17025 checklist comments

7/31/2019 17025 Checklist Comments

1/10Updated: Oct 2005Reviewed: Oct 2005 Page 1 of 10

17025CHECKLIST

WITH

INTERPRETATIVECOMMENTS

OCTOBER 2005

This document, based on the Laboratory Assessment Worksheet, includes only thoseclauses of ISO/IEC 17025 where clarification or interpretation has been sought.The interpretative comments are included in the 'Comments' column against the relevantclause(s).

These comments are a result of discussions held by NATA staff and are provided as a guideonly, as each laboratory's system is looked at in terms of its needs and situation.



4 MANAGEMENT REQUIREMENTS

4.1 Organisation

CLAUSE REQUIREMENT COMMENTS

Undue pressure

4.1.5b

ensure arrangements are in place sothat management and personnel arefree from internal and externalcommercial, financial and other

pressures that might adversely affectthe quality of their work

emphasis is on arrangements not a policy orprocedure.

Operationalintegrity

4.1.5d

ensure the laboratory has policies andprocedures to avoid involvement inactivities that compromise theconfidence in its competence,impartiality, judgement or operationalintegrity

laboratories do need to consider this issue.

intent and applicability of this clause will bedependent on both type of testing and size of laband the policies and procedures should thereforereflect this.

examples where this clause may need to beconsidered include staff who haveresponsibilities in production or marketing as wellas testing; acceptance of sub-standard materialsor services, eg. training, calibrations.

clause does require policies and procedures.

may not always be examples of 'conflict ofinterest' evident.

may be link to 4.1.5b.

4.2 Management System

Policies andprocedures

4.2.1

document policies and procedures as amanagement system to ensure qualityof all work and that they arecommunicated, available, understood

and implemented

need to ensure requirements of the Standard aremet in terms of laboratories needs and activities.

management system requirements should bethere to support (and help improve) laboratories

activities.

if variable practices observed during anassessment, may be that documentedprocedures need improving.

Quality policystatement

4.2.2

ensure the quality policy statement isissued under the authority of topmanagement and includes:

the laboratory managementscommitment to good professionalpractice and quality of its service

a statement of the laboratorys

standard of service the purpose of the management

system

a requirement for all personnel to befamiliar with and implement thequality documentation

the laboratory managementscommitment to compliance with theStandard and to continually improvethe management system

these overall objectives are to bereviewed as part of management

review.

quality policy is the labs' document and shouldreflect that "personality".

points need to be addressed to ensure intent hasbeen met rather than literally, eg authority of topmanagement.

labs should be encouraged to consider inclusionof reference to 17025 in next review of their

quality policy.




Quality manual

4.2.2, 4.2.5,

4.2.6

maintain a quality manual that:

defines management system policiesand objectives

includes or makes reference tosupporting procedures, includingtechnical procedures and outlines

structure of the documentation in themanagement system

defines the roles and responsibilitiesof technical management and thequality manager

The quality manual needs to be uniquelyidentified to the laboratory. This does nothowever necessarily mean that it must includethe name, phone number and address.

4.3 Document Control

Approval andissue

4.3.2.1

ensure documents are reviewed andapproved by authorised personnel priorto issue, and are included on a masterlist which identifies the revision statusand distribution

no requirement for amendment record per se.

Identification

4.3.2.3

all management system documentsmust be uniquely identified and includedate of issue and/or revisionidentification, page numbering, totalnumber of pages or a mark to signifythe end of the document, and theissuing authority(ies)

issuing authority doesn't necessarily have to be a"person", can be a "position".

Altered or newtext

4.3.3.2

ensure where practical, the altered ornew text is identified in the document orthe appropriate attachments

new or altered text does not necessarily have tobe identified.

4.4 Review of requests, tenders and contracts

Policies andprocedures4.4.1, 4.4.3

ensure policies and procedures relatedto review of requests, tenders andcontracts are established, maintainedand include:

defining, documenting andunderstanding customerrequirements before commencingwork

laboratorys capability and resources

appropriate method selection

work that is subcontracted by thelaboratory

important that laboratory is capable of doing thework that it commits to.

important that laboratory and its clients agree ontheir requirements initially, ie. at the time ofcontract review.

Records ofreview

4.4.2

maintain records of reviews, includingany significant discussions and/orchanges throughout the contract

evidence of contract review and changes tocontracts will vary depending on the laboratorysneeds, eg. it may be part of sample receiptrecords, order requests or part of a larger projectcontract review being undertaken by theorganisation.




