Section 1 Introduction To Quality Management-Books Download

Section 1 Introduction to Quality Management

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Introduction to Quality Management for EDXRF practice - Pursuing ISO/IEC 17025:2005 accreditation. Section 1: Introduction to Quality Management 1 1 INTRODUCTION TO QUALITY MANAGEMENT This section will provide you with examples on how to implement actions in your Quality Management program to pursue the fulfilment of the ISO 17025 requirements.



Introduction to Quality Management for EDXRF practice Pursuing ISO IEC 17025 2005 accreditation
Section 1 Introduction to Quality Management
1 3 THE DEFINITION OF QUALITY AS CONSENSUALLY AGREED BY 2005
The degree to which a set of inherent characteristics fulfils requirements
Quality can be used with adjectives such as poor good excellent
Inherent as opposed to assigned means existing in something especially as a
permanent characteristic
Requirement A need or expectation that is stated generally implied or
obligatory
Stated means usually explicitly in a document
Generally implied means that it is custom or common practice for the organization its
customers and other interested parties
Requirement is the expression in the content of a document conveying criteria to be
fulfilled if compliance with the document is to be claimed and from which no deviation is
1 3 1 THE DEFINITION OF QUALITY APPLIED TO ANALYTICAL LABORATORIES
In the case of a laboratory providing analytical results quality can be understood as the
degree of compliance to the requirements of the customers Therefore the customer
shall be requested to be specific in regard to
what type of material has been brought for analysis The type of material sample matrix
will allow to define the type of interferences that can be expected the expected detection
limits since there will be more or less attenuation scatter enhancement effects the
availability of calibration or not among other figures of performance
which elements need to be analyzed The list of required elements will address the analyst
into the selection of proper excitation measurement conditions
what is the expected concentration weight fraction of the elements in the sample The
stated concentration weight fraction allows to select a method with sufficient sensitivity
and detection limits
what is the expected uncertainty for the results One of the main figures to define the
fitness of a given method for the purpose the results are expected
1 4 ISO 9000 2005 LOOKING FOR A CONSENSUS
The ISO 9000 family of standards represents an international consensus on good quality
management practices It consists of standards and guidelines relating to quality
management systems and related supporting standards
ISO 9000 standard series was developed to assist organizations of all types and sizes to
implement and operate effective quality management systems
ISO 9000 2005 DEFINES GENERAL FUNDAMENTAL ISSUES
Introduction to Quality Management for EDXRF practice Pursuing ISO IEC 17025 2005 accreditation
Section 1 Introduction to Quality Management
1 5 ISO 9000 2005 CONTENTS
Fundamentals
o Rationale
o Requirements for QMS
o Requirements for products
o QMS approach
o Process approach
o Quality policy and quality objectives
o Role of top management
o Documentation
o Evaluation of QMS
o Continual improvement
o Role of statistical techniques
Terms and definitions
1 6 THE EIGHT QM KEY PRINCIPLES
Customer focus
Leadership
People involvement
Process approach
System approach to management
Continual improvement
Factual approach to decision making
Mutually beneficial supplier relationships
1 6 1 QM KEY PRINCIPLES CUSTOMER FOCUS
Organizations depend on their customers and therefore should understand current and
future customer needs should meet customer requirements and strive to exceed
customer expectations
THE CUSTOMER IS ALWAYS RIGHT
Introduction to Quality Management for EDXRF practice Pursuing ISO IEC 17025 2005 accreditation
Section 1 Introduction to Quality Management
1 6 2 QM KEY PRINCIPLES LEADERSHIP
Leaders establish unity of purpose and direction of the organization
Leaders should create and maintain the internal environment in such a way that
people can become fully involved and committed in achieving the organization s
objectives
TO BECOME A REAL LEADER NOT JUST THE BOSS
1 6 3 QM KEY PRINCIPLES PEOPLE INVOLVEMENT
People at all levels are the essence of an organization and their full involvement enables
their abilities to be used for the organization s benefit
IT S EVERYBODY S BUSINESS UNITY MAKES STRENGTH
Introduction to Quality Management for EDXRF practice Pursuing ISO IEC 17025 2005 accreditation
Section 1 Introduction to Quality Management
1 6 4 QM KEY PRINCIPLES PROCESS APPROACH
A desired result is achieved more efficiently when activities and related resources are
managed as a process
PROCESS APPROACH IS BASED IN THE PDCA PRINCIPLE PLAN DO CHECK ACT
