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ASCLD Accreditation Initiative Toolkit

Welcome to the ASCLD Accreditation Initiative (AAI) Toolkit designed to assist forensic science service providers (FSSPs) as they work toward accreditation to an international standard. Here you will find resources to help you design and implement a quality management system.

The ASCLD Accreditation Initiative Toolkit contains information to assist forensic science service providers in preparing for accreditation. The AAI Toolkit is organized into sections related to accreditation and quality management. It explains aspects of quality management and provides links to various resources for laboratories as they develop and implement quality management systems and work toward accreditation.

Accreditation programs for forensic science service providers (FSSPs), or crime laboratories and forensics units, are based on the ISO/IEC 17020 and ISO/IEC 17025 standards. Accrediting bodies, or organizations that award accreditation, have developed supplemental requirements that are specific to forensic science to accompany these ISO/IEC standards.

Accreditation represents the formal recognition to competent laboratories indicating technical competence to perform in conformance with industry standards. It also provides a means for customers to identify and select reliable testing, measurement and calibration services able to meet their needs.

Achieving accreditation represents the ongoing commitment to continue to strive to meet and exceed customer expectations by understanding their objectives, developing and delivering innovative solutions, and becoming an invaluable resource to the customer.

There are 2 accrediting bodies in the United States which accredit forensic service providers. These are A2LA and ANAB. CALEA is an accrediting body that accredits law enforcement agencies, but not for forensic science testing.

A2LA

ANAB

Quality Manuals from Accredited Forensic Service Providers

There are hundreds of accredited laboratories in the United States. While based on the same standards, quality manuals and policies and procedures can vary greatly among laboratories. Below are a sample of quality manuals for reference and inspiration.

This list of terms and definitions is meant to help the user understand terms used in quality management in crime laboratories and forensic units. This list is not exhaustive.

Laboratory accreditation represents the formal recognition to competent laboratories indicating technical competence to perform in accordance with industry standards. It also provides a means for customers to identify and select reliable testing, measurement and calibration services able to meet their needs.

When achieving accreditation, departments will realize an immediate return on investment in cost, time, and resources. An essential outcome of accreditation is to minimize the risk of reporting inaccurate results to the customer through continued conformance to requirements and a commitment to ensuring:

  • Repeatable and validated processes
  • Intentional stakeholder engagement
  • Employee competency and proficiency
  • Dependable customer service
  • Continuous improvement
  • Risk analysis and mitigation
  • Validated systems and practices
  • A quality management system

Achieving accreditation represents the ongoing commitment to continue to strive to meet and exceed customer expectations by understanding their objectives, developing and delivering innovative solutions, and becoming an invaluable resource to the customer.

Here are some benefits of accreditation.

  1. Accreditation improves outcomes and mitigates risks.
  2. Accreditation identifies strengths and gaps in programs and processes. Accreditation reveals what is missing from a lab’s programs and processes and focuses attention on the areas greatest needed.
  3. Accreditation promotes communication and employee empowerment across organizations. It gives each person a better understanding of how they contribute to the organization’s mission. By working toward the same standard, labs begin speaking a common language and can learn from each other’s experiences.
  4. Accreditation fosters a culture of quality and safety. When employees see the positive outcomes of a well-run system, they want to continue making improvements together.
  5. Accreditation can decrease risks and liability costs and adverse events. Other financial benefits that have been cited are improved operational efficiency and reduced liability. Accreditation tells the customers that you have made a commitment to best practices and regulatory requirements.
  6. Accreditation promotes confidence in the laboratory output with all customers, including law enforcement agencies, the criminal justice system and the general public.
  7. ISO accreditation is recognized by all in the forensic science community as the highest achievement indicating scientific and technical competence in accordance with the international standard.

Laboratories that have achieved accreditation offer assurance to customers that they are doing business with technically competent personnel that keeps risk mitigation in mind. To meet the ISO standards, the lab is required to have a good quality management system in place designed to minimize the chance of errors from occurring and the ability to take immediate action when nonconformities do occur. The ISO 17020 and 17025 standards also require labs to implement and track measures like risk-based thinking and continuous process improvement as an iterative process.

