ISO 17025 - General

requirements for the competence

of testing and calibration
laboratories
Overview
 ISO 17025 Sections
• 1. Scope
• 2. Normative References
• 3. Terms and Definitions
• 4. Management Requirements*
• 5. Technical Requirements*

• * actual accreditation requirements

What this Presentation will cover
• Management Requirements
• Technical Requirements
 Management Requirements
• Basically an ISO 9001 Quality Management
System Model that provides structure
through the following elements:
– Organization
– Quality System
– Document Control
– Review of requests, tenders and contracts
– Subcontracting of tests and calibrations
 Management Requirements
(continued)
• Continued from previous page…
– Purchasing services and supplies
– Service to the customer
– Complaints
– Control of nonconforming testing and/or
calibration work
– Improvement
– Corrective action
 Management Requirements
(continued)
• Continued from previous page…
– Preventive action
– Control of records
– Internal audits
– Management review
 4.1 Organization
• Define the organization of the lab and the
inter-relationships within the lab
• Laboratory must be Legally Identifiable
• Appoint a Quality Manager
• Have an Organization Chart
 4.1 Organization (continued)
• Outline the scope of the Management System and
what it applies to
• You can also list Permissible Exclusions as the
laboratory need not conduct all activities covered
in ISO 17025 such as:
– sampling
– testing
– calibration
– design/development of new methods
 4.1 Organization (continued)
• Appropriate authority and RE$OURCE$
must be provided to ensure quality
• Adequately supervise regular and new
personnel
• Give the right result each and every time
 4.1 Organization (continued)
• Protect clients’ confidential information /
proprietary rights
• Responsibilities of key personnel or
associated staff are defined (identify
potential conflicts of interest)
• Personnel must be free from pressures that
adversely affect work
 4.1 Organization (continued)
• Technical and Quality Manager should be
separate persons whenever possible
 4.2 Management System
• Establish, Implement and Maintain
• Involves documentation for:
– Policies
– Systems
– Programs
– Procedures
– Instructions
 4.2 Management System
(continued)
• Documentation must be
– communicated
– understood
– available to and
– implemented by...

• the appropriate personnel

 4.2 Management System
(continued)
• Quality Policy Statement includes:
– management’s commitment to good professional
practice and service intentions
– standards of service (e.g., client satisfaction,
accuracy, timeliness)
– objectives of quality system
– staff required to know quality system and implement
it
– management’s commitment to comply with ISO
17025 standard
 4.2 Management System
(continued)
• Core document is a Quality Manual
– it should reference other documents

• Defines roles and responsibilities:

– technical management
– quality manager
 4.3 Document control
• All documents must be controlled
• Master list of all documents
• Unique ID, effective date and/or revision #,
total # of pages, authority for issue
 4.3 Document control
(continued)
• Reviewed and approved before issue
• Right procedures in right areas
• Continually review (and revised)
• Prompt removal of invalid/obsolete
documents - they can’t be used!
• Archive obsolete documents
 4.3 Document control
(continued)
• Review and approve changes to documents
• ensure altered or new text is marked, as
practical
 4.3 Document control
(continued)
• Allows for hand-written changes
• Nature of change needs to be identified
• Need procedure to describe how changes
are made in documents maintained in
computerized systems
4.4 Review of Requests, Tenders
and Contracts
• Review includes:
– requirements are adequately defined, documented and
understood
– whether the lab can do the work
– the final contract is equally acceptable in the above
points
– the appropriate method is selected
– any sub-contracting
• Records must include any changes
4.4 Review of Requests, Tenders
& Contracts (continued)
• Customers are notified when deviations
from the contract occur
• Contract amendments undergo the same
review
 4.5 Sub-contracting of tests and
calibrations
• Advise and seek approval from the client,
preferably in writing (specific or partial)
• Ensure sub-contractor is competent…as in
this standard
4.5 Sub-contracting of Tests and
Calibrations (continued)
• Lab is responsible for subcontractor’s work
– unless specified by the client of regulatory
authority
• Maintain a register of all sub-contractors
(includes records)
 4.6 Purchasing of services and
supplies
• Policies/procedures for the selection of
services/supplies
• Use services/supplies of adequate quality -
verified before use
• Formal approval OR procedures to ensure that
services and materials comply with specs (records
kept)
• Maintain records on the history and any QA
approvals of suppliers
 4.7 Service to the customer
• Facilitate clarification of the customer’s
request
• Customer access to relevant testing areas
• Maintain customer contact
• Inform customer of delays or deviations
 4.7 Service to the Customer
(continued)
• Utilize customer feedback to improve
services
• Obtain feed back on regular service
(measurement of customer satisfaction
through surveys)
 4.8 Complaints
• Policy/procedures for resolution of
complaints

• Maintain records of complaints and

corrective actions
 4.9 Control of nonconforming
testing and/or calibration work
• Policy/procedures for handling bad testing
and/or calibration work
• Evaluate the significance of
nonconformance
• Fix the problem
 4.9 Control of Nonconforming
Testing Work (continued)
• Customer notified and work recalled if
necessary
• Potential recurrence brings element 4.11 -
Corrective Action into play
 4.10 Improvement
• Laboratory continually improves the
effectiveness of its management system
through:
– quality policy
– quality objectives
– audit results
– analysis of data
– corrective actions
– management review
 4.11 Corrective Action
• Policies/procedures for corrective action of
nonconforming work or departures from
policies/procedures
• Cause analysis - investigate root cause of
problem
• Identify potential corrective action
• Monitor corrective actions taken
• Special audits when necessary
 4.12 Preventive Action
• Research indicates that you can spend:
– $1 Preventing a problem, OR