4.5 Subcontracting of tests and calibrations

Competency

4.5.1, 4.5.4

ensure that subcontractors arecompetent (eg accredited laboratory)and records are maintained ofsubcontractors used and theircompetency (eg scope of accreditation)

"competent" needs to be considered on its merits.

requesting copies of endorsed reports is probablya better approach than requesting a copy of thescope of accreditation.

4.6 Purchasing services and supplies

Purchasingdocuments

4.6.3

ensure purchasing documents for itemsaffecting the quality of work arereviewed and approved for technicalcontent prior to release

laboratory must be able to demonstrate that it hasestablished and approved what it is buying fromits suppliers.

4.7 Service to the customer

Cooperation

4.7.1

cooperate with customers to clarifyrequests and monitor laboratory'sperformance whilst ensuringconfidentiality to other customers

no documented procedure required by Standard.

looking for evidence.

part of labs' good business practice.

may be under 'contract review'.

clause is applicable to small in-house testinglabs.

4.8 Complaints

Policy, procedureand records

4.8

document policy and procedure for theresolution of complaints from customersor other parties and ensure records ofthe complaints, investigations andcorrective actions (4.11) are maintained

may be handled through corrective actionprocedure.

4.9 Control of nonconforming testing and/or calibration work

Policies andprocedures

4.9.1

ensure policy and procedures areimplemented when work or results donot conform to own procedures orcustomer requirements and include:

defined responsibilities, authoritiesand actions

an evaluation of the significance ofthe non conforming work

corrective actions and decisionabout the acceptability of thenonconforming work to be takenimmediately

notification of the customer and workrecall, if necessary

defined responsibility for authorisingthe resumption of work.

documentation is required by the Standard.

may be found as part of corrective action, internalaudits and/or preventive action.

examples include QC results out of spec,

calibration/check on a piece of equipment that isout of spec.

defined responsibilities may be included in dutystatements/organisation charts etc.




4.10 Improvement

4.11 Corrective action

4.12 Preventive action

Identification andaction

4.12

ensure needed improvements andpotential sources of nonconformities areidentified and action plans developed,implemented and monitored, usingcontrols to ensure they are effective

useful info provided in the 2 notes to the clause inthe Standard.

don't just look for a preventive action' section inthe quality manual.

look for examples, eg in management andcontract reviews.

not a reaction to "mistakes".

4.13 Control of records

Corrections torecords

4.13.2.3

ensure any changes to the originalrecords (including electronic) are madeso that:

original record is not obscured

correct value entered alongside

alterations signed or initialled by theperson making the correction

equivalent measures must be takenfor records stored electronically

does not specifically require date of change to berecorded. This, however, continues to be goodlab practice and has been included in the fieldapplication documents.

4.14 Internal audits

Requirements

4.14.1

internal audits shall be conductedperiodically and in accordance with apredetermined schedule andprocedure to verify continuingcompliance with the requirements ofthe management system and NAR

quality manager is responsible forplanning and organising audits to becarried out by trained and qualified

personnel independent of activitybeing audited (where resourcespermit)

training can be internal and/or experience basedproviding there are records available todemonstrate this training.

records of qualifications of auditors may be partof staff member's training records.

person carrying out internal audits is to be'independent' where 'resources permit', thereforenot always a requirement.

if external person used to carry out internalaudits then evidence of person's training and/orqualifications to carry out the audits must beavailable in the lab.

lab needs to ensure management system meetsrequirements of the Standard, eg throughmanagement review records, authorisation ofamendments to docs, etc.




4.15 Management reviews

5 TECHNICAL REQUIREMENTS

5.2 Personnel

Authorisedpersonnel

5.2.5

ensure management has authorisedspecific personnel to:

perform specific sampling, testingand/or calibration activities

issue test reports and/or calibrationcertificates and that NATA signatoryapproval has been taken intoconsideration

give opinions and interpretations

(these are only permitted on testreports in the fields of Medical,Veterinary and Forensic testing)

operate particular types ofequipment and that records for alltechnical personnel (includingcontracted personnel) aremaintained for:

relevant authorisation(s) includingdate on which authorisation and/orcompetence is confirmed

competence

educational and professionalqualifications

training, skills and experience

training protocol/procedure (5.2.2) and/or jobdescriptions (5.2.4) may provide the detail andrecords for a lab to demonstrate authorisationand competence.

how specific training records need to be isdependent on type of testing/calibration activityand how detailed the supporting documentationis.

