| Module 1: Introduction to Quality management System and process approach |
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| | Introduction to ISO 9001:2015 internal Auditor |
Preview |
| | Session Objectives |
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| | About ISO |
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| | Why ISO |
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| | ISO 9001:2015 Definition |
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| | Need for Quality |
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| | Cost of Quality |
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| | Origin and History of ISO 9000 |
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| | Review and revision of Standards |
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| | ISO 9001 - Relevance in other Industry |
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| | The Revised Quality Principles |
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| | Process Approach |
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| | 0.3 Process approach - Model of a process based QMS |
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| | 0.3 Process approach |
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| | Evidenced based decision making |
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| | Relationship Management |
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| | 3 Core concepts |
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| | Section 1 assessment ISO 9001 |
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| Module 2: Quality management system principles & HLS |
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| | Management System |
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| | Quality Management System |
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| | What is quality management all about? |
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| | Key Changes |
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| | Key Benefits of High Level Structure |
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| | Benefits for the Organization |
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| | Process based model of QMS-Cl. 4 |
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| | HLS and the new ISO 9001:2015 Structure |
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| | Overview of ISO 9001:2015 |
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| | 1.0 Scope |
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| | 3.0 Terms and definition Sl-1 |
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| | 3.0 Terms and definition Sl-2 |
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| | 3.0 terms and definition SL-3 |
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| | section 2 assessment ISO 9001 |
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| Module 3: Context of the Organization |
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| | 4.0 Context of the organization |
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| | 4.1 Context of the Organization SL-1 |
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| | 4.1 Context of the Organization SL-2 |
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| | 4.1 Context of the Organization SL-3 |
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| | 4.2 Understanding the needs and expectations SL-1 |
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| | 4.2 Understanding the needs and expectations SL-2 |
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| | 4.3 Determining the scope of QMS |
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| | 4.4 Quality Management System & its Process- 4.4.1 |
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| | 4.4 Quality Management System & its Process- 4.4.1 |
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| | 4.4 Quality Management System & its Process- 4.4.2 |
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| | Clause 4.0 Summary |
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| | Auditing Clause 4.0 Hints |
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| | Section 4 Assessment ISO 9001 |
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| Module 4: Leadership Principles |
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| | 5.0 Leadership |
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| | 5.1 Leadership and Commitment |
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| | 5.1 Leadership and Commitment |
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| | 5.1.2 Customer focus |
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| | 5.2 Quality Policy |
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| | 5.2 Quality Policy |
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| | 5.3 Organizational Roles, Responsibilities & Authorities |
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| | Clause 5.0 Summary |
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| | Auditing Clause 5.0 Hints |
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| | Section 5 assessment ISO 9001 |
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| Module 5: Planning |
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| | 6.0 Planning |
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| | 6.1 Actions to address risks & opportunities QMS |
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| | Risks and opportunities |
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| | What is risk based thinking? |
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| | What is risk based thinking?- Why Should I adopt |
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| | What is risk based thinking?- What Should I do? |
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| | What is risk based thinking?- What Should I do? |
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| | Risk management- What is Risk |
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| | 6.2 Quality Objectives and planning to achieve |
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| | 6.2 Quality Objectives and planning to achieve |
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| | 6.3 Planning of changes |
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| | Clause 6.0 Summary |
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| | Auditing Clause 6.0 Hints |
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| | Section 6 assessment ISO 9001 |
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| Module 6: Support process |
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| | 7.0 Support Processes |
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| | 7.1 Resources 7.1.1 General |
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| | 7.1.2 Resources - People |
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| | 7.1.3 Resources - Infrastructure |
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| | 7.1.4 Resources – Environment for the operation of processes |
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| | 7.1.5 Monitoring & Measuring Resources |
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| | 7.1.5.2 Measurement traceability |
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| | 7.1.6 Organizational Knowledge QMS |
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| | 7.2 Competence |
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| | 7.3 Awareness |
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| | 7.4 Communication |
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| | 7.5 Documented Information |
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| | 7.5 Documented Information 7.5.1 General |
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| | 7.5 Documented Information 7.5.2 Creation and updating |
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| | 7.5 Documented Information 7.5.3 Control |
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| | 7.5 Documented Information |
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| | Clause 7.0 Summary |
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| | Auditing Clause 7.0 Hints |
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| | Auditing Clause 7.0 Hints |
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| Module 7: Operation |
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| | 8.0 Operation |
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| | 8.1 Operational planning and control |
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| | 8.2 Requirements for products and services |
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| | 8.2.3 Review of the requirements for products and services |
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| | 8.2.3 Review of the requirements for products and services |
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| | 8.2.4 Changes to requirements for products and services |
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| | 8.3 Design and Development of Products and Services 8.3.1 General |
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| | 8.3.2 Design and Development Planning |
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| | 8.3.3 Design and Development Inputs |
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| | 8.3.4 Design and Development Controls |
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| | 8.3.5 Design and Development Outputs |
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| | 8.3.6 Design and Development change |
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| | 8.4 Control of externally provided Products & Services |
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| | 8.4.2 Control of externally provided Products & Services - Type and extent of control |
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| | 8.4.3 Control of externally provided Products & Services – Information for external providers |
