target audience:

Quality managers, measurement and laboratory technicians, internal auditors, persons responsible for the planning, application and maintenance of measurement systems.

Training structure

  • Introduction to test process suitability
  • Measurements in the testing process
  • Resolution and discrimination of gages
  • Normal distributions
  • Bias, Linearity and Stability
  • GRR according to AIAG and ANOVA methods
  • Procedures 1, 2 and 3 according to VDA 5
  • Incapable measuring systems and conditional release
  • Attributive measuring systems
  • MSA 4 and VDA 5

Special features:

  • On the European and German market, the procedure according to VDA 5 is usually demanded. However, if required, the training can also be carried out according to MSA 4 (AIAG).
  • The VDA 5 oriented training contains exercises that are evaluated with software help (Solara or Minitab, depending on the operational situation). To carry out the training, it is sufficient to have a computer with a corresponding demo version for every 4-5 participants.

Statistical Process Control | 2 days

The seminar provides basic knowledge of statistics, such as mean value, range, standard deviation and their application in relation to production processes, deals with process capability and the creation and evaluation of different control charts.

Target audience:

Development engineers, development teams, process engineers, quality engineers, shift supervisors, team leaders in production who are entrusted with tasks related to the execution and planning of sampling inspections to determine process capability.

Training structure

  • Variation and its causes
  • Basics of statistics: population and sample, distribution, mean value, range, standard deviation, normal distribution
  • Stable processes and predictability, sporadic and systematic errors
  • Overregulation and funnel experiment
  • Central limit theorem
  • Process capability and confidence intervals and proportion of defective products for bilateral tolerances as a function of process capability. Process capability criteria for PPAP acceptance
  • Commonly used SPC Control charts
  • Statistical steering with control charts
  • Out-of-control signals for xbar cards, rules for pattern recognition
  • Process improvements with SPC
  • Stumbling blocks in the implementation of SPC
  • Process capability and test process suitability

Special features:

  • As there is a variety of different control charts, specific operational needs can be addressed by prior arrangement in order to optimize the effectiveness of the seminar.
  • The seminar contains practical exercises to illustrate the function and benefits of statistical tools.
  • If desired, the use of software can also be considered.

Effective Team-oriented problem solving | 2 or 3 days

This course focuses on team-oriented solving for complex or chronic problems. Using the 8D methodology steps, students will learn and practice how to solve complete and 8D and ensure permanent elimination of the problematic (root) causes. This course aligns with AIAG CQI-21.

Target audience:

All those who participate in or lead a problem-solving team and are using 8D to report results.

Training structure

  • Introduction: Problem solving
  • Assembling the right (size) team for problem solving
  • Developing the correct problem description
  • Containment: temporary measures to prevent further escapes
  • Root cause (3L – error/root causes)
  • Finding permanent shutdown measures
  • Decision-making, and common pitfalls
  • Evaluate permanent shutdown measures
  • Preventing repeat defects, failures and complaints
  • Ensuring team success
  • Managerial Root Cause
  • Use of checklists

Special features:

  • Internal company cases can be worked through, evaluated and discussed in the training.
  • Documents of the 8D process can be integrated into the training.
  • Both measures significantly increase the practical applicability of what has been learned.

Seminar Content

This five-day seminar covers all 12 parts of the ISO 26262 standard to give those attending the information necessary to understand the standard, and move your organization toward conformance. ISO 26262 is the Functional Safety standard that is applied to Safety Related Systems that include electric/electronic systems installed in production passenger vehicles. The course combines presentations with hands-on work and is conducted in English. There is an optional ISO 26262 Certification exam at the end of the class for those wanting to demonstrate and document their knowledge.

This course combines presentations, along with in-class group exercises to put what you are learning into practice. Concepts are reinforced by a running case study of an air bag system. Forms are used to complete the exercises as a part of the integrated workshops that include Item Definition, Hazard Analysis and Risk Assessment (HARA), Safety Goals, ASIL levels, Functional Safety Concept, Technical Safety Concept, and Hardware/Software Interface.

Who Should Attend

Those involved in the design, development, and production of electrical and electronic based vehicle products, including the systems, software and hardware engineers, and managers. Basically, all those responsible for the development and implementation of hardware and software systems in motor vehicles.

Participants should be, or plan to be, actively managing, or involved in, or aware of electrical and/or electronic items, systems, or elements that are incorporated in motor vehicles. And have the abilities, education, and experience required for the above roles.

Recommended Training and/or Experience

Participants should be involved in or aware of software and hardware development as it relates to the motor vehicle industry.

Seminar Materials

Each participant will receive a seminar manual including case studies.

Seminar Goals

  • Tailor the necessary activities to support vehicle safety lifecycle management, development, production, operation, service, and decommissioning
  • Information provided in the class can be used for ISO 26262 implementation
  • Understand functional safety aspects of the entire development process including requirements specification, design, implementation, integration, verification, validation, and configuration.
  • Understand the risk-based approach for determining risk classes Automotive Safety Integrity Levels (ASILs)
  • Use ASILs for achieving an acceptable residual risk
  • Provide requirements for validation and confirmation measures to ensure a sufficient and acceptable level of safety is being achieved

Daily Agenda (approximate, based on class discussions)

Seminar Outline

Day One

  • Chapter 1: Introduction and Overview to ISO 26262
    • ISO 26262 Purpose, Scope and Framework
  • Chapter 2: Management of Functional Safety (Part 2)
    • Safety Culture
    • Project Dependent Safety Management
    • Safety Case
    • Breakout Exercise 1: Safety Case Outline
    • Confirmation Measures
  • Chapter 3: Production and Operation (Part 7)
  • Chapter 4: Safety Element out of Context (Part 10)
  • Chapter 5: Concept Phase (Part 3)
    • Item Definition
    • Breakout Exercise 2: Item Definition

Day Two

  • Chapter 5: Concept Phase (Part 3)
    • Hazard Analysis and Risk Assessment (HARA)
    • Severity, Exposure and Controllability
    • Safety Goals
    • Breakout Exercise 3: HARA
    • Functional Safety Requirements
    • Breakout Exercise 4: Functional Safety Requirements
  • Chapter 6: ASIL-Oriented and Safety-Oriented Analyses (Part 9)
    • Example Scenario
    • Safety Analyses in ISO 26262
  • Chapter 7: System Level Development I (Part 4)
    • Technical Safety Concept
    • Hardware-Software Interface (HSI)

