I So 9001 Oxford

Quality Management
1
ISO 9000:2000
What Is Quality?
Degree to which a set of inherent characteristics

fulfils requirements
2
Quality Techniques & QMS Standards
Quality Quality Quality

Control Assurance Management
(Detection) (Prevention) (Direction)
BS 5750 ISO
1979-1987 9001/2/3
1987-2000 ISO 9001
2000
3
What Is A Quality Management System?
People
Processes
Planned
Individually
Materials
Equipment Documented
System
Resources Describes how this
happens
Implemented System
Collectively “Best Practice”
4
Why Document?
• Communication Tool
• Manage Change
• Aids consistency
• Record of Best Practice
• Enables Effective Audit
• ISO 9001 Pre-requisite
5
Documented Q.M.S.
INTENT
POLICY
QUALITY WHAT?
MANUAL
PROCEDURES HOW?
WHY?
LOCAL/WORK INSTRUCTIONS
RECORDS / FORMS PROOF
6
ISO 9001:2000
The Structure:
ISO 9001 - Q.M.S. Requirements
ISO 9004 - Q.M.S. Guidelines on Performance Improvement
ISO 9000 - Q.M.S. Fundamentals & Vocabulary
7
4.1 Control Our Processes
4.2 Control Our Documentation
5.3 Policy Objectives 5.4

5.2 Customer Focus Determine & Communicate
5.5
Authority & Responsibilities
5.1 Committed Review 5.6
8.2.1 Customer
Satisfaction 5. Managed
8.2.2 System
6. Provide Resources
8. Measure GOOD
8.2.3 Processes
Analyse COMPANY People 6.2
8.2.4 Product Improve ISO Buildings, Equipment,
Machinery, etc 6.3
8.3 Non-conforming 7. Do What the Environment 6.4
Product Customer Wants
8.4 Data & Info Planning 7.1
Corrective Selling 7.2
8.5.2 Action Designing 7.3
Purchasing 7.4
8.5.3 Preventive
Production 7.5
Action
Calibrating 7.6
8
ISO 9001:2000
Based on the 8 Quality Management
Principles:
1. Customer Focus
2. Leadership
3. Involvement of People
4. Process Approach
5. System Approach to Management
6. Continual Improvement
7. Factual Approach to Decision Making
8. Mutually Beneficial Supplier Relationships
9
Quality Management Process Model
Continual improvement of
the quality management system
Management
Responsibility
Customers Customers
Measurement, Satisfaction
Resource
analysis and
management improvement
Input Output
Requirements Product
Product
Realisation
10
So the Quality Management System
(ISO9001) defines what the organization
does to ensure that its products or
services satisfy the customer's quality
requirements and comply with any
regulations applicable to those products
or services.
ISO 14000 is primarily concerned with
"environmental management". In plain
language, this means what the
organization does to minimize harmful
effects on the environment caused by its
activities.
11
ISO 14001 is an internationally recognised
standard for environmental management system
which can be applied by any organisation. It has
much in common with ISO 9001, in particular the
PLAN - DO - CHECK- ACT concept.
As a minimum, ISO 14001 requires a commitment

to legal compliance, continual improvement and
pollution prevention. It involves the identification
and assessment of all environmental aspects and
impacts in order to determine which are
significant. These must then be managed so as to
minimise harm to the environment.
12
ISO14001 - Environmental management system model
for the international standard
Environmental Policy
Continual
Planning
improvement
•Environmental aspects
•Legal and other requirements
•Objectives and targets
Management Review •Environmental management
programmes
Implementation and Operation

Checking and Corrective Action
•Structure and responsibility
•Monitoring and measurement
•Training, awareness and competence
•Non-conformance and corrective
•Communication
and preventative action
•EMS documentation
•Records
•Document control
•EMS audits
•Operational control
•Emergency preparedness and response
13
ISO 14001
Fundamental requirements
Plan, Do, Check and Act to ensure:
• prevention of pollution
• compliance with environmental regulations (and RR
Standards)
• and continual improvement in environmental
performance
14
Typical questionnaire for ISO14001
effectiveness:
Have all employees received environmental
training and been briefed?
Are business/corporate objectives and targets
communicated to the workforce?
Can you show progress towards the achievement
of objectives and are the relevant managers and
employees aware of their actions in this respect?
Is the site in a good general state of
housekeeping?
Has the HS&E policy been reviewed and is the
updated copy available throughout the business?
Have any incidents been handled appropriately?
15
Typical questionnaire for ISO14001
effectiveness (continued):
Have responsibilities been set for communications
with the regulatory bodies?
Has there been a test of the emergency plans?
Was this documented and plans altered
accordingly?
Are all maintenance/calibration records fully up to
date?
Has a management review been undertaken and
alterations made to the EMS as necessary?
Are all operational procedures up-to-date, readily
available and being worked to?
16
Why bother Certificating?
External view from trained auditors helps focus attention on
the real issues.
Impending audits provide “motivation” to do things right.
Can be a necessary customer requirement in order to do

business.
Can give competitive advantage.
17

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Quality Management

Degree to which a set of inherent characteristics

Quality Quality Quality

(Detection) (Prevention) (Direction)

• Record of Best Practice

• Enables Effective Audit

• ISO 9001 Pre-requisite

RECORDS / FORMS PROOF

ISO 9001 - Q.M.S. Requirements

ISO 9004 - Q.M.S. Guidelines on Performance Improvement

ISO 9000 - Q.M.S. Fundamentals & Vocabulary

5.3 Policy Objectives 5.4

As a minimum, ISO 14001 requires a commitment

Implementation and Operation

Plan, Do, Check and Act to ensure:

Impending audits provide “motivation” to do things right.

Can be a necessary customer requirement in order to do

Can give competitive advantage.

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