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