Total Quality Management (TQM)

Standard course duration: 16 hours

Total Quality Management (TQM) is a philosophy of perpetual improvement. This philosophy was employed in the 1980’s and is coming back through the ISO Quality Standard. Total Quality Management is a basis for an ISO 9000 implementation. TQM is the concept that quality can be managed and that it is a process. Major topics include: Quality Mission; Quality Improvement – Projects; Quality Improvement – Organizing; Quality Improvement – Diagnosis; Quality Improvement – Remedy; Operator Errors; Cost of Quality; and Motivation for Quality.

Upon completion of this course participants will have developed an understanding of TQM methodology and will have gained experience in applying these techniques in company-specific situations.

Risk Management and Mitigation

Standard course duration: 8 hours

Risk Management is the identification, assessment, and prioritization of risks; risks can be defined as the effect of uncertainty on the achievement of objectives. Risk Mitigation is the coordinated and economical application of resources to minimize, monitor, and control the probability and/or impact of unfortunate events or to maximize the realization of opportunities.

Risks can come from threats from project failures (at any phase in design, development, production, or sustainment life-cycles), deliberate competitive attack, technological evolution, legal liabilities, uncertainty in financial markets, accidents, natural causes and disasters as well as events of uncertain or unpredictable root-cause.

The course presents participants with the definition of risk, the underlying principles of risk management, the process of identifying and evaluating risk to create a risk index for prioritization, development of options or strategies for mitigating risk, and the steps to creating a risk management plan.

Within this context, a proven Risk Management method serves as the course backbone:

  1. Identify and characterize threats
  2. Assess the vulnerability of critical projects, assets or activities to specific threats
  3. Determine the risk – the expected likelihood and consequences of specific types of threats on specific assets
  4. Identify ways to reduce those risks
  5. Prioritize risk reduction measures based on a strategy

Upon completion of the course, participants will know the logic behind and the process to develop a function-specific or company-specific Risk Management and Mitigation Plan and will be able to apply the process in their work setting. They will be able to assess, identify, evaluate, rank and prioritize risk; then develop strategies to manage the likelihood or impact of threats.

ISO Standards

Standard course duration:  Varies Based on Topics Selected

ISO 13485 Medical Devices

Standard course duration: Based on Topics Selected – Request Course Specifics

ISO 9001:2015 Awareness

Standard course duration: 8 hours

ISO 9001:2015, released in late September, 2015, will be the only accepted basic ISO standard by the end of 2018. This course is designed to provide a general overview of the changes to those who will be affected, but not responsible for directing the transition to the new standard. This course provides a definition of the new standard, Quality management principles and objectives, and then reviews the elements of the Quality Management System in the context of ISO 9001:2015.

Upon completion of this course, participants will have a current refresher of the Quality Management System, the objectives of ISO 9001:2015 and how it will impact their work environment.

ISO 9001:2015 Risk Management

Standard course duration: 8 hours

Risk Management is the major element introduced in the ISO 9001:2015 standard. This course is specifically designed to present risk and opportunity management in its ISO context and includes the following content:

• Terminology and Definitions Related to Risk
• The New Management System Requirements for Risk
• An Introduction to Risk
• Risk-Based Thinking
• Implementing Risk and Risk-Based Thinking

Upon completion of this course, participants will understand the ISO 9001:2015 context of risk management and will be able to apply it within their areas of responsibility to minimize risks to organizational objectives and maximize opportunities to meet or exceed objectives.

ISO 9001:2015 Management Review Board

Standard course duration: 8 hours

This course introduces trainees to the process approach for establishing, maintaining, and improving the quality system by establishing: a quality policy and quality objectives, corrective actions, preventive actions and continual improvement activities; methods for introducing new products; and reviews for evaluating the results of Customer satisfaction surveys. Trainees will be instructed on communicating to each and every Company employee the importance of meeting Customer requirements and identifying new opportunities for the improvement of processes, products, and the total quality system.

Upon completion of this course participants will be able to review and analyze the results of audits, customer feedback and complaints, data on process and product performance, and to evaluate the suitability, adequacy, and effectiveness of the quality system.

ISO 9001:2015 Documentation – Policy Manual

Standard course duration: 8 hours

This course introduces trainees to the development of Level I documentation for the proposed quality system that includes the Company’s Quality Policy and Objectives, its Mission Statement and its Organizational structure. Interactions with the ISO Standard and Level II documentation are discussed to illustrate the total integration of all documentation required for Registration. Trainees will be instructed on the requirements and methods for writing a full Policy Manual and, when completed, how to implement it and how to make any type of change when necessary in the future.

Upon completion of this course participants will have become fully conversant with Level I documentation as it directly relates to the activities within their Company.

