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Section /
Description
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01
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Purpose
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Presents aims and
use of software.
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02
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ISO 9001:2008
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Introduces its
background and structure as well as a process
approach. Explains general and specific clause
requirements and their application. Describes the
"Quality Principles" - the rules or belief upon
which ISO 9001:2008 is based.
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03
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Business
Requirements
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Develops your
quality strategy. Explains the business process.
Helps you to review and define your quality
requirements.
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04
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Resources
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Resources Helps you
to build and prepare your project team and source a
consultant.
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05
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Project Plan
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Explains issues relating to project planning.
Provides sample project and documentation plans
that support requirements of ISO 9001:2008.
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06
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Staff Development
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Develops quality
awareness of staff. Raises training issues for ISO
9001:2008. Presents useful operational tools and
techniques to support their work.
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07
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Implementation
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Helps you develop an
effective process-based quality system using flow
charts and measurement techniques that support ISO
9001:2008 requirements.
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08
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Auditing
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Explains need for
audits. Introduces important techniques for planning
and performing audits as well as raising and closing
of audit reports.
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09
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Certification
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Provides insight to
issues relating to preparation, assessment, common
non conformances and successful certification and
surveillance.
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10
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Continual
Improvement
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Illustrates how
continual improvement of business process can be
achieved in incremental and significant steps.
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11
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Materials
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Provides useful
sample documents necessary for ISO 9001:2008
implementation. This includes manuals, procedures,
process documents, forms, plans etc.
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Detailed
Contents
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01 Purpose
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1.0 Purpose
1.1 Purpose of Software
1.2 Transition to ISO 9001:2008
1.3 Using this software
1.4 Who can benefit from this software
1.5 ISO 9001:2008 contents
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02
ISO 9001:2008
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2.1 ISO 9001:2008
Introduction
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1 Historical Development
2 Advantages of ISO 9001:2008
3 Features of ISO 9001:2008
4 Main Changes to the ISO 9000 family of
standards
5 Standards Affected by 2000 Revisions
6 Process Management Approach
7 The Consistent Pair - ISO 9001 and ISO
9004
8 Aims of the Consistent Pair
9 Main Features of paired standards
10 Structure of ISO 9001:2008
11 Definition of Terms Used in ISO 9001:2008.
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2.2
ISO 9001:2008 General Requirements
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1 Main Sections of ISO 9001:2008 and
Requirements
2 General Requirements - Quality
Management System
3 General Requirements - Management
Responsibility
4 General Requirements - Resource
Management
5 General Requirements - Product
Realisation
6 General Requirements - Measurement
Analysis and Improvement
7 Objectives for document requirements
8 Increased flexibility and reduced
requirements for Documents
9 Terms and Definitions relating to
Documents
10 Types of Documents required by the
Quality management system
11 Control of documents
12 Specific Documentation Requirements
1 Quality Policy and Quality Objectives
2 Contents of Quality Manual
3 Quality Procedures
4 Product and Process related Documents
13 Documenting a Process Approach
14 Compliance with ISO 9001:2008
