Transcript De nieuwe ISO 17025

The new ISO/IEC 17025
11 May 1999, Beltest
Peter Vermaercke
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Goals of the new standard based on
lessons from the past
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A document for laboratories (not accredited also) written in lab
language, but it can be used for assessments
A document applicable to both testing and calibration laboratories, that
if applied OK generates technically valid results
Adjust the standard to new ideas, new experiences on the field and new
demands (e.g. professional judgement, developments of new methods,
sampling)
Assure the conformity with ISO 9001 stating that ISO 9001 doesn’t
guarantee competence
A full alignment between ISO and CEN through parallel voting
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A long way before getting there
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'82: first ISO guide 25
'89: draft used to make up EN 45001 under EC pressure
'90: ISO/IEC guide 25
'94: ISO/CASCO WG 10 where both accreditors and
laboratories participate
'97: Committee Draft for public comments and from guide to
International Standard
’98: Further drafts and checking against ISO 9001/2
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The current status is that the end is
near
• Voting ended beginning ‘98
• Formally accepted as standard, but 7 countries (USA, Japan,
Australia, some Europeans) voted against
• New comments in new draft April 20, 1999 (expectation: only a
few votes against now)
• Then: publication of ISO/IEC 17025 with two month voting, no
comments
• End ‘99: formal publication
• EN 45001: Problem: parallel voting required parallel enquiries!
Since this was forgotten: another delay
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The text has changed a lot, not the
essence
• Two parts : 4. Management and 5. Technical requirements
• Technical: broader scope and, more emphasis on measurement
uncertainty, traceability separated for calibration and testing labs and
opinions and recommendations allowed
• QS: Relationship with customer, evaluation suppliers, cause
analysis, effectiveness and preventive actions, opinions
• Also ‘guidance notes’ (cfr L1/Beltest)
• Annex A: Relationship with ISO 9000
• Annex B: specific requirements for competence stating that every lab
is different and needs a different approach according to size, type of
activities, … (lab has to show)
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Full compliance with ISO
9001/2:1994 is guaranteed!
• Compliance with ISO 17025 guarantees that the lab operates in accordance
with ISO 9001:1994 or ISO 9002:1994, not the other way around
 note: compliance of QS for ISO 9001 engages in design/development of new methods or
combining standard/non-standard test methods
 note: ISO 9002 for standard methods
• But ISO 17025 is not a sector specific approach of ISO 9000 (as others),
ISO 9000 is foreseen to be revised in ‘2000 (no solution):
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Note: but, the demand of the labs cause mainly new adjustments in the QS for an alignment
towards ISO 9000, no rewriting in full! ILAC asks that the lab gives clear indication where the
existing documentation addresses the new requirements and identify additions
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How to implement it in assessments
is not clear yet
• ILAC wants a harmonised approach: Workgroup on
 text on ‘bridging’ document between EN 45001 and ISO 17025
and ISO guide 25 (also flexible scope?);
 text on transition period (min. 1 year, max. 2 years!);
• Beltest wants to implement ASAP since we are already close to
ISO 17025
 auditing in normal way + special remarks on typical new items
for one year
 no NBN required to start! No new L1 required
 training of assessors
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Future changes are foreseen but not
for now
• Revision of the whole EN 45000 structure
 difference between 45001/EN45004/EN45011?;
 new structure on ‘functions’;
 alignment of all ISO guides, EN standards to ISO standards
(as done for ISO 17025);
now started: alignment of EN 45003, ISO guide 58, …(concerning auditing
and accreditation of bodies) to ISO standard
 don’t worry: several years ….
