ISO9000

Question 1

What is ISO9000?

Answer 1

It is a family of Quality Management standards and guidelines.
Aimed primarily at achieving customer satisfaction by preventing nonconformity at all stages from design through to servicing.
Aims to give customers the confidence that their suppliers are actually doing what they said they’d do.

Question 2

ISO9000 basic requirements:

Answer 2

• Processes that affect quality are documented
• Records + data that describe that quality are maintained
• Processes produce consistent quality
• “Say what you do. Do what you say. Prove it. Improve it.”

Question 3

ISO9000 aims

Answer 3

• to improve quality awareness
• to reduce requirement for supplier audit
• to facilitate international trade

Question 4

ISO9000 why bother?

Answer 4

• existing/potential customers insist
• “badge” is good for business
• good way of enforcing discipline on the workforce.

Question 5

ISO9000 Problems/concerns

Answer 5

• Often results in a costly, inflexible, paperwork nightmare, yielding no quality improvements.
• Standard must be “owned” by entire organisation
• Worldwide shortage of experienced quality consultants

Question 6

EQFM Self Assessment Model

Answer 6

Enablers–>
Leadership(10%)>
People, Strategy and Politics, Partnerships(9,8,9%)>
Processes (14%)

Results–>
People, Customers, Society(9,20,6%)>
Key Performance Results(15%)

Question 7

ISO9000 8 Principles to achieve “quality focus”

Answer 7

Customer Focus.
Leadership.
Involvement of people.
Process design.
Systems approach to management.
Continual improvement.
Factual approach to decision making.
Mutually beneficial supplier relationships.

Question 8

Four Levels of documentation

Answer 8

Quality policy manual: This is a policy document, detailing what you intend to do.
Quality procedures manual: A more detailed series of documents detailing how you will carry out the “whats”.
Quality records: These are proofs that the “hows” have been carried out.
Work Instructions: These are the small details that explain how specific tasks which affect quality or the customer are carried out.

Question 9

ISO9000:2015

Answer 9

Quality Management systems - Fundamentals and vocabulary
Provides guidance on the development and implementation of a quality management system.
Not a product standard but applicable to both manufacturing and service industries.

Question 10

ISO9001:2015

Answer 10

Quality Management systems - Requirements
Places particular emphasis on identifying the objectives of the organisation, how their achieved, the risks , and if there are any alternative ways to meet them.

Question 11

ISO 9000 Issues addressed from Management Responsibility

Answer 11

Policy, objectives, planning, system

Question 12

ISO 9000 Issues addressed from Resource Management

Answer 12

Human resources, information, facilities

Question 13

ISO 9000 Issues addressed from Product realisation

Answer 13

Customer, design, purchasing, production

Question 14

ISO 9000 Issues addressed from Measurement, analysis and improvement

Answer 14

Audit, process, product control, improvement

Question 15

Factors that would be measured in self-assessment exercises that go beyond ISO9000

Answer 15

Awards and prices go beyond ISO 9000 by demanding the company considers

• Leadership
• Customer satisfaction
• Processes
• Impact on society
• Employee concerns