15 Quality Procedures for ISO 9001:2008
16 Quality Records for ISO 9001:2008
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2.3 ISO 9001:2008
Clause Requirements
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1.0 Scope
1.1 General
1.2 Application
2.0 Normative reference
3.0 Terms and definitions
4.0 Quality Management System
4.1 General Requirement
4.2 Documentation Requirements
4.2.1 General Requirement
4.2.2 Quality Manual
4.2.3 Control of Documents
4.2.4 Control of Quality Records
5.0 Management Responsibility
5.1 Management Commitment
5.2 Customer Focus
5.3 Quality Policy
5.4 Planning
5.4.1 Quality Objectives
5.4.2 Quality Management System Planning
5.5 Responsibility, authority and
communication
5.5.1 Responsibility and Authority
5.5.2 Management representative
5.5.3 Internal communication
5.6 Management Review
5.6.1 General
5.6.2 Review Input
5.6.3 Review Output
6.0 Resource Management
6.1 Provision of Resources
6.2 Human Resources
6.2.1 General
6.2.2 Competence, awareness and training
6.3 Infrastructure
6.4 Work Environment
7.0 Product Realisation
7.1 Planning of Product Realisation
7.2 Customer -Related Processes
7.2.1 Determination of requirements
related to the product
7.2.2 Review of Requirements related to
the Product
7.2.3 Customer Communication
7.3 Design and Development
7.3.1 Design and Development Planning
7.3.2 Design and Development Inputs
7.3.3 Design and Development Outputs
7.3.4 Design and Development Review
7.3.5 Design and Development Verification
7.3.6 Design and Development Validation
7.3.7 Control of Design and Development Changes
7.4 Purchasing
7.4.1 Purchasing Process
7.4.2 Purchasing Information
7.4.3 Verification of Purchased Product
7.5 Production and Service Provision
7.5.1 Control of Production and Service
Provision
7.5.2 Validation of Processes for
Production and Service Provision
7.5.3 Identification and Traceability
7.5.4 Customer Property
7.5.5 Preservation of product
7.6 Control of monitoring and measuring
devices
8.0 Measurement, Analysis and Improvement
8.1 General
8.2 Monitoring and Measurement
8.2.1 Customer Satisfaction
8.2.2 Internal Audit
8.2.3 Monitoring and Measurement Processes
8.2.4 Monitoring and Measurement of
Product
8.3 Control of Non-conforming Product
8.4 Analysis of Data
8.5 Improvement
8.5.1 Continual Improvement
8.5.2 Corrective Action
8.5.3 Preventive Action
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2.4 ISO 9001:000 Application of Clause 7
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1 Introduction
2 Scope of a
quality management system
3 Application
of ISO 9001:2008 Requirements
4
Justification of exclusions
5 Typical
exclusions
6 Exclusions not permitted
7 Subcontracted processes
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Approach of Certification Bodies
9 Case
Examples
1 Jobs Limited - Recruitment Agency
2 Metal Fabrications Limited - Metal
Fabrication
3 Hospital Hotel Services - Provision of
Laundry Services
4 Keyboards Limited - Manufacture of
Keyboards
5 Retail Shops Limited - In-house software
services to retail outlets
6 Screwdrivers Limited - Manufacturer of
spanners
7 Bike Limited - Design, manufacture and
supply of bicycles
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2.5 Quality Management Principles
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1 Introduction to Quality Management
Principles and application
2 Background to the Quality Management
principles
3 Quality Management Principles
4 Principle 1 - Customer-Focused
Organisation
5 Principle 2 - Leadership
6 Principle 3 - Involvement of People
7 Principle 4 - Process Approach
8 Principle 5 - Systems Approach to
Management.
9 Principle 6 - Continual Improvement
10 Principle 7 - Factual approach to
decision making
11 Principle 8 - Mutually beneficial
supplier relationships
12 Alignment of the Quality Management
Principles to ISO9001:2008
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03
Business Requirements
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3.0 Business
Requirements
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3.1 Quality Strategy
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1 Introduction
2 Winning senior management commitment
3 Inform your senior managers
4 Assess your current performance
5 Determine your resource requirements
6 Expertise
7 Time
8 Read it up and do it yourself
9 Get training and doing it yourself
10 Engage a consultant
11 A combined approach
12 Cost
13 Determine overall time-scales
14 Involving your staff
15 Involving customers and suppliers
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3.2 Business Process
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1 Introduction
2 What makes it work?
3 Operating Systems
4 The Process
5 Process Management
6 A strategy for process improvement
7 Learning about the process
8 Steps required for process improvement
1 Step 1 - Produce a schematic
2 Step 2 - Analyse the process
3 Step 3 - Controlling the process
4 Step 4 - Planning the improvement
9 The ISO 9001:2008 process model
1 The ISO 9001:2008 processes
10 The process based approach
1 The process cell
2 Application of a process based approach
11 The process model for quality management
systems
1 Internal cycle
2 External cycle
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3.3 Define your quality requirements