5.3 Accommodation and environmental conditions

5.4 Test and calibration methods and method validation

Uncertainty of

measurement

5.4.6.1

calibration laboratories or testing

laboratories performing their owncalibrations must have and implementprocedures for estimating theuncertainty of measurement for allcalibrations

must be raised and discussed with lab staff as

per field application document.




5.5 Equipment

5.6 Measurement traceability

5.7 Sampling

Procedures andplan

5.7.1

ensure procedures for sampling areavailable at the sampling location andinclude:

a sampling plan (based onappropriate statistical methods,wherever reasonable)

factors to be controlled to ensurevalidity of the test/calibration results

further discussions being held at field and AAClevel, eg in relation to where and when it appliesand whether or not accreditation will be availablefor the sampling plan aspect of this clause.

5.8 Handling of test and calibration items

5.9 Assuring the quality of test and calibration results

5.10 Reporting the results

Test reports andcalibrationcertificates

5.10.1, 5.10.8

results of tests and calibrations mustbe reported accurately, clearly,unambiguously, objectively and inaccordance with any specificinstructions in the methods

test reports and calibrationcertificates must include allinformation requested by thecustomer, required by the methodand necessary for the interpretationof the test or calibration results

results may be reported in asimplified way when performed forinternal customers or in the case of awritten agreement with customer,however, any information notreported to the customer, but is

normally required to be, must bereadily available in the laboratory

test reports and calibrationcertificates must be designed toaccommodate each type of test orcalibration carried out and tominimise the possibility ofmisunderstanding or misuse

for details on the use of the NATAendorsement refer to the FieldApplication Document and the NATARules.

"simplified" reports are being considered by theField Managers (FM). If a laboratory makes sucha request, it must be forwarded to the relevantFM and the Technical Manager.




Test reports

5.10.2, 5.10.3

test reports must include theinformation listed in the Standardunder 5.10.2 items (a) to (k) and theFAD

- a title (a)

- name and address of the

laboratory, and the locationwhere the testing/calibrationswere carried out, if different fromthe address of the location (b)

- unique identification of thetest/calibration document,including on each page anidentification to ensure the pageis recognised as part of thedocument and a clearidentification of the end of thedocument (c)

-name and address of thecustomer (d)

may not be needed where lab carries out in-house testing - use commonsense approach.

may also be met by inclusion of customer nameand code, eg. project or job number that istraceable within the laboratorys records.

- identification of the method used(e)

- description, condition andidentification of the item tested orcalibrated (f)

- date of receipt of test/calibration

item where applicable and thedate the work was carried out (g)

- reference to the sampling planand procedures used by thelaboratory or other bodies whereapplicable (h)

- results with, where appropriate,the units of measurement (i)

- name, function and signature orequivalent identification ofperson authorising the

test/calibration document (j)

- statement to the effect that theresults relate only to the itemstested or calibrated whereapplicable (k)

"function" can be approved signatory or job title.




5.10.2, 5.10.3(contd)

where necessary for theinterpretation of the test results theitems included in 5.10.3.1 (a) to (e)must also be included in the testreport with the exception of (d) whichis not allowable under NATAsregulations except for Medical,Veterinary and Forensic testing

- deviations, additions orexclusions from the test method,and specific test conditions, egenvironmental conditions (a)

- statement of compliance/non-compliance with requirementsand/or specifications (b)

- statement on the estimateduncertainty of measurementwhere applicable (information onuncertainty is needed in test

reports when it is relevant to thevalidity or application of theresults, when a customersinstruction requires or when theuncertainty affects compliance toa specification limit) (c)

- opinions and interpretationswhere appropriate and needed(d)

- additional information requiredby specific methods or

customers (e) test reports containing the results of

sampling must also include theadditional requirements listed in5.10.3.2 (a) to (f) as necessary forthe interpretation of the test results

- date of sampling (a)

- unambiguous identification of thematerial sampled (b)

- location of sampling includingany diagrams, sketches orphotographs (c)

- reference to the sampling planand procedures used (d)

- details of environmentalconditions during sampling (e)

- any standard or specification forthe sampling method orprocedure and deviations,additions or exclusions from thespecification (f)


10/10


Opinions andinterpretations

5.10.5

are not permitted on test reports unlesswritten authority has been granted byNATAs Chief Executive except forMedical, Veterinary and Forensic testing

statements of fact and compliance are notconsidered to be an opinion.

currently extensive discussion at an internationallevel regarding the inclusion of opinions on testreports.

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