1 6 5 QM KEY PRINCIPLES SYSTEM APPROACH TO MANAGEMENT
Identifying understanding and managing interrelated processes as a system contributes
to the organization s effectiveness and efficiency in achieving its objectives
Introduction to Quality Management for EDXRF practice Pursuing ISO IEC 17025 2005 accreditation
Section 1 Introduction to Quality Management
1 6 6 QM KEY PRINCIPLES CONTINUAL IMPROVEMENT
Continual improvement of the organization s overall performance should be a permanent
WE ARE GOOD BUT WE CAN BE EVEN BETTER
1 6 7 QM KEY PRINCIPLES FACTUAL APPROACH TO DECISION MAKING
Effective decisions are based on the analysis of data and information
WE BELIEVE IN PEOPLE BUT MUCH MORE IN THE FACTS
1 6 8 QM KEY PRINCIPLES MUTUALLY BENEFICIAL SUPPLIER RELATIONSHIPS
An organization and its suppliers are interdependent and a mutually beneficial relationship
enhances the ability of both to create value
ONE HAND WASHES THE OTHER AND BOTH WASH THE BODY
Introduction to Quality Management for EDXRF practice Pursuing ISO IEC 17025 2005 accreditation
Section 1 Introduction to Quality Management
1 7 KEY ELEMENTS IN QUALITY MANAGEMENT
1 8 QUALITY MANAGEMENT CONNOTATIONS
Ethic value performing at own best effort
Documented procedures and records help to ensure traceability and dependability
Mutually beneficial outcome for supplier and customers
Customer satisfaction increases
Supplier organization efficiency competence and capabilities enhance continuously
1 9 OTHER RELEVANT QUALITY STANDARDS FROM THE ISO 9000
ISO 9001 2000 Quality Management Systems Requirements
ISO IEC 17025 2005 General requirements for the competence of testing
calibration laboratories
Introduction to Quality Management for EDXRF practice Pursuing ISO IEC 17025 2005 accreditation
Section 1 Introduction to Quality Management
1 9 1 INTRODUCTION TO THE ISO 9001 2000
ISO 9001 2000 Quality Management Systems Requirements
ISO 9001 2000 is an international standard that gives requirements for an
organization s Quality Management System QMS It is the only standard in the ISO
9000 family that can be used for the purpose of conformity assessment
The objective of ISO 9001 2000 is to provide a set of requirements that if effectively
implemented will provide you with confidence that your XRF Laboratory can consistently
provide analytical services that
Meet customer needs and expectations and
Comply with applicable regulations
The requirements cover a wide range of topics including top management
commitment to quality customer focus adequacy of its resources employee
competence process management for production service delivery and relevant
administrative and support processes quality planning product design review of
incoming orders purchasing monitoring and measurement of its processes and
products calibration of measuring equipment processes to resolve customer
complaints corrective preventive actions and a requirement to drive continual
improvement of the QMS Last but not least there is a requirement to monitor
customer perceptions about the quality of the analytical services you provide
ISO 9001 2000 does not specify requirements for the analytical services you are selling
That is up to your costumers to define by making clear their own needs and
expectations for the analytical service As an example if you provide XRF instruments
and consumables they might refer to product specifications drawings national or
international product standards supplier s catalogues or other documents as
appropriate
CONFORMITY TO THIS STANDARD DOES NOT ITSELF DEMONSTRATE THE COMPETENCE
OF THE LABORATORY TO PRODUCE TECHNICALLY VALID DATA AND RESULTS IN TESTS
OR CALIBRATIONS
1 9 2 INTRODUCTION TO THE ISO IEC 17025 2005
ISO IEC 17025 2005 General requirements for the competence of testing
calibration laboratories
ISO IEC 17025 2005 specifies the general requirements for the competence to carry out
tests and or calibrations including sampling It covers testing and calibration performed
using standard methods non standard methods and laboratory developed methods
ISO IEC 17025 2005 is for use by XRF laboratories in developing their management
system for quality administrative and technical operations XRF laboratory customers
regulatory authorities and accreditation bodies may also use it in confirming or
recognizing the competence of laboratories Accreditation bodies that recognize the
Introduction to Quality Management for EDXRF practice Pursuing ISO IEC 17025 2005 accreditation
Section 1 Introduction to Quality Management
competence of testing and calibration laboratories should use this International
Standard as the basis for their accreditation
Compliance with regulatory and safety requirements on the operation of laboratories is
not covered by ISO IEC 17025 2005
COMPLIANCE TO THIS STANDARD IMPLIES OPERATION IN ACCORDANCE WITH ISO
CONFORMITY TO THIS STANDARD DOES NOT IMPLY CONFORMITY OF THE LABORATORY
