John Neuner, Program ManagerASCLD/LAB-InternationalCWAGJanuary 28, 2010Sacramento, California

• Brief history of ASCLD/LAB accreditation in the US

• The US movement to ISO/IEC 17025 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 17025 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 17025 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 www.ilac.org

• 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 17025 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.

www.iso.org To purchase ISO documents

www.ansi.org To purchase ISO documents (in English)

www.ilac.org FREE G19 document

www.ascld-lab.org Program guidance documents that could be helpful

www.ascld-lab.net ASCLD/LAB interpretations of numerous accreditation requirements

John K. Neuner, Program ManagerASCLD/LAB-International

919-773-2600

jneuner@ascld-lab.org

www.ascld-lab.org