Overview of Standards

Overview of Standards

Rob Bettinson and Katherine Monnery UKAS Awareness Sessions

• 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


• 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 a Standard?

• 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 ISO?

• 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.

What is an ISO Standard?

• 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.

Role of International Standards?

• ISO 9001:2008 (previously 2000)

• ISO/IEC 17025:2005

• ISO/IEC 17020:1998

• Forensic Science Regulator Standard

What Standards are available?

Quality 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

ISO 9001:2008

UKAS and Certification

UKAS Accreditatio

n

GovernmentRecognition

Certification BodyE.g. LRQA, BSI, ISOQAR

ISO 17021

Certified OrganisationE.g. Police Force or any organisation wishing to be certified

ISO 9001

PeerEvaluation ISO 17011

General requirements for the competence of testing and calibration laboratories

Scope 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

ISO/IEC 17025:2005

UKAS and Accreditation

UKAS Accreditatio

n

GovernmentRecognition

Testing Laboratory or Inspection Body

E.g. FSS, LGC, Met Police

ISO 17025 or ISO 17020

CustomersE.g. Police Forces, Courts, Defence Solicitors

Customer Requirements

PeerEvaluation ISO 17011

Fundamental 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 17025 vs ISO 9001

• 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

ISO/IEC 17020:1998

• ISO17025 - Laboratory based activities

• ISO17020 - Scene of Crime activities

Use of Standards in Forensic Science

• 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

Guidance Documents

Definition of an objective test from ILAC G19

‘A 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 Testing

Objective 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 Testing

The 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

Forensic Laboratory

• 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

The importance of Accreditation in Forensic Science

UKAS and Forensic Science

UKAS has been involved in assessing Forensic laboratories since the 1980’s

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 Documents

•Computer Crime, Mobile Phone Examination, Audio

•Firearms, FDR, Explosives

• 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

Forensic Science Regulators Standard

European Framework Decision

Decision 2009/905/JHA – 30 November 2009

Objective – ‘to ensure that the results of laboratory activities carried out by accredited FSP’s 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 FSP’s accredited to EN ISO/IEC 17025 within any other Member State.’

‘This purpose is achieved by ensuring that FSP’s carrying out laboratory activities are accredited by a NAB as complying with EN ISO/IEC 17025’

European Framework Decision

Applies 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’

• Questions and Discussion?
