4-Day • ISO 13485:2016 Medical Devices—QMS—LEAD AUDITOR

www.littsquality.comLitts Quality Technologies, Inc. is a progressive business that provides quality consulting to organizations that are interested in improving their processes. LQT, Inc. specializes in supporting manufacturing and service clients in quality management, systems, auditing, engineering, training, and metrology. We pride ourselves in understanding customer needs, wants, and expectations.We help improve both leadership and teamwork skills within companies in need of continual organizational improvement. LQT, Inc. strives to help all of its clients achieve a superior level of quality, in turn allowing them to gain competitive advantages in their marketplace.If you are looking for a Quality Consulting business to assist in the implementation of a quality management system, conduct internal or external audits, provide quality techniques training or improve your measurement processes, contact us. We can help your company unite as a team and fly towards a successful future.Litts Quality Technologies is anExemplar Global Recognized Traning Provider.

Litts Quality Technologies, Inc.

4-day  ISO 13485:2016 Medical Devices—Quality Management Systems—Requirements for LEAD AUDITOR, Exemplar Global Certified virtual course.

<h2><strong>This is an ISO 13485:2016 Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes LEAD AUDITOR Exemplar Global Certified Course</strong></h2><p>Litts Quality Technologies, Inc. will be conducting this 4-day class virtually via a Zoom live, interactive meeting.</p><h2>SESSION DATES </h2><p><strong>This is a 4-day class split over two weeks.</strong></p><p>8:30am – 4:30pm • Tuesday, July 20th</p><p>8:30am – 4:30pm • Wednesday, July 21st</p><p>8:30am – 4:30pm • Tuesday, July 27th</p><p>8:30am –4:30pm • Wednesday, July 28th </p><p>Prior to the course you will be emailed the necessary Zoom meeting link. This will require a computer or mobile phone in order to access. Availability to have a camera and microphone is required.</p><p></p><h2>Who Should Attend:</h2><ul><li>Quality Managers</li><li>Regulatory Managers</li><li>Current Internal Auditors</li><li>Potential Internal Auditors</li><li>Auditors who want to start the process of becoming Third-Party Auditors</li><li>Purchasing employees</li><li>Any  team member of an organization that is registered to or wants to become registered to ISO 13485:2016 to gain an understanding of the requirements.</li></ul><p>Please register on-line here, or email <a href="mailto:rick@littsquality.com" target="_blank" rel="nofollow noopener noreferrer">rick@littsquality.com</a>, or call <a target="_blank" rel="nofollow noopener noreferrer">1-877-LQT-6001</a> {1-877-578-6001}. If you have any questions regarding this information please feel free to contact us.</p><p></p><h2>COURSE OBJECTIVE</h2><p>The major objective of this course is to provide knowledge in the method of Leading Quality Management System (QMS) audits using the Process Approach auditing method. Attendees will also be able to apply their learned knowledge in leading improvement of their organization audit process.</p><p>The attendees will be able to function as Lead Internal (First Party) or Interested party (Second Party) auditors. In addition, this will provide knowledge to begin the process of becoming a Certified Body (Third-party) auditor.</p><p>Exercises and quizzes are used to help with the understanding of the ISO 13485:2016 Standard and Process Based Auditing Techniques.</p><p><strong>Added benefit of taking this Certified Course:</strong></p><p>Attendees will Receive from Exemplar Global</p><ul><li><p>12 months of ongoing professional development and support through direct access to a series of tailored learning content</p></li></ul><ul><li><p>Exemplar Global Graduate personnel certification to enhance their employment potential</p></li></ul><ul><li><p>Access to complete the Work Style Assessment self-coaching tool for professional growth</p></li></ul><ul><li><p>Access to an exclusive LinkedIn community to interact with other graduates and industry professionals to promote networking opportunities and skill sharing</p></li></ul><ul><li><p>Continuing professional development opportunities through access to webinars, online articles, and events</p></li></ul><ul><li><p>Greater support on their career path</p></li></ul><h2></h2><h2>COURSE OUTLINE</h2><h3>DAY 1</h3><ul><li>Introductions</li><li>Course