Day Three

  • Chapter 8: Hardware Level Development I (Part 5)
    • Specification of Hardware Safety Requirements
    • Hardware Design
    • Evaluation of the Hardware Architectural Metrics
    • Breakout Exercise 5: Fault Metrics
    • Evaluation of Safety Goal Violations Due to Random Hardware Failures
  • Chapter 9: Evaluation of Hardware Elements (Part 8)
    • Classification of Evaluated Hardware Element
    • Hardware Evaluation
    • Proven-in-Use Argument
  • Chapter 10: Hardware Level Development II (Part 5 revisited)
    • Initiation of Product Development at the Hardware Level
    • Hardware Integration and Verification
  • Chapter 11: Software Level Development (Part 6)
    • General Topics for Product Development at the Software Level
    • Specification of Software Safety Requirements

Daily Agenda (approximate, based on class discussions)

Day Four

  • Chapter 11: Software Level Development (Part 6)
    • Software Architectural Design
    • Breakout Exercise 6: Walkthrough vs. Inspection
    • Verification by Review
    • Control Flow Analysis and Data Flow Analysis
    • Software Unit Design and Implementation
    • Software Unit Verification and Testing
    • Coverage Metrics
    • Software Integration Testing
  • Chapter 12: System Level Development II (Part 4 revisited)
    • Item Integration and Testing
    • System Integration and Testing
    • Vehicle Level Integration
    • Safety Validation
    • Functional Safety Assessment
    • Release to Production
  • Chapter 13: Supporting Processes (Part 8)
    • Integration of ISO 26262 with ISO 9001 or IATF 16949
    • Breakout Exercise 7: Integration with Other Standards

Daily Agenda (approximate, based on class discussions)

Day Five

  • Chapter 13: Supporting Processes (Part 8)
    • Distributed Development
    • Specification and Management of Safety Requirements
    • Configuration Management
    • Change Management
    • Verification
    • Documentation Management System
    • Qualification of Software Tools
    • Breakout Exercise 8: Confidence in Tools
    • Qualification of Software Components
    • Evaluation of Hardware Elements
    • Proven in Use Argumentation
    • Interfacing an Application that is Out of Scope of ISO 26262
    • Integration of Safety-Related Systems not Developed According to ISO 26262
  • Chapter 14: Guideline on Application of ISO 26262 to Semiconductors (Part 11)
  • Chapter 15: Adaption of ISO 26262 to Motorcycles (Part 12)
  • Chapter 16: ISO 26262 Implementation Strategy

Optional ISO 26262 Certification Exam – Final 3 hours of Day Five

Three Levels of Certification

Level 1

Functional Safety Engineer Provisional (FSEP)

Knowledge Requirements:

  • One week of Functional Safety Training and pass the ISO 26262 Certification exam.

Prerequisites:

  • At least three years of relevant professional experience, an engineering degree or work experience equivalency with degree.

Level 2

Functional Safety Engineer (FSE)

Knowledge Requirements:

  • One week of Functional Safety Training and pass the ISO 26262 Certification exam.

Prerequisites:

  • Submit a case study demonstrating experience in Functional Safety that can be verified. The case study should demonstrate a broad understanding from Safety Plan to Safety Case (work products).
  • Interview with an Omnex Functional Safety Expert.
  • At least five years of relevant industry experience.

Level 3

Functional Safety Expert (FSX)

Knowledge Requirements:

  • One week of Functional Safety Training and pass the ISO 26262 Certification exam

Prerequisites:

  • Submit two case studies demonstrating the ability to conduct confirmation reviews, evidence of communication and a broad understanding from Safety Plan to Safety Case.
  • Interview with an Omnex Functional Safety Expert.
  • At least five years of relevant industry experience.

Seminar Content

This five-day course is designed to give the attendee a detailed understanding of Automotive SPICE and methods for assessing software development processes.

The Automotive SPICE Process Assessment Model is used to perform conformant assessments of the software process capability in the development of automotive systems in accordance with the requirements of ISO/IEC 33002.

Upon completion of this course you will be able to apply the evaluation methods used in Automotive SPICE to assess and improve your company’s processes. Methods to integrate Automotive SPICE with both ISO 26262 (Functional Safety) and IATF 16949 (Automotive Quality Management Systems) will be covered in class.

The auditing guidelines of ISO 19011—including the audit process and methodologies, e. g., planning and conducting an audit, writing nonconformity statements, preparing an audit summary and report, and verifying corrective actions—and their application in an Automotive SPICE developmental environment will be covered. Case studies from the automotive industry to develop skills for identifying nonconformities will be used.

Who Should Attend

The seminar has been developed for professionals in system and software engineering (architects, developers, test engineers, etc.), process managers, project managers, consultants, quality managers and other participants involved with development projects of software and electronics companies in the automotive industry.

The second part of the seminar (assessment) is primarily designed for those performing assessments, but can also be valuable for Software Managers, ASPICE Implementers, Quality Assurance Managers, ASPICE Implementation and/or Transition Team Members, and all others who would like to develop competency in Automotive SPICE.

Recommended Training and/or Experience

We recommend the participants have some experience in the development of complex technical systems or in process optimization. Background in developing embedded systems projects, software systems projects, quality management systems, or functional safety will be helpful.

A basic understanding of project management, quality management and system and software engineering processes is helpful, but not required.

Seminar Materials

Each participant will receive a seminar manual and a breakout workbook that includes a running case study of an Automotive Software Project to illustrate an Automotive SPICE audit.