– $10 Correcting a problem, OR

– $100 Recalling a defective product/service

• Should be an easy choice

 4.12 Preventive Actions
(continued)
• This is a new concept from ISO 9000
– it is a proactive approach
– involves trend analysis
– involves risk assessment, etc.
• Opportunities for improvement should include:
– Action Plans
– Assessment of effectiveness
 4.13 Control of Records
• Documents are living things that are used

• Records: are dead things that are stored

– Exhumed once in awhile, but generally out of
sight
 4.13 Control of Records
(continued)
• Procedures for identification, collection,
indexing, access, storage, maintenance and
disposition of:
– quality records
– technical records
• Records must be legible, traceable,
retrievable, held secure and in confidence
 4.13 Control of Records
(continued)
• Technical records are retained and contain
sufficient information to establish an audit
trail
• Observations, data and calculations are
recorded at the time they are made
• Mistakes crossed out, corrected and
initialed/signed
 4.13 Control of Records
(continued)
• Keep records for:
– Measurements
– Observations
– Customer information
• Use a pen
• Initial the records so that they are traceable
• Include the date
 4.14 Internal Audits
• Schedule audits

• Performed at least annually

• Address all elements of quality system and

ISO 17025
 4.14 Internal audits (continued)
• Trained auditors

• Independent of activity being audited

• Report findings
 4.14 Internal Audits (continued)
• timely corrective action

• follow-up audits verify effectiveness of

corrective actions
 4.15 Management Reviews
• Those with executive responsibilities will
periodically review:
– supervisor reports
– audit/assessment reports
– corrective/preventive actions
– proficiency results
– increased or new work
– customer feedback and complaints
– resources and staff training
 4.15 Management Reviews
(continued)
• Records of review are kept and follow-up
actions must be executed

• Some consider this to be the most important

element in the standard
 Technical Requirements
• Outlines the elements in attaining
competence to perform specific tests and/or
measurements
 Technical Requirement
(continued)
• General
• Personnel
• Accommodation and Environmental
Conditions
• Test and Calibration Methods and Method
Validation
• Equipment
 Technical Requirements
(continued)
• Measurement Traceability
• Sampling
• Handling and Transportation of Test and
Calibration Items
• Assuring the Quality of Test and
Calibrations Results
• Reporting the Results
 5.1 General
• Outlines the factors contributing to
Correctness and Reliability
• Highlights the uncertainty of measurement
concept
 5.2 Personnel
• Personnel, expanded to 5 paragraphs
– Competence of technical staff & supervision
emphasized
– Policies and procedures to identify training needs
are required
– Personnel should be permanent or contract
– Minimum job description contents given
– Specific personnel assigned specific tests (i.e.,
Authorized Personnel)
 5.3 Accommodation and
Environmental Conditions
• Accommodation and environmental conditions
must be adequate to ensure correct performance
of tests / calibrations
• Tests / calibrations to be stopped if conditions
compromise results
• Incompatible activities to be separated
• Access to facilities to be controlled
• Good housekeeping measures to be in place
 5.4 Methods & Validation
• Test methods must be validated and an
estimate of measurement uncertainty made
• Any method deviation must be documented
• Selected methods must meet client needs
• Reference methods are preferred
• Lab to inform client if client-specified
method not appropriate
 5.4 Methods and Validation
(continued)
• Non-standard methods validated and
approved by customer
• Validation requirements listed
• Uncertainty of Measurement is calculated
• Control of Data through:
– calculations and data transfers
– computers and automated equipment
 5.5 Equipment
• Equipment must be:
– available,
– capable of achieving required accuracy,
– under an established calibration program
– operated by authorized personnel
– uniquely identified
• Equipment must have readily available
instructions on use and maintenance
 5.5 Equipment (continued)
• Records maintained & include location, model
#, maintenance schedule etc. & check that it
meets specifications
• Calibration status indicated
• Out of service equipment identified clearly
• If it goes outside lab, validate before use
• Safeguard against inadvertent adjustment (e.g.,
use passwords for computer control)
 5.6 Measurement Traceability
• Ensure an adequate program for equipment
calibration

• Ensure calibration is traceable to SI units,

Certified Reference Materials (CRM) or
inter-lab validated agreed methods or
consensus standards
 5.7 Sampling
• Ensure sampling procedures are available and
include a statistically valid plan (where
applicable)
• Deviations from the plan are recorded
• Ensure procedures for data recording to
include sampler ID, location, date,
conditions, statistical basis, etc. (i.e.,
traceability)
 5.8 Sample Handling
• Document procedures for sample handling such
as receipt, storage, labeling, disposal
• Ensure test samples are uniquely identified
• Establish acceptance criteria
• Ensure deficiencies recorded and client told
• Ensure lab can provide for sample integrity
• Ensure required environmental conditions
maintained
 5.9 Quality Assurance
• Ensure use of CRM’s & internal reference materials
• Ensure participation in Proficiency Testing
programs
• Ensure insertion of replicates and retesting of
retained samples
• Ensure correlation of sample characteristics
• Ensure documentation & charting of controls &
statistical analysis of data
 5.10 Reporting of Results
• Specifies what test reports should contain including
title, method, result units, signing authority, unique
sample identifier, etc
• Provides for interpretations with basis of such
documented - compliance, sampling information,
variance, test conditions, etc
• Subcontracted work to be identified
• Report amendments identified as “supplemental” &
references original
 5.10 Reporting of Results
(continued)
• Quality is signing your name to the results!