Transcript Dispelling Myths Surrounding ISO/IEC 17020

Erin Henry - Oklahoma State Bureau of Investigation
By PresenterMedia.com
Objectives
Identify the “myths”
Provide Background on the Review Process
Background Info for 17020
General Comparison – 17025/17020
Detailed Comparison – 17025/17020
Conclusions
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 4.1 Impartiality and Independence (6)
and undue influence
4.2 Confidentiality (3)
4.1.5.c – policies to ensure protection
of customer’s confidential information
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
General Comparison – 17025/17020
17025
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)
6.2.12 – condition of stored items shall be
assessed periodically to detect deterioration.
5.3 Accommodation and
7.2.4 – Requires documented procedures and
Environmental Conditions (5)
appropriate facilities to avoid deterioration or
damage to inspection items.
5.4 Methods and Method
7.1 Inspection Methods and Procedures (9)
Validation (& UOM) (14)
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)
Personnel Procedures - Requirements
17025
•
•
•
•
Identifying needs and providing
training
Relevant to present and anticipated
tasks
Effectiveness shall be evaluated
Lab formulate goals re: education,
training, skills
17020
•
•
•
•
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
•
•
•
•
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
17020
•
•
“ . . . 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
•
•
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
17020
•
•
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??
[email protected]
405-330-6724