Seminar Goals

  • Detailed understanding of what Automotive SPICE PAM 3.0 is and the motivation behind the model
  • Detailed understanding of process capability levels 1 (HIS-Scope), 2 and 3
  • Detailed understanding of traceability requirements according to Automotive SPICE
  • Understanding of how to evaluate process risks and drive process improvements
  • Understanding of how Automotive SPICE integrates with other standards (ISO 26262 and IATF 16949)
  • Sufficient knowledge and understanding of the assessment process according to Automotive SPICE
  • Detailed understanding of how to perform internal and/or second party assessments
  • Understanding of how to rate and determine the capability level

Seminar Outline

Day One

  • Introduction to Automotive SPICE: Definition, History, Structure, Key Concepts
    • Breakout Exercise – Project Management (MAN.3)
  • Understanding Automotive SPICE Requirements (SYS.2, SW.1)
    • Breakout Exercise – Requirements (SYS.2, SW.1)

Day Two

  • Understanding Architectural, Design, Implementation, and Testing (SYS.3, SW.2, SW.3)
    • Breakout Exercise – Testing (SW.4, SW.5, SW.6, SYS.4, SYS.5)
  • Supporting Processes and Supplier Monitoring (SUP.8, SUP.9, SUP.10, ACQ.4)
    • Breakout Exercise – Quality Assurance (SUP.1)

Day Three

  • Understanding Capability Levels 2 and 3
    • Breakout Exercise – Evaluation of PA 2.1 and 2.2
    • Breakout Exercise – Evaluation of PA 3.1 and 3.2
  • Integration of Automotive SPICE with ISO 26262 and IATF 16949
    • Breakout Exercise – Mapping HIS ASPICE Processes to IATF 16949 Clauses
    • Breakout Exercise – Mapping ASPICE to ISO 26262
    • Breakout Exercise – Scenario Evaluation (SUP.9)
  • ASPICE Final Exam

Day Four

  • Introduction to Assessment Programs
  • Assessment Planning and Preparation
    • Breakout Exercise – Creating Assessment Plan and Schedule
  • Performing the Assessment
  • Audit Findings and Nonconformity Statements
  • Reporting the Assessment Results

Day Five

  • Assessment Follow-up
    • Breakout Exercise – Performing Automotive SPICE Assessment

Seminar Content

Join Omnex for this important industry approach integrating AIAG and VDA FMEAs. Omnex FMEA experts many who are writers of the FMEA standards have worked extensively with both AIAG and VDA FMEAs formats. They will show you how to manage your existing AIAG or VDA FMEAs and the steps to transition to the AIAG-VDA FMEA approach.

Omnex will share best in class practices to get the most of the AIAG-VDA DFMEA including managing requirements, working with the supply chain, integrating PPMs and also creating a product and process architecture for managing FMEAs. Get the greatest savings by employing Design Reuse and also linking PPM history with AIAG-VDA FMEA. Most of all, get hands on real world experience working with AIAG-VDA DFMEA at our Open Enrollment or on your product onsite.

This 2.5 or 3 day seminar addresses all of the elements of the Design Failure Mode Effects Analysis (DFMEA) and Design Verification Planning process, and defines it as a process within your organization. This class was designed as a “how to” for practitioners and facilitators. This training offers an optional certification exam in addition to an optional one or two days of workshop to develop your own product using AIAG-VDA DFMEA (onsite training only).

The training is a hands on approach to understanding and using the seven steps of the AIAG-VDA FMEA process and to understand how it is managed as a process. This course is intended to be a dynamic,hands-on offering with approximately half the class time spent in workshops.

The approaches discussed and employed in this course are consistent with the intent and guidelines in the AIAG-VDA FMEA Handbook (1st edition, 2019) issued by AIAG and VDA, APQP Second Edition, and IATF 16949:2016.

Who Should Attend

Those who have direct responsibility for introducing new products and/or a new manufacturing processes and systems would benefit from this seminar. This includes: program/product managers, quality managers, design engineers, manufacturing engineers, APQP team members and others who have direct responsibility for new product development and improvement.

Those directly responsible for DFMEA creation or facilitation should attend this course to upgrade their skills to the AIAG VDA DFMEA 1st Edition.

Recommended Training and/or Experience

No prior knowledge is necessary. However, a mix of students with knowledge of product design & development and/or manufacturing and basic Quality Assurance concepts is preferred.

Background in AIAG FMEA 4th edition or VDA FMEA is good, but not required.

Seminar Materials

Each participant will receive a seminar manual and a workbook including all team breakout exercises.

Seminar Goals and Competencies

  • Provide a hands-onapproach to the DFMEA process and its relationship to program deliverables and status reporting to provide the competencies needed to introduce new products and processes smoothly.
  • Apply the AIAG-VDA Seven Step Approach to developing SFMEA and DFMEA.
  • Apply the major changes, improvements, and benefits of AIAG-VDA DFMEA
  • Study the changes and differences between AIAG VDA FMEA and AIAG FMEA 4th Edition. How to make the results of both approaches the same?
  • Detail best in class methods of AIAG VDA Design FMEA implementations.
  • Create a Block Diagram, P Diagram, and Interface Diagram
  • Link DFMEA with DVPR and use Prevention Checklists
  • Link SFMEA, DFMEA, Process Flow, PFMEA, and Control Plans
  • Learn how to link DFMEA to failure and warranty history and Cost of Poor Quality (COPQ)
  • Hands on “use of AIAG-VDA FMEA software” and understand role of software in AIAG-VDA FMEA
  • Implementation of the AIAG-VDA and other Supply Chain Standards
  • Use of AIAG-VDA DFMEA Checklist to evaluate DFMEAs completed and to provide consistency when DFMEA is applied.
  • Developing AIAG-VDA DFMEA Transition and Implementation Plan.