Objectives and Requirements</li><li>An overview of Exemplar Global</li><li>An overview of the International Organization for Standardization (ISO) and available resources offered</li><li>The Strategic Direction and Context of an organization</li><li>The Concepts and Language used in the Standards</li><li>The goals and objectives of the ISO 13485:2016 Medical Device—Quality Management Systems—Requirements for Regulatory Purposes Standard, ISO 9000:2015 Quality Management Systems—Fundamentals and Vocabulary and ISO 9004:2018 Quality Management—Quality of an Organization—Guidance to achieve Sustained Success Family of Standards</li><li>Concepts and language</li><li>Definitions</li></ul><ul><li>Begin the detailed review of ISO 13485:2016 Standard Clauses with exercises through-out</li></ul><h3></h3><h3>DAY 2 </h3><ul><li>Quiz</li><li>Continuing review of the detailed requirements of the ISO 13485:2016 Standard Clauses</li></ul><ul><li>The concepts of auditing using the Process Approach based upon ISO 19011:2018 Guidelines for Auditing Management Systems</li><li>The terms and definitions used in auditing</li><li>The Six Steps of Auditing Activities based upon ISO 19011:2018 Guidelines for Auditing Management Systems</li><li>Review of an Audit Procedure and related forms</li></ul><h3></h3><h3>DAY 3 </h3><ul><li><p>Quiz</p></li><li><p>Continuing review of The Six Steps of Auditing Activities based upon ISO 19011:2018 Guidelines for Auditing Management Systems </p></li><li>GMP’s</li><li>Risk Management</li><li>Review of an Audit Procedure and related forms</li><li>Attendees begin review a case study and prepare to perform Mock Process Audits</li><h3></h3><h3>DAY 4 </h3></ul><ul><li>Quiz</li><li>Perform case study Mock Process Audits</li><li>Writing audit reports</li><li>Writing requests for corrective actions</li><li>How to follow-up and close out Corrective Actions</li><li>Complete the Exemplar Global Work Style Assessment self-coaching Tool (Note: Will need the ability to be able to access the Exemplar Global website – a link will be provided)</li><li>Final Test</li><li>Course Evaluation</li></ul><h2></h2><h2>COURSE MATERIALS</h2><p>Litts Quality Technologies, Inc. will provide a:</p><ul><li><p>Student Workbooks (electronic, hardcopy, or a combination of both sent to you following registration)</p></li><li><p>Certificates</p></li></ul><h2></h2><h2>PREREQUISITES</h2><p>Attendees are required to obtain a copy of the ISO 13485:2016 standard and review prior to attending the course. This will help with navigating through the standard during the sessions. In addition, attendees need to bring the copy to the class.</p><p>It is also highly recommended, (but not necessary to attend the class) that the attendees obtain a copy of the ISO 19011:2018 Guidelines for Auditing Management Systems and bring it to the class.</p><h2></h2><h2>COURSE REQUIREMENTS</h2><p>A final test is administered the last day to evaluate the acquired knowledge and determine the effectiveness of the course program as required by management system standards.</p><h2></h2><h2>COST OF THE PROGRAM</h2><p>NOW 20% OFF: $1,340.00 per attendee. </p><p>A 5% discount is offered for 3 or more attendees from the same organization registered at the same time. Email <a href="mailto:rick@littsquality.com" target="_blank" rel="nofollow noopener noreferrer">rick@littsquality.com </a>to obtain promo code. </p><p>You must sign up by July 13th in order to have time to receive the course materials.</p><h3>PAYMENT TERMS</h3><p>Credit Card Payment or Check (received prior to the first day of the training class) are accepted.</p><p></p><h2>CANCELLATION POLICY</h2><p>All cancellations must be received by <strong>JULY 12, 2021</strong>. After that date, any payments cannot be refunded. However, alternate attendee(s) may take the course in place of the person(s) who originally enrolled.</p><p><strong>Litts Quality Technologies, Inc. reserves the right to cancel the training program should sufficient enrollment not be achieved by the cut-off date and shall not be responsible for any attendee costs associated with cancelled transportation or accommodation reservations.</strong></p>

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4-Day • ISO 13485:2016 Medical Devices—QMS—LEAD AUDITOR

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4-Day • ISO 13485:2016 Medical Devices—QMS—LEAD AUDITOR

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