Purpose of the QMS

To achieve quality
To ensure that the organisation can
produce conforming product
To help ensure that customers are
satisfied
To assist the organisation in running its
business successfully
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Audit Objectives
To verify that the QMS conforms to
ISO 9001
To verify that the organisation conform
to the QMS
To ensure that the QMS is effective in
helping the organisation to satisfy
customers
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Process Auditing

What is a process?
Why audit processes?
What about clauses?
What about procedures?

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What is a Process?
A set of interrelated or interacting activities
which transforms inputs into outputs
ISO 9000:2000

INPUT

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ACTIVITY

OUTPUT

What is a Process?

A department e.g. design; sales; etc.

A production/assembly line
A project

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Quality Management System

Continual Improvement
Management
Responsibility

C
U
S
T
O
M
E
R

R
e
q
u
i
r
e
m
e
n
t

Measurement
Analysis
Improvement

Resource
Management

Input

S
a
t
i
s
f
a
c
t
i
o
n

Product
(and/or Service)

Realisation

Output

Product /
Service

Quality Management Process Model

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C
U
S
T
O
M
E
R

Plan-Do-Check-Act
Plan - establish what needs
to be achieved and
organise resources
Do - implement the
processes
Check - monitor and
measure the
processes and their
outputs
Act - respond to findings
from the checking activities
in order to improve

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Act Plan
Check Do
CC

Processes
Realisation Processes

Supporting
Processes

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Organisational
Processes

Processes
Supportin
g Doc Cont

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Realisatio
n Design

Organisational
HR

Records

Sales

IT

Audits

Planning

Finance

Man Rev

Buying

Marketing

Nonconf.

Manuf.

Bus Dev

Corr/Prev
action

Test &
Despatch

Facilities
Man

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Process Audit Planning

Management controls

Input

Process/Activity

Resources

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Output

Typical Inputs/Outputs
Sales enquiries sales orders
Design requirements design
specification
Purchase requirements delivered
goods
Shop floor orders finished product
Request for maintenance repaired
equipment
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Management Controls
Procedures
Codes of practice
Statutory and regulatory requirements
Objectives and targets
Internal audits
Monitoring and measuring activities
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Resources
Competent people
Infrastructure and work environment
Materials
Information
Utilities
Support services
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What About Clauses?

Must be addressed for certification
Should not be the primary focus of the
audit - can be checked later
Generic clauses checked everywhere
Specific clauses as required

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Typical Generic Clauses

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4.1 General requirements

4.2.3 Control of documents
4.2.4 Control of records
5.1 Management commitment
5.2 Customer focus
5.4 Planning

Typical Generic Clauses

5.5 Responsibility, authority &
communication
6 Resources
8.1 General
8.2 Monitoring and measurement
8.4 Analysis of data
8.5 Improvement
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Typical Specific Clauses

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7.2 Sales
7.3 Design
7.4 Purchasing
7.6 Calibration
8.2.2 Internal audit
8.3 Nonconforming product

Specific Area e.g. stores

7.5.1
7.5.3
7.5.5
8.2.4

8.3
8.5.2
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Control of production provision

Identification and traceability
Preservation of product
Monitoring & measurement of
product
Nonconforming product
Corrective action

What About Procedures?

Only 6 required there may not be one
for the process being audited
The process may consist of more than
1 procedure
The auditor must establish what the
process is and how it is controlled

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Control of a Process
Methods of control may include:
Documented procedure
Training, education, experience competence
Supervision
Flowchart/process map
Diagrams/pictures/forms
Software
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Verifying Effectiveness
Does the system work?
Does the output provide a suitable
input
for the next process?
What objectives exist?
How do they monitor the effectiveness
of the system? (see 8.2.3)
What improvements have been made?
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Verifying Effectiveness e.g.

Purchasing:
Stock shortages
Rejected goods at goods received
Nonconformance in production due to
faulty raw materials
Customer complaints
Delayed orders due to late delivery of raw
materials
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Audit Planning

Look for the sequence of activities

Trace forward or trace back
Based on departments/processes not clauses

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Reporting Findings
People
Skills
Competence

Materials
Equipment

Inputs

Measures

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Process

Outputs

Methods
Procedures