Seminar Outline

  • Course Overview and Introductions
  • Setting the Stage: APQP Overview
  • Chapter 1 – Introduction to Failure Modes and Effects Analysis (FMEA)
  • Chapter 2 – Developing an FMEA
    • – The Seven Step Approach
  • Chapter 3 – Design FMEA Prerequisites
    • – The Customer
    • – Step 1:Scope of Analysis
    • – Boundary Diagram
    • – Breakout Exercise
    • – Step 2:Structural Analysis
    • – Breakout Exercise
    • – Step 3:Design Functions – Function Analysis
    • – Breakout Exercise
    • – Robust Designs
    • – P-Diagram
    • – Interface Matrix
  • Chapter 4 – Developing the Design FMEA
    • – DFMEA Structure and Form
    • – Header Information
    • – Item / Functions and Requirements
    • – Breakout Exercise
    • – Step 4:Design Failure Modes – Failure Analysis
    • – Breakout Exercise
    • – Potential Causes
    • – Breakout Exercise
    • – Step 5:Design Controls – Risk Analysis
    • – Breakout Exercise
    • – Step 6:Optimization
    • – Breakout Exercise
    • – Step 7:Results Documentation
  • Chapter 5 – Test Planning and Reporting (DVP&R)
    • – Design Validation
    • – Noise Factors
    • – Testings
  • Chapter 6 – Implications of the AIAG-VDA FMEA
    • – What has changed in the AIAG-VDA FMEA vs the 4th Edition
      • – The AIAG-VDA DFMEA will be compared to the AIAG 4th Edition DFMEA using the case study completed during training. (This is relatively easy using software that supports both editions.)
    • – Use of AIAG-VDA DFMEA Checklists to evaluate DFMEAs completed
    • – Changes to the organization and Supply Chain
      • – What are Supply Chain Standards and why they are important
    • – Requirements Management for AIAG-VDA FMEA
    • – Software needs with AIAG-VDA FMEA
      • – AIAG 4th Edition is 2 dimensional and AIAG-VDA FMEA is 3 Dimensional
      • – Reuse of Information and Products/Process Families and Continual Improvement
    • – Linkages of SFMEA, DFMEA, and PFMEA including PPAP
    • – Change Management and FMEA Updates
    • – PPM Defect history, Cost of Poor Quality and FMEA linkages
    • – Getting Started Checklist and Action Plan
  • Summary
  • Certification Exam for AIAG-VDA DFMEA – Optional

Note 1: Breakouts will be conducted using AIAG-VDA FMEA Software

Note 2: Omnex can offer training in IQFMEA, Plato or AQuA Pro for onsite training

Note 3: You can add two additional days for Facilitator Training (onsite training only)

Note 4: You can add one or two days to develop a DFMEA using your product. It will be best if you have a 4th Edition DFMEA for comparison purposes. This training can include your component suppliers.

Seminar Content

Join Omnex for this important industry approach integrating AIAG and VDA FMEAs. Omnex FMEA experts many who are writers of the FMEA standards have worked extensively with both AIAG and VDA FMEAs formats. They will show you how to manage your existing AIAG or VDA FMEAs and the steps to transition to the AIAG-VDA FMEA approach.

Omnex will share best in class practices to get the most of the AIAG-VDA PFMEA including managing requirements, integrating PPMs and Warranty history and creating a product and process architecture for managing FMEAs. Get the greatest savings by employing Process Reuse and also linking PPM and Warranty history with AIAG-VDA PFMEA. Most of all, get hands on real world experience working with AIAG-VDA PFMEA, Process Flow (Structure Analysis), and Control Plan at our Open Enrollment or at your product onsite.

This 2.5,or 3 day seminar addresses all of the elements of the Process Failure Mode Effects Analysis (PFMEA) and Control Planning process, and defines it as a process within your organization. This class was designed as a “how to” for practitioners and facilitators. The training is a hands on approach to understanding and using the seven steps of the AIAG-VDA PFMEA process. This course is intended to be a dynamic, hands-on offering with approximately half the class time spent in workshops.

This seminar offers an insight to the linkages between various aspects of the PFMEA process. Specifically, the development and linkage of process flows/structure analysis and control plans are addressed. It shows how Process Flows/structure analysis, Control Plans and shop floor documentation can be used to achieve process standardization and improvement.

The approaches discussed and employed in this course are consistent with the intent and guidelines in the AIAG-VDA FMEA Handbook (1st edition, 2019) issued by AIAG and VDA, APQP Second Edition, and IATF 16949:2016.

Who Should Attend

Those who have direct responsibility for introducing new manufacturing processes and systems would benefit from this seminar. This includes: program/product managers, quality managers, design engineers, manufacturing engineers, APQP team members and others who have direct responsibility for new process development and improvement.

Those directly responsible for PFMEA creation or facilitation should attend this course to upgrade their skills to the AIAG VDA PFMEA 1st Edition.

Recommended Training and/or Experience

No prior knowledge is necessary. However, a mix of students with knowledge of product design & development and/or manufacturing and basic Quality Assurance concepts is preferred.

Seminar Materials

Each participant will receive a seminar manual, workbook, and a AIAG-VDA PFMEA and Control Plan checklist for evaluating FMEAs and Control Plans and including all team breakout exercises.

Seminar Goals and Objectives

  • Provide a hands-on approach to the FMEA process and its relationship to program deliverables and status reporting to provide the competencies needed to introduce new processes smoothly.
  • Apply the AIAG-VDA Seven Step Approach to developing Process Flow, PFMEA and Control Plans
  • Apply the major changes, improvements, and benefits of AIAG-VDA PFMEA
  • Study the changes and differences between AIAG VDA FMEA and AIAG FMEA 4th Edition. What are the changes and differences in the two approaches? How to make the results of both approaches the same?
  • Link SFMEA, DFMEA, Process Flow, PFMEA, and Control Plans
  • Hands on “use of AIAG-VDA FMEA software” and understand role of software in AIAG-VDA FMEA
  • Developing AIAG-VDA PFMEA and also AIAG PFMEA 4th Edition and transitioning approach internally
  • Use of AIAG-VDA PFMEA and Control Plan Checklists to evaluate PFMEAs completed and to develop consistency between PFMEAs and Control Plans in the organization
  • Learn how to link PFMEA to failure and warranty history and Cost of Poor Quality (COPQ)
  • Developing AIAG-VDA PFMEA Transition and Implementation Plan
  • After this training, the participants will have a clear understanding of the following
    • – Process Flow and AIAG-VDA PFMEA Structure Analysis
    • – Links between Process Flow, PFMEA, Control Plan and Work Instructions
    • – Process FMEA and Control Plan
    • – All aspects of the 1st edition of FMEA handbook (2019) released by AIAG and VDA

