accreditation will it still be needed or will other schemes show up?

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Shanon Skinner
8 years ago
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1 By Leif Madsen, DELTA, President of Eurolab Denmark Member of ISO WG 44 We re facing the revision of ISO 17025, that may entail significant changes in how the laboratories are operated. Other developments might influence the laboratories: larger laboratories Clustering Competition Markets accreditation will it still be needed or will other schemes show up? Such questions and challenges arise, and will Eurolab as an organization be ready to develop together with such changes? 1

Other developments might influence the laboratories: larger laboratories Clustering Competition Markets accreditation

2 Laboratory 1941 Acoustical Laboratory 2015 EMC Testing Wide Range of laboratories Analytical Medical Chemical Environmental Chemistry Pollution Noise Calibration Legal Metrology Equipment Compliance Inspection NDT Product Compliance Reliability EMC MID / FDA 2

Chemistry Pollution Noise Calibration Legal Metrology Equipment

3 Wide Range of requirements EU legislation / EA Directives Regulations EA Documents NB National Body ISO ISO National Conditions of accreditation Sector depended conditions National legislation National regulations Statutory orders Certification bodies Clustering Inclusion / exclusion Tendency in ISO towards Process oriented requirements / guidelines Infrastructure Organization & Personnel Equipment & Facility Methodology Processing Pre processes Core process Post processes Quality Assurance Management Procedures Internal Audit Management review.. 3

Inclusion / exclusion Tendency in ISO towards Process oriented requirements / guidelines Infrastructure Organization & Personnel Equipment &

4 Tendency in laboratories Increased Competition Sectoring (Specialised rather than wide range) Clustering / Mergers Cost efficiency Increased request for proof of compliance Justification of test requirement & conditions Efficiency of test methodology / reduce test time IoT Internet of Things The Internet of Things (IoT) is the network of physical objects or "things" embedded with electronics, software, sensors and connectivity to enable it to achieve greater value and service by exchanging data with the manufacturer, operator and/or other connected devices. Each thing is uniquely identifiable through its embedded computing system but is able to interoperate within the existing internet infrastructure. 4

objects or "things" embedded with electronics, software, sensors and connectivity to enable it to achieve greater value and service by exchanging data with the manufacturer,

5 IoT Roadmap IoT Lab on a chip Miniaturization for chemistry, physics, biology, materials science and bioengineering Danish Technical University DTU: The Lab on a Chip strategic research field devises technology based solutions for problems concerning analysis and synthesis in the fields of biomedicine, environment, and energy. Solutions in the format of microdevices are produced using the materials and fabrication methods developed within the department. Applications range from drug candidate screening through monitoring of viral contamination to engineering of organ like Body on a Chip devices. miniaturized chemical analysis systems detection of chemical reactions in microfluidic systems Microfluidic diagnostic technologies for global public health 5

Solutions in the format of microdevices are produced using the materials and fabrication methods developed within the department.

6 IoT Lab on a chip Nature.com/Insight: The ability to perform laboratory operations on small scales using miniaturized (lab on a chip) devices has many benefits. Small volumes reduce the time taken to synthesize and analyze a product; the unique behavior of liquids at the microscale allows greater control of molecular concentrations and interactions; and reagent costs and the amount of chemical waste can be much reduced. Designing and fabricating such systems is extremely challenging, but physicists and engineers are beginning to construct highly integrated and compact labs on chips with exciting functionality. Recent advances in the application of microfluidic chip based technologies such as chemical synthesis, the study of complex cellular processes and medical diagnostics. Driving parameter: New Applications = Test Methodology IoT Distributed Weather data 6

reagent costs and the amount of chemical waste can be much reduced.

7 IoT Distributed Weather data IoT Distributed Weather Data Data provided to the public 7

8 IoT Air Quality Index (AQI) Pollution IoT Air Quality Index (AQI) Pollution 8

9 IoT Air Quality Index (AQI) Pollution IoT Air Quality Index (AQI) Pollution 9

10 IoT Air Quality Index (AQI) Pollution IoT Air Quality Index (AQI) Pollution 10

11 IoT Challenges Transformation of data into information Reliablity of Measured values traceability Statistics (post processing) Averaging Many > high creditability Selecting Inclusion / exclusion of outliers Compilation Point of measurement (local) Point of interpretation / outliers (regional) Point of dissemination / (global) Who is in control of IoTs Assessment? Eurolab challenges Structure Psychical laboratory / Virtual Laboratory / No Laboratory Laboratories to inspect Virtual Laboratory? Merging Equipment, Method and references Processing approach ISO IoT Lab on a chip New approach methodology validation product assessment IoT Global data Open communication including individual interpretation of data Traceability Average of many > high creditability Impartiality Measuring point National intervention Interpretation of data Algorithms Outliers on a distributed population Proficiency testing / Validation / Verification When Needed? Ömer Güzel: Testing without laboratory facilities may be common practice 11

Eurolab challenges Structure Psychical laboratory / Virtual Laboratory / No Laboratory Laboratories to inspect Virtual Laboratory?

12 Eurolab: Aims and Activities EUROLAB is a not for profit organisation composed of 25 national associations all over the Europe. Grouping over 2,000 conformity assessment bodies and representing over 100,000 technical experts and laboratory practitioners. EUROLAB General Objective Promote cost effective testing, calibration and measurement services, for which the accuracy and quality assurance requirements were adjusted to the actual needs. Key Objectives Representation by formulating and voicing the opinion of laboratories regarding economic, political and technical issues having a direct impact on laboratories activities both on the European scene and world wide Co ordination by interfacing with organisations having activities of interest to the laboratory community, and striving to avoid duplication of efforts and activities EUROLAB should be the major multisectorial and horizontal forum for the circulation and exchange of information and experience in development of Test, measurement and analytical methods The use of test and analytical results in the implementation of legislation and directives, in product certification and acceptance, and in technical evaluations New measurement and testing techniques for example within the EC framework programmes, as well as Quality assurance measures Thank you! 12

EUROLAB General Objective Promote cost effective testing, calibration and measurement services, for which the accuracy and quality assurance requirements were adjusted to the actual needs.

NEW AND GLOBAL + OLD APPROACH PRODUCT LEGISLATION: A. Standard questionnaire to be filled for each sector individually:

IV. NEW AND GLOBAL + OLD APPROACH PRODUCT LEGISLATION: A. Standard questionnaire to be filled for each sector individually: Sector: Noise emission in the environment by equipment for use outdoors Directive