Course curriculum

  • 01

    Introduction to ISO 9001:2015 and process approach

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    • How to Use the Membership Resource Library Template
    • Intro of ISO 9001:2015 FREE PREVIEW
    • An introduction to quality management
    • About ISO
    • Why ISO??
    • ISO 9001:2015 Definition
    • Need for quality
    • Cost of Quality
    • Origin of ISO 9000
    • Review and revision of standards
    • ISO 9001 - relevance in other industry
    • 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
  • 02

    Module - 2 Quality management system principles and HLS

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    • Management system
    • Quality management system
    • What is quality management all about??
    • Key Changes
    • Key benefits of HLS
    • 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 & 2.0 Normative ref
    • 3.0 Terms and definition -1
    • 3.0 Terms and definition -2
    • 3.0 Terms and definition -3
  • 03

    Module 3 Context of the Organization

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    • 4.0 Context of the organization
    • 4.1 Context of the organization
    • 4.1 Context of the Organization 02
    • 4.1 Context of the organization 03
    • 4.2 understanding the needs and expectations - SL1
    • 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
    • Summary of Clause 4
    • Auditing Clause 4
  • 04

    Module 4 Leadership Principles

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    • 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 Organisational roles, responsibilities & authority
    • Summary of Clause 5
    • Auditing clause 5
  • 05

    Module 5 Planning

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    • 6.0 Planning
    • 6.1 Actions to address risks and opportunities
    • 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
    • Summary of Clause 6
    • Auditing of clause 6
  • 06

    Module 6 Support Process

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    • 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 process
    • 7.1.5 Monitoring & Measuring resources
    • 7.1.5.2 Measurement traceability
    • 7.1.6 Organisational knowledge QMS
    • 7.2 Competence
    • 7.3 Awareness
    • 7.4 Communication
    • 7.5 Documented information
    • 7.5.1 Documented information - General
    • 7.5.2 Documented information - Creation and updation
    • 7.5.3 Documented information - Control
    • 7.5 Documented information
    • Summary of Clause 7
    • Auditing of Clause 7
    • Auditing of Clause 7
  • 07

    Module 7 Operation

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    • 8.0 Operation
    • 8.1 Operational planning and control
    • 8.2 Requirements for products & services
    • 8.2.3 Review of the requirements for products and services
    • 8.2.3 Review of the requirements 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
    • 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
    • Summary of Clause 8.0
    • Summary of Clause 8.0
    • Auditing clause 8.0
  • 08

    Module 8 Performance evaluation

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    • 9.0 Performance evaluation
    • 9.1 Monitoring, measurement, analysis and evaluation 9.1.1 General
    • 9.1.2 Customer satisfaction
    • 9.1.3 Analysis and evaluation
    • 9.2 Internal Audit
    • 9.2 Internal Audit
    • 9.3 Management Review
    • 9.3.2 Management review input
    • 9.3.3 Managment Review output
    • Summary of Clause 9.0
    • Auditing Clause 9.0
  • 09

    Module 9 Improvement

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    • 10.0 Improvement
    • 10.1 General
    • 10.2 Nonconformity and corrective action
    • 10.2 Nonconformity and corrective action
    • 10.3 Continual improvement
    • Summary of Clause 10.0
    • Auditing Clause 10.0
    • 3 years - external Audit Cycle
  • 10

    Module 10 Internal Audit Introduction

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  • 11

    Module 11 Planning and preparation for an audit

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    • Different stages in a audit Cycle
    • Audit Management - Planning & Preparation of Audit
    • Internal audits
    • Planning & preparation for an Audit
    • Planning & Preparation for an audit
    • Initiating the audit
    • Audit criteria Vs Audit scope
    • Selection of an audit team
    • Document review
    • Preparation for On-site audit
  • 12

    Module 12 Performing an audit

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    • Audit management- Performing an Audit
    • Performance of an Audit
    • Collecting information to audit conclusion
    • Participants
    • Key qualities of an auditor
    • Attitude of Auditor
    • Communication process
    • Communication process
    • Communication process
    • Communication process
    • Communication process
    • Communication process
    • Communication Process
    • Questioning techniques
    • Questioning techniques
    • Clarifying questions
    • Documentary evidence & Follow up actions
    • How do auditors find evidence?
    • Time Management - Advantages of preparing a "Checklist" before an Audit?
    • Preparing checklist format
    • Purpose of Checklist
    • Visit the field - Move around
    • Observation skills
    • Observe operational Control
    • Performing an Audit
    • Follow Audit trails
  • 13

    Module 13 Audit reporting and NCR Writing tips

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    • Audit Management - reporting an audit
    • Audit reporting
    • Writing nonconformity reports
    • Concepts relating to requirements
    • Writing nonconformity reports- Objective evidence
    • Examples of objective evidence
    • Writing nonconformity reports
    • Writing nonconformity reports
    • NCR's and corrective action
    • Do' and dont's
    • Writing nonconformity reports - scenario - Example
    • Writing nonconformity reports- scenario- Example
    • Matrix or cluster analysis
    • Auditor and Auditee
    • Corrective action
    • Difficulties encountered in internal audits
    • A piece of Counsel
    • Conclusion
  • 14

    Final Assessment

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    • Section 1 Multiple Choice Questions