The cost of accreditation will vary. To receive a cost estimate, the laboratory should contact the accrediting body for a quote for accreditation and the accreditation cycle.

Please note that annual maintenance for lab equipment, competency and proficiency testing of lab personnel must be considered in the reoccurring costs to maintain accreditation.

On average, it can take 18 – 24 months. However, there are many variables that can impact the speed and progression of reaching your accreditation goal.

Once the laboratory has selected an accrediting body, the laboratory and the accrediting body work together on preparing for accreditation. Prior to submitting an application to the accrediting body, the FSSP should understand the requirements for the accreditation program and the complexities involved in their scope of accreditation.

Many standards are available in forensic science. Standards Development Organizations such as ASTM and ASB have published standards specific to the different disciplines.

The OSAC Registry is a repository of selected published and proposed standards for forensic science. These documents contain minimum requirements, best practices, standard protocols, terminology, or other information to promote valid, reliable, and reproducible forensic results.

The standards on this Registry have undergone a technical and quality review process that actively encourages feedback from forensic science practitioners, research scientists, human factors experts, statisticians, legal experts, and the public. Placement on the Registry requires a consensus (as evidenced by 2/3 vote or more) of both the OSAC subcommittee that proposed the inclusion of the standard and the Forensic Science Standards Board.

OSAC encourages the forensic science community to implement the published and proposed standards on the Registry to help advance the practice of forensic science.

Prior to purchasing the ISO standard, contact the accrediting body to review their accreditation programs and which program is best suited for your lab.

https://www.iso.org/standards.html

Document control refers to a set of procedures intended to oversee the creation, review, approval, release, revisions, distribution, access, storage, security, and disposal of documents. It is the basis upon which compliance, accuracy, integrity, efficiency, and accountability are built. Remember – when you create a document you need to make sure the correct version is available to all that need access to the document.

Those that perform a quality management system audits, gap assessments and internal audits, a common question that people ask is: “Do I need to control this document?” Here are some considerations to be aware of shown below:

Documents can be in any media: “Any media” means that documents can be written in paper, electronic, video, audio or similar formats. The documents can be written, pictorials, flow charts, or a combination of these formats.

Documents Need to be Identified: A simple identifier is the title of the document appearing on the footer or header of each page.

Documents Need to be Approved: Designate a person or group of people with the authority to determine whether documents need to be controlled and approved. Ideally, the person, such as a document control officer, should be someone that is aligned with the strategic direction of the laboratory and understands the implications and impact of the document.

Documents Need to be Controlled Version Control: Documents must have an identifiable version number visible throughout the document to determine if the correct version is being used. The version can be alphanumeric or by date.

Distribution Control: Documents must be made available to individuals that have a need to know and must be easily accessible.

Keeping Document Control Effective
Here are some examples of keeping document control simple:

Document Stamps: Stamps showing the document status such as: “Reference Only,” “Uncontrolled,” “Not a Controlled Document,” “Master Copy,” etc.

Footer Controls: “Not valid if printed,” “Check system for latest version,” “Not valid after 24 Hours,” etc.

Watermark Controls: Using watermark to notate “Draft”, “Controlled”, “Uncontrolled”, etc.

All these are methods of control but can be misunderstood by those using them. Remember, these are controls; however, assessors will always check for effectiveness. Assessors will consider whether or not the laboratory knows where to find the current version of the document.

What is the Most Common Document Control Issue When Employees are Asked: “What Document do you use?”

Employees may point to a document on their laptop or desktop, or pull the document out from their toolbox or desk drawer, and in most cases, these copies are out of date.

Summary of Document Control

Document Control is used to help the laboratory document processes and procedures that are critical to operate. These documents should align with the strategy and help the laboratory meet requirements in a consistent manner.

Organizing documents on your server? View this Document Tree.

A laboratory’s documentation of compliance with the quality manual is measured through an accreditation/audit process. Such accreditation inspections or audits are performed by forensic scientists, either internal or external to the laboratory, and are intended to evaluate and document and operational compliance with established standards.

