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The ISO17025 standard: Why? What? How?
Presentation · July 2017
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WG 1
Standardisation
Information on
ISO17025
June 2017
by Nele Schmitz
nele.schmitz@thuenen.de
www.globaltimbertrackingnetwork.org
Why ISO17025?
In general
ISO 9001 is the master standard with ISO
17025 being a specific application of that
standard to testing and calibration laboratories
ISO/IEC 17025:2005
General requirements for the competence of testing and calibration
laboratories
ISO/IEC 17025:2005 specifies the general requirements for the competence to carry out tests
and/or calibrations, including sampling. It covers testing and calibration performed
using standard methods, non-standard methods, and laboratory-developed methods.
ISO/IEC 17025:2005 is for use by laboratories in developing their management system for quality,
administrative and technical operations. Laboratory customers, regulatory authorities and
accreditation bodies may also use it in confirming or recognizing the competence of laboratories.
https://www.iso.org/standard/39883.html
3
Process vs. system competence?
standards
system?
Process standard: provides a methodology to perform processes
(series of actions or operations) in a consistent and reproducible way
Management system standard: specifies process requirements that
can be applied to any organization, regardless of the product it
makes or the service it performs.
[IEEE]
Process: System:
A set of interrelated or A set of interrelated or interacting
interacting activities which parts to establish policy and
transforms inputs into objectives, and to achieve those
outputs (results in change) objectives
Level at which work takes Defined for high organizational
place control levels
[IANZ, ISO]
4
Process vs. system
standards
Process standard: provides a methodology to perform processes
(series of actions or operations) in a consistent and reproducible way
Management system standard: specifies process requirements that
can be applied to any organization, regardless of the product it
makes or the service it performs.
[IEEE]
System:
Unifies the focus of A set of interrelated or interacting
different functional units parts to establish policy and
(processes) to the main objectives, and to achieve those
goals of the organization objectives
Defined for high organizational
control levels
[IANZ, ISO 2008]
5
communication The (sub)process(es) of timber tracking
other lab activities
Sampling standard
policies
personnel
Transport & Storage standard
trainees Process
Sample preparation standard standards for
infrastructure procedures Lab analysis consistency
&
supplies documentation reproducibility
Data analysis standard
customers Interpretation of results standard
Reporting
subcontractors
The system standard
System standard to align processes towards the main goal, focus on
process effectiveness and efficiency, consistent performance delivering
customer confidence and transparency of operations within the organisation
[ISO 2008]
6
What we can learn
from the human case
Timber
Prüm convention May 2005: to exchange data regarding DNA, Forest
fingerprints (...) and to cooperate against terrorism terrorism
DNA profiles can be entered into the national database of DNA only GTTN
database
when typed in ISO/IEC certified laboratories
+
ISO 17025:2005 is not sufficient to guarantee the quality of the results.
GTTN
It is essential to show the laboratory working method to the scientific guidelines
community in order to obtain reliable and robust analytical results
[Ricci 2014]
7
ISO/IEC certified laboratories
Labs developed their own working method independently
Only few accredited labs
Quality of the results has been called into question more than once
To generate a reliable genetic profile is not always trivial and
sometimes the interpretation can be subjective
Junk
science !
Statistics are still a challenge
The evolution of the ISO 17025:2005 accreditation in the field of
forensic DNA cannot be separated from sharing the procedures for the
interpretation of the data
[Ricci 2014]
8
Why ISO17025?
An example
World’s first ISO
accredited genebank
2008: International Potato Center
in-vitro genebank
Implementation process up to initial accreditation: 1 year!
Key?
pre-existing documentation
advanced laboratory information systems
high staff motivation
Principles of an ISO compliant quality management system:
transparent
ISO quality management is a process aimed at
internal controls continuous improvement through critical review
regular external review and it is not a final goal
[Galsworthy et al. 2009]
10
Needed:
extensive process & protocol level documentation
information technology infrastructure
consultant to support upper management
activation of in-house expertise: motivation, improvements in
infrastructure & process management
Implementation phase:
managing all documents > Wiki technology Helped identify gaps
standardisation of all documents
training of internal auditors
appointment of an ISO manager to coordinate audits
validation of the processes
further improvement of protocols, procedures, and supporting IT
infrastructure
Helped to manage departure of key staff as new staff
could quickly be incorporated
[Galsworthy et al. 2009]
11
What is ISO 17025?