QMS TO ALL THE REQUIREMENTS OF ISO 9001
1 9 2 1 C ONTENTS OF ISO IEC 17025 2005
Management requirements Technical requirements
Organization Personnel
Management system Accommodation and
Document control environmental conditions
Review of request contracts Test calibration methods and
and tenders method validation
Subcontracting Equipment
tests calibrations Measurement traceability
Purchasing services supplies Sampling
Services to the customer Handling of test calibration
Complaints items
Control of nonconformities Assuring the quality of the
Improvement results
Corrective actions Reporting the results
Preventive actions
Control of records
Internal audits
Management reviews
THIS STANDARD PROVIDES RECOMMENDATIONS FOR
COMPETENCE FOR CALIBRATION AND TESTS
METHOD VALIDATION
TRACEABILITY AND UNCERTAINTY
1 9 2 2 G ENERAL REQUIREMENTS ISO IEC 17025 2005
A QMS complying to the requirements of this standard will also meet the principles of
This standard incorporates the requirements to prove the competence to carry out tests
and calibrations including sampling and to generate technically valid data
The specific requirements to ensure measurement traceability method validation and
estimation of the uncertainty of the provided results are emphasized
1 9 2 3 S ELECTION OF TEST CALIBRATION METHODS
Introduction to Quality Management for EDXRF practice Pursuing ISO IEC 17025 2005 accreditation
Section 1 Introduction to Quality Management
The laboratory shall use appropriate methods and procedures for all tests calibrations
within its scope These include sampling handling transport storage and preparation of
the items to be tested calibrated
When the customer does not specify the method to be used the laboratory shall select
methods that have been published in international regional or national standards or by
reputable technical organizations or in relevant scientific texts and journals or as
specified by the manufacturer of the equipment
Although one of the most advantageous features of XRF analysis is its high versatility a
careful selection of a particular method implementation shall be made for each
application One shall be aware that XRF is a phenomenon not a method in itself
based on which a large and diverse groups of analytical solutions have been
implemented While selecting a particular implementation of XRF you shall be aware of
what type of material needs to be analyzed
which elements need to be determined
what is the expected concentration weight fraction of the elements in the sample
what is the expected uncertainty for the results
1 9 2 4 M ETHOD VALIDATION
The laboratory shall validate non standard methods laboratory developed methods and
standard methods used outside their intended scope and amplifications and
modifications of standard methods to confirm that the methods are fit for the intended
CALIBRATION INSTRUCTIONS PURCHASED FROM MANUFACTURER OF CALIBRATION
DEVICES SHALL BE VERIFIED AT LEAST ON FIRST IMPLEMENTATION IN THE PRACTICE
The techniques used for the determination of the performance of a method should be
one or a combination of
calibration using standards or reference materials
comparison with results achieved with other methods
inter laboratory comparisons
systematic assessment of the factors influencing the results
assessment of the uncertainty of the results
In XRF spectrometry is common to use in house developed methods Method validation
is realized by carrying out measurements on appropriate reference material or
comparison with results of reliable independent methods This is due to the fact that
result values in certified reference materials are of a higher metrological level than
individual laboratory results Matrix reference materials are the most commonly used
Method validation is a process of verifying that a method is fit for purpose this
means fit for solving a particular analytical problem
Method validation is a process of establishing the performance characteristics and
limitations of a method and the identification of the influences that may change these
characteristics and to what extent Which analytes can it determine in which matrices
in the presence of which interferences
Introduction to Quality Management for EDXRF practice Pursuing ISO IEC 17025 2005 accreditation
Section 1 Introduction to Quality Management
A collaborative study of a method involves practical testing of the written version of
the method in its specific style and format by a number of laboratories on identical
In house method validation is not a standardized term It is used in this context to
denote the method validation process carried out by one laboratory
Single laboratory method validation This term is used when the method is developed
and validated in the same laboratory
1 9 2 5 E VALUATION OF THE CHARACTERISTICS OF PERFORMANCE OF A METHOD
The main characteristics of performance of the method that shall be assessed during
method validation are
selectivity of the method
