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Forensic Science International 288 (2018) 1 – 9 Contents lists available at ScienceDirect Forensic Science

Contents lists available at ScienceDirect

Forensic Science International

journal homepage: www.elsevier.com/locat e/f orsciint Review Article The international development of forensic

Review Article

The international development of forensic science standards A review

Linzi Wilson-Wilde

National Institute of Forensic Science, Australia New Zealand Policing Advisory Agency, L6, T3, WTC, 637 Flinders Street, Melbourne, VIC 3008, Australia

T3, WTC, 637 Flinders Street, Melbourne, VIC 3008, Australia A R T I C L E

A R T I C L E

I N F O

Article history:

Received 19 October 2017 Received in revised form 2 March 2018 Accepted 7 April 2018 Available online 16 April 2018

Keywords:

Forensic Science

ISO

Standards

TC272

Standards development

Accreditation

A B S T R A C T

Standards establish speci cations and procedures designed to ensure products, services and systems are safe, reliable and consistently perform as intended. Standards can be used in the accreditation of forensic laboratories or facilities and in the certi cation of products and services. In recent years there have been various international activities aiming at developing forensic science standards and guidelines. The most signi cant initiative currently underway within the global forensic community is the development of International Organization for Standardization (ISO) standards. This paper reviews the main bodies working on standards for forensic science, the processes used and the implications for accreditation. This paper speci cally discusses the work of ISO Technical Committee TC272, the future TC272 work program for the development of forensic science standards and associated timelines. Also discussed, are the lessons learnt to date in navigating the complex environment of multi-country stakeholder deliberations in standards development. Crown Copyright © 2018 Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license ( http://creativecommons.org/licenses/by-nc-nd/4.0/ ).

Contents

1. Introduction

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2. Accreditation and certi cation

 

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3. Standards development

 

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3.1. Country standards development organizations

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3.2. Regional standards development organizations

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4. International Organization for Standardization (ISO)

 

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5. ISO Committee TC272

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6. Conclusions

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7

. Con ict of interest

 

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Acknowledgments

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References

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1. Introduction

Documented standards are an important aspect of life in a modern society. They are aimed at providing con dence to the users of products and services; that those products and services are delivered to a particular level of quality [1] . By using a product or service, delivered in accordance to a standard, the users can have con dence that the product or service is reliable,

E-mail address: linzi.wilson-wilde.nifs@anzpaa.org.au (L. Wilson-Wilde).

works to the expected level and will provide the anticipated outcome. The term standard is often used to describe a number of different types of documents, such as those developed by government recognized Standards Development Organizations (SDOs), education and training standards, or documents that articulate agreed speci cations and are developed by an agency, or group of agencies. Here we focus on standards developed through a formal process via a recognized SDO. SDO standards are documents that specify the quality require- ments for a product or service and in doing so provide guidance to

0379-0738/Crown Copyright © 2018 Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license ( http://creativecommons.org/licenses/by-nc-nd/ 4.0/ ).

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L. Wilson-Wilde / Forensic Science International 288 (2018) 1 9

the supplier in how to deliver the product or service to that benchmark [1] . Standards are practical and do not set aspirational targets; they are not meant to articulate a gold standard, or a minimum standard, but rather a benchmark that balances community expectations against what can realistically be deliv- ered (taking into account technology, market forces, safety etc.). Standards also reinforce a common language that de nes quality and safety criteria, representing a peer-recognised approach to service delivery at a particular point in time. In order to keep pace with changes to community expectations, developments in technology and market place dynamics, standards are reviewed regularly; at least every ve years for an international standard [2] . In a forensic context, standards do not replace the forensic facility s procedure documents, methods or policies. Practitioners continue to determine the appropriate method to apply to a particular process. As standards are voluntary documents, devel- oped by consensus and applied by choice (unless their use is mandated by government or written into a contract), acceptance is contingent upon ownership by a broad base of stakeholders and experts (local, state, federal/national/country agencies and advi- sory bodies, academia, and industry). Traditionally, the forensic industry has remained largely unregulated by governments, with a reliance on voluntary standards and limited public investment in developing forensic- speci c standards. Standards organizations have typically relied on interest groups to propose new standards, with a focus on self- nancing by industry stakeholders. However, over the past decade there has been a strong call internationally for the development of relevant quality forensic standards [3] . While there is a conscious and genuine drive to establish, where possible, internationally applicable and authoritative standards for forensic science, the current picture at the global, regional, or national level is relatively complex. This is in terms of the activities of standard-producing bodies, and the relationships between such bodies and their outputs. This paper provides a review of the current activities in the development of forensic-speci c standards and makes comment on the future direction.

