Dispelling Myths Surrounding ISO/ IEC 17020

Dispelling Myths Surrounding ISO/IEC 17020 Erin Henry - Oklahoma State Bureau of Investigation ByPresenterMedia.com

Objectives Identify the “myths” Provide Background on the Review Process General Comparison – 17025/17020 Detailed Comparison – 17025/17020 Conclusions Background Info for 17020

What Myths? • 17020 is easier than 17025 • 17020 is built around the use of professional judgment instead of testing and is therefore a better fit than 17025 for some disciplines • Crime Scene • Latent Prints • Firearms/Toolmarks • Digital Evidence? • UOM/Traceability is not included with 17020

Background and Process • Reasons for the comparison • Wanted to know if 17020 had any advantages over our current system • Needed to evaluate impact on O.S. 74-150.37 • Method for the comparison • Started by obtaining a copy of ISO/IEC 17020:2012 and reading it • Researched different guidance documents • EA-5/03 M:2008 • IAF/ILAC – A4:2004 • Draft Revision of ILACG19 • Created a correlation table to identify any gaps • Evaluated language on related topics

17020 General Info • Conformity assessment - requirements for the operation of various types of bodies performing inspection • Work can include “the examination of materials, products, installations, plants, processes, work procedures or services, and the determination of their conformity with requirements . . .” (emphasis added) • “Inspection activities can overlap with testing and certification activities . . .” • “ . . . Many types of inspection involve professional judgment to determine acceptability against general requirements . . .”

17020 General Info • Other “new” concepts in 17020: • Independence Requirements – Have to classify the organization as Type A (third party), B (in-house), or C (combination) inspection body. • Management System Requirements • May choose option A which is to fulfill the applicable requirements within 17020 • Or can choose option B which is to fulfill ISO 9001 requirements

17020 Background • IAF/ILAC-A4:2004 “Testing performed by an inspection body may fall into one of two categories namely functional and analytical. . . Analytical testing . . . is a laboratory activity and therefore does not come within the scope of ISO/IEC 17020. Inspection bodies wishing to undertake such laboratory type analytical testing as part of an inspection will need to do so in accordance with the relevant requirements in ISO/IEC 17025.” (emphasis added)

17020 Background - Continued • EA-5/03 M:2008 • Guidance for the Implementation of ISO/IEC 17020 in the field of crime scene investigation • “ . . . However, when analytical techniques are used for analysis of exhibits then ISO/IEC 17020 should not be used and ISO/IEC 17025 should be implemented for this part of a procedure independent of whether it is done on site or in laboratory monitored conditions.”

17020 Background – Continued • ILACG19 Draft – Being developed to provide guidance on the accreditation of forensic science entities regardless of which standard is used (17020 or 17025) • “ . . . Appropriate applications of ISO/IEC 17020 and ISO/IEC 17025 should be made by accrediting bodies based upon the presence or absence of testing in the segment of the forensic science process in question.”

What is testing? From ISO/IEC 17000:2004 Testing – determination of one or more characteristics of an object of conformity assessment, according to a procedure

General Comparison – 17025/17020

Topic Specific Comparison - Personnel • Similarities: • Competence of staff or utilizing staff with appropriate qualifications • Policies/procedures relating to training and qualifications of staff • Documentation of duties, responsibilities and authorities of staff • Records re: education, training, competence, skills, technical knowledge, experience, authorization, (and monitoring)

Personnel Procedures - Requirements 17025 17020 • Identifying needs and providing training • Relevant to present and anticipated tasks • Effectiveness shall be evaluated • Lab formulate goals re: education, training, skills • Competence requirements – education, training, technical knowledge, and skills • Selecting, training, formally authorizing, and monitoring inspectors • Must address 3 stages • Induction period • Mentored work period • Continuing Training • Routine Monitoring

Topic Specific Comparison - Methods • Similarities • Methods should be appropriate for the intended use • Whenever possible should use a “standard method”

Methods - Specific Requirements 17025 17020 • Requires validation (5.4.4) • Guidance on procedure (Note 1) • Scope • Equipment • Data to be recorded • Criteria for approval/rejection, etc. • Topics for validation (detection limit, selectivity, interference from sample, etc.) (5.4.5.3) • Additional Notes • “ . . . use the methods and procedures for inspection which are defined in the requirements against which inspection is to be performed. Where these are not defined, the inspection body shall develop specific methods and procedures . . .” (7.1.1) • Non-standard procedures “shall be appropriate and fully documented.” (7.1.3)

Topic Specific Comparison - Nonconformities • Both standards focus on: • Identifying nonconformities • Determining cause • Correcting the issue • Preventing future occurrences • Reviewing effectiveness

Nonconforming Work - Requirements 17025 17020 • Additional detail in 4.11 • Root cause analysis • Additional notes • Also guidance under section 4.9 • Evaluating need to suspend work • Evaluating significance • Immediate correction • Determination of acceptability • Customer notified and work recalled • Authorizing work to resume • Only addressed through corrective action section • Mostly list format

Closing Thoughts . . . • Does 17020 address UOM and Traceability? • Is 17020 a “better fit” for certain disciplines? • Is 17020 “easier?” • What about “Efficiency of Quality?”

Questions?? Erin.Henry@osbi.ok.gov405-330-6724

Dispelling Myths Surrounding ISO/ IEC 17020