linearity when applicable
sensitivity
reproducibility of the results
trueness of the results
uncertainty of the results
detection limits
robustness against external influences and or interferences
1 9 2 6 U NCERTAINTY ESTIMATION CHART
A calibration or testing laboratory shall have and apply
a documented procedure to estimate the uncertainty of
the measurements or calculated results derived from
such measurements
When the nature of the method may preclude rigorous
metrological and statistically valid estimation of
uncertainty the laboratory shall identify all the
components of uncertainty and to make a reasonable
estimation following the steps shown in the chart
Since EDXRF has different quantitative approach or
methodologies for the determination of element
concentration the uncertainty budget must be carried
out for the specific quantitative method used
1 9 2 7 M EASUREMENT TRACEABILITY
All equipment used for tests calibrations including those for subsidiary measurements
having effect for the validity of the results shall be calibrated prior to use The
laboratory shall have an established programme and a procedure for equipment
calibration
Traceability of the measurement standards and measuring instruments to the
International System of Units SI is established by means of an unbroken chain of
Introduction to Quality Management for EDXRF practice Pursuing ISO IEC 17025 2005 accreditation
Section 1 Introduction to Quality Management
calibrations or comparisons linking them to relevant primary standards of the SI units of
measurements
WHEN USING EXTERNAL CALIBRATION SERVICES TRACEABILITY OF THE RESULTS
SHALL BE ASSURED BY THE USE OF CALIBRATION SERVICES FROM LABORATORIES
THAT CAN DEMONSTRATE COMPETENCE MEASUREMENT CAPABILITY AND
TRACEABILITY
CALIBRATIONS THAT CAN NOT BE MADE STRICTLY IN SI UNITS SHALL PROVIDE
CONFIDENCE IN MEASUREMENTS BY ESTABLISHING TRACEABILITY TO APPROPRIATE
MEASUREMENT STANDARDS CERTIFIED REFERENCE MATERIALS SPECIFIED METHODS
OR STANDARDS
Even though traceability to an SI unit is the desired goal direct linkage is not easy and
is not the usual line of approach in XRF analysis The SI unit is rather linked indirectly to
a measurement procedure For this purpose the measurand needs to be defined as a
function of the measurement parameters This provides the working equation that
models the experimental measurement and conditions and ascribe results to the
measurand Subsequently the correctness of the working equation method
specification in representing the real situation is assessed through validation and
uncertainties evaluated
1 9 2 8 S UMMARY ON ISO IEC 17025
You must have learned that ISO IEC 17025 2005 provides recommendations to ensure
the quality and traceability of electrical calibrations via
method validation
traceability
estimation of the uncertainty of the provided results
1 9 3 QUALITY MANAGEMENT IN ANALYTICAL LABORATORIES ISO STANDARDS
APPLICABILITY
Since a quality assurance programme involves more work increased costs and
additional paperwork one may be tempted to ask What are the benefits Is it worth the
The main benefit of a quality assurance programme in an XRF Laboratory is that it
provides assurance to the laboratory itself as well as those who rely on its services
that it is operating under control and that it is producing data of consistent and proven
On the question of costs you should consider the following situation Suppose you are
doing an XRF analysis that cost 100 to perform and for whatever reason you get a
wrong result This means you have just spent 100 to obtain perfectly useless
information Furthermore costly decisions may be made on the basis of this erroneous
information
Quality assurance ensures that most results are correct and that incorrect results are
detected and corrected so that only useful information is produced
Introduction to Quality Management for EDXRF practice Pursuing ISO IEC 17025 2005 accreditation
Section 1 Introduction to Quality Management
1 How can we design a QMS aimed to ensure the quality of measurements in
analytical laboratories Which recommendations and instructions shall be taking
into account as to make such QMS compliant to ISO 9000 standard series
requirements
a We shall follow the ISO 9000 2005 principles using this standard terms
and definitions
b Meeting customer requirements is not an easy task in analytical
laboratories but
2 ISO 9001 2000 provides recommendations that are extremely useful for the
organization of the work if
a the services are designed to meet customer needs customer focus
b the work is organized as a process
c resources are efficiently managed
d procedures and records are maintained
e the quality of the work is monitored and
f actions are addressed to ensure continual improvement
3 ISO IEC 17025 2005 provides recommendations to ensure the quality and
traceability of test and calibrations


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