2. Accreditation and certi cation

Standards can be applied through self-regulation, certi cation or accreditation. Self-regulation relies on self-assessment and attestation. There is often a confusion regarding the difference between accreditation and certi cation. Certi cation refers to the provision by an independent body of a written assurance (a certi cate) that the product, service or system in question meets speci c requirements [4] . This is conducted using the require- ments detailed in management-based standards [5] . Accreditation refers to the formal recognition by an independent body (generally known as an accreditation body), using technical experts that a facility operates according to international standards [4] . This is also called conformity assessment and is conducted using competency-based standards [5] . Therefore, certi cation refers to an assessment of a product, service, or system against set requirements, whereas accreditation refers to the assessment of competence, of a body or agency, based on technical knowledge, against set requirements. Certi cation can also apply to a person. Accreditation and certi cation are both undertaken using third- party bodies, which are in turn accredited to perform this service. Many accreditation bodies are signatories to the International Laboratory Accreditation Cooperation (ILAC) [6] . ILAC is the international organization for accreditation bodies operating in accordance with ISO/IEC 17011:2004 Conformity assessment General requirements for bodies providing assessment and accreditation of conformity assessment bodies and supplementary requirements documents [7] . ILAC is involved in the accreditation

of conformity assessment bodies under an international, multilat- eral Mutual Recognition Arrangement (MRA) [8] , also called the ILAC Arrangement. Conformity assessment is conducted on four different types of laboratories/facilities as follows:

Testing laboratories using ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories [9] . This standard includes generic requirements that are applicable to any type of testing laboratory, with an emphasis on the use of validated methodology. It does not specify or seek to standardize the methodology followed within

a particular sector, such as the speci c requirements for sampling and testing in a forensic facility or at the crime scene. Calibration laboratories using ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories [9] . Medical testing laboratories using ISO/IEC 15189:2012 Medical laboratories Requirements for quality and competence [10] . This standard is used by medical laboratories to develop their quality management systems. Inspection bodies using ISO/IEC 17020:2017 Conformity Assess- ment Requirements for the Operation of Various Types of Bodies Performing Inspection [11] , This standard establishes generic criteria for inspection bodies in the examination of materials, products, installations, plant, processes, work proce-

dures or services to provide certi cation. Although this standard has also been applied to crime scene examination laboratories, it does not include speci c requirements for sampling and testing

in a forensic facility or at the crime scene.

The competency-based standards above are developed by the ISO C ommittee on CO nformity AS sessment ( CASCO ) [12] . In a forensic context, these standards are used to accredit the organization as a whole and con rm that the organization is competent to produce a reliable product or service [5] . CASCO limits the number of competency-based standards that are developed and the ILAC MRA limits accreditation to the three standards listed above [8] . Other standards that may be relevant are management-based standards, which are used for auditing/certi cation of products and services as follows:

ISO/IEC 9001:2015 Quality management systems Require- ments [13] . ISO/IEC 14001, Environmental management systems Require- ments with guidance for use [14] .

Management-based standards do not certify the organisation as a whole, but rather an aspect of the organisation, such as the management system [5] . In a forensic context, accreditation to one of the three ILAC prescribed ISO competency-based standards covers the generic aspects of a facility, including management, training and general processes. They do not give speci c guidance to any particular forensic discipline and do not provide any speci c guidance for eld or medical applications. Therefore, in 2007, ILAC developed an additional document that approaches the forensic science process as a whole, and provides common guidance in areas where activities overlap, or where insuf cient instruction is provided (such as for eld-based testing). The resulting document, ILAC G19:08/2014 Modules in Forensic Science Process [15] , provides guidance for laboratories, scene of crime investigation units and other entities involved in examination and testing in the forensic science process. In addition, national accreditation bodies have produced further guidance documents for the application of the ISO

