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 9000:2000 is based.
03
Business Requirements
Develops your quality strategy. Explains the business process. Helps you to review and define your quality requirements.
04
Resources
Resources Helps you to build and prepare your project team and source a consultant.
05
Project Plan
Explains issues relating to project planning. Provides sample project and documentation plans that support requirements of ISO 9001:2000.
06
Staff Development
Develops quality awareness of staff. Raises training issues for ISO 9001:2000. Presents useful operational tools and techniques to support their work.
07
Implementation
Helps you develop an effective process-based quality system using flow charts and measurement techniques that support ISO 9001:2000 requirements.
08
Auditing
Explains need for audits. Introduces important techniques for planning and performing audits as well as raising and closing of audit reports.
09
Certification
Provides insight to issues relating to preparation, assessment, common non conformances and successful certification and surveillance.
10
Continual Improvement
Illustrates how continual improvement of business process can be achieved in incremental and significant steps.
11
Materials
Provides useful sample documents necessary for ISO 9001:2000 implementation. This includes manuals, procedures, process documents, forms, plans etc.
Detailed Contents
01 Purpose
1.0
Purpose1.1
Purpose of Software 1.2
Transition to ISO 9001:2000
1.3
Using this software 1.4
Who can benefit from this software 1.5
ISO 9001:2000 contents
02 ISO 9001:2000
2.1 ISO
9001:2000 Introduction
1
Historical Development2
Advantages of ISO 9001 20003
Features of ISO 9001 20004 Main
Changes to the ISO 9000 family of standards5
Standards Affected by 2000 Revisions6
Process Management Approach7 The
Consistent Pair - ISO 9000 and ISO 90048 Aims
of the Consistent Pair9
Main Features of paired standards10 Structure
of ISO 9001:200011
Definition of Terms Used in ISO 9001:2000.
2.2
ISO 9001:2000 General Requirements
1 Main
Sections of ISO 9001:2000 and Requirements2
General Requirements - Quality Management System3
General Requirements - Management Responsibility4
General Requirements - Resource Management5
General Requirements - Product Realisation6
General Requirements - Measurement Analysis and Improvement7
Objectives for document requirements8
Increased flexibility and reduced requirements for Documents9
Terms and Definitions relating to Documents10
Types of Documents required by the Quality management system11
Control of documents12
Specific Documentation Requirements
1 Quality Policy and Quality Objectives
2 Contents of Quality Manual
3 Quality Procedures
4 Product and Process related Documents13
Documenting a Process Approach14
Compliance with ISO 9001:200015
Quality Procedures for ISO 9001:200016
Quality Records for ISO 9001:2000
2.3 ISO
9001:2000 Clause Requirements
1.0
Scope1.1
General1.2
Application2.0
Normative reference3.0
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
2.4 ISO
9001:000 Application of Clause 7
1
Introduction
2 Scope of a quality management system
3 Application of ISO 9001:2000 Requirements
4 Justification of exclusions
5 Typical exclusions
6 Exclusions not permitted
7 Subcontracted processes
8 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
2.5
Quality Management Principles
1
Introduction to Quality Management Principles and
application2
Background to the Quality Management principles3
Quality Management Principles4
Principle 1 - Customer-Focused Organisation5
Principle 2 - Leadership6
Principle 3 - Involvement of People7
Principle 4 - Process Approach8
Principle 5 - Systems Approach to Management.9
Principle 6 - Continual Improvement10
Principle 7 - Factual approach to decision making11
Principle 8 - Mutually beneficial supplier relationships12
Alignment of the Quality Management Principles to
ISO9001:2000
03 Business Requirements
3.0 Business
Requirements
3.1 Quality
Strategy
1 Introduction2 Winning senior
management commitment3 Inform your
senior managers4 Assess your
current performance5 Determine your
resource requirements6 Expertise7 Time8 Read it up and
do it yourself9 Get training
and doing it yourself10 Engage a
consultant11 A combined
