
Define audits as a systematic, independent, and documented process for obtaining objective evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled.
Explore how ISO establishes international standards for auditing management systems, including ISO 9001, ISO 14001, ISO 45001, ISO 27001, and ISO 22000, to ensure quality, safety, and sustainability.
Define quality objectives as specific, measurable goals aligned to the quality policy. Apply smart criteria to set targets across departments to improve patient satisfaction, reduce wait times, and prevent errors.
Explore the quality management system overview (QMS), detailing quality policy, patient-centered care, risk management, evidence-based practices, safety culture, continuous improvement, audits, and accreditation to meet regulatory and customer requirements.
Define the scope of a quality management system as the range of activities, processes, products and services the organization covers, including locations, departments, and applicable requirements.
Maintain integrity by reporting honestly and including relevant non-conformity with evidence. Apply fair presentation, due professional care, confidentiality, independence, and evidence-based, risk-based approaches to audit planning and findings.
Learn to conduct and plan audits of management systems under ISO 45001, covering audit scope, criteria, evidence, findings, nonconformities, root-cause analysis, and corrective actions.
Understand normative references and terms and definitions per ISO 9001 and ISO 9000 2015, and learn to demonstrate conformity through continuous improvement, risk and legal registers, and customer KPIs.
Explore the context of the organization by identifying internal and external issues, interested parties, and scope, using swot analysis to align ISO 9001:2015 requirements with stakeholder needs.
Demonstrate how top management commits to quality by establishing and communicating a concise quality policy, aligning objectives, and building a culture of quality that prioritizes customer focus and continual improvement.
This lecture explains ISO 9001 planning, covering risk and opportunity handling, quality objectives, and changes planning within the PDCA cycle to set measurable targets, allocate resources, and monitor progress.
Explore ISO 9001 clause 7, focusing on resources, competence, awareness, communication, and documented information to support a robust quality management system and continual improvement.
Explore ISO 9001 clause 8 operation, detailing operational planning and control, production and service provision, design and development, supplier controls, traceability, and release to meet customer requirements and quality standards.
Evaluate quality management system performance through plan-do-check-act, monitoring, measuring, analyzing, and evaluating data to ensure effectiveness, customer satisfaction, internal audits, and management review outcomes.
Define the quality management system and quality policy, emphasizing patient-centered care, evidence-based practice, safety culture, audits, and data-driven continuous improvement.
Plan-do-check-act approach guides the risk assessment of health and safety hazards, identifying and controlling risks from high to low using alarp and the hierarchy of controls.
Master the plan do check act cycle to drive continual improvement within management systems, emphasizing context, scope, interested parties, and supplier evaluation.
Identify and transform risk into opportunity using SWOT analysis, conduct risk assessment and evaluation, implement controls from elimination to PPE, and align with emergency planning and KPIs.
1A. Foundations of Quality Management System
1A1. Quality Management System overview
1A2. Definitions of Quality
1A3. QMS - Principles
1A4. Objectives of Quality Management System
1A5. Importance of Quality
1A6. Evolution of quality management system concepts
1A7. ISO 9001 and the ISO 9000 series of standards
1A8. Road Map to Become a Quality Auditor
2A. QMS Overview and IOS 9001 Chapter / Clauses and its Uses in Audits
2A1. Explanation of Chapters-1-10
2A2. Chapter 1. Scope
2A3. Normative References
2A4. Terms and Definitions
04. Clause 4 - Context of the organization
05. Clause 5 - Leadership & Commitment
06. Clause 6 - Planning
07. Clause 7 - Support
08. Clause 8 - Operation
09. Clause 9 - Performance Evaluation
10. Clause 10 - Improvement
Describe the ISO 9001 Quality Management System (QMS)-Requirements standard and development process
Identify ISO 9000:20xx QMS terms
Describe the intent and requirements of ISO 9001:20xx
Determine the evidence needed to demonstrate conformity to ISO 9001:20xx
Apply the process approach and Plan-Do-Check-Act (PDCA) methodology
Evaluate documented information required by ISO 9001:20xx and the interrelationships between the quality processes, quality planning, policy, and objectives
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 behaviours necessary for an effective and efficient conduct of a management system audit
Establish and plan the activities of an audit team
Manage the audit process
Prepare the audit report and perform an audit follow-up
· Understanding ISO 9001: Participants learn about the purpose, scope, and structure of the ISO 9001 standard. They gain insight into the principles of quality management and the key concepts underlying ISO 9001 requirements.
· Requirements of ISO 9001: Participants study the specific requirements outlined in the ISO 9001 standard, including those related to leadership, planning, support, operation, performance evaluation, and improvement of the QMS.
· QMS Implementation: Participants learn how to plan, develop, implement, and maintain a QMS based on ISO 9001 requirements. This includes understanding the documentation requirements, defining processes, setting quality objectives, and establishing monitoring and measurement mechanisms.
· Auditing Skills: Participants acquire auditing skills necessary to conduct internal audits of the organization's QMS. They learn audit planning, preparation, execution, and reporting techniques, as well as how to identify non-conformities and opportunities for improvement.
· Continuous Improvement: Participants understand the importance of continual improvement in a QMS and learn how to identify areas for improvement, implement corrective and preventive actions, and measure the effectiveness of quality management processes.
· Risk-based Thinking: Participants learn about the concept of risk-based thinking and its application in quality management. They understand how to identify, assess, and address risks and opportunities within the organization's processes and QMS.
· Documentation and Record Keeping: Participants gain knowledge of the documentation and record-keeping requirements of ISO 9001, including document control, record retention, and maintaining a documented QMS.
· Roles and Responsibilities: Participants understand the roles and responsibilities of key stakeholders involved in the QMS, including top management, process owners, internal auditors, and other personnel.
· Case Studies and Practical Examples: Many ISO 9001 courses include case studies, practical examples, and interactive exercises to reinforce learning and demonstrate real-world applications of ISO 9001 principles and requirements.