Seminar Outline

  • Chapter 1: Introduction to Failure Mode and Effects Analysis (FMEA)
    • o What is an FMEA?
    • o Maintaining FMEAs
    • o Types of FMEAs
  • Chapter 2: Developing a PFMEA
    • o The FMEA Team
    • o Basic Structure of an FMEA
    • o Conducting an FMEA
  • Chapter 3: Process FMEA Prerequisites
    • Requirements
    • Scope of the Analysis – Step 1
    • Process Flow Diagram
      • o Breakout Exercise 1
    • Structure Analysis – Step 2
      • o Breakout Exercise 2
    • Function Analysis – Step 3
      • o Breakout Exercise 1
    • Process Failure Modes
    • Failure Analysis – Step 4
    • Breakout Exercise 4
    • Risk Analysis – Step 5
    • Process Controls
    • Breakout Exercise 5
    • Indices and Action Plans
    • Breakout Exercise 6
    • Breakout Exercise 7
    • Optimization – Step 6
    • Step 7: Results Documentation
  • Chapter 4 – Process Control Plans
    • o What is a Control Plan?
    • o IATF 16949 Requirements
    • o Control Plan Header Information
    • o Control Plan Fields
    • o Breakout Exercise 8
  • Chapter 5 – Implications of the AIAG-VDA FMEA
    • o What has changed in the AIAG-VDA FMEA vs the 4th Edition
      • o The AIAG-VDA PFMEA will be compared to the AIAG 4th Edition PFMEA using the case study completed during training.
    • o Use of AIAG-VDA PFMEA Checklists to evaluate PFMEAs completed
    • o Changes to the organization and Supply Chain
      • o What are Supply Chain Standards and why they are important
    • o Requirements Management for AIAG-VDA FMEA
    • o Software needs with AIAG-VDA FMEA
      • o Reuse of Information and Products/Process Families and Continual Improvement
    • o Linkages of SFMEA, DFMEA, and PFMEA including PPAP
    • o Change Management and FMEA Updates
    • o PPM Defect history, Cost of Poor Quality and FMEA linkages
    • o Getting Started Checklist and Action Plan
  • Summary
  • Certification Exam for AIAG-VDA PFMEA – Optional

Note 1: Breakouts will be conducted using AIAG-VDA FMEA Software

Note 2: Omnex can offer training in IQFMEA, Plato or AQuA Pro for onsite training

Note 3: You can add two additional days for Facilitator Training (onsite training only)

Note 4: You can add one or two days to develop a PFMEA using your product. It will be best if you have a 4th Edition PFMEA and Control Plan for comparison purposes.

Seminar Content

Omnex is an Exemplar Global Certified TPECS provider for Exemplar Global-QM, Exemplar Global-AU and Exemplar Global-TL Competency Units. This seminar fully covers the ISO 9001 requirements in addition to the requirements of AS9100D, which is the quality management standard for Aviation, Space and Defense organizations. Other topics include audit systems, the auditing process and audit instruments; the documentation process, conducting an audit, writing the audit report, and taking corrective action. Auditing case studies to develop skills for identifying nonconformities will be used.

Aerospace Process Approach Auditing has three main components – Process Auditing, Customer Focus and Leadership Auditing – each of which must follow the requirements laid out in AS9101F. This course will give instruction and guidance on conducting the Process Audit using the PEAR form and Turtle Diagrams, as well as other requirements specific to AS9101F.

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

Note: The QM competency unit can only be used for ISO 9001 auditor certification. There is an additional AS9100D e-Learning module offered through IAQG which also must be completed to become an IAQG-certified aerospace auditor.

Who Should Attend

This seminar is designed for Management Representatives, AS9100D Implementation Teams, Internal Auditors and others who would like to develop judgment and decision-making in AS9100D and learn the auditing process for first, second, and third party auditors.

Recommended Training and/or Experience

An extensive understanding of the AS9100D requirements and/or work experience in applying AS9100D is recommended.

Seminar Materials

Each participant will receive a seminar manual and a breakout workbook that includes auditing case studies.

Seminar Goals

  • Understand the application of Quality Management Principles in the context of ISO 9001 and/or AS9100D.
  • Relate the quality management system to the organizational products, including services, and operational processes.
  • 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.

Seminar Outline

Day One

  • Introduction and Welcome
  • The ISO 9000 & AS9100 Family of Standards Explained
  • Introduction to ISO 9001 and AS9100D
  • ISO 9001 and AS9101F Requirements

Day Two

  • ISO 9001 and AS9101F Requirements (cont’d)
  • Introduction to Turtle Diagrams and Audit Trails
  • Management of Audit Programs
  • Audit Planning and Preparation
    • Breakout Exercise 1: Scope and Objectives
    • 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 Nonconformities
  • Closing Meeting
  • Completing the Audit Report
  • Corrective Action and Closeout

Day Four

  • Leading Audit Teams
  • Customer-Specific Requirements
  • Management System Certification Scheme and Auditor Qualifications
  • Review of Audit Process and Audit Management Strategies
    • Case Study Mock Audit

Day Five

  • Practical Application of Audit Principles and Instructor Interviews

Seminar Content

This five-day seminar is designed to provide participants with an understanding of how the risk management elements of Aerospace Advanced Product Quality Planning (APQP) help ensure successful launches based on robust New Product Development processes through the use of Design and Process FMEAs, as well as how to employ the same tools to manage continual improvement in products and processes. The multidisciplinary approach to APQP knowledge management is stressed as essential to shortening development cycle times and reducing launch risk in new product introduction.

This seminar also provides guidance on the Aerospace PPAP. It shows where and when to incorporate prevention tools such as DFMEA, DFM/DFA, Process Flow, PFMEA, Control Plans, MSA, and SPC. This class provides a comprehensive overview of the overall APQP and Core Tools suite.

APQP and PPAP with the associated tools needs to be integrated with AS9100D clause 8.0 Operation.

Who Should Attend

  • Program Managers
  • Project Managers
  • Quality Managers
  • Process Engineers
  • PPAP Coordinators
  • APQP Team Members
  • All other Risk Management personnel

Recommended Training and/or Experience

  • Basic understanding of management systems
  • Some exposure to the New Product Development (NPD) process

Seminar Materials

Each participant will receive a seminar manual and a workbook including all team breakout exercises with a running case study on creating Design and Process FMEAs.