The structure
Main points of the In what follows focus is on
ISO17025 tests (with timber tracking
tools in mind)
Excl. compliance with
regulatory & safety requirements
on the operation of laboratories
Scope
Who? laboratories carrying out tests and/or calibrations,
including sampling
What? developing their management system for quality, competence of
administrative and technical operations laboratories
How? Normative references
vocabulary
Terms & Definitions Degree to which a set of
inherent characteristics of an
Documents indispensable for application object fulfils requirements
https://www.iso.org/obp/ui/#iso:std:iso-iec:17000:ed-1:v1:en product, service, process, person,
http://jcgm.bipm.org/vim/en/ organisation, system, resource
https://www.iso.org/obp/ui/#iso:std:iso:9000:ed-4:v1:en
Management requirements
Structure & function to perform, check and act
Technical requirements
Accounting for factors determining correctness and reliability of tests
[ISO/IEC 17025: 2005]
13
Main points of the
ISO17025
Exkl. compliance with
regulatory & safety requirements
on the operation of laboratories
Scope
Who? laboratories carrying out tests and/or calibrations,
including sampling
What? developing their management system for quality, competence of
administrative and technical operations laboratories
How? Normative references
vocabulary
Terms & Definitions Degree to which a set of
inherent characteristics of an
Documents indispensable for application object fulfils requirements
https://www.iso.org/obp/ui/#iso:std:iso-iec:17000:ed-1:v1:en product, service, process, person,
http://jcgm.bipm.org/vim/en/ organization, system, resource
https://www.iso.org/obp/ui/#iso:std:iso:9000:ed-4:v1:en
Management requirements
Structure & function to perform, check and act
Technical requirements
Accounting for factors determining correctness and reliability of tests
[ISO/IEC 17025: 2005]
14
Sub-points
Management
requirements
Organisation Frame
Management system the system
Document Control
Review of requests, tenders and contracts Work
Subcontracting of tests do
Purchasing services and supplies
Service to the customer
external check
Complaints
Control of nonconforming testing
Improvement
act
Corrective action
Preventive action
Control of records
Internal audits internal check
Management reviews
[ISO/IEC 17025: 2005]
15
Frame
the system
! management system also
applies to remote sites and
Quality manager
temporary facilities
irrespective of other duties
responsibility and authority for implementation
Organisation of quality management system
lab’s (non)-permanent facilities direct access to highest level of management
technical and managerial personnel
policies and procedures for save info storage and communication
appropriate communication processes
Quality manual
Management system laboratory’s management
documents on policies, systems, programmes, procedures system policies related to
and instructions necessary to assure quality of test results quality
Document Control
procedures to control all documents that form part of its management system
documents are available
documents are periodically reviewed
invalid or obsolete documents are promptly removed
procedures to control document changes
[ISO/IEC 17025: 2005]
16
assessment will be against (i) the
standard (ii) your quality manual
Outline for a quality manual must be a working document!
include as much flexibility as possible
PLAN MAINTENANCE
quality policy statement & accreditation(s) staff records, training and review
organisation and management document control & security
security of premises
job descriptions
approved signatories ADMINISTRATION OF WORK
acceptance of work procedures for: handling of samples,
quality documentation allocation of work, recording of results,
premises and environment quality checking of results, reporting of
results
DO policy on retention & disposal of records
test methods & introduction of new ones
equipment & reference standards CHECK & ACT
traceability of measurements method validation & uncertainty of
calibration and maintenance of measurement
instruments quality control
disposal of samples and other waste non-conforming work
confidentiality procedures for audit & review of quality
system
corrective, preventive action &
improvement
[UNIDO 2009] 17
Frame
the system
Note
When you are assessed, the accreditation body will determine whether you are
compliant on the day of assessment
However, assessors will be far more interested in satisfying themselves that you
have a robust management system which will maintain compliance on a routine
basis. The assessors normally visit only once a year so the steps which you
take to maintain and monitor compliance between visits are a key issue
compliance that day
Assessment
robustness of management
system to maintain compliance
[UNIDO 2009 ]
18
Work
do
Records of reviews and discussions
Review of requests, tenders and contracts with a customer are maintained
following policies & procedures to ensure: Customer informed of any deviation
requirements are well defined and understood from the contract
lab has capability and resources to meet requirements
appropriate test is selected Repeat of review
process if contract needs to
Review also covers
be amended after the start
subcontracted work
Lab is responsible for the
Subcontracting of tests subcontracted work
with a competent subcontractor, e.g. ISO accredited
advise customer (and gain approval) in writing Keep a register of subcontractors
with evidence of ISO compliance
Purchasing services and supplies
policy & procedures for selection, purchase, (reception and storage) of services
