ISO 9001:2008
Assured ISO 9001:2008
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Section / Description

01

Purpose

 

Presents aims and use of software.

02

ISO 9001:2008

 

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.

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 9001:2008.

06

Staff Development

 

Develops quality awareness of staff. Raises training issues for ISO 9001:2008. 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 9001:2008 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 9001:2008 implementation. This includes manuals, procedures, process documents, forms, plans etc.

Detailed Contents


01 Purpose

 

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

02 ISO 9001:2008

 

2.1 ISO 9001:2008 Introduction

 

 

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.

 

 2.2 ISO 9001:2008 General Requirements

 

 

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

 

2.3 ISO 9001:2008 Clause Requirements

 

 

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

 

2.4 ISO 9001:000 Application of Clause 7

 

 
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
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 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

03 Business Requirements

 

3.0 Business Requirements

 

3.1 Quality Strategy

 

 

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

 

3.2 Business Process

 

 

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

 

3.3 Define your quality requirements

 

 

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

04 Resources

 

4.1 Build your project team

 

 

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

 

4.2 Choosing a consultant

 

 

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

05 Project Plan

 

5.0 Project Plan

 

 

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

06 Staff Development

 

6.1 Quality Awareness

 

 

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

 

6.2 Training your team on ISO 9001:2008

 

 

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

07 Implementation

 

7.0 Implementation

 

1 Assessment

 

 

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

 

2 Flowcharting

 

 

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:-

 

3 Gap Analysis

 

 

1  Identify areas for improvement
2  Consider your customer needs

 

4 Performance Measurement

 

 

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

 

5 Quality System Development

 

 

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

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 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

09 Certification

 

9.0 Certification

 

 

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

10 Continual Improvement

 

10.0 Continual Improvement

 

 

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

11 Materials

 

Quality Manual

 

 

QM - Quality Manual

 

Quality Procedures

 

 

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

 

Operational Processes

 

 

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

 

Flowcharts

 

 

1 Administration
2 Document Control
3 Design Process
4 Goods Receiving Process
5 Order Review
6 Quality Planning

 

Useful Guides

 

 

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

 

Plans

 

 

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

 

Questionnaires

 

 

1 Questionnaire - Customer Satisfaction
2 Questionnaire GAP Analysis -ISO 9001:2008 Assessment
3 Questionnaire - Supplier Assessment/Quality Assurance

 

Quality Records and Registers

 

 

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

 

General

 

 

1 End User Licence Agreement
2 User guide - Navigational aids
3 FAQs - Frequently Asked Questions
 

Comprehensive sections with guides and quality system templates

 
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