erin henry - oklahoma state bureau of investigation by presentermedia.compresentermedia.com
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DISPELLING MYTHS SURROUNDING ISO/IEC 17020Erin Henry - Oklahoma State Bureau of Investigation
By PresenterMedia.com
ObjectivesIdentify 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 ILAC G19
• 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• ILAC G19 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
17025 17020
1 Scope 1 Scope
2 References 2 References
3 Terms and Definitions 3 Terms and Definitions
4 Management Requirements 4 General Requirements
4.1.4, 4.1.5 – avoid conflicts of interest and undue influence4.1.5.c – policies to ensure protection of customer’s confidential information
4.1 Impartiality and Independence (6)4.2 Confidentiality (3)
General Comparison – 17025/1702017025 17020
4.1 Organization (16) 5.1 Administrative Requirements (5)5.2 Organization and Management (7)
4.2 Management System (7) 8.1 Management System Requirements (Options) (3)8.2 Management System Documentation (5)
4.3 Document Control (10) 8.3 Control of Documents (8)
4.4 Review of Requests (8) 7.1.5 Requires contract or work order control system which ensures that work to be done is within its expertise, customer requirements are adequately defined, work is controlled by regular review and corrective action
General Comparison – 17025/1702017025 17020
4.5 Subcontracting (4) 6.3 Subcontracting (4)
4.6 Purchasing Services and Supplies (4)
6.2.11 – Where relevant, procedures required for selection and approval of suppliers, verification of incoming goods and services, and ensuring appropriate storage facilities.
4.7 Service to Customer (2)
4.8 Complaints (1) 7.5 Complaints and Appeals (5)7.6 Complaints and Appeals Process (5)
4.9 Nonconforming Work (2-7)
8.7.1 – The inspection body shall establish procedures for identification and management of nonconformities in its operations.
General Comparison – 17025/17020 17025 17020
4.10 Improvement (1)
8.5.3 – management review outputs must include decisions and actions related to improvement of effectiveness of management system and improvement of inspection body related to fulfilling 17020.
4.11 Corrective Action (5) 8.7 Corrective Actions (4-10)
4.12 Preventive Action (2) 8.8 Preventive Actions (3)
4.13 Control of Records (7) 7.3 Inspection Records (2)8.4 Control of Records (2)
4.14 Internal Audits (4) 8.6 Internal Audits (5)
4.15 Management Reviews (2) 8.5 Management Review (5)
General Comparison – 17025/17020
17025 17020
5 Technical Requirements 5 Structural Requirements
5.1 General (2)
5.2 Personnel (5) 6.1 Personnel (13)
5.3 Accommodation and Environmental Conditions (5)
6.2.12 – condition of stored items shall be assessed periodically to detect deterioration.7.2.4 – Requires documented procedures and appropriate facilities to avoid deterioration or damage to inspection items.
5.4 Methods and Method Validation (& UOM) (14) 7.1 Inspection Methods and Procedures (9)
5.5 Equipment (12) 6.2 Facilities and Equipment (15)
General Comparison – 17025/17020
17025 17020
5.6 Traceability (6)
6.2.7 – Overall program of calibration of equipment shall be designed and operated to ensure measurements made by inspection body are traceable to national or international standards of measurement where applicable and available.6.2.8 – Reference standards shall be calibrated providing traceability to national or international standard of measurement.6.2.10 – Reference materials shall, where possible, be traceable to national or international reference materials, where they exist.
General Comparison – 17025/17020
17025 17020
5.7 Sampling (3)7.1.2 – The inspection body shall have and use adequate instructions on inspection planning and on sampling and inspection techniques . . .
5.8 Handling Test Items (4) 7.2 Handling Inspection Items and Samples (4)
5.9 Assuring Quality of Test Results (2)
5.10 Reporting the Results (13) 7.4 Inspection Reports and Certificates (5)
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)
17025• 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
17020
Personnel Procedures - Requirements
Topic Specific Comparison - Methods
•Similarities• Methods should be appropriate for the
intended use• Whenever possible should use a “standard
method”
17025• 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)
17020
Methods - Specific Requirements
Topic Specific Comparison - Nonconformities• Both standards focus on:
• Identifying nonconformities• Determining cause • Correcting the issue • Preventing future occurrences• Reviewing effectiveness
17025• 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
17020
Nonconforming Work - Requirements
Closing Thoughts . . .
•Does 17020 address UOM and Traceability?
• Is 17020 a “better fit” for certain disciplines?
• Is 17020 “easier?”
•What about “Efficiency of Quality?”
