Course Objective:
Upon completion of this training, the participant will be able to:
Define the requirements of ISO 9001:2015
Develop and audit plan
Conduct the internal audit
Perform effective review and follow-up
Course Content:
1) Review of the Standard
- Context of the organization
- Understanding the organization & its context
- Understanding the needs & expectations of interested parties
- Determining the scope of the QMS
- The QMS
- Process approach
2) Leadership & commitment
- Quality policy
- Organizational roles, responsibilities & authorities
3) Planning Actions to address risks & opportunities
- Quality objectives & planning to achieve them
- Planning of changes
4) Support Resources
- Competence
- Awareness
- Communication
- Documented information
5) Operation Operational planning & control
- Determination of market needs & interactions with customers
- Operational planning process
- Control of external provision of goods & services
- Control of external provision of goods & services
- Development of goods & services
- Production of goods & services
- Release of goods & services
- Nonconforming goods & services
6) Performance evaluation Monitoring, measurement analysis & evaluation
- Internal Audit
- Management Review
7) Improvement Nonconformity & corrective action
8) What is auditing
- Types of audits
- Qualifications of an auditor
9) Purpose of auditing
- Preparing for the Audit
- Defining objectives
- Review of relevant documentation
- Details and strategies of the audit process
- Review of audit tools
- Developing the audit plan
10) Conducting the Audit
- Audit protocol
- What is objective evidence?
- How to diagnose conformance and nonconformance
- Audit techniques
- Effective audit documenting
- Structured steps for conducting audits
- Preparing final report
11) Exit meeting
- Review and agreement
- Measures for implementing corrective action
- Corrective actions and implementation time line
- Follow-up
- Review for effectiveness
12) Hands on Exercises
- Proprietary Documentation utilized
- Structured sequence of a typical audit through proprietary exercises