L. Wilson-Wilde / Forensic Science International 288 (2018) 1 9

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competency-based standards [16 20] . Speci c requirements for a discipline or process, not covered in the ISO competency-based standards, can therefore be covered within these documents, providing further guidance. These can then be applied in the accreditation process, and picked up within the scope of accreditation to a competency-based standard and supplement the facility s quality assurance framework. Accreditation of forensic laboratories in the USA is conducted mainly by the ANSI-ASQ National Accreditation Board (ANAB), which in 2016 merged the American Society of Crime Laboratory Directors/Laboratory Accreditation Board (ASCLD/LAB) into its program [21] . The program also accredits forensic facilities outside the USA, including facilities in Mexico, Bangladesh, Caymen Islands, Bermuda, Brazil, Oman, Algeria, New Zealand, Canada Malaysia, and Singapore [22] . The American Association for Laboratory Accreditation (A2LA) is another major agency offering forensic accreditation [23,24] and the National Association of Medical Examiners (NAME) provides voluntary accreditation for Medical Examiner s of ces [25] . In Europe, accreditation is covered under the 2009 European Union Act under the EU Treaty requiring forensic service providers to be accredited [26,27] . In the United Kingdom, accreditation is conducted by the United Kingdom Accreditation Service (UKAS) [28] and in Australia accreditation is conducted by the National Association of Testing Authorities (NATA) [29] . The type of accreditation and who conducts that accreditation for a forensic facility will depend on the services and disciplines offered, coupled to what accreditation options are available. Facilities will need to adopt competency-based standards to be accredited to and the accreditation agency to provide the assessment. Different accreditation agencies may de ne different additional requirements for accreditation and specialise in certain discipline types, such as eld-based, laboratory-based, or medical- based. Certi cation can also be performed by third parties to assess the competence of a person. The relevant standard is ISO/IEC 17024:2012, Conformity assessment General requirements for bodies operating certi cation of persons [30] . The relationship between the facility, methods and practitioners and the quality assurance framework, including accreditation, certi cation and standards is illustrated in Fig. 1.

certi fi cation and standards is illustrated in Fig. 1 . Fig. 1. Relationship between the

Fig. 1. Relationship between the forensic environment and the quality framework, outlining the role of standards. Adapted from Brandi and Wilson-Wilde [26] .

3. Standards development

Within any country, technical involvement in the development of a standard is the responsibility of the SDO. All SDOs are themselves accredited for the development work and representa- tion of the country in the international standards development process. In Australia, the Standards Development and Accreditation Committee (SDAC) accredits SDOs (for example, industry associ- ations) to develop Australian standards and also to represent national interests in international standard development [31] . Many international standards development committees make use of subcommittees (SCs) and working groups (WGs) for various tasks, to reduce delays and to prepare drafts on given subjects, ready for committee discussion and voting. Although members of WGs do not formally represent national interests, the relevant SDO is expected to ensure that the views of members of WGs are in harmony with any established national committee position. The imperative of developing and adopting international standards is also formally stated. The World Trade Organization (WTO) through the Technical Barriers to Trade (TBT) Agreement [32] obliges signatory countries not to raise non-tariff barriers to trade, with speci c provisions relating to standards. Article 2.4 notes that where technical regulations are required, the member country shall use international standards that exist, barring circumstances where fundamental climatic/geographical factors or technological impediments exist [32] . The policy of many national standards bodies is to base their standards on interna- tional standards to the maximum extent feasible, and to use the WTO TBT Agreement as a benchmark. There are many bene ts for active participation in international standardization, including [26,33 34] :

Consistency of practice within and between laboratories/ facilities across countries and sectors. International standards generally re ect the best global experi- ence of industry and regulators. Facilitating participation in international certi cation schemes. Ensuring a country s interests are voiced in the development of international standards. Ensuring a country s obligations to the WTO are met. Increasing professional mobility by de ning standards of quality for all forensic practitioners. Nurturing judicial and societal con dence in forensic facility output due to global applicability.

It is important to note that accreditation to standards is not solely to give guidance to the facility, it is also for the users or purchasers of the product or service. In a forensic context this is law enforcement and the judiciary. When a facility is accredited, it provides con dence to law enforcement and the justice system that that forensic services provided are produced to an appropriate level of quality. This speci ed level of quality can be equated to the purchase of a bicycle helmet for a child. Which one is more likely to provide the purchaser with more con dence the helmet produced to no standard, or the one independently accredited as manufactured in accordance with an international standard? Accreditation/certi cation to a standard provides con dence to the purchaser of the bike helmet, that the helmet is t for purpose. The same can be said for law enforcement and the justice system as the users of forensic services.

