John Neuner, Program Manager ASCLD/LAB-International CWAG January 28, 2010 Sacramento, California

Brief history of ASCLD/LAB accreditation in the US The US movement to ISO/IEC accreditation Current issues facing the quality of crime laboratory accreditation ASCLD/LAB’s support of EMA – developing a crime laboratory accreditation program in Mexico

About thirty years ago, in 1982, the first crime laboratories in the US were accredited by ASCLD/LAB in the state of Illinois For the first twenty-two years (from 1982 through 2004), laboratories were accredited to what has become known as the ASCLD/LAB Legacy accreditation standards

ASCLD/LAB Legacy standards were created by crime laboratory directors and maintained and constantly improved by those same crime laboratory directors (known as the ASCLD/LAB Delegate Assembly) The director of each ASCLD/LAB accredited laboratory is a voting member of the Delegate Assembly

371 crime laboratories are currently accredited by ASCLD/LAB (98 in the ISO accreditation program) Including US federal, state, local and private laboratories Including 12 laboratories outside the US

In 2003, the ASCLD/LAB Delegate Assembly voted to transition to the use of ISO/IEC as the foundation for crime laboratory accreditation The new program, based on ISO standards is called the ASCLD/LAB-International program

Today, crime laboratories in the US seeking ASCLD/LAB accreditation must demonstrate conformance with ISO/IEC and the ASCLD/LAB-International Supplemental Requirements for Testing Laboratories How are ISO standards and “supplemental requirements” developed?

A committee of subject matter experts from around the world draft the standards The draft standards are released for public comment and ultimately voted on by all ISO members Each participating country (economy) has a single vote to adopt an ISO standard

When the ISO standards are adopted, each “sector” of a country’s economy that will use the standard has the right to develop what most call “sector specific supplemental requirements”

“Sectors” of an economy may include:  Housing (or building materials)  Automobile industry  Food production  Health Care  Forensic Science  Others

Each “sector” of an economy may develop “sector specific supplemental requirements” The International Laboratory Accreditation Cooperation (ILAC) developed a general set of “sector specific supplemental requirements” for use in forensic science ILAC G19 – available free at

ASCLD/LAB does not use ILAC G19 ILAC G19 was based to a large degree on an outdated version of the ASCLD/LAB Legacy standards (1997) The updating of ILAC G19 is a slow, international process

ASCLD/LAB developed our own set of “sector specific supplemental requirements” for forensic science “ASCLD/LAB-International Supplemental Requirements for Testing Laboratories” Most crime laboratory accrediting bodies around the world use more than ILAC G19 (US, Canada, United Kingdom, Australia, etc.)

ASCLD/LAB is currently updating the “ASCLD/LAB-International Supplemental Requirements for Testing Laboratories.” These should be ready in a few months. The ILAC G19 document is also currently undergoing an update and will likely be finalized late this year or early 2011.

With input from subject matter experts, the ASCLD/LAB Board of Directors drafts all revisions to the supplemental requirements The draft is released to all interested parties for public comment Public comments are considered by the ASCLD/LAB Board of Directors

A second draft is prepared and released for public comment A final version is then released for a thirty- day voting period by all current members of the ASCLD/LAB Delegate Assembly With a positive vote the supplemental standards are adopted

Other accreditation requirements may be developed by “regulators” in a country In US forensic science, an important regulator is the director of the Federal Bureau of Investigation (FBI) who issues quality assurance standards for DNA analysis Public health agencies in some US states also regulate certain toxicology testing (like blood alcohol analysis)

Laboratories seeking ASCLD/LAB- International accreditation in the US must demonstrate conformance with: o ISO/IEC 17025:2005 o Sector specific supplemental requirements o Applicable regulatory requirements

ASCLD/LAB “sector specific” and “regulatory” requirements ensure that using ISO/IEC for accreditation considers issues of importance to forensic science Key issues identified in the US to strengthen the quality of forensic science services are no different than the issues faced in other countries

Making the accreditation of crime laboratories mandatory using internationally accepted standards as the basis for accreditation Ensuring that each person working in a crime laboratory meets minimum education and training standards; can demonstrate technical competence; and receives ongoing developmental training and proficiency testing

Establishing standards for issuing clear and complete test reports Ensuring the use of valid test methods Ensuring that each crime laboratory has an appropriate relationship with any parent body

Ensuring that each laboratory has and follows a comprehensive, documented quality management system Ethics requirements are in place The ASCLD/LAB-International program supports all of these key issues

Over the last twenty-five years, other countries have turned to ASCLD/LAB as a model for implementing their own crime laboratory accreditation program Australia and Taiwan are two examples Other countries have relied on ASCLD/LAB for the direct accreditation of crime laboratories

With current participation in ISO-based accreditation, ASCLD/LAB’s approach to accreditation outside the US has changed The changes will impact how ASCLD/LAB approaches the accreditation of crime laboratories in Central and South America - including Mexico

2008 – ASCLD/LAB was formally recognized by the InterAmerican Accreditation Cooperation (IAAC) 2009 – ASCLD/LAB was formally recognized by the International Laboratory Accreditation Cooperation (ILAC) Following formal, international recognition ASCLD/LAB signed mutual recognition arrangements (MRA) with the IAAC & ILAC

As an IAAC and ILAC MRA signatory, ASCLD/LAB will now work in harmony with other MRA signatories, like the Mexican Accreditation Entity (EMA) As interest in crime laboratory accreditation has grown within Mexico, ASCLD/LAB has worked with EMA to support their development of an accreditation program

ASCLD/LAB representatives continually interact with EMA representative at IAAC and ILAC meetings An ASCLD/LAB representative made a presentation about crime laboratory accreditation during EMA’s celebration of International Accreditation Day in 2008

In cooperation with EMA, ASCLD/LAB presented a week-long assessor training course in Mexico City An EMA representative observed ASCLD/LAB conducting a full assessment of a crime laboratory in the US

In support of the cooperative relationship established by the IAAC and ILAC MRAs, and in accordance with the international approach to “cross border” accreditation, ASCLD/LAB has no plans to offer the direct accreditation of crime laboratories within Mexico unless invited to do so by EMA ASCLD/LAB will continue to support EMA in the development of a crime laboratory accreditation program in Mexico

ASCLD/LAB will respond to certain requests directly from crime laboratory directors within Mexico Having a laboratory representative observe the ASCLD/LAB assessment of a crime laboratory in the US (remember that the EMA program will also be based on ISO/IEC 17025, and the accreditation process will be the same)

Have a laboratory representative attend an ASCLD/LAB-International Assessor Training Course in the US (learning to be an assessor will prepare that person to become a better internal auditor for your own laboratory, and would also prepare that person to become a technical assessor for EMA) Connecting a crime laboratory from Mexico with an ISO accredited laboratory in the US that can share examples of documented, ISO-compliant policies and procedures

ASCLD/LAB fully supports the ongoing efforts to establish a sound crime laboratory accreditation program within Mexico. We stand ready to assist in any way that is mutually agreeable to EMA and in any way that supports the cooperative principles of the IAAC and ILAC MRAs and international, cross border accreditation activities.

To purchase ISO documents To purchase ISO documents (in English) FREE G19 document Program guidance documents that could be helpful ASCLD/LAB interpretations of numerous accreditation requirements

John K. Neuner, Program Manager ASCLD/LAB-International