Seminar Goals

  • Describe the Aerospace APQP and PPAP requirements
  • Assist an organization in implementing these requirements
  • Provide a hands-on approach to FMEAs and their relationship to program deliverables and status reporting
  • Provide the competencies needed to introducing new products and processes smoothly
  • Gain knowledge and understanding in the creation and use of Design FMEAS:
    • Block Diagrams and Interface Matrix
    • Linkages between Block Diagrams, SFMEAs, DFMEAs, DVP and other design tools
    • Linkages between PFMEAs and S/DFMEAs
    • Using FMEA as an analytical process
    • S/DFMEAs and DVPs
  • Gain knowledge and understanding in the creation and use of Process FMEAs:
    • Process Flows
    • Linkages between Process Flows, PFMEAs, Control Plans and Work Instructions
    • Linkages between PFMEAs and S/DFMEAs
    • Using FMEA as an analytical process
    • Characteristics Matrix
    • Process FMEAs and Control Plans

Seminar Outline

  • Introduction to AS9145
  • General APQP and Phase 1 Requirements
  • APQP Phase 2 Requirements
  • APQP Phase 3 Requirements
  • APQP Phase 4 Requirements
  • APQP Phase 5 Requirements
  • Production Part Approval Process
  • FMEA Introduction
  • Putting an FMEA Together
  • DFMEA Prerequisites
  • Developing the DFMEA
  • DFMEA – Component Level
  • Test Planning and Reporting
  • PFMEA Prerequisites
  • Developing the PFMEA
  • Using PFMEA to Improve the Process
  • FMEA and the Product Realization Process
  • Control Plans
  • Work Instructions

Seminar Content

This Two-day seminar is designed to provide participants with an understanding of how the risk management elements of Aerospace Advanced Product Quality Planning (APQP) help ensure successful launches based on robust New Product Development processes, as well as how to employ the same tools to manage continual improvement in products and processes. The multidisciplinary approach to APQP knowledge management is stressed as essential to shortening development cycle times and reducing launch risk in new product introduction.

This seminar also provides guidance on the Aerospace PPAP. It shows where and when to incorporate prevention tools such as DFMEA, DFM/DFA, Process Flow, PFMEA, Control Plans, MSA, and SPC. This class provides a comprehensive overview of the overall APQP and Core Tools suite.

APQP and PPAP with the associated tools needs to be integrated with AS9100D clause 8.0 Operation.

Who Should Attend

Senior Managers and individuals with direct responsibility for introducing new products or new manufacturing technologies will benefit from this seminar.

Those responsible for APQP and PPAP in the Aerospace industry as well as AS9100D implementation team members will also benefit from this seminar.

Recommended Training and/or Experience

  • Basic understanding of management systems
  • Some exposure to the New Product Development (NPD) process

Seminar Materials

Each participant will receive a seminar manual including exercises.

Seminar Goals

  • Describe the Aerospace APQP and PPAP requirements
  • Assist an organization in implementing these requirements

Seminar Outline

  • Introduction to AS9145
  • General APQP and Phase 1 Requirements
    • Phase 1 Discussion: Gaps and Opportunities
  • APQP Phase 2 Requirements
    • Phase 2 Discussion: Gaps and Opportunities
  • APQP Phase 3 Requirements
    • Phase 3 Discussion: Gaps and Opportunities
  • APQP Phase 4 Requirements
    • Phase 4 Discussion: Gaps and Opportunities
  • APQP Phase 5 Requirements
    • Phase 5 Discussion: Gaps and Opportunities
  • Production Part Approval Process
    • PPAP Discussion: Gaps and Opportunities

ISO 13485 is the international standard that specifies requirements for a quality management system (QMS) where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. ISO is the International Organization for Standardization (www.iso.org), an independent, non-governmental membership organization and the world’s largest developer of voluntary International Standards, headquartered in Geneva, Switzerland. Requirements of ISO 13485 are specific to organizations providing medical devices, regardless of the type or size and can be used by any organization involved in one or more stage(s) of the life-cycle of a medical device.

The primary objective of ISO 13485 is to facilitate harmonized medical device regulatory requirements for QMSs. Compliance with ISO 13485 is often recognized as the first step in achieving compliance with European regulatory requirements. The Standard excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements so organizations whose QMS conforms to ISO 13485 cannot claim conformity to ISO 9001 unless their QMS also conforms to all the requirements of ISO 9001. QMSs are not equivalent to product and service standards. If any requirement(s) is/are not applicable due to the nature of the medical device(s) for which the QMS is applied, the organization does not need to include such a requirement(s) in its QMS. If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the QMS.

Learn from Omnex’s QMS experts on how to implement and/or audit ISO 13485 systems including risk management methodology with disciplined problem solving methods.

The Medical Device Single Audit Program was developed by a group of medical device regulators to allow recognized third-party auditors to conduct a single audit of a medical device manufacturer that will cover ISO 13485:2016 and their respective regulatory requirements.

The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale.

The FDA along with Therapeutic Goods Administration of Australia, Brazil’s Agencia Nacional de Vigilancia Sanitaria, Health Canada, Japan’s Ministry of Health, Labour and Welfare, the Japanese Pharmaceuticals and Medical Devices Agency, the World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme and the European Union (EU) will be participating in a MDSAP Pilot. The FDA will accept the MDSAP audit reports as a substitute for routine Agency inspections. MDSAP audit will satisfy the relevant requirements of the medical device regulatory authorities participating in the pilot program.

Omnex specializes in implementing MDSAP programs that integrate ISO 13485 along with multiple regulatory requirements of agencies worldwide. Contact us for more information on how Omnex can help your organization.

Seminar Content

Omnex is an Exemplar Global Certified TPECS provider for Exemplar Global-MD, Exemplar Global-AU and Exemplar Global-TL Competency Units. This seminar fully covers the ISO 13485:2016 requirements. Other topics include audit systems, the auditing process and audit instruments; the documentation process, conducting an audit, writing the audit report and evaluating corrective actions. Auditing case studies will be used to develop the required auditing skills based on ISO 19011.