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1 Introduction
2 What is quality?
3 Thinking about definition
4 Quality is Good - Excellence is better
5 Meeting or exceeding the real
requirements
6 Information flows and quality
7 Quality Assurance
8 Quality of design
9 Quality and conformance to design
10 Quality management
11 What is quality management?
12 Quality Assurance is better than
control
13 Quality - the trick is in the timing
14 Objectives of your quality management
system
15 Benefits of quality management
16 Calculate your cost of quality
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04
Resources
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4.1 Build your
project team
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1 Build your project team
2 Develop management skills
3 Team Leader Skills
4 The Leadership task
5 Planning
6 Team development
1 The functional team
2 Forming
3 Storming
4 Norming
5 Performing
6 Cross functional teams
7 Task or project teams
8 The wider team
7 Effective use of project teams
8 Conduct effective team meetings
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4.2 Choosing a
consultant
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1 Choosing a consultant
2 Where to find the right consultant
3 How to choose your consultant
4 The consultant's brief
5 The consultant's proposal
6 Presentation of proposal
7 Selecting the consultant
8 Accepting the contract
9 Signing the contract
10 Assessing the quality system
11 Preparing the action plan
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05
Project Plan
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5.0 Project Plan
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1 Produce Your Project Plan
2 Planning
3 Commitment and Application
4 Project Team
5 The Project Manager
6 Project Manager's Responsibility
7 Authority, Responsibility and Reporting
8 Define Scope, Deliverables and
Time-scales
9 Project Plan
10 Estimating the Effort Required
11 Determine Success Criteria
12 Achieving Registration to ISO 9001:2008
13 Customer Awareness
14 Culture Change
1 The decision making process
2 Attitudes of management and staff
3 Attitude to training
4 Attitude to goals and objectives
5 Attitudes to communication
15 Quality Improvement
16 Staff Involvement
17 Identify Key Milestones
18 Determine work tasks and actions
19 What Needs to be Done?
20 Documentation Plan for ISO 9001:2008
21 Allocate duties and Responsibilities
22 Who will do what?
23 How will it affect current activity?
24 What skills will have to be upgraded?
25 Review of Progress
26 How are You going to review progress
27 Produce Implementation Plan
28 Finalise your project plan
29 Effectively communicate the plan
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06
Staff Development
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6.1 Quality
Awareness
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1 Develop quality awareness
2 Develop quality awareness of staff
3 How to plan for quality awareness
4 How to educate staff and management
5 Workshops
6 Training for all staff
7 Internal trainers
8 Communications
9 Recommended actions
10 Deliverables
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6.2 Training your team on ISO 9001:2008
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1 Purpose
2 Effective Training
3 Awareness Training
4 Requirements of ISO 9001:2008
5 Quality Manual
6 Quality Procedures
7 Training Plan
8 Training Records
9 Identifying training needs
10 Approach to training sessions
11 Train staff on probel solving and
analysis techniques
12 Identifying root causes
13 Data analysis techniques
14 Identifying solutions
15 Implementing solutions
16 Permanent solutions
17 Measuring improvements
18 Tools and Techniques
1 Brainstorming
2 Cause and effect fishbone chart
3 Moving averages
4 Scatter diagrams
5 Pareto Analysis
6 Statistical process control
7 Control chart
19 Knowing how to do a job
20 Training towards error free work
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07
Implementation
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7.0 Implementation
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1 Assessment
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1 Introduction
2 Status
3 Customer Satisfaction
4 Operational Performance
5 Quality Objectives
6 Identify Strengths and Weaknesses
7 Whish strengths and weakness are relevant
8 Review current practices
9 Quality Management System
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2 Flowcharting
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1 Introduction
2 Establish a process team
3 Gather the appropriate staff in a
suitable setting or room
4 Decide which chart symbols you want to
use
5 Flowcharting Process
1 Identify your key processes
2 Establish a process team
3 Gather the appropriate staff in a
suitable setting or room
4 Decide which chart symbols you want to
use
5 Ask what the current process is
6 Start with the first out to the process
7 Identify the output to the first process
8 For each step
9 Link all process outputs
10 On completion of the chart. Check that:-
11 Record the date
12 Analyse the process by:-
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3 Gap Analysis
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1 Identify areas for improvement