ISO 9001:2015 Documentation – Procedures

Standard course duration: 12 hours

This course introduces trainees to the development of Level II documentation for the proposed quality system including associated records and control plans. Interaction with Level I and Level III documentation is discussed to illustrate their integration and the formation of vertical links necessary for comprehensive auditing. Trainees will be instructed on the requirements and methods for writing a full set of Procedures and, when completed, how to implement them and make changes when necessary in the future.

ISO 9001:2015 Documentation – Work Instructions

Standard course duration: 40 hours

This course introduces trainees to the development of Level III documentation for the ISO 9000 system including associated records and control plans. Interaction with the ISO 9001 standard and Level I and II documentation (Policy Manual and Procedures) are discussed to illustrate the total integration of all documentation required for ISO 9000 registration. Trainees will be instructed on the requirements and methods for writing a full set of Work Instructions according to ISO 9001 standard. When completed, they will understand how to implement them and how to make changes when required in the future.

Upon completion of this course participants will have become fully conversant with Level III documentation. Trainees will also learn how to implement Level III documentation and how to make any changes when necessary in the future.

ISO 9001:2015 Implementation Workshop

Standard course duration: 40 hours

Building on the prior course, this workshop-format course moves from the management commitment level to the execution and control level. The course begins with a review of the company’s decisions regarding the linkage of objectives, interested parties, risk, opportunities and processes in its QMS and moves to preparation for and the conducting of a formal gap analysis. From the gap analysis, the participants will learn to assess the gaps in terms of activities and resources required to close the gaps. They will prioritize the areas of deficiency and lay out a plan to address the gaps, including schedule and resources. Next they will execute the defined plan.

Upon completion of this course, participants will understand at a detailed level the requirements of ISO 9001:2015 compliance as defined by the company and they will have experienced the steps necessary to bring the company into compliance.

ISO 9001:2015 Internal Auditor and Corrective Action

Standard course duration: 24 hours

This course follows up the implementation phase with a workshop on the audit process, training internal auditors in the same elements covered in the initial management course. The course includes the conducting of an internal audit to determine compliance with the new standard and with the company’s strategy and philosophy of implementing it.

Areas covered are:

• Terminology and definitions
• Introduction to the changes
• Background and purpose of a Quality Management System (QMS)
• A look at the requirements
• Achieving control and evidence
• Emphasis on top management
• Process management
• Linking objectives, interested parties, risk, opportunities and processes
• Knowledge management
• Change management
• Specific requirements

The audit will be followed by determination of any corrective actions needed to be in full compliance and prepared for a certification audit.

Upon completion of this course, participants will be able to continue to conduct internal audits on a periodic basis as determined by their QMS and will be able to identify, implement (if appropriate) and monitor corrective action.

ISO 9001:2015 Performance Measurements

Standard course duration: 8 hours

The most important reason for measuring performance is to improve performance. Measuring the performance of an organization can be a large and complex task. Performance measurements must be designed on a Company or situation-specific basis, reflecting the Company’s objectives and operational environment. Employees must view measurement as an integral and important part of their jobs and the ISO 9000 certification. The objective of the course is to provide a practical approach on how to design and implement a performance measurement system – an important component of a successful ISO 9000 implementation and a continuous performance improvement program. The course provides guidance on establishing operational performance measurements and linking them to business objectives and results. It concentrates on four types of measurements: performance, managerial, operational, and departmental measurements.

Upon completion of this course participants will be able to design and implement various measurements in selected operational areas, departments, and business units. The Company’s performance criteria and objectives will be used in the course to provide a practical application of the acquired knowledge.

ISO 9001:2015 Warranty & Repair

Standard course duration: 12 hours

This is a required course for those companies who provide servicing of their products. This course introduces trainees to the disciplined servicing of products returned for repair, whether under warranty or not, and to the use of methods in which Customer Satisfaction can be measured. Specific process work flows will be drafted and additional Procedures and Work Instructions will be written to achieve the desired results.

Upon completion of this course, participants will be able to implement the specific processes to address warranty and repair requirements of the Standard.

ISO 9001:2015 New Product Development

Standard course duration: 8 hours

This is a required course for those companies who design and develop new products. This course introduces trainees to the benefits of planning prior to product introduction by developing adequate and capable processes, considering associated risks and consequences, and employing appropriate process control measures. Trainees will be instructed on the development of specific procedures and instructions, the training of process operators, and the establishment of appropriate records demonstrating process conformity.

Upon completion of this course participants will be able to verify and validate product requirements through an understanding of the acceptable criteria, inspection and testing programs, controlling material and component purchases, and ensuring the compatibility of human resources, equipment, facilities, and health and safety requirements.