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

Transcription

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

2 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 Predicting future trends for ISO Acknowledgements Questions & Answers

3 Introduction

4 Introduction

5 The Quality Management System

6 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

7 The Quality Management System - CONTINUES Regulatory Requirements Policy Manual Requirements of the body that provides recognition (e.g. SANAS) Quality Manual Procedures Work Instructions Forms Customer Requirements Hierarchy of the QMS Requirements from the relevant Standard (e.g. ISO 17025) Source: Adapted from the United Nation Office on Drug and Crime, UNODC (2009:5)

8 QMS and its Product Life Cycle In this case our QMS is prone to failure Established Implemented Improved ULTIMATE GOAL is Effectiveness QMS

9 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

10 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

11 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)

12 (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

13 Findings from the research study - continues 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%

14 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.

15 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

16 Findings from the research study - continues Results from the frequency table Valid Frequency Percentage Percentage Cumulative Percentage Operates independently Valid Part of bigger organisation Total

17 Findings from the research study - continues The corresponding frequency bar chart

18 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?

19 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

20 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 > 0.5 and produced reliable results since correlation were relatively compact.

21 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.

22 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

23 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

24 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

25 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

26 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

27 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

28 (Part 2) ISO 9001 trends World distribution of ISO 9001 certificates according to the ISO survey for 2013

29 ISO 9001 trends - continues ISO 9001 evolution for South Africa 3565 ISO 9001 CERTIFICATES DISTRIBUTED 1007 ISO 9001 CERTIFICATES DISTRIBUTED

30 ISO 9001 trends - continues A total of 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

31 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 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.

32 Predicting ISO 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

33 Predicting ISO future trends - continues Future trend for ISO as well as laboratory accreditation, in general, will continue to increase mainly in specific sectors such as energy and environment management

34 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

35 Thank You