3.1. Country standards development organizations

SDOs can be country based or regional. The American Society for Testing and Materials (ASTM International) [35] is the main

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American SDO and has published over 12,000 ASTM International standards. ASTM International has over 140 technical committees including the Forensic Standards Committee E-30 [36] . Committee E-30, created in 1970 and meeting annually, has approximately 685 members and seven subcommittees. It has published approximately 64 standards. The standards are relative- ly short, covering various scienti c methodologies as follows [36] :

E30.01 Criminalistics 38 standards and ve proposed new standards. E30.11 Interdisciplinary seven active standards and two proposed new standards. E30.12 Digital and Multimedia Evidence seven active standards and four proposed new standards. E30.90 Executive eight active standards and no proposed new standards. E30.92 Terminology one active standard and one proposed new standard.

Two further E-30 subcommittees do not have any active or proposed standards. These are support committees: E30.93 Awards and E30.94 Liaison and therefore do not create standards [36] . The United States has a long history of working towards standardized procedures and guidelines. Since 1988 the Federal Bureau of Investigation Laboratory has supported Technical (and later Scienti c) Working Groups (TWGs/SWGs) [37] . There were 21 SWGs in existence in 2014; however, it is thought that many of these will transition into the Organization of Scienti c Area Committees (OSACs) program administered by the National Institute of Standards and Technology (NIST) [37 39] . The OSACs are developing forensic science consensus documents [37] . These documents will promote standardization by detailing minimum requirements, best practices and standard protocols. Butler 2015 provides a good overview of the work being undertaken in the USA, including the SWGs and OSACs [39] . The documents produced by OSAC are voluntary and OSAC approved standards are placed on a public registry. As at the time of writing, there are currently 8 documents listed [38] . OSAC have developed a catalogue of external standards and guidelines produced by various organ- isations around the world and this database is available on their website [38] . It is important to note that the SWGs and OSACs are not government recognised SDOs, so in order to convert OSAC documents to formal standards, OSAC will need to partner with an SDO [39] . The OSAC framework is currently being reviewed [37,39] and the model is anticipated to be adapted. The British Standards Institution (BSI), established in 1901, was the world s rst national standards body [40] . BSI has published over 50,000 standards and has approximately 1200 committees [40] . In 2012 BSI published a Publically Available Speci cation (PAS), PAS 377:2012 Speci cation for consumables used in the collection, preservation and processing of material for forensic analysis. Requirements for product, manufacturing and forensic kit assembly. [41] . The Forensic Science Regulator [42] has also published a Codes of Practice and Conduct for forensic science providers and practitioners in the Criminal Justice System. [18] . The Codes of Practice and Conduct have a series of appendices and guidance documents detailing speci c require- ments for quality forensic science service provision. There are currently eight appendices and nine guidance documents attached to the Codes of Practice and Conduct [42] . Whilst these are guidance documents and not standards, accreditation through UKAS meets the requirements as detailed in the Codes of Practice and Conduct [28] . Australia has developed a number of forensic science standards through Standards Australia and committee CH041 Forensic

Analysis [26,33 34] . To date seven standards have been published as follows [33] :

AS 5239 2011 Examination of ignitable liquids in re debris AS 5388.1 2012 Forensic analysis Recognition, recording, recovery, transport and storage of material AS 5388.2 2012 Forensic analysis Analysis and examination of material AS 5388.3 2013 Forensic analysis Interpretation AS 5388.4 2013 Forensic analysis Reporting AS 5483 2012 Minimizing the risk of contamination in products used to collect and analyse biological material for forensic DNA purposes. This standard is currently still active to allow for manufacturers to transfer over to AS ISO 18385, after which it will be removed. AS ISO 18385:2017 Minimizing the risk of human DNA contamination in products used to collect, store and analyse biological material for forensic purposes

The Australian standard AS 5483 and the AS 5388 series have been used as the basis for developing ISO standards.