2 Consider your customer needs
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4 Performance
Measurement
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1 Introduction
2 Designing a Performance Measurement
System
3 Are Your Performance Measures Useful?
4 Implementing a Performance Measurement
System
5 Using your measures to plan for ISO
9001:2008
6 General Requirements of ISO 9001:2008
7 Measurement Techniques
8 Monitoring and Measurement of Process
9 Monitoring and Measurement of Products
10 Performance Reporting
11 Performance Reporting Guidelines
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5 Quality System
Development
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1 Develop quality manual and procedures
2 Your documentation plan
3 Good reasons for documenting procedures
and process documents
4 What should the process documents
contain?
5 Which process documents are required?
6 Starting with flowcharts
7 Addressing the clause requirements
8 Writing effective procedures and process
documents
9 Work instructions
10 Records and forms
11 Control of quality system documents
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08
Auditing
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8.0 Auditing Process
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1 Purpose - why audit?
2 Benefits - audit outcomes?
3 Internal Auditor training
1 The auditor
2 Training course
3 Purpose of training course
4 Workshop exercises
5 Learning outcomes
4 Planning quality audits
5 Quality auditor responsibilities - task
and duties
6 Audit preparation
1 Where to start?
2 Informing the department
3 Audit checklist
4 Be vigilant
7 Audit approach
1 Method
2 Vertical Audit
3 Trace forward
4 Trace backward
5 Horizontal audits
6 Random audits
7 Conducting quality audits
1 Are you ready to audit?
2 The Opening Meeting
3 Questions and answer techniques
4 Audit interviews
5 Developing a question
6 Supplementary questions
7 The "art" of effective auditing
8 Some responses
9 Auditor's approach
10 Non conformance and corrective action
1 Recording non conformance
2 Categorising non conformities
3 Corrective and preventive action
11 Reporting audit results
1 Closing meeting
2 The final audit report
12 Management reviews
1 Review process
2 Review participants
3 Review meeting
4 Records
5 Review procedure
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09
Certification
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9.0 Certification
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1 Introduction
2 Purpose of Certification
3 Certification Process
4 Applying for Certification
5 Assessing the Quotations
6 Assessment Scheduling
7 Documentation Review
8 Pre-Assessment
9 Preparing For Formal Assessment
10 Formal assessment
11 Maintaining your ISO 9001:2008 approval
12 Assessments against the ISO 9001:2000
standards (interim)
13 Assessments against the ISO 9001:2008
standard
14 Competence of Auditors
15 Areas of interest to the assessor
16 Common deficiencies found by assessors
1 Clause 1.0 Scope
2 Clause 4.2.3 Control of Documents
3 Clause 4.2.4 Control of Quality Records
4 Clauses 5.1 and 5.5 Management
5 Clause 5.4.1 Quality Objectives
6 Clause 6.2.2 Competence, Awareness and
Training
7 Clause 7.2 Customer Related Processes
8 Clause 7.3 Design and Development
9 Clause 7.4 Purchasing
10 Clause 7.5.1 Control of production and
service provision
11 Clause 7.5.3 Identification and
Traceability
12 Clause 7.12 Customer Property
13 Clause 7.5.5 Preservation of Product
14 Clause 7.6 Control of Monitoring and
Measuring Devices
15 Clause 8.2.2 Internal Audit
16 Clauses 8.2.3 & 8.2.4 Monitoring &
Measurement of Processes & Products
17 Clause 8.3 Control of Non Conforming
Product
18 Clause 8.4 Analysis of Data
19 Clauses 8.5.2 and 8.5.3 Corrective and
Preventive Action
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10
Continual Improvement
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10.0 Continual Improvement
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1 Introduction
2 Stepped Improvements
3 Marked Improvements
4 Continual Improvement Process
5 Quality Teams for Incremental
Improvements
6 Marked Improvements following Lead Time
Reduction Strategy
1 New Improvement Strategies
2 Our Current Performance