approach12 Cost13 Determine
overall time-scales14 Involving
your staff15 Involving
customers and suppliers
3.2 Business
Process
1
Introduction2 What
makes it work?3
Operating Systems4 The
Process5 Process
Management6 A
strategy for process improvement7 Learning
about the process8 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 improvement9 The ISO
9001:2000 process model
1 The ISO 9001:2000 processes10 The
process based approach
1 The process cell
2 Application of a process based approach11 The process
model for quality management systems
1 Internal cycle
2 External cycle
3.3 Define
your quality requirements
1
Introduction2 What is
quality?3 Thinking
about definition4 Quality
is Good - Excellence is better5 Meeting
or exceeding the real requirements6
Information flows and quality7 Quality
Assurance8 Quality
of design9 Quality
and conformance to design10 Quality
management11 What is
quality management?12 Quality
Assurance is better than control13 Quality
- the trick is in the timing14
Objectives of your quality management system15
Benefits of quality management16
Calculate your cost of quality
04 Resources
4.1 Build
your project team
1 Build your
project team2 Develop
management skills3 Team Leader
Skills4 The Leadership
task5 Planning6 Team
development 1 The functional
team 2 Forming 3 Storming 4 Norming5 Performing6 Cross
functional teams7 Task or
project teams8 The wider team7 Effective use
of project teams8 Conduct
effective team meetings
4.2 Choosing
a consultant
1 Choosing a
consultant2 Where to find
the right consultant3 How to choose
your consultant4 The
consultant's brief5 The
consultant's proposal6 Presentation
of proposal7 Selecting the
consultant8 Accepting the
contract9 Signing the
contract10 Assessing the
quality system11 Preparing the
action plan
05 Project Plan
5.0
Project Plan
1 Produce
Your Project Plan2 Planning3 Commitment
and Application4 Project
Team5 The
Project Manager6 Project
Manager's Responsibility7 Authority,
Responsibility and Reporting8 Define
Scope, Deliverables and Time-scales9 Project
Plan10 Estimating the Effort Required11 Determine
Success Criteria12 Achieving
Registration to ISO 9001:200013 Customer
Awareness14 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 communication15 Quality
Improvement16 Staff
Involvement17 Identify
Key Milestones18 Determine
work tasks and actions19 What
Needs to be Done?20 Documentation Plan for ISO 9001:200021 Allocate
duties and Responsibilities22 Who will
do what?23 How will
it affect current activity?24 What
skills will have to be upgraded?25 Review of
Progress26 How are
You going to review progress27 Produce
Implementation Plan28 Finalise
your project plan29 Effectively communicate the plan
06 Staff Development
6.1 Quality
Awareness
1 Develop
quality awareness2 Develop
quality awareness of staff3 How to plan
for quality awareness4 How to educate
staff and management5 Workshops6 Training for
all staff7 Internal
trainers8 Communications9 Recommended
actions10 Deliverables
6.2 Training
your team on ISO 9001:2000
1 Purpose2 Effective
Training3 Awareness
Training4 Requirements
of ISO 9001:20005 Quality Manual6 Quality
Procedures7 Training Plan8 Training
Records9 Identifying
training needs10 Approach to
training sessions11 Train staff
on probel solving and analysis techniques12 Identifying
root causes13 Data analysis
techniques14 Identifying
solutions15 Implementing
solutions16 Permanent
solutions17 Measuring
improvements18 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 chart19 Knowing how
to do a job20 Training
towards error free work
07 Implementation
7.0
Implementation
1 Assessment
1 Introduction2 Status3 Customer
Satisfaction4 Operational
Performance5 Quality
Objectives6 Identify
Strengths and Weaknesses7 Whish
strengths and weakness are relevant8 Review current
practices9 Quality
Management System
2
Flowcharting
1 Introduction2 Establish a
process team3 Gather the
appropriate staff in a suitable setting or room4 Decide which
chart symbols you want to use5 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:-
3 Gap
Analysis
1 Identify areas
for improvement2 Consider your
customer needs
4 Performance
Measurement
1 Introduction2 Designing a
Performance Measurement System3 Are Your
Performance Measures Useful?4 Implementing a