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| | 8.5 Production and service provision 8.5.1 Control of Production and service provision |
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| | 8.5.2 Identification and Traceability |
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| | 8.5.3 Property belonging to customers or external providers |
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| | 8.5.4 Preservation |
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| | 8.5.5 Post-delivery activities |
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| | 8.5.6 Control of changes |
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| | 8.6 Release of products and services |
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| | 8.7 Control of nonconforming outputs |
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| | 8.7 Control of nonconforming outputs 8.7.2 |
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| | Clause 8.0 Summary |
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| | Clause 8.0 Summary |
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| | Auditing Clause 8.0 Hints |
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| | Section 7 Assessment ISO 9001 |
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| Module 8: Performance Evaluation |
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| | 9.0 Performance evaluation |
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| | 9.1 Monitoring, measurement, analysis and evaluation |
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| | 9.1 Monitoring, measurement, analysis and evaluation 9.1.2 Customer satisfaction |
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| | 9.1 Monitoring, measurement, analysis and evaluation 9.1.3 analysis and evaluation |
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| | 9.2 Internal audit 9.2.1 |
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| | 9.2 Internal Audit 9.2.2 |
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| | 9.3 Management Review 9.3.1 |
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| | 9.3 Management review Inputs 9.3.2 |
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| | 9.3 Management Review 9.3.3 |
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| | Clause 9.0 Summary |
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| | Auditing Clause 9.0 Hints |
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| Module 9: Improvement |
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| | 10.0 IMPROVEMENT |
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| | 10.1 General |
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| | 10.2 Nonconformity and corrective action 10.2.1 |
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| | 10.2 Nonconformity and corrective action 10.2.2 |
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| | 10.3 Continual improvement |
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| | Clause 10.0 Summary |
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| | Auditing Clause 10.0 Hints |
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| | External Audit Cycle ISO 9001 |
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| | THANK you |
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| | Section 8 & 9 Assessment ISO 9001 |
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| Module 10: Internal Audit introduction ISO 19011:2018 |
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| | Introduction to ISO 19011- Internal audit |
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| | Audit definition |
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| | Audit - Terms and Definitions |
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| | Principles of Auditing |
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| | Principles of Auditing |
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| | Audit Objectives |
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| | Internal Vs External Audits |
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| Module 11: Planning and preparation for an audit |
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| | Planning and preparation of audit - different stages in an audit cycle |
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| | Audit Management |
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| | Internal Audits |
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| | Planning and preparation for an audit |
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| | Planning and preparation of audit |
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| | Planning and preparation for an audit- Initiating the audit |
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| | Audit criteria Vs audit scope |
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| | Planning & Preparation of an Audit Selection of an audit team |
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| | Planning & Preparation of an Audit - Document review |
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| | Planning & Preparation for an Audit Preparation for on-site audit |
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| Module 12: Performing an audit |
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| | Performing an audit- Audit Management |
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| | Performance of an Audit |
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| | Performing an Audit – From collecting information to audit conclusions |
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| | Audit team - Participants |
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| | Key qualities of an auditor |
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| | Performing an Audit – Audit Approach – Attitude of Auditor |
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| | Audit approach - Communication process |
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| | Audit approach - Communication process |
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| | Audit approach - Communication process |
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| | Audit approach - Communication process |
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| | Audit approach - Communication process |
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| | Audit approach - Communication process |
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| | Audit approach - Communication process |
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| | Audit Approach – Questioning techniques |
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| | Audit Approach – Questioning techniques |
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| | Audit approach - Communication process- clarifying questions |
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| | Documentary evidence and follow up actions |
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| | Performing an Audit – How do auditors find evidence ? |
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| | Time management - Preparing a Checklist Format |
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| | Preparing a Checklist Format |
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| | Purpose of checklists |
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| | Visit the field – Move around |
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| | Performing an Audit -Observe Operational Control |
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| | Performing an Audit -Observe Operational Control |
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| | Section Quiz IQA |
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| | Follow Audit trials |
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| Module 13: Audit reporting and NCR writing tips |
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| | Audit Management - reporting an audit |
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| | Audit reporting |
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| | Audit reporting – Writing Non-conformity reports |
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| | NCR’s & Corrective actions Concepts relating to requirements |
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| | Audit reporting – Writing Non-conformity reports |
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| | NCR’s and Corrective actions -Examples of Objective Evidence |
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| | Audit reporting – Writing Non-conformity reports |
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| | Audit reporting – Writing Non-conformity reports |
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| | NCR’s and Corrective action |
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| | Writing Non-conformity reports Do and donts |
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| | Writing Non-conformity reports- scenario- 1 |
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| | Writing Non-conformity reports- scenario- 2 |
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| | Writing Non-conformity reports- matrix |
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| | Writing Non-conformity reports- auditor and auditee |
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| | Writing Non-conformity reports- corrective action |
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| | Difficulties encountered during internal audits |
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| | A piece of counsel |
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| | THANK you |
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| Final Assessment |
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| | ISO 9001 Final assessment |
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