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

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

3. 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 for some disciplines
Crime Scene
Latent Prints
Firearms/Toolmarks
Digital Evidence?
UOM/Traceability is not included with 17020

4. Background and Process
Reasons for the comparison
Wanted to know if had any advantages over our current system
Needed to evaluate impact on O.S
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

5. 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 . . .”

6. 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

7. 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 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 ” (emphasis added)

8. 17020 Background - Continued
EA-5/03 M:2008
Guidance for the Implementation of ISO/IEC in the field of crime scene investigation
“ However, when analytical techniques are used for analysis of exhibits then ISO/IEC should not be used and ISO/IEC should be implemented for this part of a procedure independent of whether it is done on site or in laboratory monitored conditions.”

9. 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 and ISO/IEC should be made by accrediting bodies based upon the presence or absence of  testing in the segment of the forensic science process in question.”

10. 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

11. General Comparison – 17025/17020 17025 17020 1 Scope 2 References
3 Terms and Definitions
4 Management Requirements
4 General Requirements
4.1.4, – avoid conflicts of interest and undue influence
4.1.5.c – policies to ensure protection of customer’s confidential information
4.1 Impartiality and Independence (6)
4.2 Confidentiality (3)

12. General Comparison – 17025/17020 17025 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

13. General Comparison – 17025/17020 17025 17020 4.5 Subcontracting (4)
4.6 Purchasing Services and Supplies (4)
– 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.

14. 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
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)

15. 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)
– 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)

16. 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.
– Reference materials shall, where possible, be traceable to national or international reference materials, where they exist.

17. 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)

18. 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)

19. 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

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

21. 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.) ( )
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)

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

23. 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

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

25. Questions??