Advance Your Quality Expertise

Managing Compliance – Implementing a Compliance Management System Based on ISO 37301

Every organization has compliance obligations that it must manage effectively to avoid or reduce the risk of business interruptions, penalties, damages to its reputation, and other undesired results. The more complex an organization, the higher will be its compliance-related risks. Compliance must not depend on one person or department but is to be seen as a company-wide effort based on solid values, integrity, and a compliance culture.

Since its publication in 2021, ISO 37301 has received much interest worldwide from organizations that are interested in the benefits of an effective compliance management system. Could ISO 37301 be the new ISO 9001?

Through this workshop students will gain a solid understanding of the requirements of ISO 37301 and how to implement a compliance management system in any type of organization.

In this workshop we will review the requirements of ‘ISO 37301:2021 Compliance Management Systems – Requirements with guidance for use’ in detail and discuss through interactive sessions how these requirements can be applied effectively in any type of organization. The participants will gain a solid understanding of the intent of the requirements of ISO 37301 and how they are inter-connected.

In a step-by-step approach and through a hands-on case study they will learn how to implement a compliance management system in an organization.

Topics:

• Demand of the new ISO 37301 – A contextual issue
• Application and benefits of a compliance management system (CMS) based on ISO 37301
• Terms and definitions related to compliance management systems
• Values and good governance
• Roles and responsibilities within a CMS
• Elements of a CMS
• Compliance related risks
• How to determine a credible scope of a CMS
• Compliance culture and the principles of compliance governance

Tuesday, Oct. 4 – Wednesday, Oct. 5, 2022

Instructor: Elisabeth Thaller
Level: Beginner
Price: $795

ISO 13485 Internal Workshop

This “ISO 13485:2016 Internal Quality Systems Auditor” competency-based 2-day course teaches a general understanding of the concepts of the ISO 13485:2016 standard and the principles and practices of effective internal audits in accordance with ISO 19011:2018, “Guidelines on Auditing Management Systems.” Experienced instructors explain the clauses of ISO 13485:2016 in detail and guide students through internal audits that are required for a quality management system based on ISO 13485:2016. Our qualified instructors will also help you to boost your audit capabilities with the latest developments of the new 19011 standard. Students gain necessary auditing skills through a balance of formal classroom tutorials, practical role-playing, group workshops, and open forum discussions.

Learning Objectives:

• Describe the ISO 13485 Medical Device Quality Management System (QMS) – Requirements for Regulatory Purposes standard and development process
• Identify medical device QMS terms
• Describe the intent and requirements of ISO 13485:2016
• Determine the evidence needed to demonstrate conformity to ISO 13485:2016
• Apply the process approach and Plan-Do-Check-Act (PDCA) methodology
• Describe the relationship between ISO 13485:2016 and applicable regulatory requirements
• Apply the principles, processes, and methods of auditing
• Demonstrate the activities involved in preparing for an audit
• Determine an effective audit in the context of the auditee’s organizational situation
• Apply effective audit skills and practice personal behaviors necessary for an effective and efficient conduct of a management system audit

This session includes a comprehensive review of ISO 13485:2016 and audit systems:

• The Challenge for Top Management
• Eight Quality Management Principles
• The ISO Standard Explained
• Family of Standards
• Detailed read/review/explanation of ISO 13485:2016 Requirements

Exclusions - 

• Overview of ISO 13485:2016 Requirements: Clause 4
• Overview of ISO 13485:2016 Requirements: Clause 5
• Overview of ISO 13485:2016 Requirements: Clause 6
• Overview of ISO 13485:2016 Requirements: Clause 7
• Overview of ISO 13485:2016 Requirements: Clause 8

Tuesday, Oct. 4 – Wednesday, Oct. 5, 2022

Instructor: Angelo Scangas
Level: All
Price: $795

Remote Auditing: The Good, the Bad and the Ugly

It’s been more than two years since the auditing profession was catapulted into the “remote” arena. We blustered, stumbled, and thrashed our way up the steep learning curve striving to maintain the integrity of an essential QMS process.