This class also covers the comparable 21 CFR 820 content for additional guidance for organizations in the Medical Device sector.

Attendees who successfully pass the exams during this course will achieve a Certificate of Attainment for the following competency units:

  • Exemplar Global-MD
  • Exemplar Global-AU
  • Exemplar Global-TL

Who Should Attend

This seminar is designed for Management Representatives, ISO 13485:2016 Implementation Teams, Auditors and others who would like to learn the widely-used international management systems auditing process.

Recommended Training and/or Experience

An understanding of the ISO 13485:2016 requirements and a minimum 12 months of work experience in applying or auditing quality management systems is recommended. The first 1.5 or 3 days of this class are offered separately for those new to auditing or quality management.

Seminar Materials

Each participant will receive a seminar manual and a breakout workbook that includes auditing case studies.

Seminar Goals

  • Understand the application of Quality Management Principles in the context of ISO 13485:2016.
  • Relate the quality management system to the organization’s medical devices and provision of related services.
  • Understand the application of the principles, procedures and techniques of management systems 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.
  • Understand conflict management principles.
  • Prepare and complete the audit report.

Seminar Outline

Day One

  • Introduction and Welcome
  • Chapter 1 – Introduction to ISO 13485
  • Chapter 2 – The ISO 13485 Standard Explained
    • MD Written Exercise 1 (individual)
  • Chapter 3 – Overview of ISO 13485:2016 Requirements
    • MD Written Exercises 2a, 2b (Audit Scenarios)

Day Two

  • Overview of ISO 13485:2016 Requirements (cont’d)
    • Breakout Exercise 2c (Audit Scenarios)
    • MD Written Exercise (individual)
  • Introduction to Management System Audit Trails
    • AU Breakout Exercise 1: Scope and Objectives
  • Management of Audit Programs
  • Management System Audit Planning and Preparation
    • AU Breakout Exercise 2: Documentation Review
    • AU Breakout Exercise 3: Audit Plan

Day Three

  • Performing the Audit
    • AU Breakout Exercise 4: Conducting the Audit
  • Writing Nonconformity Statements
    • AU Breakout Exercise 5: Writing Nonconformities
  • Closing Meeting
  • Completing the Audit Report
  • Corrective Action and Closeout
    • AU Written Exercise (individual)

Day Four

  • Review of Audit Process and Audit Management Strategies
    • Case Study Mock Audit

Day Five

  • Instructor Interviews as needed
    • TL Written Exercise (individual)

OMNEX a global management system training organization, is now offering QMS Lead Auditor training based on both ISO 13485:2016 and international Medical Device Single Audit Program (MDSAP). The five-day training is focused on international MDSAP and ISO 13485 compliant medical device auditing methods. “Medical device auditing requires technical knowledge as well as a deep understanding of international medical device regulations”. Students participating in this course will gain knowledge and skills to conduct audits of ISO13485: 2016 management system requirements in accordance with the new MDSAP Audit Model. OMNEX’s Lead Auditor Training course will teach students to plan, conduct, report and follow-up on QMS audits in accordance with ISO 13485:2016 and MDSAP. Auditing standards include MDSAP requirements, ISO 19011 & ISO 17021 (MDSAP auditors need to follow ISO 17021)

Considering the ISO 13485:2016 management system requirements and various regulatory authorities compliance requirements around the world and the global supply chains involved, for multinational organizations, a comprehensive program like ‘OMNEX’s MDSAP Lead Auditor Training’ is incredibly valuable. The course provides extensive practical training and hand-on exercises, which will help prepare medical device auditors to identify critical nonconformities and meet international regulatory requirements.” The course is designed for medical device professionals with responsibility for conducting or implementing internal audits, supplier audits or corporate audits. Quality directors, regulatory managers and professionals responsible for managing internal, corporate, supply chain or certification responsibilities may also benefit from the program.

Upon completion the participants will be capable to audit ISO 13485:2016 and all-participating applicable regulatory body compliance requirements. OMNEX also offers the ISO13485/MDSAP Lead Auditor Training course available at client locations around the world.

Participants in the training will learn from highly experienced instructors with decades of experience in medical device quality management systems. Upon completion of this training, delegates will be able to support their organization to maintain compliance to ISO 13485 and jurisdiction requirements in the countries participating in the MDSAP program.

This course will help you:

  • Improve auditing skills focused on regulatory auditing
  • Assess your own audit models and suggest improvement
  • Be prepared to support an efficient MDSAP audit by your selected Auditing Organization

Participants will gain the Knowledge and skills to:

  • Demonstrate awareness of MDSAP fundamentals
  • Explain the structure and scope of the MDSAP audit
  • Maintain MDSAP and organizational regulatory compliance
  • Understand MDSAP reporting and nonconformity grading methods
  • Explain the differences between MDSAP and other QMS audits such as ISO 13485:2016
  • Determine MDSAP documentation requirements
  • Prepare to host a successful MDSAP audit
  • Audit seven MDSAP auditing process requirements
  • Plan, conduct and lead MDSAP audits
  • Analyze data sources and control interactions required during process audits
  • Use correct jurisdictional terminology
  • Understanding auditing to ISO 19011 and ISO 17021 requirements

Who should attend?

Quality Assurance and Regulatory Affairs professionals within medical device organizations currently active in participating jurisdictions and organizations expanding their market reach to jurisdictions participating in MDSAP.

Recommended Training and/or Experience

Thorough understanding of ISO 13485:2016 with experience in auditing ISO 13485:2016 QMS.

Course Duration: 5 days

How will I learn?

Our high impact accelerated learning approach that increases learning by improving knowledge retention and skill application. This course is activity-based, resulting in a deeper understanding of the material and a greater impact on job performance.

Seminar Content

This five-day seminar covers all 14 Clauses of the ISO 21434 standard to give those attending the information necessary to understand the standard, and move your organization toward conformance. ISO 21434 is the draft cybersecurity standard that is applied to Cybersecurity Related Systems that include electric/electronic, wired and wireless communication systems installed in production passenger vehicles. The course combines presentations with hands-on work and is conducted in English. There is an optional ISO 21434 Certification exam at the end of the class for those wanting to demonstrate and document their knowledge.

