Overview of StandardsRob Bettinson and Katherine MonneryUKAS Awareness Sessions
Overview of Standards What is a Standard? What is ISO and what is an ISO Standard? What standards are available? ISO 9001 ISO/IEC 17025 ISO/IEC 17020
Application of Standards in Forensic Science Forensic Regulators Standard
What is a Standard? A standard is an established norm or requirement It is usually a formal document that establishes uniform technical criteria, methods, processes and practices It may be developed privately or unilaterally, for example by a corporation, regulatory body, military Standards organisations often have more diverse input and usually develop voluntary standards: these might become mandatory if adopted by a government, business contract, etc.
What is ISO? The International Organization for Standardization is a global federation of national standards bodies (ISO member bodies), e.g.: British Standard Institution (BSI) in UK National Standards Authority of Ireland (NSAI) American National Standards Institute (ANSI) in USA
It launches the development of new standards in response to sectors and stakeholders that express a clearly established global need for them.
What is an ISO Standard? A normative document Responding to international need Developed according to consensus procedures Approved by the ISO membership and members of the responsible committee
Adopted by regional & national standards bodies
What is an ISO Standard? ISO standards are developed by technical committees comprising experts from the industrial, technical and business sectors which have asked for the standards. These experts may be joined by representatives of government agencies, testing laboratories, consumer associations, non-governmental organizations and academic circles.
Role of International Standards? International Standards, and their use in technical regulations on products, processes and services play an important role in sustainable development and trade facilitation through the promotion of safety, quality and technical compatibility. Standardization contributes to the basic infrastructure that underpins society including health and environment while promoting sustainability and good regulatory practice.
What Standards are available? ISO 9001:2008 (previously 2000) ISO/IEC 17025:2005 ISO/IEC 17020:1998 Forensic Science Regulator Standard
ISO 9001:2008Quality Management Systems - RequirementsScope of ISO 9001: specifies requirements for a quality management system focuses on the effectiveness of the quality management system in meeting customer requirements consistently provide product that meets customer and applicable regulatory requirements
ISO 9001:2008 Applicable to all organisations irrespective of industry or product Certification not accreditation Offered by Certification Bodies Certification Bodies can be UKAS accredited to ISO 17021 However, Non-accredited Certification Bodies can also offer certification
UKAS and CertificationPeer Evaluation ISO 17011 Government Recognition
UKAS Accreditatio nISO 17021
Certification Body E.g. LRQA, BSI, ISOQAR
Certified Organisation E.g. Police Force or any organisation wishing to be certified
ISO/IEC 17025:2005General requirements for the competence of testing and calibration laboratoriesScope of ISO/IEC 17025: demonstrate that they (laboratories) operate a quality system, are technically competent, and are able to generate technically valid results
specifies the general requirements for the competence to carry out tests and/or calibrations including sampling
ISO/IEC 17025:2005 UKAS assess and accredit directly against ISO/IEC 17025 Two main sections Management Requirements and Technical requirements Used in relation to a variety of types of testing and calibration (flexible in its application) ILAC G19 clarifies the application in a forensic context
UKAS and AccreditationPeer Evaluation ISO 17011 Government Recognition
UKAS Accreditatio nISO 17025 or ISO 17020
Testing Laboratory or Inspection Body E.g. FSS, LGC, Met Police
Customers E.g. Police Forces, Courts, Defence Solicitors
ISO/IEC 17025 vs ISO 9001Fundamental difference:ISO/IEC 17025 covers several technical competence requirements that are not covered in ISO 9001:2000 Certification against ISO 9001 does not in itself demonstrate the competence of the laboratory to produce technically valid data and results.
ISO/IEC 17020:1998 ISO/IEC 17020 applies to inspection activities Historically this standard has covered inspection relating to product design, products, material & equipment installations, plant processes & services. ISO 17020 leaves a lot to interpretation, IAF/ILAC-A4 provides guidance on the application of the standard Inspections can be based on professional judgement Will be used for Scene of Crime accreditation EA-5/03
Use of Standards in Forensic Science
ISO17025 - Laboratory based activities
ISO17020 - Scene of Crime activities
Guidance Documents ISO17025 ILAC G19 Guidelines for Forensic Science Laboratories
ISO17020 EA 5/03 Guidance for the implementation of ISO/IEC 17020 in the field of crime scene investigation
Definition of an objective test from ILAC G19A test which having been documented and validated is under control so that it can be demonstrated that all appropriately trained staff will obtain the same results within defined limits. These defined limits relate to expressions of degrees of probability as well as numerical values.
Forensic TestingObjective tests will be controlled by: Documentation of the test Validation of the test Training and authorisation of staff Maintenance of equipment And where appropriate Calibration of equipment, use of appropriate reference materials, provision of guidance for interpretation, checking of results, testing of staff proficiency, recording of equipment / test performance
Forensic LaboratoryThe term laboratory is often used to mean:-
The organisation being assessed
or The facilities where relevant activities are being carried out e.g. garage / workshop / office/ firing range/photographic studio
The importance of Accreditation in Forensic Science Assessment against internationally recognised standards Allows for the comparability of the quality of evidence presented in cross border cases
Independent assessment by competent third party Demonstration of continuing technical competence Demonstration of impartiality Gives confidence to customers reduces risk
UKAS and Forensic ScienceUKAS has been involved in assessing Forensic laboratories since the 1980s UKAS helped to develop the guidance document ILAC G19 used in the assessment of forensic labs to ISO17025 and is involved in the committee undertaking the revision A range of forensic laboratories are now accredited, from large multi-site organisations to smaller specialist laboratories Agreement between UKAS and the Custodian of the National DNA Database Lab 32
Areas currently accredited include:Drugs, Accelerants, Toxicology, Glass, Paint Toolmarks, Footwear, Vehicles Fingerprints enhancement and comparison Body Fluids, Fibres, BPA DNA Subject and Crime samples, LCN, Paternity
Questioned DocumentsComputer Crime, Mobile Phone Examination, Audio Firearms, FDR, Explosives
Forensic Science Regulators Standard Being developed by the FSR in conjunction with interested parties Comments have been sought and integrated into subsequent drafts Incorporates requirements from ISO17025 and ISO17020 Will be a UK specific standard Organisations wanting to be assessed against the FSR standard will need to be accredited to the appropriate core standard (ISO17025 or ISO17020) Will include additional requirements to the core standard
Forensic Science Regulators Standard Appendices will relate to specific evidence type / activity Invitation to Tender for the production of the Appendices has been published Once the standard is published organisations can request assessment against the Regulators Standard
UKAS will have MoU with FSR Organisations will need to sign a disclaimer with UKAS to allow sharing of information with the FSR The FSR standard will be referenced on the UKAS schedule of accreditation
European Framework DecisionDecision 2009/905/JHA 30 November 2009 Objective to ensure that the results of laboratory activities carried out by accredited FSPs in one Member State are recognised by the authorities responsible for the prevention, detection and investigation of criminal offences as being equally reliable as the results of laboratory activities carried out by FSPs accredited to EN ISO/IEC 17025 within any other Member State. This purpose is achieved by ensuring that FSPs carrying out laboratory activities are accredited by a NAB as complying with EN ISO/IEC 17025
European Framework DecisionApplies to laboratory activities resulting in:a) DNA profile
b) Dactyloscopic data (fingerprints)Laboratory activity means any measure taken in a laboratory when locating and recovering traces on items, as well as developing, analysing and interpreting forensic evidence, with a view to providing expert opinions or exchanging forensic evidence
Overview of Standards
Questions and Discussion?