Course overview
This highly participative three-day course provides comprehensive instruction on auditing quality management systems based on the ISO 9001:2015 requirements. The course begins with a high-level overview of ISO 9001:2015 standard. Practical workshops, case studies, and simulated assessments will help you develop an understanding of how the requirements affect your organization and your audits. The training teaches process-based audit skills useful for both internal and external audits. Real-world audit situations allow you to practice your auditing skills and techniques, ensuring that you fully grasp the requirements of auditing to the ISO 9001:2015 standard.
“ASK THE ASSESSOR” – Gain insight, best practice advice, and tips from a certified ISO 9001 Lead Assessor!
Key session topics
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Overview of ISO 9001:2015 requirements
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Critical linkages between the quality policy, objectives, management review, and internal auditing
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Understanding risks and opportunities
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Design and development controls
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Determination of requirements for products and services
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Control of externally provided products and services
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Coordinate a quality management system audit
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Construct an audit program and the preparation of audit checklists
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Audit effectively
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Prepare nonconformity statements
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Evaluate the significance of audit findings
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Methods for improving communication skills
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Report audit findings and conclusions
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Develop and implement corrective action programs
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Evaluate corrective action responses
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Effectively follow up on audit findings to recognize if the nonconforming situation has been effectively resolved
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Understanding the difference between quality system registration and accreditation
Registering a group?
Get your group discount code and assistance with group registration.
Who should attend?
Those responsible for planning and scheduling an internal audit program for ISO 9001, those who must perform audits to ISO 9001, quality assurance managers, quality assurance professionals, ISO project managers and team members.
Meet Your Instructor
Senior Instructor Gretchen McAuliffe
Labtopia co-founder and Principal, Gretchen is expert at developing integrated systems for regulated industries. She specializes in providing QA support to ISO and GxP manufacturers, laboratories, and distributors, as well as managing and conducting domestic and international audits for such organizations. Additional areas of expertise include quality management systems, technical writing, business process mapping, database requirements and implementation, document control, and laboratory compliance.
When facilitating, she draws on her analytical capabilities, attention to detail, and cross-sector professional experience, providing richly informative, immediately actionable instruction to her learners.