and supplies not used until compliance is checked
evaluate suppliers and keep records of these evaluations list approved ones
Purchasing documents not released
until technical content is reviewed
[ISO/IEC 17025: 2005]
and approved
19
Work
external check
Service to the customer
cooperate with customers in monitoring lab performance (e.g. lab access to
witness tests, dispatch items for verification)
seek feedback from customers > improve
Complaints
policy and procedure for resolution of complaints
records of all complaints, investigations and corrective actions taken
[ISO/IEC 17025: 2005]
20
Work
act
Control of nonconforming testing work
policy and procedures to be implemented when work or work results are not conform to
own or customer requirements
Improvement
when nonconforming
management system should be continually improved work could recur
Corrective action
policy and procedure for corrective action when nonconforming work identified
determine root cause(s) of the problem
identify appropriate corrective actions
monitor corrective actions to ensure effectiveness
audit appropriate areas of activities when doubts on general laboratory’s compliance
Preventive action
When improvement opportunities are identified or preventive action required
[ISO/IEC 17025: 2005]
21
Work
internal check
Control of records
procedures for identification, collection, indexing, access, filing, storage, maintenance and
disposal of quality records & technical records
observations, data, calculations
legible & readily retrievable
sufficient to establish audit trail (incl. staff)
secure & in confidence sufficient to repeat tests
records of corrective & preventive accumulations of info indicating
actions, reports from internal whether specified quality or + e.g. HR and customer feedback
audits & management reviews process parameters are achieved
Internal audits & Management reviews
responsibility of
periodically and according to predetermined schedule and procedure
quality manager
of lab activities of management system + lab activities
independent of
by qualified personnel by top management
audited activity
for compliance with for suitability and effectiveness changes
Follow-up management system and or improvements
ISO corrective action
[ISO/IEC 17025: 2005]
22
Sub-points
Technical
requirements
Personnel Frame
Accommodation and environmental conditions
Test methods and method validation Work
Equipment testing
Measurement traceability
Sampling
Handling of test items prior
Assuring the quality of test results
Reporting the results
post
All these factors determine correctness & reliability of tests
All of the following applies when “relevant to
correct performance of tests concerned”
[ISO/IEC 17025: 2005]
23
Frame
Personnel
competence (by education, training or experience) supervision of trainees
job descriptions formulated by lab management
policy & procedures to identify needs, provide and evaluate training
compliance with lab management system supervision
records of competence for all technical personnel
education, training, experience incl. date of
authorisation to perform particular steps of the testing process confirmation
Accommodation and environmental conditions
facilitate correct performance of tests > valid results & required quality particular care when
working in remote or
temporary lab facilities
document technical requirements
monitor, control and record environmental conditions
separate neighbouring areas with incompatible activities
controlled access of areas affecting quality of tests
good housekeeping in the lab
[ISO/IEC 17025: 2005]
24
Work instructions, standards,
manuals, reference data
testing shall be kept up to date
Methods incl. sampling,
Test methods and method validation handling, transport, storage,
preparation of test items
selection of methods
meet customer needs + appropriate for the test
lab shall confirm proper
preferably international, regional or national standards operation of standard
other methods may be used if appropriate and validated methods
> laboratory-developed methods: planned with updates and informed personnel
> non-standard methods
validation of methods confirmation by examination
= objective evidence of fulfilment of requirements for intended use
record results, procedure used and statement on fitness of method
range and accuracy relevant to customers’ needs
estimation of uncertainty of measurement
for all calibrations
min.: identify all components of uncertainty and make reasonable estimation
control of data
[ISO/IEC 17025: 2005]
25
control of data
calculations & data transfers > checks in a systematic manner
computers or automated equipment
software validated
procedures for data protection when using equipment
hardware maintained and provided with appropriate outside permanent control
environmental and operating conditions of the lab > ensure
requirements are met
Equipment
all items of sampling, measurement & test equipment available in the lab
capable of achieving accuracy required & calibrated/checked before use not conform > taken
out of service
operated by authorised personnel
up-to-date procedures for safe handling, transport, storage, use and planned
maintenance
safeguarded from adjustments records of each item of incl. calibration
equipment and its software status
“Frame”
> controlled lab access
[ISO/IEC 17025: 2005]
26
when not possible > traceable to:
certified reference materials
specified methods/consensus
standards
Measurement traceability
measurements are traceable to the International System of Units (SI)
lab programme & procedure for calibration of reference standards
