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Audit Objectives

To verify that the QMS conforms to

ISO 9001

To verify that the organisation conformto the QMS

To ensure that the QMS is effective in

helping the organisation to satisfycustomers

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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 ACTIVITY OUTPUT

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What is a Process?

A department e.g. design; sales; etc. A production/assembly line

A project

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CC

UUSS

TT

OO

MM

EE

RR

RReeqquuiirree

mmeenntt

ProductProduct(and/or Service)(and/or Service)

RealisationRealisation

ManagementManagement

ResponsibilityResponsibility

ResourceResource

ManagementManagement

MeasurementMeasurementAnalysisAnalysis

ImprovementImprovement

CC

UUSS

TT

OO

MM

EE

RR

SSaattii

ssffaacc

ttiioonn

Product /Product /

ServiceService

Input Output

Quality Management SystemQuality Management System

Continual ImprovementContinual Improvement

Quality Management Process Model

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Plan-Do-Check-Act

Plan - establish what needsto be achieved andorganise resources

Do - implement theprocesses

Check - monitor andmeasure theprocesses and theiroutputs

Act - respond to findingsfrom the checkingactivities in order toimprove

A

C D

Plan

Check

Act

Do

P

C

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Processes

Realisation Processes

Supporting

Processes

Organisational

Processes

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Processes

Design

Sales

Planning

Buying

Manuf.

Test &

Despatch

Doc Cont

Records

Audits

Man Rev

Nonconf.

Corr/Prev

action

HR

IT

Finance

Marketing

Bus Dev

Facilities

Man

Supporting Realisation Organisational

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Process Audit Planning

Input Output

Management controls

Resources

Process/Activity

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Typical Inputs/Outputs

Sales enquiries sales orders

Design requirements design

specification Purchase requirements deliveredgoods

Shop floor orders finished product

Request for maintenance repairedequipment

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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 theaudit - can be checked later

Generic clauses checked everywhere

Specific clauses as required

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Typical Generic Clauses

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

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Typical Specific Clauses

7.2 Sales

7.3 Design

7.4 Purchasing

7.6 Calibration

8.2.2 Internal audit

8.3 Nonconforming product

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Specific Area e.g. stores

7.5.1 Control of production provision

7.5.3 Identification and traceability

7.5.5 Preservation of product 8.2.4 Monitoring & measurement of

product

8.3 Nonconforming product 8.5.2 Corrective action

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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 rawmaterials

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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

ProcessInputs Outputs

Materials

Equipment

PeopleSkills

Competence

Measures MethodsProcedures