An internal audit should begin with the team clearly understanding why the audit is being conducted.

The following questions should be answered before the audit begins:

  • Why is audit being conducted?
  • How will the audit support the organization in achieving its goals and objectives?
  • What enterprise risk(s) does the audit address?
  • Was an audit conducted in the past, and if so, what were the results of the previous audit(s)?
  • Have there been significant changes in the process recently or since the previous audit?

Request and obtain documentation on how the process works is the next step in preparing for an audit.

Locate the following information for the audit:

  • All policies, procedure documents, and organization charts
  • Key reports used to manage the effectiveness, efficiency, and process success
  • Access to systems and applications used in daily work
  • Description and listing of master data for the processes being audited, including all data fields and attributes

Before meeting with stakeholders, the internal audit team should hold a meeting to confirm a high-level understanding of the objectives of the audit. Audit planning and the audit plan are important to ensure participant roles and expectations are clear and audit objectives are met.

More Information Coming Soon

More Information Coming Soon

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Accreditation Programs

The accrediting bodies and other external companies provide training and educational resources to assist in understanding the ISO/IEC17020 or ISO/IEC 17025 standards and accreditation program.

Overview of ANAB and the ANAB Accreditation Process

ISO/IEC 17025 for High Level Management

ISO/IEC 17025:2017 Preparation for Forensic Service Providers (Web-based)

Understanding the Requirements and Concepts of ISO/IEC 17025:2017

ISO/IEC 17020:2012 Preparation for Forensic Service Providers (Web-Based)

Understanding the Requirements and Concepts of ISO/IEC 17020:2012

Leadership and Management

ASCLD Leadership Academy

The ASCLD Leadership Academy is a training program for managerial personnel in forensic science laboratories. The Academy is open to ASCLD members and non-members alike. The Academy is comprised of 3 levels which build upon one another. More information on the ASCLD Leadership Academy may be found here.

Forensic Technology Center of Excellence

Resources and education related to operating and managing a lab are available on the Forensic Technology Center of Excellence website:

 
Quality Management Training

There are many opportunities to obtain training and education in quality management both virtually and in-person.

The Annual ASCLD Symposium is held each Spring and includes workshops and plenary sessions which may include topics in quality management.

AFQAM hosts and annual training seminar each Fall. The meeting is comprised of workshops and a plenary session.

 

Measurement Traceability

https://anab.ansi.org/training/measurement-traceability/

Internal Auditing

https://anab.ansi.org/training/forensic-internal-auditing-iso-iec-17025/

https://anab.ansi.org/training/forensic-internal-auditing-iso-iec-17020/

Corrective Action Process and Cause Analysis

https://anab.ansi.org/training/corrective-action-cause-analysis-forensic/

Risk-Based Thinking for Forensic Service Providers

https://anab.ansi.org/training/risk-based-thinking-forensic-service/

Laboratory accreditation represents the formal recognition to competent laboratories indicating technical competence to perform in accordance with industry standards. It also provides a means for customers to identify and select reliable testing, measurement and calibration services able to meet their needs.

When achieving accreditation, departments will realize an immediate return on investment in cost, time, and resources. An essential outcome of accreditation is to minimize the risk of reporting inaccurate results to the customer through continued conformance to requirements and a commitment to ensuring:

  • Repeatable and validated processes
  • Intentional stakeholder engagement
  • Employee competency and proficiency
  • Dependable customer service
  • Continuous improvement
  • Risk analysis and mitigation
  • Validated systems and practices
  • A quality management system

Achieving accreditation represents the ongoing commitment to continue to strive to meet and exceed customer expectations by understanding their objectives, developing and delivering innovative solutions, and becoming an invaluable resource to the customer.

Here are some benefits of accreditation.