reference materials are traceable to SI units or certified reference materials
procedures for safe handling, transport, storage and use of reference standards
and reference materials > protect their integrity
procedures & schedules
for intermediate checks
[ISO/IEC 17025: 2005]
27
Work
prior
Sampling
procedures for recording relevant data and operations relating to sampling
incl. other recorded data:
lab sampling procedures: sampler id,
environmental
available at sampling location conditions, location
based on appropriate statistical methods
addressing factors to be controlled to ensure validity of test results
Handling of test items
procedures for transportation, receipt, handling, protection, storage, retention and disposal
of test items
to protect integrity
system for identifying test items throughout their lab life
of (secured) items
in doubt of suitability of test item or on specifics of the test required
consult customer before proceeding + record discussion
Assuring the quality of test results
monitor validity of tests to detect trends outside pre-defined criteria planned action
planned & reviewed [ISO/IEC 17025: 2005]
28
Work
post
for internal customers or if
written agreement: test report
can be simplified
Reporting the results
accurately, unambiguously and objectively
usually in a test report incl. all info requested by customer and
incl. deviations from test
where necessary for interpretation: method and info on
identification of test report, lab, customer, test item(s), method specific test conditions
date of receipt and performance of test
sampling procedures (incl. date and location) incl. info on environmental
conditions during sampling
test results + estimated uncertainty of measurement
(results by subcontractors clearly identified) clearly indicated as such and
opinions and interpretations documented
identification of person authorising test report
requirements mentioned
in case of electronic transmission of results under “Control of data” apply
format of reports: designed to accommodate each type of test and to
minimise possibility of misunderstanding or misuse
amendments to test reports: only in form of a further document
if completely new test report > uniquely
[ISO/IEC 17025: 2005]
identified with reference to original
29
How to get
ISO17025
accredited?
Preparatory steps
What you should
know
Time period of the process from application to accreditation
Few months up to a few years depending on the current state of the quality
management
Does the lab already have a quality
Costs manager? Did he/she get already
training in ISO17025? Is there already
Fee rates will depend on various factors, such as: a quality management manual?
the complexity of the accreditation procedure
the scope of the accreditation
the size of the applicant organisation
Additional fees will be payable if several assessors, specialist units, divisions
or public authorities are involved in the process.
Validity of accreditations
Accreditations are generally valid for a period of five years, but must be
monitored on a regular basis.
[www.dakks.de]
31
Formulation of scope
of accreditation
A laboratory will have only some of its methods accredited and
perhaps not even the majority
a laboratory is accredited for a specific list of methods
the laboratory will need to select methods to offer as part of the
scope when it makes its application for accreditation
Overall, the laboratory should select a scope of methods which includes those
it performs routinely and those where either commercial or legal issues make
accreditation advantageous.
The International Laboratory Accreditation Cooperation (ILAC) wrote a
guideline for the formulation of scopes of accreditation for laboratories
[UNIDO 2009]
32
Self-examination for
compliance with
ISO17025
A questionnaire pointing to where you need to make changes and
where your lab is already ISO 17025 compliant is available as an
appendix of this guidebook.
not the whole of ISO 17025 is covered but,
if you get a high score you are very well
placed to make the final adjustments
33
References
Galsworthy, D., et al. (2009). Gaining and maintaining the world's first ISO Accreditation for a
genebank. 15th Triennial ISTRC Symposium. Lima, Peru, International Society for Tropical
Root Crops.
IANZ http://www.ianz.govt.nz/new-article-goes-here/
IEEE https://www.ieee.org/education_careers/education/standards/standards_glossary.html
ISO/IEC 17025:2005. General requirements for the competence of testing and calibration
laboratories.
ISO 2008. ISO 9000 Introduction and Support Package: Guidance on the Concept and Use of
the Process Approach for management systems. ISO/TC 176/SC 2/N 544R3
Ricci, U. (2014). "Establishment of an ISO 17025:2005 accredited forensic genetics laboratory
in Italy." Accreditation and Quality Assurance 19(4): 289-299.
UNIDO (2009). Complying with ISO 17025. A practical guidebook for meeting the requirements
of laboratory accreditation schemes based on ISO 17025:2005 or equivalent national
standards. Vienna, United Nations Industrial Development Organization.
34
The objective of the Global Timber Tracking Network (GTTN) is to promote the operationalization of innovative tools for
wood identification and origin determination, to assist the fight against illegal logging and related trade around the globe.
GTTN is an open alliance that cooperates along a joint vision and the network activities are financed through an open multi-
donor approach. GTTN phase 2 coordination (2017-2019) is financed by the German Federal Ministry of Food and
Agriculture (BMEL).
35
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