3 Common Problems affecting Lead Time
4 Benefits of WIP Reduction
5 Example of Lead Time Calculation
6 Example of production operation without
any improvements
7 Example of improved production operation
8 Benefits of lead time reductions
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11
Materials
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Quality Manual
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QM - Quality Manual
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Quality Procedures
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QP 01 - Control of Non Conformance
QP 02 - Control of Quality Records
QP 03 - Corrective and Preventive Action
QP 04 - Document Change Control
QP 05 - Internal Auditing
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Operational
Processes
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OP 01 - Calibration of Measuring Equipment
OP 02 - Internal Communication
OP 03 - Computer Back - Up
OP 04 - Control of External Documents
OP 05 - Customer Focus
OP 06 - Design Control
OP 07 - Stock Control
OP 08 - Stock Inspections
OP 09 - Inspection of Incoming Material
OP 10 - Training
OP 11 - Inspection of Product
OP 12 - Job Descriptions
OP 13 - Maintenance of Plant and Equipment
OP 14 - Order Review
OP 15 - Preservation of Product
OP 16 - Performance Reporting
OP 17 - Plant Infrastructure & Work Environment
OP 18 - Supplier Assessment and Approval
OP 19 - Planning Product Realisation
OP 20 - Purchase Order Processing
OP 21 - Quality Management Review
OP 22 - Review of Quality Objectives
OP 23 - Quality Planning
OP 24 - Application of Statistical Techniques
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Flowcharts
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1 Administration
2 Document Control
3 Design Process
4 Goods Receiving Process
5 Order Review
6 Quality Planning
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Useful Guides
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1 Guide - Cost of Quality and Case Studies
2 Guide - Infrastructure and Environment
3 Guide - Internal Communications
4 Guide - ISO 9001 Structures
5 Guide - Waste is Lost Profit & Case
Studies
1 Case study 1 - PCB manufacturer
2 Case study 2 - Architects
3 Case study 3 - Milk dairy
4 Case study 4 - Opto- electronic
manufacturer
5 Case study 5 - Electronic assembly
6 Case study 6 - Garment manufacturer
7 Guide - performance reporting
8 Guide - performance report
9 Guide - quality objectives
10 Guide - Quality Policy
11 Guide - Requirements for procedures &
records
12 Guide - Statistical Techniques
13 Guide - management skills questionnaire
14 Guide - team building skills
15 Guide - staff training needs analysis
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Plans
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1 Plan - Calibration Schedule
2 Plan - ISO 9001:2008 Project Plan
3 Plan - ISO 9001: Documentation
4 Plan - Product Realisation
5 Plan - Internal Audits Schedule
6 Plan - Management Review Agenda
7 Plan - Equipment Maintenance Schedule
8 Plan - Production Meeting Agenda
9 Plan - Sales Review Meeting Agenda
10 Plan - Staff Training Plan and Matrix
11 Plan - QMS Quality Plan
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Questionnaires
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1 Questionnaire - Customer Satisfaction
2 Questionnaire GAP Analysis -ISO 9001:2008
Assessment
3 Questionnaire - Supplier Assessment/Quality
Assurance
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Quality Records and
Registers
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1 Record - Calibration
2 Record Staff Training
3 Record - Suppliers Approved List and Record
4 Register - Quality Records
5 Form - Stock Inspection
6 Report - Internal Audit
7 Checklist - Internal Audit
8 Register - Corrective Action
9 Form - Corrective Action
10 Form - Purchasing Order
11 Register - Master Register for QMS Documents
12 Register - External Documents
13 Register - Change Note
14 Form - Change Note
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General
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1 End User Licence Agreement
2 User guide - Navigational aids
3 FAQs - Frequently Asked Questions
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