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Quality Management System: the future of Laboratory
Accreditation based
on
ISO/IEC 17025 standard
01 October 2014
Sam Thema
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