ISO 17020 ACCREDITATION &

NAME ACCREDITATION
OUR EXPERIENCE AND REMOVING THE MISCONCEPTIONS

• Barbara C. Wolf, M.D., Districts 5 & 24 Medical Examiner’s Office, FL

• Sally S. Aiken, M.D., Spokane County Medical Examiner’s Office, WA
• Amy C. Gruszecki, D.O., American Forensics, Mesquite, TX
• Ponni Arunkumar, M.D., Cook County Medical Examiner's Office, IL
• Roger A. Mitchell, Jr., M.D., Office of the Chief Medical Examiner,
Washington, DC
 ISO 17020 ACCREDITATION &
NAME ACCREDITATION

Where we are and how we got here

Barbara C. Wolf, M.D., Districts 5 & 24 Medical Examiner’s Office, FL

 THE EARLY DAYS

• 1976: First NAME Accreditation certificates awarded

• 1977: Inspection and Accreditation became a NAME program.
• 2009: Annual inspector training was instituted.
FIRST NAME CORE INSPECTION
 NAME ACCREDITED OFFICES

• Number of accredited offices as of August, 2019:

▪ 83 Fully Accredited
▪ 9 Provisionally Accredited
• The population now served by NAME accredited offices is
approximately 149, 857, 097.
 BLUE=FULL
R E D = P ROV I S I O N A L
 INTERNATIONAL OUTREACH PROGRAM

• 2005: Forensic Medicine Division of the Health Sciences

Authority in the Republic of Singapore becomes first
international office to be accredited by NAME.
• The I & A Committee will continue partnering with the
International Relations Committee to further the NAME
accreditation process on the international level.
 ISO/IEC 17020 PROGRAM

• 2016: NAME entered into an agreement with ANSI-ASQ National

Accreditation Board (ANAB) to develop an ISO/IEC 17020 program for
medical examiner/coroner offices that seek ISO (International
Organization for Standardization) accreditation, either solely or in
addition to accreditation under the NAME Core program
• Ad hoc ISO Transition Committee organized to develop sample policies
aimed at ISO/IEC 17020 requirements to assist offices seeking to apply for
ISO accreditation
 ANAB/NAME JOINT ACCREDITATIONS

• January, 2019: American Forensics, Mesquite, TX becomes first office to

undergo re-accreditation inspection under the NAME Autopsy Services
program jointly with assessment under ISO/IEC Standard 17020

• March, 2019: Office of the Medical Examiner of Cook County, Chicago, IL

underwent inspection for re-accreditation under the NAME core
accreditation program jointly with assessment under ISO/IEC Standard 17020,
as well as under Standard 17025 for forensic toxicology.
THE FUTURE:

Everything that’s old is new again.

ISO 17020 ACCREDITATION AND
NAME ACCREDITATION

Sally S. Aiken, MD
Spokane County Medical Examiner’s Office
 ISO (EQUALS)

• Founded 1947
(72 years)
• 21,740 standards
to date
 NAME RELEVANT STANDARDS

• 9001 Quality management

• 15189 Medical Laboratories—requirements for quality and
competence
• 17020 Conformity Assessment Requirements for the
operation of various types of bodies performing
inspections
• 17025 General requirements for the competence of testing
and calibration laboratories
 ISO NUMBERS?

• 16982 Ergonomics of human-system interaction-usability methods supporting

human-centered design
• 17020 Conformity assessment requirements for the operation of various
types of bodies performing inspections
• 17025 General requirements for the competence of testing and calibration
laboratories
• 17047 Application of Braille on signage, equipment, and appliances
• 17075 Leather-Chemical determination of chromium (VI) content in leather
 OF 21,740 ISO CHOICES, WHY ISO17020?

• No ISO standard is specific to Medical

Examiners/Coroners
• ISO standards tend to be general, large organizations don’t
want to develop quality management systems for each
department/function
• Developing a new ISO standards takes years, and begins
with demonstration of a “market need”.
 ISO STANDARDS IN PLAY

9000 Series ISO 17025

• Quality management for businesses 1987 • For competence of testing and calibration
laboratories-1999 For analytical testing
• Many other ISOs use elements of quality laboratories
management from 9000s
• Many toxicology laboratories
• In ISO 17020, you forego quality
management sections if you already have a • Technical requirements for correctness and
management system compliant with ISO reliability of tests in a laboratory. Focus on
9001 uncertainty, and analytical validation
• 17025 and 17020 have “equal weight” in the
world
• Management requirements similar in 17020
and 17025
 MORE OF THOSE 21,740 ISOS

ISO 15189 ISO 17020!!!!!!

