Week 5 and 6

Question 1

Using the below standard, identify the sections within it and what each section means. BS EN ISO 9001: 2008

Answer 1

BS EN ISO 9001: 2008

BS - British Standard

EN - European Normale

ISO - International Standard

9001 - Standard Number

2008 - Year issued

Question 2

How are standards developed

Answer 2

Consensus - the views of all interests are taken into account: manufacturers, vendors and users, consumer groups, testing laboratories, governments, engineering professions and research organisations.

Industry-wide - global solutions to satisfy industries and customers worldwide.

Voluntary - international standardisation is market-driven and therefore based on voluntary involvement of all interests in the market place.

Question 3

What does QMS stand for, define it and identify its functions?

Answer 3

QMS - Quality Managment systems “Collective plans, activities, and events that are provided to ensure that a product process or service will satisfy given needs”

QMS functions:

• Design &ndevelopment
• Sales & marketing
• Manufacturing
• Purchasing
• Sub contracting
• Training
• Installation & Servicing
• Management reviews

Question 4

What are the benefits of QMS

Answer 4

Standard procedures in place for staff

Focus on customer requirements

Better leadership from top management

Better supplier relationships

Sales tool (can be applied to sales brochures)

Required in many industries

Limits litigation

Question 5

Draw and label the diagram of a Quality management system.

Answer 5

Question 6

Identify the 10 sections that make up a QMS model:

Answer 6

1. Scope
2. Normative references
3. Terms and definitions
4. Context of the organization
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance evaluation
10. Improvement.

Question 7

With a QMS, what categories are addressed within Section 4 - Context of the organisation.

Answer 7

4. 1 Understanding the organisation and its context
5. 2 Understanding the needs and expectations of interested parties
6. 3 Determining the scope of the quality management system
7. 4 Quality management system and its processes

• must establish, implement, maintain and continually improve the QMS
• assign responsibilities and authorities for processes

Question 8

With a QMS, what categories are addressed within Section 5 Leadership

Answer 8

5. 1 Leadership and commitment
6. 2 Policy
7. 3 Organisational roles, responsibilities and authorities

Ensures responsibilities and authorities for relevant roles are assigned, communicated and understood

Question 9

With a QMS, what categories are addressed within Section 6 - Planning

Answer 9

6. 1 Actions to address risks and opportunities
7. 2 Quality objectives and planning to achieve them
8. 3 Planning of changes

• Must determine what, how, who, when, etc
• Quality objectives must be documented.

Question 10

With a QMS, what categories are addressed within Section 7 - Support

Answer 10

7. 1 Resources
8. 2 Competence
9. 3 Awareness
10. 4 Communication
11. 5 Documented information

The support required to meet the organisation’s goals.

Question 11

With a QMS, what categories are addressed within Section 8 - Operations

Answer 11

8. 1 Operational planning and control
9. 2 Requirements for products and services
10. 3 Design and development of products and services
11. 4 Control of externally provided processes, products and services
12. 5 Production and service provision
13. 6 Release of products and services
14. 7 Control of nonconforming outputs

The heart of the management system (the business).

Question 12

With a QMS, what categories are addressed within Section 9 - Performance evaluation

Answer 12

9. 1 Monitoring, measurement, analysis and evaluation
10. 2 Internal audit
11. 3 Management review

Determining what is to be monitored, measured, analysed and evaluated will enable the organisation to determine ‘if the management system suitable, adequate and effective ?’

How the performance of the QMS is evaluated.

Question 13

With a QMS, what categories are addressed within Section 10 - Improvement

Answer 13

10. 1 General
11. 2 Nonconformity and corrective action

• Nonconformities (including complaints) must be reacted to and applicable action is taken
• Root cause analysis must be considered based on its significance
• The effectiveness of corrective action must be reviewed
• Change QMS if required
• Evidence of action taken from nonconformities must be documented
• Evidence of results of corrective action must be documented.

10.3 Continual improvement

• Organisations must continually improve the suitability, adequacy and effectiveness of the QMS
• Must consider results of analysis and evaluation, and outputs from management review.

Question 14

Provide a brief summary of the clause structure of a QMS for sections 4-10

Answer 14

4. Context of the organization

Understanding the organization and its context

Understanding the needs and expectations of interested parties

5. Leadership

Leadership and commitment

Policy

Organizational roles, responsibilities and authorities

6. Planning

Actions to address risks and opportunities

Objectives and plans to achieve them.

7. Support

Resources

Competence

Awareness

Communication

Documented information

8. Operation

Operational planning and control

9. Performance evaluation

Monitoring, measurement, analysis and evaluation

Internal audit

Management review

10. Improvement

Nonconformity and corrective action

Continual improvement.