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ISO 9001:2008Quality Management System

Awareness Training

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What is Quality?

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• Degree of excellence?• Relative nature or kind?• General excellence?

The Concise Oxford Dictionary

IS QUALITY:

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QUALITY

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Fitness for purpose

Quality is,

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However, ‘Fitness for Purpose’ needs to be defined in a ‘Specification of Requirements’

Therefore;Quality becomes ‘Conformance with Specified Requirements

Quality is not Excellence

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Product Quality

Technical specifications Service quality Communication Availability/Continuity Reliability

CustomerLoyalty

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Over Specification

Specification

Under Specification

= QUALITY

= No Quality

= No Quality

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The degree to which a set of inherent characteristics fulfils requirements.

ISO 9001:2008

Quality is,

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Development of Management Thought

Scientific Management

Frederick Taylor• Scientific• Standardization• Production control• Cost • Efficiency

Management Theory

Henry Fayol• Management

functions• One superior• Management

training

Bureaucracy

Max Weber• Responsibilit

y and audthorities

• Procedures• Expertise

1880 1940

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DETECTING ERRORS

Quality Control

PURPOSE:

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Detecting Errors

Checking

Backward

Management Principle

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SPACE PROJECT ?

•%1 Nature

•% 4 Personal Reasons

•% 95 Management Systems

3 Root Causes of Errors

%1

%4

%95

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PREVENTING ERRORS

Quality Assurance

New Management Thought

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Change in Management Thought

Detecting errors

• Quality control

Backward

Preventing errors• Feedback• Systems

• Quality assurance/management

Forward

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1. Cost of preventing poor quality2. Cost of poor quality

Cost of Poor Quality;

Internal Costs External Costs

Quality Costs

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CONTINUAL IMPROVEMENT

Quality Management

Continual Improvement

The Deming Cycle

PLAN

CHECK

DO

ACT

PER

FO

RM

AN

CE

TIME

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Development of ISO 9001

ISO 9001:1987

ISO 9001:1994

ISO 9001:2000

Correct reduction Error detection Preventing errors (partly)

+ Preventing errors

+ Continual improvement

QMQM MonitoringMonitoring QA TQMQMQC

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International Organization for Standardization

What is ISO ?

1947

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8 Management Principles

Customer focus Leadership Involvement of people Process approach Systematic approach to management Continual improvement Factual approach to decision making Mutually beneficial supplier relationships

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A set of interrelated or interacting activities which transforms inputs into outputs.

ISO 9001:2008

Process :

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Process

Input from previous process

Output to next process or customer

Resources

Control Data and

instructions

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Advantages of ISO 9001

• Improved financial performance of the business by planning and achieving results using efficient and effective processes.

• Enhanced sales, as a result of an improved ability to satisfy customers.• An enhancement to the organisation's reputation for satisfying customers

needs.• Reduced cost of poor quality.• A better motivated and trained workforce.• Improved staff morale and an increase in confidence within the whole

organisation.• Encourages an open approach to problems and therefore, more chance of

their solution and avoidance of their repetition.

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Disadvantages of ISO 9001

%45

%15

%15

%10

%10%5

% 45 Increase in bureacracy

% 15 Increase in paperwork

% 15 Worthless investment needs

% 10 Excellence

% 10 Loosing flexibility

% 5 Loosing responsibility conciousness

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4.1 General Requirements

ScopeOutsourced processes

4.2 Documentation Requirements

4.2.1 General4.2.2 Quality Manual4.2.3 Control of Documents4.2.4 Control of Records

4. Quality Management System

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5.1 Management Committement

5.2 Customer Focus

5.3 Quality Policies

5.4 Planning 5.4.1 Quality Objectives 5.4.2 Quality Management System Planning

5.5 Responsibility, Authority and Communication5.5.1 Responsibility and Authority5.5.2 Management Repsentative5.5.3 Internal Communication

5.6 Management Review5.6.1 General5.6.2 Review Inputs5.6.3 Review Outputs

5. Management Responsibility

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6.1 Provision of Resources6.2 Human Resources6.3 Infrastructure6.4 Work Environment

6. Resources Management

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7.1 Planning of Product Realization

7.2 Customer Related Processes7.3 Design and Development

7.4 Purchasing

7.5 Product and Service Provision7.5.1 Control of Product and Service Provsion7.5.2 Validation of Processes7.5.3 Product Identification and Traceability7.5.4 Customer Property7.5.5 Preservation of Products

7.6 Control of Monitoring and Measuring Equipment

7. Product Realization

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8.1 General 8.2 Monitoring and Mesurement

8.2.1 Customer Satisfaction8.2.2 Internal Audits8.2.3 Monitoring and Measurement of Processes8.2.4 Monitoring and Measurement of Products

8.3 Control of Nonconforming Products 8.4 Analysis of Data 8.5 Improvement

8. Measurement, Analysis and Improvement

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Gives advice to management on how to minimise failure

Deals with the prevention of problems Learn from mistakes and prevent

recurrence of failures Continual improvement in

effectiveness

ISO 9000

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Primary aim is to achieve good management control

Standard does not guarantee perfection at all times

Standard does not supersede technical specifications or standards

ISO 9001 aligns with ISO 14001

QUALITY SYSTEMS

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Where the overall responsibility for product realisation belongs to the organisation, if a process such as design is outsourced or subcontracted, then it can not be excluded from the scope

Must include the management of such processes

OUTSOURCING

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Document what you are doing

Do what you documented

Record what you did !

DOCUMENTATION

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may take the form of:

hard copy (paper)

electronic data (computer)

both forms need to be controlled in accordance with clause 4.2.3 and 4.2.4 of ISO 9001: 2008

Quality System Documentation

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tool for management control

as a basis for training

as an aid to doing the job

to help think things through

as an aid to audit

Benefits of Documentation

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LEVEL 1 – Quality Manual

LEVEL 2 – Quality Procedures

LEVEL 3 – Detailed Instructions

Traditional Quality Documentation Structure

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Documentation System

Document Guide Rule Descriptive

Subject to change

Records Evidence Demonstration

Subject to maintain

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Ensuring that the system is conforming to ISO 9001 requirements

Ensuring the system is implemented Ensuring the system is effective

Tool : error detection “not purpose”

Auditing

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Clause 5.4.1 of ISO 9001

Could cover:• Management Processes

• Reduction in planning time

• Production or service delivery processes• Reduction in scrap or processing errors

• The product or service itself• Reduction in customer returns or complaints

Quality Objectives