HO3 - L12: Quality Standard

Question 1

What does ISO 9000 family of standards do?

Answer 1

provide guidelines and tools to ensure that products and services consistently meet the expectation of the customer and to ensure that quality is continually improved.

Question 2

What is the history of ISO 9000?

Answer 2

1. Pressure for standards from military after WWII
2. This led to MOD ‘05’ and NATO ‘AQAS’ series of standards
3. These were combined into BS 5750:Parts 1,2,3(1979)
4. In 1987 the quality standard ISO 9000 was formally adopted throughout Europe and the US as the basis for quality systems.
   5, Most leading companies in the field of quality assurance and industrial expertise in general have allowed their own standards to be superseded by the ISO 9000.
   (Over 400,000 companies in 158 countries)

Question 3

What is ISO 9000?

Answer 3

1. generic series of quality management standards accepted throughout the
   world.
2. set of requirements and guidelines that define the way an effective quality
   management system (QMS) should operate.
3. strategic management tool essential for effective control and best business practice
4. Based on many years of experience
5. A basis for assessment and registration that provides assurance of quality to customers.

Question 4

What is ISO 9000 NOT?

Answer 4

1. Product standard: does not address spec. of product.
2. Restrictive in a way company operates: well designed QMS will support entrepreneurial culture.
3. Written to map straight onto a business process: Interpretation required

Question 5

What are standards in ISO 9000 family?

Answer 5

1. ISO 9000:2015
2. ISO 9001:2015
3. ISO 9004:2009
4. ISO 19011:2011

Question 6

Explain ISO 9000:2015

Answer 6

Covers basic concepts and language.

Question 7

Explain ISO 9001: 2015

Answer 7

sets out the requirements of quality management system

Question 8

Explain ISO 9004: 2009

Answer 8

• focuses on how to make a quality management system

more efficient and effective

Question 9

Explain ISO 19011:2011

Answer 9

• sets out guidance on internal and external audits of quality
  management systems.

Question 10

Which ISO 9000 standard that carries certification?

Answer 10

ISO 9001: has range of standards for quality management systems that are based on ISO 9001 but adapted to specific sectors and industries.

Question 11

What is the aim of any quality system?

Answer 11

provide a systematic approach to design and manufacture in order to prevent failures and to provide objective, documented evidence
that an agreed quality level has been achieved

Systematic approach to design and manufacture to prevent failures

Question 12

What happens when quality system meets requirements of ISO 9001:2015?

Answer 12

certified as such by an independent third party.
This reduces the requirement for assessment by individual customers and the need for customers to define their own quality system requirements.

Question 13

What is the philosophy behind TQM?

Answer 13

quality should pervade all aspects of business of the company
whereas the standard is slightly more limited.

Question 14

What are the seven principles ISO 9000 series are based on?

Answer 14

1: Customer focus
2: Leadership
3. Engagement of people
4. Process approach
5: Improvement
6: Evidence based decision making
7: Relationship management
CLEPIER

Question 15

Explain principle 1: Customer focus

Answer 15

Organizations depend on their customers: should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.

Question 16

Explain principle 2: Leadership

Answer 16

Leaders establish unity of purpose and direction of the organization.
They should create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives.

Question 17

Explain Principle 3: Engagement of people.

Answer 17

People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization’s benefit

Question 18

Explain principle 4: Process approach

Answer 18

A desired result is achieved more efficiently when activities and related resources are managed as a process.

Question 19

Explain principle 5: Improvement

Answer 19

Improvement of the organization’s overall performance should be a permanent objective of the organization

Question 20

Explain principle 6: Evidence based decision making.

Answer 20

Effective decisions are based on the analysis of data and information.

Question 21

Explain principle 7: relationship

Answer 21

An organization and its external providers (suppliers, contractors, service providers) are interdependent and a mutually beneficial relationship enhances
the ability of both to create value.

Question 22

As a graduate engineer how will ISO9001 certification affect you?

Answer 22

Documentation: eg SOP: expected to follow

Audits: internal and external
(verification of doing what you’re supposed to do)

Quality training