This course will provide insight into great practices that have emerged, gaffs to be avoided and benefits to be derived. Through lecture and exercises, we’ll cover a variety of topics: application of risk-based thinking to the process, audit planning, technology issues, pitfalls to avoid, interview techniques to compensate for diminished environmental perception, scheduling, and many other useful tips. Participants will be encouraged to come ready to discuss challenges they’ve encountered and success stories they’ve experienced. The course has applicability to first, second, and third-party auditors.  Attendees will leave with a greater understanding of how to successfully transition a cornerstone of quality management from up close and personal to remote.

Wednesday, Oct. 5, 2022

Instructor: Denise Robitaille
Level: All
Price: $695

An Introduction to ISO 9001: Structure and Requirements

Many times each year, someone is hired and/or promoted into a Quality Management position and discovers the ISO 9001 requirements for the first time. The small 27-page standard is unfamiliar and oftentimes difficult to completely understand. The purpose of the tutorial is to introduce students to ISO 9001:2015 quality management system concepts in easy-to-understand words.

The tutorial is designed to provide a brief awareness of ISO 9001 system requirements, the process approach, risk-based thinking, and the quality management principles. Questions of clauses will be answered.

Bringing your own copy of the ISO 9001:2015 standard is the optimal situation; however, if you forget to bring your copy of the standard you can use the checklist provided in class as a substitute.

Job aids include:

• ISO 9001:2015 Checklist with comments
• Summary of the quality management principles.

Learning Outcomes:

Upon the completion of the tutorial, you will be able to:

• Identify the quality management system concepts and relate them to your organization
• Restate ISO 9001 system requirements in your own words
• Define what the process approach means
• Link the quality management principles to everyday activities

Wednesday, Oct. 5, 2022

Instructor: Paul Russell
Level: Beginner
Price: $695

Mitigating Risks in Remote Auditing

It is the audit process and understanding the risks involved in collecting objective evidence that determines the validity of audit results. This applies to both remote and onsite audit methods. Both audit methods have pros and cons and risks that need to be mitigated to validate the audit results. During the pandemic, more companies including registrars moved to remote auditing as a method to maintain audit schedules. Without proper training and infrastructure, the validity of some remote audits is unknown; But data shows, remote auditing itself, when risks are mitigated, is a viable audit method.  

In this workshop, participants will work “hands on” assessing the remote auditing process using PFMEA to articulate potential failure modes, learn and apply the uses of technology in auditing, address communication issues, and define actions to improve your remote audit’s performance. Bring your collaborative program, mobile devices, drones, and laptops!

Tuesday, Oct. 4, 2022

Instructor: Shauna Wilson
Level: All
Price: $695

Assessing the Human Factors of Digitalization

The uncertainty and instability of today’s current business environments require agility to sustain process improvement. Technology continues to evolve and market changes are occurring at a rapid pace. Stagnation of thought must be avoided. A critical element to success in surviving this current situation is effectively understanding and utilizing the existing human capital. Understanding and developing human capital as these concepts apply in Quality 4.0 Digitization contributes to achieving organizational excellence.

• Participation as a virtual or face-to-face team member or leader to accomplish a goal or objective.
• Integration of human resource analytics to evaluate process performance.
• Application of the interactions of technology and analytics with human factors within a process.
• Identification of the potential obstacles to accomplishing the integration of the human and technical aspects of digitization in a process.

Classroom activities include evaluating these critical activities through discussion and quality tool exercises from the perspective of a quality auditor.

Wednesday, Oct. 5, 2022

Instructor: Milt Krivokuca
Level: All
Price: $695

Writing Effective Audit Reports

This one-day course is for novice and experienced auditors who are looking to increase the effectiveness of their audit reports. Many organizations feel like their internal audits do not get the management visibility and attention that they deserve.  A more professional approach to internal audit reporting can help to improve this condition. A common shortcoming of many audit reports is that they are only a list of nonconformances and do not accurately reflect everything that was examined during the audit, leading the reader to wonder if all processes and requirements were examined. Participants will learn how to write effective non-conformance reports and Opportunities for Improvement and how to compile it all together into a comprehensive audit report that is easy to read and understand. This course is ideal for both new and experienced internal auditors. Every organization has compliance obligations that it must manage effectively.

Wednesday, Oct. 5, 2022

Instructor: Denis Devos
Level: All
Price: $695