3.2. Regional standards development organizations

There are two main regional standards development areas:

Europe and Globally. In Europe there are three of cially recognized standardization organizations [43] :

1. European Committee for Standardization (CEN).

2. European Committee for Electrotechnical Standardization (CENELEC).

3. European Telecommunications Standards Institute (ETSI).

From a global perspective there are two main SDO bodies [1] :

1. International Organization for Standardization (ISO).

2. International Electrotechnical Commission (IEC).

ISO is the largest regional SDO and globally the most signi cant for forensic science standards development, whilst CEN is the main European SDO developing forensic standards. CEN involves 34 European countries [43] and is located in Belgium. CEN will not develop con icting or similar standards to ISO and vice versa [44] . In CEN the Forensic Standards Committee CEN/TC419 Project Committee Forensic science services, is involved in developing forensic standards [45] . TC419 was established in May 2012 in order to work on European standards for forensic science services. In 2017 TC 419 transferred all of its work on developing a set of standards that de ne procedures for forensic science processes, to ISO, using the Vienna Agreement [44] . CEN standards become a European Standard once published and CEN members are obliged to withdraw any pre-existing standards that are in con ict [46] . However, ISO members have the option to adopt and publish international ISO standards and may maintain country standards if they determine they are more applicable [2] ; this is a signi cant distinction between the CEN and ISO environments. European countries may be members of both CEN and ISO. The advantage of CEN membership is that standards can be developed to address speci c European regional issues. In recent years some European regional standards produced by CEN and CENELEC, in the absence of an international standard, have been so widely used internationally that they have become recognised as de facto international standards. Although many SDOs will only adopt standards that are compatible with country practices and methodology, an issue

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arises when regional or national standards, in the absence of international standards, become de facto standards in the view of the judiciary.

4. International Organization for Standardization (ISO)

ISO, located in Switzerland, has published over 21,500 standards and is the largest International regional standards body, made up of 162 countries [1,47] . ISO develops joint standards with IEC. ISO uses Technical and Project Committees in the development of standards. A Technical Committee (TC) is a permanent committee that can be tasked with the development of a standard. A Project Committee (PC) is created for the development of one speci c standard, after which it is disbanded [2] . ISO member countries can sign up to be a P or O member of a PC or TC Committee developing Standard(s). Participating (P) members are voting members who create a mirror committee within their own country SDO. Observing (O) members can attend meetings and make comments, but do not have a vote [2] . The key principles for the ISO standard development process are that the standards should respond to a need in the market, be based on global expert opinion, be developed through a multi-stakeholder process and be based on consensus. Decisions are reached by consensus according to a formula. Within ISO, a decision is passed when two-thirds of the participating member countries who submit a vote are in the af rmative and no more than one-quarter of total possible votes are in the negative [2] . Compliance with the international standards of ISO and IEC remain strictly voluntary (only when standards are cited by regulators do they become mandatory requirements). Standards will be used by industry, SDOs, and regulatory agencies only if they meet the needs of the countries involved. There are strict ISO rules for the development of standards that all member countries must adhere to and are detailed in the ISO Directives Part 1 and 2 [2,48] . From a forensic perspective, the challenge is not to develop standards that are too prescriptive with respect to methodology, recognizing existing accepted practice, but still de ne expectations of reliability and consistency of results. It is also important to have broad stakeholder engagement to ensure applicability and broad community acceptance of the published standards. The ISO process itself follows the following six stages as outlined in the ISO Directives Part 2 [48] : proposal, preparatory, committee, enquiry, approval and publication stages. These are linked to standard draft development stages, which are considered by the Working Groups, Technical/Project Committee and ISO member countries as illustrated in Fig. 2 .

5. ISO Committee TC272

ISO TC272 began as a Project Committee in April 2013. The Project Committee was responsible for developing published standard: ISO/IEC 18385:2016 Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes Requirements [49] . In December 2015, the committee converted to a Technical Commit- tee to develop a broader range of forensic standards. The scope of TC272 is de ned as Standardization and guidance in the eld of Forensic Science [50] . This includes the development of standards that pertain to laboratory and eld-based forensic science techniques and methodology in broad general areas such as the detection and collection of physical evidence, the subsequent analysis and interpretation of the evidence, and the reporting of results and ndings [50] . In addition, TC272 develops standards targeted at manufacturers of forensic equipment and consumables. As at the time of writing, TC272 has 23 participating and 18 observing country members [50] (see Fig. 3 . and Table 1 for details). ISO TC272 has a liaison arrangement, where members from other committees or organizations can participate in the standards development process [2] . The two current TC272 committee liaisons are with ILAC and the International Committee of the Red Cross. TC272 has ve working groups as follows: vocabulary, collection, products, analysis and interpretation and reporting. Fig. 4 illustrates the committee structure and the standards that have or are being developed by each of the working groups. The committee has the following approved standards currently in development:

ISO/FDIS 21043.1 Forensic Sciences Terms, de nitions and framework [51] , currently at Approval Stage 50. ISO/FDIS 21043.2 Forensic Sciences Recognition, recording, recovering, transport and storage of material [52] , currently at Approval Stage 50. ISO/WD 21043.3 Forensic Sciences Analysis and examination of material [53] , currently at Preparatory Stage 20. ISO/WD 21043.4 Forensic Sciences Interpretation [54] , currently at Preparatory Stage 20. ISO/WD 21043.5 Forensic Sciences Reporting [55] , currently at Preparatory Stage 20. ISO/WD 20964 Speci cation for consumables used in the collection, preservation and processing of material for forensic analysis Requirements for product [56] , currently at Prepara- tory Stage 20.

The Committee s Strategic Business Plan can be found on the ISO website [57] . It is hoped that the standards currently in

website [57] . It is hoped that the standards currently in Fig. 2. Illustration of the

Fig. 2. Illustration of the ISO standards development process [48] .

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L. Wilson-Wilde / Forensic Science International 288 (2018) 1 9

/ Forensic Science International 288 (2018) 1 – 9 Fig. 3. World Map outlining the locations

Fig. 3. World Map outlining the locations and type of TC272 members. [50] .

Table 1 Member countries to TC272 as at September 2017 [50] .

Participating member countries

Observing member countries

Australia

Argentina

Austria

Bulgaria

Belgium

China

Canada

Cyprus

Denmark

Czech Republic

Egypt

Finland

France

Iran, Islamic Republic of

Germany

Korea, Republic of

Hungary

Malaysia

Italy

Malta

Japan

Mongolia

Mexico

Philippines

Netherlands

Portugal

New Zealand

Romania

Poland

Slovakia

Russian Federation

Thailand

Serbia

Uganda

Singapore

United Arab Emirates

Spain

Sweden

Switzerland

United Kingdom

United States

development at the Preparatory Stage, will be completed by the end of 2020. In addition to the standards being developed by TC272, there are a number of other ISO committees and standards relevant to forensic science. Joint ISO/IEC Technical Committee 1 (JTC1) [58] has three subcommittees developing standards relevant to forensic science.

1. Subcommittee ISO/IEC JTC 1/SC 27 IT Security Techniques [59] has developed two standards relevant to digital forensics:

ISO/IEC 27042: 2015. Information Technology Security Techniques Guidelines for the Analysis and Interpretation of Digital Evidence [60] . ISO/IEC 27037: 2012. Information Technology Security Techniques Guidelines for Identi cation, Collection, Acqui- sition and Preservation of Digital Evidence [61] .

2. Subcommittee ISO/IEC JTC 1/SC 37 Biometrics [62] is developing the following standard:

ISO/IEC AWI 22842.1 Information technology Biometric performance testing and reporting Part 1: Methodology and tools for the validation biometric methods for forensic evaluation and identi cation application. The standard is currently under development, at Preparatory Stage 20 [63] .

3. Subcommittee ISO/IEC JTC 1/SC 40 IT Service Management and IT Governance [64] has published the following standard:

ISO/IEC 30121:2015 Preview. Information technology Governance of digital forensic risk framework [65] .

Additionally, ISO TC 106/SC 3 Terminology [66] is developing the following standard relevant to forensic science:

ISO/CD 20888. Dentistry Forensic dental data set. The standard is currently under development, at Committee Stage 30 [67] .

All of the above forensic speci c standards may be used as guidance by law enforcement and forensic scientists, however, they are not equivalent to competency-based standards and cannot be used as substitutes for conformity assessment. They can however be utilised within a quality framework, or as previously discussed, independently assessed in third party accreditation within the scope of accreditation to a competency-based standard. There are numerous lessons that can be learnt from the experiences of ISO TC272 to date. Agreement to terminology is vital to the application of the standards and takes signi cant discussion, revision and compromise. Standard development always takes longer than rst thought, is more complicated than anticipated and issues are always raised that were not considered by the drafting committee and during each round of commenting. This demon- strates the importance of the cycles of member country consider- ation at the different ISO stages. However, sometimes a lack of understanding of how the commenting process works is experi- enced. Member countries must provide a suggestion for a change for the Committee to consider. This is not always done and instead an issue is raised, with no suggested alternative. This leaves the Committee to try and reach a solution in the committee plenary, with hundreds of comments to resolve, coupled with language differences between some county members; it can be an almost impossible task. The Committee must often therefore reject the