Performance Measurement System5 Using your
measures to plan for ISO 9001:20006 General
Requirements of ISO 9001:20007 Measurement
Techniques8 Monitoring and
Measurement of Process9 Monitoring and
Measurement of Products10 Performance
Reporting11 Performance
Reporting Guidelines
5 Quality
System Development
1 Develop
quality manual and procedures2 Your
documentation plan3 Good reasons
for documenting procedures and process documents4 What should
the process documents contain?5 Which process
documents are required?6 Starting with
flowcharts7 Addressing the
clause requirements8 Writing
effective procedures and process documents9 Work
instructions10 Records and
forms11 Control of
quality system documents
08 Auditing
8.0 Auditing
Process
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
outcomes4 Planning
quality audits5 Quality
auditor responsibilities - task and duties6 Audit
preparation 1 Where to
start? 2 Informing the
department 3 Audit
checklist 4 Be vigilant7 Audit approach 1 Method 2 Vertical Audit 3 Trace forward 4 Trace backward 5 Horizontal
audits 6 Random audits7 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 auditing8 Some responses9 Auditor's
approach10 Non
conformance and corrective action 1 Recording non
conformance 2 Categorising
non conformities 3 Corrective and
preventive action11 Reporting
audit results 1 Closing
meeting 2 The final
audit report12 Management
reviews 1 Review process 2 Review
participants 3 Review meeting 4 Records 5 Review
procedure
09 Certification
9.0
Certification
1 Introduction2 Purpose of
Certification3 Certification
Process4 Applying for
Certification5 Assessing the
Quotations6 Assessment
Scheduling7 Documentation
Review8 Pre-Assessment9 Preparing For
Formal Assessment10 Formal
assessment11 Maintaining
your ISO 9001:2000 approval12 Assessments
against the ISO 9000:1994 standards (interim)13 Assessments
against the ISO 9001:2000 standard14 Competence of
Auditors15 Areas of
interest to the assessor16 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
10 Continual Improvement
10.0
Continual Improvement
1 Introduction2 Stepped
Improvements3 Marked
Improvements4 Continual
Improvement Process5 Quality Teams
for Incremental Improvements6 Marked
Improvements following Lead Time Reduction Strategys 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
11 Materials
Quality
Manual
QM - Quality
Manual
Quality
Procedures
QP 01 - Control
of Non ConformanceQP 02 - Control
of Quality RecordsQP 03 -
Corrective and Preventive ActionQP 04 - Document
Change ControlQP 05 - Internal
Auditing
Operational
Processes
OP 01 -
Calibration of Measuring EquipmentOP 02 - Internal
CommunicationOP 03 - Computer
Back - UpOP 04 - Control
of External DocumentsOP 05 - Customer
FocusOP 06 - Design
ControlOP 07 - Stock
ControlOP 08 - Stock
InspectionsOP 09 -
Inspection of Incoming MaterialOP 10 - TrainingOP 11 -
Inspection of ProductOP 12 - Job
DescriptionsOP 13 -
Maintenance of Plant and EquipmentOP 14 - Order
ReviewOP 15 -
Preservation of ProductOP 16 -
Performance ReportingOP 17 - Plant
Infrastructure & Work EnvironmentOP 18 - Supplier
Assessment and ApprovalOP 19 - Planning
Product RealisationOP 20 - Purchase
Order ProcessingOP 21 - Quality
Management ReviewOP 22 - Review
of Quality ObjectivesOP 23 - Quality
PlanningOP 24 -
Application of Statistical Techniques
1 Guide - Cost
of Quality and Case Studies2 Guide - Infrastructure and Environment3 Guide - Internal Communications4 Guide - ISO
9001 Structures5 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's manufacturer 5 Case study 5 -
Electronic assembly 6 Case study 6 -
Garment manufacturer7 Guide -
performance reporting8 Guide -
performance report9 Guide -
quality objectives10 Guide -
Quality Policy11 Guide - Requirements for procedures & records12 Guide - Statistical Techniques13 Guide - management skills questionnaire14 Guide - team
building skills15 Guide - staff
training needs analysis
Plans
1 Plan -
Calibration Schedule2 Plan - ISO
9001:2000 Project Plan3 Plan - ISO
9001: Documentation4 Plan - Product
Realisation5 Plan -
Internal Audits Schedule6 Plan -
Management Review Agenda7 Plan -
Equipment Maintenance Schedule8 Plan -
Production Meeting Agenda9 Plan - Sales
Review Meeting Agenda10 Plan - Staff
Training Plan and Matrix11 Plan - QMS
Quality Plan
