Subject Revision and Exam preparation

CNAM-IIM MIM 2008-9

Course M232
Session QMI 12
Quality Management and ISO9001

Quality Management
© Improve QPI Ltd 2009 Slide 1
ISO9001

How can ISO9001 benefit my organisation?

Identify at least two examples of the likely benefits of

implementing an ISO9001 compliant QMS (internal, external)

- for an organization developing products

(eg laptop computers)
- for an organization providing services
(eg hospital administration)
- for a manufacturing organization
(eg automotive components)
- for customers
- for an organization's management
- for suppliers of an organization

Quality Management
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ISO9001

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 ISO9001 processes

What are the five main sections of ISO9001?

4.
5.
6.
7.
8.

Quality Management
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ISO9001

Monitoring and measurement

Provide two examples of monitoring and measurement within an

ISO9001 QMS for

a) design and development activities

b) Warehouse / distribution operations

c) technical help desk

How do you determine whether the products or services delivered

meet quality requirements?

Quality Management
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ISO9001

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 The practicalities - 1

1. in an organisation, who is responsible for the QMS

2. who supports and maintains an organization’s QMS?

3. who can request or suggest a change to the QMS?

4. how is a request for change defined and its progress monitored?

5. what type of actions does ISO9001 expect if a product defect is

found?

Quality Management
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ISO9001

The practicalities - 2
1. Management Structure
Does ISO9001 require that the organisational management
structure is defined and maintained?
2. Staff issues
Provide two examples of ISO9001 requirements relating to the staff
of an organization.
3. QMS operation
State two ways in which performance of the QMS and the delivery
of its products and services are assessed or reviewed.
4. Time and cost
Does ISO9001 require that products are delivered on time?
5. Certification body / registrar
What does a Certification body do?
Quality Management
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ISO9001

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 Quality Audit

1. What are the different types of audit? (and who performs the
audit?)

2. For each type of audit, provide an example of why it is being

performed

3. How are the results of a quality audit recorded?

4. Provide an example of the output from a quality audit.

5. Who can perform a quality audit?

Quality Management
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ISO9001

Quality Audit

1. Summarise the main sections of a quality audit report

2. Identify 2 key outputs from a quality audit

3. Who performs a quality audit?

4. Who accepts the conclusions of a quality audit?

5. How does senior management review the performance and outcome

of the audit programme?

Quality Management
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ISO9001

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 Understanding ISO9001
(Yes or No?)
1. The CEO or Managing Director must approve and sign the Quality
Policy
2. ISO9001 applies to delivery of products and services
3. An organisation must support its products or services after
delivery
4. There must be evidence of testing before product release or
delivery
5. Products and services offered to customers must be defined or
specified
6. “Product realization” processes apply in to all products and
services

Quality Management
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ISO9001

Understanding ISO9001 - 2

(Yes or No?)
1. All staff must receive training appropriate for their job or role
2. An organization must define the skills and competences needed by
its staff
3. All processes, procedures and tasks performed must be defined and
documented
4. The format and content of all quality records must be defined
before work is performed.
5. All faults or defects reported in delivered products must be
recorded and corrected
6. All faults or defects reported in delivered services must be recorded
and corrected

Quality Management
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ISO9001

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 QMS actions

to comply with ISO9001, what should happen next?

1. A quality audit finds a project is not following the testing process

defined in the QMS
2. A customer complaint letter is received
3. A fault is found in a product already released
4. Customer response time targets for a help desk are achieved
5. Two versions of the same product specification are found to have
the same version number
6. A project is completed
7. The customer sends approval for the the contract by email

Quality Management
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ISO9001

Good practice
Does ISO9001 allow the following practices?

1. The QMS processes are available only on the company intranet

2. Project records are deleted 1 month after the project has finished

3. Each production team defines its own quality control procedures

4. The weekly production planning meeting is performed only when

the production manager requires it

5. The quality manager is also the site facilities manager

Quality Management
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ISO9001

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 Good practice?
(if bad, what would you do?)
1. The product was released before testing was completed, as
instructed by the commercial manager.
2. Due to a delayed delivery, components for the production line
were obtained from a supplier not on the approved supplier list.
3. The product specifications were changed without informing the
customers
4. The last planned milestone progress review was cancelled
5. The customer was not offered a service level agreement for
providing technical support
6. The support team monthly report included customer suggestions
for product improvements

Quality Management
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ISO9001