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Legend
• New element to be verified by assessor
 no big change in QS and in most cases already there
 since it was already mentioned in L1
• New element to be Verified by assessor
 either big change in QS or in most cases not yet there
• Tips for dealing with this for lab
• Tips for assessor to be realistic
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4.1 Organisation
• Legal identity
• Satisfy needs of the client, regulatory authorities and authorities
providing recognition
• Protection of clients info, property rights, protection of electronic
storage and transmission of data
• Impartiality, independence, integrity
• Responsibilities of key personnel of the large organisation that
influence testing activities (QM, Tech M, Support M)
• Organisational links, responsibilities
• Technical manager, supervision
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4.1 Continued
 Replacement defined
 QM responsible for QS that has direct access to direction
 Organisation chart of departments and organisation chart of
functions in manual
 General function descriptions in manual
 Detailed function descriptions and organisation chart with
names and replacements in separate documents
 Only for people influencing quality
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4.2 Quality System
• QM: policy, system, programmes, procedures, instructions
communicated, understood, available, implemented
• Quality Policy, issued by ‘chief executive’ and contents defined
• Objectives
• QM that makes reference to supporting procedures (also
technical) and define the structure of the QS
• Make a manual a more static document e.g.
policy ( years …) in manual, objectives (yearly) in separate
documents or in mgt review
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4.3 Document Control
• Control of QS documents:
 internal data: manual, procedures, instructions, test methods,
calibration methods, …
 external data: regulations, standards, drawings, software, specs,
….
 written, digital, photo’s, …
• Document approval
 all documents issued to staff shall be reviewed and approved
 master list (or equivalent) with revision status and distribution
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4.3 Document Control
 Authorised editions are available at the location needed
(right document at the right place)
 Invalid or obsolete documents removed or assured against
unintented use
 Obsolete retained documents are marked
 Periodic review and revision of procedures
 Changes should be reviewed and identified
 Amendments by hand defined
 Description of computerised system also for changes
 easily assessable: don’t do any nit picking
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4.4 Review of requests, tenders and
contracts
• Procedures for review of requests, tenders and contracts
 requirements including the methods to be used are defined and
documented
 capacity and resources to meet the requirements
 appropriate test method is selected meeting the clients’
requirements
 difference between request/tender resolved
• Records of reviews of request, tender, contracts
• Client and affected personnel is informed about any
requirement/deviation
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4.4 Contract review: ctd
• For internal clients more simplified
• Capacity, skills and experience mainly reviewed for new things
• Review of non repetitive routine tasks: date and initials of Lab
responsible
• Review of repetitive routine tasks: only review of initial enquiry
• Also oral contracts allowed? Yes, but review to be made and
client to be informed on the choice of the method
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4.5 Subcontracting
• For unforeseen reasons or on a continuing basis to a competent
(ISO 17025) subcontractor
• Client is advised
• Lab is responsible (except when client or authority specifies
subcontractor)
• Register
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4.6 Purchasing
• Procedure for selection and purchasing of services and products
that affect the quality
 data on services and supplies
 reviewed and approved technical content
 procedure for evaluation of suppliers records of evaluations and
list of approved
• Procedure for reception and storage of consumables
• Procedure for incoming inspection and verification to specs
• Make a simple system
• Don’t ask an evaluation or a list for every bottle, glas, ...
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4.7 Service to the client
• Co-operation to clarify requests and the performance in relation
to the work performed
• In QM general clauses on
 reasonable access for witnessing
 preparation of items needed for verification purposes
 how to give advice (is stimulated in this standard)
 information of deviations
• Obtain feedback from client by surveys and discuss in mgt.
review
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4.8 Complaints
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Procedure for resolution of complaints
Investigation of corrective actions see 4.10
Requires more paper: simple form or informatics
Don’t be satisfied with one complaint or a narrow definition of
complaint
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4.9 Control of non conforming work
• Procedure what to do if an aspect of your test does not conform
with the procedure
 evaluation of the significance and remedial actions
 if necessary, client informed and work recalled
• If this non conforming work could reoccur: corrective action
procedure (see 4.10) (feedback to the system)
• Examples: QC, Calibrations, Consumables checks, staff
observations or supervision, checking of test reports, interlab
results, …
• Simple system, no separate form needed for everything!
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Verify this for QC, interlab
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4.10 Corrective actions
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Procedure for CA (corrective actions = feedback to QS)
Cause analysis: determine root cause
Corrective action: to prevent recurrence!
Monitor results of CA’s: are they effective?
Additional audits
Make on your form or database of CA’s clear: What is problem,
What is cause, Who will do what CA by When = action plan
When has it been done? Has it been implemented effectively?