  1. Accreditation improves outcomes and mitigates risks.
  2. Accreditation identifies strengths and gaps in programs and processes. Accreditation reveals what is missing from a lab’s programs and processes and focuses attention on the areas greatest needed.
  3. Accreditation promotes communication and employee empowerment across organizations. It gives each person a better understanding of how they contribute to the organization’s mission. By working toward the same standard, labs begin speaking a common language and can learn from each other’s experiences.
  4. Accreditation fosters a culture of quality and safety. When employees see the positive outcomes of a well-run system, they want to continue making improvements together.
  5. Accreditation can decrease risks and liability costs and adverse events. Other financial benefits that have been cited are improved operational efficiency and reduced liability. Accreditation tells the customers that you have made a commitment to best practices and regulatory requirements.
  6. Accreditation promotes confidence in the laboratory output with all customers, including law enforcement agencies, the criminal justice system and the general public.
  7. ISO accreditation is recognized by all in the forensic science community as the highest achievement indicating scientific and technical competence in accordance with the international standard.

Laboratories that have achieved accreditation offer assurance to customers that they are doing business with technically competent personnel that keeps risk mitigation in mind. To meet the ISO standards, the lab is required to have a good quality management system in place designed to minimize the chance of errors from occurring and the ability to take immediate action when nonconformities do occur. The ISO 17020 and 17025 standards also require labs to implement and track measures like risk-based thinking and continuous process improvement as an iterative process.

The cost of accreditation will vary. To receive a cost estimate, the laboratory should contact the accrediting body for a quote for accreditation and the accreditation cycle.

Please note that annual maintenance for lab equipment, competency and proficiency testing of lab personnel must be considered in the reoccurring costs to maintain accreditation.

On average, it can take 18 – 24 months. However, there are many variables that can impact the speed and progression of reaching your accreditation goal.

Once the laboratory has selected an accrediting body, the laboratory and the accrediting body work together on preparing for accreditation. Prior to submitting an application to the accrediting body, the FSSP should understand the requirements for the accreditation program and the complexities involved in their scope of accreditation.

Consider the stakeholder chart below and the impact on those stakeholders when preparing for accreditation. The lab may want to include stakeholders in the planning for accreditation.

Stakeholders Table Image
Stakeholders Table Image
Stakeholders Table Image

The link below will show an example of how documents can be aligned with the ISO 17025:2017 requirements.
Document Tree


  • Begin by reviewing the accreditation programs on their website. For example: www.anab.org and www.a2la.org or https://www.pjlabs.com/
  • Contact accrediting bodies to discuss their program and costs estimates. Also, discuss which ISO standard may be best suited for your lab based on your operations and the scope of accreditation. (ISO 17025:2017 or ISO 17020:2012)
  • Once the lab decides which standard to use and the accrediting body, purchase the standard (www.iso.org)
  • Contact that accrediting body to obtain their checklists/requirements required for accreditation. These checklists are in addition to the ISO standard.

One way is to network with other accredited labs. Other examples:

  • Review documents from accredited laboratories to understand how the manuals are structured and aligned with the ISO requirements.
  • Schedule a visit to observe an assessment or an internal audit of an accredited laboratory.
  • Join ASCLD and have access to over 800 members from domestic and international laboratories, industry, and other forensic organizations.
  • Attend virtual and in-person training from the accrediting body or other resources such a these free webinars: https://www.pjlabs.com/training/pjla-webinars
  • Attend the annual ASCLD symposium to network with other accredited laboratories.
  • Consider assistance from the ASCLD Accreditation Initiative https://www.ascld.org/accreditation-initiative/
  • Check out the resources on the ASCLD Accreditation Initiative Toolkit
  • Dedicate resources to the accreditation process to include a quality manager.

Links to Training Providers

check it out

Video Library

The ASCLD Accreditation Initiative has been funded through the following: The Forensic Technology Center of Excellence (FTCOE), led by RTI International, is supported through a Cooperative Agreement from the National Institute of Justice (NIJ), Office of Justice Programs, U.S. Department of Justice (awards 15PNIJ-21-GK-02192-MUMU, 2016-MU-BX-K110, & 2011-DN-BX-K564). The FTCOE supports the implementation of new forensic technology and best practices by end users and is dedicated to elevating the status of forensic science through advancing technology, sharing knowledge, and addressing challenges. The FTCOE bridges the gap between the scientific and the justice communities.