• Came after 17025 (2003), based on • No use of instrumentation for analytical

17025 and ISO 9001 testing

• Designed for Medical Laboratories • RELIANCE ON PROFESSIONAL

JUDGEMENT
• Emphasizes analytical tests
• Focus on impartiality, independence,
• Added patient samples, acceptable confidentiality
turnaround, testing in medical • Similar management system as 17025
emergencies (9001)
 PESKY AND QUIRKY ISO TERMS

• Inspection: examine closely, to compare against established standards. Involves

examination, measurements, testing.
• Inspection: the autopsy
• Inspector: investigator who uses professional judgement at a death scene,
forensic pathologist who performs autopsy
• Inspection body: Medical Examiner or Coroner’s Office
• Inspection system: rules, procedures, and management for carrying out office
functions
ISO 17020 NAME Core
Accreditation
 ISO 17020 VERSUS NAME CORE
ACCREDITATION
ISO 17020 Core Accreditation
• Broader, more generic—need to fit for • More specific requirements: 90% of reports
“bodies performing inspections” in 60 days, Ground faults
• Quality management, Quality management, • 5 items in checklist on QA (A8)
Quality Management 4 items on performance evaluation (G8)
• Ongoing internal audits for improvement, • Yearly checklist completion to maintain
complaint management accreditation
• Technical competence and training • All facets of operation addressed:
emphasis photography, histology, facility etc.
• Much more expensive • Less expensive
• More management, no medicine • The practice of medicine
 WHY C AN’T NAME ADMINISTER NAME
ACCREDITATION AND ISO ACCREDITATION?

• NAME Core Accreditation belongs to us,

we make the rules
• ISO Accreditation is International—we
don’t make the rules
• ISO Accreditation Services: There’s an
ISO for that
• Accreditation bodies are accredited to
ISO 170ll
• Accreditation bodies are signatories to
ILAC—International Laboratory
Accreditation Cooperation
 EXAMPLES OF ACCREDITATION BODIES

• ANAB
• CAP
• Canada: Standards Council of Canada

Private companies that are accredited to perform ISO

Accreditations have a limited number of ISOs in their
repertoire.
 ORDER OF OPERATIONS

▪ ISO 17020 does not supplant NAME

Accreditation
▪ NAME Accreditation is the foundation
▪ It would be difficult to achieve 17020
without Core Accreditation first
▪ ISO 17020 is internationally recognized
and for NAME Accredited offices that
want robust quality management and
continual improvement
 4.1-4.2 Bias and Confidentiality
5.1 Administrative Requirements
5.2 Organization and Management
6.1 Personnel
Quality Assurance and Performance Improvement
6.21-6.25 Facilities
6.2.6-6.2.12 Measurement Traceability
6.2.13-6.2.15 Computers and Defective Equipment
6.3 Subcontracting
7.1-7.1.9 Inspection Methods
7.2-7.4 Handling Inspection Items, Inspection Records, Inspection
Reports and Certificates
7.5-7.6 Complaints and Appeals
Complaints and Appeals Policy
Complaint Tracking Form
8.2-8.3 Management Documentation
8.4 Management System Documentation, Control of Records
ISO 8.5- 8.8
AF Chapter 22 Internal Audit
8.6-8.7 Campobosso
ISO 8.5- 8.8

A complete set of sample ISO 17020 policies is available on the

NAME website, under the Inspection/ Accreditation Tab
NAME ISO 17020 TRANSITION
SUBCOMMITTEE

Commercial: Part 2
TIME THE DEVOURER OF ALL
THINGS.

Metamorphoses, IX, l. 500

Practical Aspects of ISO
Accreditation
Amy C. Gruszecki, MSFS, DO
 ISO Accreditation
• ISO is based on documentation and chain of custody
procedures

• It is applicable to many organizations -manufacturing, health

care, and forensics organizations.

• In my experience very similar to a CAP inspection.

 ISO Accreditation
• ISO Accreditation goes hand in hand with NAME core
accreditation.

• What NAME requires for accreditation - ISO requires proof that

it is being done.

• Example policies are present on the NAME website.

 ISO Accreditation
• Simplified - ISO is

- saying in a procedure that you do something

- and proving up that you do it

- keeping a chain of custody.

 Must demonstrate
• Confidentiality

• No conflict of interest
 Examples
• track the time an autopsy exam starts
• What time the body is removed from the cooler and by whom
• What time the exam ends
• when stock tissue is put away and by whom

• Easy for large organizations with a LIMS

• Smaller organizations can use paper documentation
Some points of contention
 Proficiency testing
• ANAB has accepted the proficiency testing approved by NAME
– The ASCP case studies (Check Samples)
 Calibration
• Calibrate scales

• Rulers that are calibrated (these can be bought!)

• Calibration must be traceable (means there is a certificate).

 Witnessing
• Need to observe another forensic pathologist performing an
autopsy.

