Be able to conduct internal audits to Quality Management Systems
The aim of this course is to provide delegates with the knowledge and skills required to perform an internal audit of part of a quality management system based on ISO 9001 (or equivalent), and report on the effective implementation and maintenance of the management system in accordance with ISO 19011.
Objectives of Course
Delegates will, at the end of the course be able to:
• With reference to the PDCA cycle, explain the process-based quality management system model for ISO 9001 and the role of an internal audit in the maintenance and improvement of quality management systems
• Explain the role and responsibilities of an auditor to plan, conduct, report and follow-up an internal quality management system audit, in accordance with ISO 19011
• Plan, conduct, report and follow-up an internal audit of part of a quality management system based on ISO 9001, and in accordance with ISO 19011
2 full Days: Day 1: 9am- 5pm | Day 2: 9am- 5pm
To be successful on the course delegates must:
• Complete/attend all elements of the course
• Pass the continuous assessment (focused on the three learning objectives).
Delegates are expected to have the following prior knowledge:
1. ISO 9001:2015 Foundation (QMS)
2. Management systems
• The Plan, Do, Check, Act (PDCA) cycle
• The core elements of a management system and the interrelationship between top management responsibility, policy, objectives, planning, implementation, measurement, review and continual improvement.
3. Quality management
• The fundamental concepts and the seven quality management principles (see ISO 9000)
• The relationship between quality management and customer satisfaction.
4. ISO 9001- An understanding of the requirements of ISO 9001 and the commonly used quality management terms and definitions, as given in ISO 9000, which may be gained by completing a CQI and IRCA Certified ISO 9001:2015 Foundation (QMS)Training course or equivalent.
Detailed Course Outcomes
Delegates will as a minimum, come out of the course able to do the following:
1. With reference to the PDCA cycle, explain the process-based quality management system model for ISO 9001 and the role of an internal audit in the maintenance and improvement of quality management systems.
- Explain the purpose of a quality management system and the business benefits of improving the quality management system performance.
- With reference to ISO 9001 (or equivalent):
- Outline the model of a process-based quality management system and the structure and content of ISO 9001, referring to the PDCA cycle as appropriate
- Outline the relationship between the quality management system purpose, external and internal issues, relevant interested parties’ relevant requirements, scope, top management leadership and commitment, quality policy, quality objectives, resources, operation, monitoring, measurement, analysis, evaluation and improvement, and the significance of these for QMS auditors
- Explain the processes, process criteria, process controls and outputs involved in quality management and the significance of these for QMS auditors
- Outline the requirements for an internal audit as described in ISO 9001 Clause 9.2.
• Define an internal quality management system audit including:
- The terms and definitions used in auditing, referencing ISO 19011 and ISO 9001 as appropriate
- Tyypical objectives for internal quality management system audits, including determination of conformance, evaluation of capability, evaluation of effectiveness and identification of potential improvement, and suggest how these different types of audit can contribute to the maintenance and improvement of quality management systems.
2. Explain the role and responsibilities of an auditor to plan, conduct, report and follow-up an internal quality management system audit in accordance with ISO 19011.
• Audit process
Outline the process for performing an audit, from its initiation through to conducting the audit follow-up
- Explain the purpose and significance of the audit objectives, scope and criteria
- Explain audit preparation activities including preparing the audit plan, assigning work to the audit team and preparing work documents
- Outline the process for conducting audit activities, from conducting the opening meeting through to preparing audit conclusions and closing the audit
- Explain the evidence-based approach to audit and outline the process for collecting and verifying information, including different sources of information and use of sampling methods
- Explain how audit findings are determined by evaluating audit evidence against the audit criteria
- Outline different audit methods, including on-site and remote audits, and audit activities requiring human interaction or no human interaction
- Explain the purpose and typical content of an internal audit report, including recording nonconformity
- Explain the corrective action process and audit follow-up activities.
• Auditor responsibilities
- Explain the role and responsibilities of the auditor at each stage of the audit process
- Explain the need for effective communication with the auditee throughout the audit process
- Explain the principle of auditor confidentiality.
3. Plan, conduct, report and follow-up an internal audit of part of a quality management system based on ISO 9001 and in accordance with ISO 19011.
• Planning the audit
- Establish that the scope, objectives, criteria, duration and resources for an audit are appropriate
- Prepare an on-site audit plan that is appropriate to the above
- Prepare the necessary work documents, such as an audit checklist, sampling plan and forms.
• Conducting the audit
- Demonstrate the ability to conduct opening meetings effectively
- Demonstrate the ability to build a rapport with the auditee during the audit, including sensitivity to the needs and expectations of the auditee
- Demonstrate the ability to manage audit interviews effectively, including the ability to formulate effective audit questions
- Demonstrate the ability to implement the audit plan, to use work documents and to follow audit trails
- Demonstrate the ability to collect and verify audit evidence by means of appropriate sampling
- Evaluate audit evidence and generate audit findings appropriate to the audit objectives, scope and criteria.
• Report and close the audit
- Give feedback to the auditee on the audit findings and resolve any issues arising
- Prepare and present the audit report, including reporting conformity and nonconformity.
• 2.3.4 Follow-up the audit- Conduct audit follow-up activities, including gathering audit evidence to verify the completion and effectiveness of actions taken.