• Use e.g. internal audit for check of effectiveness
• Check of the effectiveness is difficult, but do it
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4.11 Preventive actions
• PA’s = opportunities for needed improvement and to reduce the
likelihood of occurrence of potential sources of non
compliances
• Action plan
• Control for effectiveness
• Use a macroscopic view on data: several IQC, several EQC,
overview of complaints and overview of internal and external
audits to look for similar problems occurring in other fields,
analysis of objectives, … e.g. in a management review
• Don’t be satisfied with one PA
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4.12 Control of records
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Technical and QA-records
Retrievable and traceable, period
Storage, security
Electronic data
Traceable to the job, the person, the date
Mistakes (crossed out, correct value aside, person, …)
• easily assessable: don’t do any nit picking
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4.13 Internal audits
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Planning under responsibility of QM (1 year)
All elements, including testing
Trained, qualified and independent personnel
CA’s defined
Records of audited activities, findings, CA’s
Verification of effectiveness
Use same principle as CA
Don’t be satisfied with one CA
At least two auditors are needed,
Reward a detailed audit
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4.14 Management reviews
• Periodic review for effectiveness of QS (1 year)
• Complete content defined:
 Suitability of policy and procedures
 Reports of managerial personnel and outcome of audits
(internal and external)
 CA’s and PA’s
 EQC, IQC, Client feedback (survey?), complaints
 Changes in volume / type of work
 Resources and training
 Objectives of current year and next year
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4.14 Management review
• Record of review and actions with action plan
• Make a fixed agenda of these meetings (if points are not relevant
just say it) and make minutes of the meeting with an action plan
• Don’t be satisfied with one action on an action plan, but reward
a detailed review
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5.1 General
• The extend to which the factors human, accommodation, validation
of methods, equipment, measurement traceability, sampling, test
items contribute to the total uncertainty of measurement differs from
test to another. These factors shall be taken into account in
developing methods, procedures, training and qualification of
personnel, selection and calibration of equipment, …
• Full measurement uncertainty budget or, if impossible, estimation
of important factors
• Talk to your colleagues
• Auditing is sampling, so audit at least those elements for every test
for sure
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5.2 Personnel
• Ensure competence and authorise (including date) operation of
equipment, performing tests, evaluation of results, signing reports
• Under training: supervision
• Qualified upon education, training, experience, skills and records
 special personnel certification can be mandatory
 note: see special EAL/EA/ILAC guides
 statistical qualification: link it to your uncertainty budget
• Goals for education, training and skills: training needs
• Personnel under employment or under contract (QS and supervision)
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5.2 Personnel
• Job descriptions (responsibilities, required expertise and
experience, qualifications and training programs)
• Special authorisation for sampling, tests/calibrations, issuing
test reports/certificates, giving opinions, operating equipment
• When scope of accreditation includes opinions and
interpretations: verification of this, but the accreditation does
not cover the opinion itself
• Verify qualification, if relevant, and whether they know their
limits, this is what they are allowed to do and not allowed
• Only for people relevant to the scope of accreditation
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5.3 Accommodation
• Everything for a correct performance including environmental
conditions
• Control of the environmental conditions
 control of this dependent upon the importance in the UM
 stopped when it might jeopardise the results
• Cross contamination
• Access based on particular circumstances
• Good housekeeping
 only refer to safety and health procedures when relevant for the QS
• No ‘Fort Knox’, we are not S&H auditors
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5.4 Test methods and validation
• Instructions, where the absence could jeopardise the results readily
available (e.g. standards are there)
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 including sampling, handling, transport, storage, preparation of samples, analysis, statistical
techniques, Id, scope, equipment, RM, env. Conditions, checks, data, uncertainty
 maintained current and readily available
 deviations should be documented, justified, authorised, accepted (by customer?)
Methods that meet requirements, last version
 if no requirements set, you choose published methods
 otherwise, validation for its intended use, agreement with customer (?)