• Need to observe court testimony

No defined time intervals!

 Resources involved
• Time
• Lots of office supplies!
• The application fees

• Can use a consultant – though not necessary.

ISO 17020 AND 17025

Cook County Medical Examiner’s Office

 BENEFITS OF ISO ACCREDITATION

• Uniformity of quality systems

• Internationally recognized standard of quality
• Process improvement
• Decreases mistakes
• Regulatory compliance
• Specific expectations
 PROCESS TO ACCREDITATION

• In depth review of all current procedures and processes

• Compare current procedures and processes to ISO 17020 standard
requirements
• Implementation of ISO 17020 requirements
• Quality Manual is essential
• Quality Manager to oversee process
 PROCESS TO ACCREDITATION

• Document root cause analysis and corrective actions for non conformances
• Document management system to house SOPs, non conformances, and
proficiency testing
 ISO 17020 CHALLENGES

• Cost of Accreditation
• Determination of proper scope
• Extensive checklist requirements
• All requirements must be met prior to being granted accreditation. (0
deficiencies allowed)
• Requires a dedicated quality manager to oversee process
• Testing laboratories require ISO 17025 accreditation
 PROCESS CHALLENGES

• NAME and ISO inspection concurrently requires extensive preparation

• ISO stresses on quality management and chain of custody
• NAME stresses on work environment and medicolegal functions of the office.
 Government of the District of Columbia
OFFICE OF THE CHIEF MEDICAL EXAMINER

Preparing for Accreditation

ISO-017020:2012

Roger A. Mitchell Jr. MD

Chief Medical Examiner

District of Columbia
Office of the Chief Medical Examiner
 Dual Accreditation

NATIONAL ACCREDITATION
(National Association of Medical Examiners)

TO

INTERNATIONAL ACCREDITATION
(ISO/IEC 17020:2012 Conformity assessment-Requirements for
the operation of various types of bodies performing inspection)

TO

DUAL ACCREDITATION
 Investment in ISO Accreditation Process

• Investment is to ensure strong foundation and sustainability.

– Reorganization of Records Division to Include Quality Management
– Purchased/Maintained Quality Software
– Identified and Trained Quality Manager in ISO process
– Developed Internal Quality Committee
• Select Managers meet monthly to discuss
quality related issues
– Development of Executive QCAR Review
 Additional Investment

• Investment in an ISO Quality Consultant

– Performed Gap Analysis to for ISO Compliance
– Performed ISO 017020 – NAME Accreditation Checklist Crosswalk
– Prepared Agency for Internal Audit
– Performed Internal Audit
• Established Standard Operating Procedure for the Internal Audit.
Internal Audit Flow Diagram
 Non-Conformities Identified

• Health & Safety (3)

• Proficiency Testing (5) 18 Total
• Personnel/Training (3) Non-
• Expert Testimony (1) Conformities
• Calibration (1)
• Evidence Storage (2)
• Chemical Log (2)
• Labeling Reagents (1)
 Continued Preparation
ISO 17020 ACCREDITATION PREPARATION
1. Written Procedures for Evidence (security/control/handling)
✓ SOP Improvement - SOP # Mort 1.005 – Evidence Collection and Handling
2. Written Reports
✓ Exam Reports (Autopsy and External)
✓ Investigation Reports
✓ Anthropology Reports
3. Technical and Administrative Review of Reports and Supporting Records
✓ SOP Development - SOP # QC 1.001
4. Testimony Monitoring/Moot Court Training for Forensic Pathologists and Death Investigator
➢ MOU Development with the Office of the Attorney General (OAG)
5. Technical Procedures
✓ SOP Development - Death Investigations
6. Training program
✓ Training Manual Draft completed
7. Proficiency testing
➢ Death investigations, Pathology, and Anthropology
8. Corrective and Preventative Action Process
✓ SOP # QC 1.001
✓ SOP # QC1.003
 Appropriation

• Supervisory Records Management Specialist – Grade MS14 FY2015 - $8,333.52

– Move from IT Specialist ($101,860) to Supervisory Records Mgt Specialist
($110,193.52)
• Training ($2000 per person for $12,000)
– ISO Materials $2600
• Qualtrax Implementation and Training - $71,415
– Qualtrax Maintenance $12,500
• Quality Assurance Specialist – Grade CS11, Step 7 FY2016 - $5765
– Move from Records Management Specialist ($59,049) to Quality Assurance
Specialist ($64,814)
• ISO Consultant - Precision Digital Forensics $50,000
• Quality Assurance Specialist – Grade CS12, Step 9 – FY2017 – New Position -
$92,250
• ANAB ISO Inspection Cost – $18,600 Initial Year

$189,548.52
Investment over ~3 years