This course combines presentations, along with in-class group exercises to put what you are learning into practice. Concepts are reinforced by a running case study of an air bag system. Forms are used to complete the exercises as a part of the integrated workshops that include Item Definition, Threat Analysis and Risk Assessment (TARA), Cybersecurity Goals, CAL levels, Cybersecurity Concept, and Hardware/Software Interface.

Who Should Attend

Those involved in the design, development, and production of electrical and electronic based vehicle products, including the systems, software and hardware engineers, and managers. Basically, all those responsible for the development and implementation of hardware and software systems in motor vehicles.

Participants should be, or plan to be, actively managing, or involved in, or aware of electrical and/or electronic items, systems, or elements that are incorporated in motor vehicles. And have the abilities, education, and experience required for the above roles.

Recommended Training and/or Experience

Participants should be involved in or aware of software and hardware development as it relates to the motor vehicle industry.

Seminar Materials

Each participant will receive a seminar manual including case studies.

Seminar Goals

  • Tailor the necessary activities to support vehicle cybersecurity lifecycle management, development, production, operation, service, and decommissioning
  • Information provided in the class can be used for ISO 21434 implementation
  • Understand cybersecurity aspects of the entire development process including requirements specification, design, implementation, integration, verification, validation, and configuration.
  • Understand the risk-based approach for determining risk classes cybersecurity assurance levels (CALs)
  • Use CALs for achieving an acceptable residual risk
  • Provide requirements for validation and confirmation measures to ensure a sufficient and acceptable level of cybersecurity is being achieved.

Daily Agenda (approximate, based on class discussions)

Day One

  • Chapter 1: Introduction and Overview to ISO 21434
    • ISO 21434 Purpose, Scope and Framework
  • Chapter 2: Overall Cybersecurity Management (Clause 5)
    • Cybersecurity Governance
    • Cybersecurity Culture
    • Cybersecurity Risk Management
    • Cybersecurity Audit
    • Information sharing
    • Confirmation Measures
  • Chapter 3: Project Dependent Cybersecurity Management (Clause 6)
    • Tailoring of Cybersecurity Activities
    • System or Component out of Context
    • Cybersecurity Planning
    • Cybersecurity Case
    • Breakout Exercise 1: Safety Case Outline
  • Chapter 4: Post-Development Phases (Clauses 10-13)
    • Production, Operation, Maintenance, and Decommissioning
  • Chapter 5: Concept Phase (Clause 8)
    • Cybersecurity Relevance
    • Item Definition
    • Breakout Exercise 2: Item Definition

Day Two

  • Chapter 5: Concept Phase (Clause 8) (cont’d)
    • Threat Analysis and Risk Assessment (HARA)
    • Breakout Exercise 3: Threat and Risk Analysis
    • Cybersecurity Goals
    • Cybersecurity Concept
    • Breakout Exercise 4: Cybersecurity Requirements
  • Chapter 6: CAL-Oriented and Cybersecurity-Oriented Analyses (Annex F)
    • Cybersecurity Assurance Levels (CAL)
    • Usage of CALs
  • Chapter 7: Risk Assessment Methods (Clause 7)
    • Asset Identification
    • Vulnerability Analysis
    • Breakout Exercise 5: Vulnerability Analysis
    • Attack Feasibility Analysis
    • Risk Determination
    • Risk Treatment

Day Three

  • Chapter 8: Product Development I (Clause 9.1)
    • Introduction to Design & Verification
    • Structure of Cybersecurity Requirements
    • Refined Cybersecurity Design
    • Cybersecurity Controls
    • Design Principles
  • Chapter 9: Product Development II (Clause 9.1)
    • Hardware Development
    • Reference Model
    • Hardware Design Principles

Daily Agenda (approximate, based on class discussions) 

  • Chapter 10: Product Development III (Clause 9.1)
    • Software Development I
    • Design Principles
    • Breakout Exercise 6: Walkthrough vs. Inspection
    • Design Verification

Day Four

  • Chapter 11: Product Development IV (Clause 9.1)
    • Software Development II
    • Verification Compliance
    • Testing Environments
    • Item Integration and Testing
    • System Integration and Testing
    • Test Cases
  • Chapter 12: Validation at Vehicle Level & Release for Post-Development (Clauses 9.2 & 9.3)
    • Cybersecurity Validation
    • Cybersecurity Assessment
    • Breakout Exercise 6: Developing a Cybersecurity Case
    • Release for Post-Development

Daily Agenda (approximate, based on class discussions)

Day Five

  • Chapter 13: Supporting Processes (Clause 14)
    • Quality Management Systems
    • Change Management
    • Documentation Management
    • Configuration Management
    • Requirements Management
    • Verification
    • Breakout Exercise 8: Confidence in Management Systems
    • Tool Management
    • Distributed Cybersecurity Activities
  • Chapter 14: ISO 21434 Implementation Strategy

Optional ISO 21434 Certification Exam – Final 3 hours of Day Five

Three Levels of Certification

Level 1

Cybersecurity Engineer
Provisional (CSEP)

Knowledge Requirements:

  • One week of Automotive Cybersecurity Training and pass the ISO 21434 Certification exam.

Prerequisites:

  • At least three years of relevant professional experience, an engineering degree or work experience equivalency with degree.

Level 2

Cybersecurity Engineer (CSE)

Knowledge Requirements:

  • One week of Automotive Cybersecurity Training and pass the ISO 21434 Certification exam.

Prerequisites:

  • Submit a case study demonstrating experience in Automotive Cybersecurity that can be verified. The case study should demonstrate a broad understanding from Cybersecurity Plan to Cybersecurity Case (work products).
  • Interview with an Omnex Cybersecurity Expert.
  • At least five years of relevant industry experience.

Level 3

Cybersecurity Expert (CSX)

Knowledge Requirements:

  • One week of Automotive Cybersecurity Training and pass the ISO 21434 Certification exam

Prerequisites:

  • Submit two case studies demonstrating the ability to conduct confirmation reviews, evidence of communication and a broad understanding from Cybersecurity Plan to Cybersecurity Case.
  • Interview with an Omnex Cybersecurity Expert.
  • At least five years of relevant industry experience.

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