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Quality Management System: the future of Laboratory

Accreditation based

on

ISO/IEC 17025 standard

01 October 2014

Sam Thema

samt@sanas.co.za

Presentation Outline

.

Introduction

The Quality Management System

The QMS and its production life cycle

The ISO 9001 standard

Findings from the research study

ISO 9001 trends

Questions & Answers

Predicting future trends for ISO 17025

Acknowledgements

Introduction

Introduction

The Quality Management System

The Quality Management System - CONTINUES

The QMS is required for planning, implementing, improving

organizational business processes to ensure that

organizational objectives are achieved

Established

Implement

Improve

Effectiveness

QMS

Regulatory

Requirements

Requirements of

the body that

provides

recognition

(e.g. SANAS)

Customer

Requirements

Requirements

from the relevant

Standard

(e.g. ISO 17025)

Policy Manual

Quality Manual

Procedures

Work Instructions

Forms

Hierarchy of the QMS

Source: Adapted from the United Nation Office on Drug and Crime, UNODC (2009:5)

The Quality Management System - CONTINUES

QMS and its Product Life Cycle

Established

Implemented

ULTIMATE GOAL is

Effectiveness

Improved

In this case our QMS is

prone to failure

QMS

The ISO standards

What is ISO 9001 standard ?

An example of a Quality Management System

Comprised of 8 sections, namely:

The scope:

Normative references

Terms and Definitions

The ISO standards - continues

What is ISO 9001 standard ?

General requirements and documentation requirements

Resource management

Product realization

Measurement, analysis and improvement

Management responsibility

Senior management commitment

The ISO standards - continues

What is ISO 9001 standard ?

Management responsibility

Senior management commitment

This provided the rationale behind the

study conducted by Thema (2014)

(Part 1) Findings from the research study

What was the topic of the research study ?

Investigating the impact of the attitude of senior laboratory

management towards the QMS: A case study on SANAS

accredited laboratories in Gauteng

The targeted sample ?

Sample was comprised of both calibration and testing

laboratories

Using a probability sampling technique a sample of 120

was chosen and a total of 79% completed questionnaires

were returned leading to a response rate of 65.83%

Findings from the research study - continues

The Demographic Characteristics ?

The respondents were asked to provide demographic

information on gender, age, race, level of education,

experience, number of employees and on whether the

Laboratory operated independently or as part of a bigger

organization.

Findings from the research study - continues

The Demographic Characteristics ?

Results revealed that none of the demographic characteristics

had any significant influence on the topic under research

except between laboratories operating independently or as

part of the bigger organization

Findings from the research study - continues

Frequency

Percentage

Valid

Percentage

Cumulative

Percentage

Valid

Operates

independently

42

53.2

53.2

53.2

Part of bigger

organisation 37 46.8 46.8 100.0

Total 79 100.0 100.0

Results from the frequency table

Findings from the research study - continues

The corresponding frequency bar chart

Findings from the research study - continues

What were the findings ?

Laboratories that operated as part of a bigger organization

has shown a more positive attitude toward the QMS as

compared to those who operated independently

Any literature supporting to this finding ?

Findings from the research study - continues

Any literature report

The report from Viswanathan and Sulphey (2012:80)

maintained that most of the larger organisations are ISO 9001

certified and this help them to streamline their QMS and their

practices. This compels top management to improve

processes in all stages of the value chain

Findings from the research study - continues

Factor Analysis

A factor analysis was conducted as a data reduction

technique and the sample was proven to be adequate to

perform a factor analysis with the Kaiser-Meyer-Olkin

measure scoring 0.710 > 0.5 and produced reliable results

since correlation were relatively compact.

Findings from the research study - continues

Factor Analysis

SPSS output from Bartlett’s test of sphericity was found to be

significant (p < 0.001), an indication of data not multi-collinear

and not an identity matrix and as a result factor analysis was

appropriate.

Findings from the research study - continues

Factor Analysis

A six factor solution was reached through factor analysis

suggesting that a six factor was adequate to represent data.

These factors accounted for approximately 69.28% of the

variation indicating a 69.28% relationship between the

measured variable and the latent factors

Findings from the research study - continues

Six Factors drawn from factor analysis

Improvement opportunities which can be achieved through

the implementation of an effective QMS

Evidence of commitment from senior laboratory managers

towards the QMS

Findings from the research study - continues

Six Factors drawn from factor analysis

Factors indicating the benefits senior laboratory

management can achieve through the implementation of

an effective QMS.

Responsibilities of senior laboratory management and

their contribution towards the establishment of a QMS

Findings from the research study - continues

Six Factors drawn from factor analysis

Integration of the QMS with the organisational

strategy

Level of knowledge of senior laboratory management

towards the QMS

Findings from the research study - continues

Correlation Analysis

A correlation analysis was conducted to measure the

association between the variables (B8 to B15). These

variables were considered in order to provide answers in

relation to the first research question: “Investigation of the

impact of the attitude of senior laboratory management

towards the QMS”

Findings from the research study - continues

The results from correlation coefficient indicated that in

general there was a moderate to strong correlation between

the variables (B8 up to B15). This was a confirmation that a

positive correlation existed between the independent

variable, that is “attitude of senior laboratory management”

and the dependent variable, which was the “QMS ”

In general senior management from SANAS accredited

laboratories demonstrated a positive attitude towards their

QMS

Findings from the research study - continues

(Part 2) ISO 9001 trends

World distribution of ISO 9001 certificates according to

the ISO survey for 2013

ISO 9001 trends - continues

1007 ISO 9001

CERTIFICATES

DISTRIBUTED

ISO 9001 evolution for South Africa

3565 ISO 9001

CERTIFICATES

DISTRIBUTED

A total of 1 541 983 ISO certificates issued worldwide

according to the ISO 2013 survey

4% increase compared to 2012

Most notably, Energy management standard (ISO 50001)

and environmental management (ISO 14001) have shown

an increase demand of 116% and 20% respectively

ISO 9001 trends - continues

The conclusion from ISO the survey is in agreement with literature reports

Sampaio, Saraiva and Rodrique (2011:5) conducted a

study on the ISO 9001 certification worldwide between

1993 to 2010. The study revealed that there is an upward

increase of ISO 9001 certification worldwide as time

progresses.

Franceschini, Galetto and Cecconi (2006:523) observed a

saturation effect after a certain period of fast growth.

ISO 9001 trends - continues

Predicting ISO 17025 future trends

Laboratories and accreditation will continue to play a key

critical role through out the energy supply value chain and

environmental management

Energy providers and environmental management sectors

will continue to rely on accurate tests and calibration

measurements to monitor a wide range of areas from flow

measurement devices to pressure metrology

Predicting ISO 17025 future trends - continues

Future trend for ISO 17025 as well as laboratory

accreditation, in general, will continue to increase mainly

in specific sectors such as energy and environment

management

Acknowledgements

SANAS management and my other colleagues from

SANAS for supporting my research study

Dr Elsabe Steyn, John Peart, Neville Tayler and the

previous SANAS CEO Dr Mike Peet who provided me with

the initial guidance and support during my research study.

All SANAS accredited laboratories who responded to the

research survey

Thank You