• Design plans for laboratory developed methods
• Non standard tests and new methods shall be validated before use
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5.4 Methods and validation
• Validation parameters according to intended use
 go from solid proof to common knowledge: using RM,
comparison with other methods, interlaboratory comparisons,
systematic assessment, scientific understanding
 choose parameters matched to the needs
• Records of the results, procedure for validation, report of fitness for
use
• Take into account risks, cost, needs and technical possibilities
linking it to the UM
• Here a dialogue and agreement between technical assessor and lab
is needed, no audit
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5.4 Measurement uncertainty
• Procedure for estimating uncertainty for calibrations
 note: calibration = measurements made to establish the traceability chain
• And for test labs (if not statistically, solid estimation)
 uncertainty budget according to GUM-guide
 note: requires a lab to attempt a reasonable estimation e.g. by using professional judgement
• Degree of rigor dependent upon method, client, …
• Where well-recognised test methods specifies limits measurement
uncertainty: to be respected
• All components which are of importance shall be taken into account
 note: if contribution is < 1/5 or 1/10 of the largest contribution then this one can be ignored
 note: predicted long term behaviour not: unless it influences CRM value e.g radiological
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• Here a dialogue between technical assessor and lab is needed, no audit
5.4 Control of data
• Calculations and data transfer to be controlled also back up,
restore, confidentiality
• Computers, automated equipment:
 user developed software: documented and validated
 commercial off the shell (word processing, database,
statistics) are validated
 protection of data
 maintenance and good operation conditions
• Still remains vague how far we can go
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5.5 Equipment
• All equipment available with unique ID
• Calibration for key quantities before use and planned
• Operated by authorised personnel and user instructions
available
• Records: inventory and logbook of checks, calibrations,
maintenance, repairs, …
• Procedures for safe handling, transport, maintenance
• Maintenance plan and repairs: out of use, effect of defect
• Marking or ID of calibrations
• Intermediate checks and adjustments
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5.6 Measurement Traceability
• Calibration labs:
 traceable to SI: primary standards, secondary standards
(calibrated by metrology institute), external calibration by
labs having ISO 17025
 If not available: CRM, interlabs, …
• Testing labs:
 If calibration is dominant factor in uncertainty apply same
as for others, if not, more relaxed
• Reference standards and Reference materials:
 Calibration of RS, RM: CRM or traceable to SI, intermediate
checks, transport and storage
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5.7 Sampling
• Sampling plan and procedures available on site, statistical base
• Client deviations from sampling plan: recorded, included in all
documents and communicated
• Records of all relevant data
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5.8 Test items
• Procedure for transport, receipt, handling, protection, storage
(environmental conditions, security), retention, disposal
• ID so that they can not be confused
• Receipt: NC
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5.9 QC
• Procedures for QC:
 trends are detectable
 statistical techniques
 planned and reviewed monitoring
 CRM or secondary RM
 interlabs
 note: participation to proficiency testing may be a requirement for accreditation
 replicate tests
 retesting
 Type and volume of the work
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5.10 Reports
• Reports with all info as requested by the customer
 note: client is the person placing the order or authorising the contract
• Which may be a simplified way (e.g. internal, written
agreement), all relevant info available
 note: in the case where a legal requirement exists no written agreement is needed
• Content and layout
 statement on compliance/non-compliance with requirements
 uncertainty: where applicable, when relevant to the validity
or application of the result, client instructions, uncertainty
affects compliance
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5.10 Test reports, ctd.
 opinions and interpretations
 where appropriate and needed
 clearly marked
 conformity, fulfilment of contractual requirements, recommendations
of how to use results, guidance for improvements
 compliance against defined, objective criteria: no opinion or
interpretation
 sampling data
• Subcontractors
• Format: electronic, standardised
• Amendments, supplements: standard sentence
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5.10 Calibration Certificates
• Layout
 see test reports
 environment, uncertainty, traceability
 compliance (which clauses)
• Results before and after adjustments
• Nothing on calibration interval
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Conclusion
• QS more aligned with ISO 9000
 better PR
 requires more documentation for labs
 more explicit text reduces the desire and limits the freedom
to adapt QS to new idea’s
• Technical requirements were implicitly already there
• Validation in Belgium already at a high level, but assessor has
bigger power to ask for it
• The Beltest assessments were already at the level of ISO 17025
(for technical certainly, for QS some adjustments)
• Better text for calibration labs, same conclusion for BKO
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References
• Measurement uncertainty:
http://www.vtt.fi/ket/eurachem/publications.htm
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