L. Wilson-Wilde / Forensic Science International 288 (2018) 1 9

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/ Forensic Science International 288 (2018) 1 – 9 7 Fig. 4. Governance structure of ISO

Fig. 4. Governance structure of ISO TC272, highlighting the ve Working Groups (dark grey) and the standards that have been developed (grey with lines), almost competed (grey with dots) and are in the process of being developed (white).

comment based on there being no alternative offered. In these cases, countries have the option to reconsider the comment and resubmit with an alternative during the following commenting period. Occasionally, the comments received demonstrate a lack of understanding of what a standard is. These comments suggest either an aim for the standards to be a gold standard in order to drive an unrealistic change in the short term, or minimum standard so there is no change; both of these positions are incorrect. This is because a standard is a benchmark that the community can achieve at a particular point in time. Some change will often be required, but it must be generally acceptable in the relevant community and generally achievable. There is no point in developing a standard that will take forensic facilities ve years to reach; at that time the standard will need to be reviewed again. Instead a standard should reect what is an accepted benchmark for quality forensic science services at the time of publication, noting that the document is a living document which will be updated and will change and adapt over time, requiring incre- ments of continuous improvement. The development of standards within TC272 requires compro- mise to cater for competing country priorities, which can have a political overlay. Language dif culties in the development process at committee meetings must be taken into account. Country representatives where English is a second language must be given time to consider the discussions and, if required, go back to previous comments to continue discussion. This may make the Committee process take longer, but it ensures all member opinions are taken into account during the discussion and representatives are comfortable, or at least understand the reasoning behind the outcomes and committee resolutions. One concern that is sometimes raised, is that ISO standards can be Euro-centric, as there are often more European country member representatives; the author has not experienced this in uence in the ISO TC272 deliberations. What the author has experienced is the numerous discussions regarding the use of the terms shall , should , may and can . According to the ISO Directives [2] the term shall is a requirement that must be adhered to (100% of the time), should refers to a recommendation (that is preferred), may represents a permission and can refers to a possibility and capability [2] . The issues arise in the application of the terms shall and should in particular, with many discussions regarding

whether clauses should be a requirement or recommendation. Additionally, courts of law and users of the forensic services may interpret a recommendation as a requirement. These terms therefore have signi cant implications for the Committee when writing the standard and many committee discussions and country comments focus on the level attached to the clauses. Once the standards developed by ISO TC272 are published, ISO member countries will need to determine whether to adopt them. In doing this they will need to consider any pre-existing standards that may be similar, such as in the case of Australia, that has existing standards relating to the forensic science process. Country SDO committees can either choose to retain the original country standard, update the original country standard with learnings and requirements from the new ISO standard, or adopt the ISO standard as a replacement to the original country standard. Standards developed under the Vienna Agreement [44] will be adopted by CEN and so it will be compulsory in all CEN member countries to withdraw any pre-existing standards that are in con ict.

6. Conclusions

Global collaboration in any sphere will always be subject to competing country priorities and political overlays. These are further exacerbated by language dif culties and geographical distances in the standard development process. The issue of distance is particularly pertinent to Australia, more so as standard development increasingly focuses on self- nancing by industry stakeholders. The challenge will be to produce standards that are not prescriptive with respect to methodology, but recognise existing accepted practice and form an achievable, cohesive and consoli- dated quality and risk management benchmark for forensic science facility managers and accrediting bodies. The ultimate purpose of a standard however, is not for the service provider, but rather the customer. Independent accreditation to forensic standards pro- vides con dence to police and the judicial system that the forensic services provided are t for purpose and produced to an appropriate level of quality. This aspect cannot be understated and is the ultimate reason why forensic facilities should move to adopt international forensic standards. The work of ISO TC272 will be an important component in that achievement.

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L. Wilson-Wilde / Forensic Science International 288 (2018) 1 9

Con ict of interest

The author declares no con ict of interest.

Acknowledgments

The author would like to thank Stephen Smith for assistance with images and David Neville, Monja Korter and James Brandi for their helpful comments on the manuscript.

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