A Quality System for laboratories:

Introduction
Margryt

Oldenhof

Quality is
everywhere

Intermezzo
Question: What is quality?
Participant discussion

Quality is:
The degree to which an item or process meets or exceeds the
customers requirements and expectations

The degree to which a set of inherent (existing) characteristics

fulfils requirements

A satisfied customer
Act as agreed
Flexibility

Laboratory processes:
Black box or transparancy?

client ->input-> laboratory ->output -> client

Report
Report

Good Quality System

Starting were is matters most:

Laboratory

The Laboratory Process

Report
Laboratory

Sample

ISO/IEC 17025:2005 scope

General requirements for the

competence of testing and calibration
laboratories

Accreditation: formal confirmation:

1 - working conform ISO 17025
2 competence of laboratory

ISO 17025 structure

Management requirements ->
working processes
2. Technical requirements -> competence
1.

Accreditation versus certification

Accreditation (ISO 17025)
1. Conformity
2. Compentence

Certification (i.e.ISO 9001)

1. Conformity

Focus ISO 9001

Satisfied customer
Continous improvement

ISO17025:2005 compared to ISO

9001
ISO 17025: 2005 includes the principles of

ISO 9001 but follows not exactly all the

requirements of ISO 9001

Deming-circle
PLAN

ACT

DO

CHECK

PlanDo-Check-Act cycle
Planning phase: define targets, quality

policy and procedures

Do: implementation phase
Check: control phase
Act: Action, adaptation and correction
phase based on findings and decide to
make changes to a process, policy etc.

Documentation of activities

Act as described
Describe the way you act
Documentate procedures
Follow the procedures and record relevant*
information and non-conformities
relevant* for the management and/or technical
requirements

Quality triangle

Q-policy
Q-managementsystem

HRM ICT Financia Technical

l
services
services
Primary proces

Administration

Documentation system

Q-Policy
statement
Q-manual

Procedures ( SOPS)

Instructions and forms