MODULE C: VERSLAG VAN DE hoofdAUDITOR (EN ISO 15189:2022)

ID-code: B-xxx.xx.xx Module C Vertrouwelijk

MODULE C: VERSLAG VAN DE hoofdAUDITOR

(EN ISO 15189:2022)

1Vertegenwoordigers van de instelling

Functie Aan te passen naar de door de instelling gebruikte naamgeving	Naam
Verantwoordelijke managementsysteem
Technisch verantwoordelijke
…

2evaluatie van de opvolging van de corrigerende maatregelen naar aanleiding van de vorige audit

ID code van de voorgaande audit

De evaluatie van de opvolging van de tekortkoming wordt genoteerd als “+” wanneer alle elementen voldoende opgevolgd en opgelost zijn en deze afgesloten kan worden.
Een nieuwe tekortkoming XX-Ay of XX-By (XX= initialen auditor, y=volgnummer van de tekortkoming in dit deelverslag), wordt gedefinieerd indien

• er deelelementen nog niet opgelost zijn; en/of

• er elementen niet in orde zijn; en/of

• de doorgevoerde oplossing aanleiding gegeven heeft tot een nieuwe tekortkoming.

Tekortkoming vorige audit Beoordeling van de opvolging en effectiviteit van de genomen corrigerende maatregel(en) Evaluatie

3Verslag van de audit

Gelieve achter elk normelement de evaluatie aan te geven:

• + (bekeken en in orde);

• XX-Ay of XX-By (bekeken, maar met tekortkoming: XX=initialen auditor, y=volgnummer van de tekortkoming in dit deelverslag);

• nb (niet bekeken);

• nvt (niet van toepassing).

1. Normeisen

EN ISO 15189: 2022 § 4: General requirements

Normelement 2022	Normelement 2012	Omschrijving	Evaluatie
4.1	4.1.1.3	Impartiality
4.1		Impartiality: Structured and managed – committed – responsible & no compromise - identify threats - mitigate threats
4.2	4.1.1.3 - 5.10.1 – 5.4.2	Confidentiality
4.2.1		Management of information: Responsible – legally enforceable agreements – management of all patient information – privacy & confidentiality – inform user and/or patient in advance
4.2.2		Release of information: Release confidential information – notification of patient – information from a source other than the patient – confidential identity
4.2.3		Personnel responsibility: Personnel acting on behalf of lab – keep confidential
4.3	4.1.1.3 - 4.1.2.2 – 4.4.1 – 4.14.2 - 5.4.2 - 5.4.3 – 5.4.6 – 5.4.7 -5.7.2 – 5.9.1	Requirements regarding patients
4.3		Requirements regarding patients: Opportunities for patients – publicly available info – periodic review – disclosure of incidents – treatment with due care and respect – informed consent – closure, acquisition or merger – making relevant info available – free from discrimination

Belangrijkste bekeken documenten:

Algemene beschrijving van de vaststellingen inclusief de verwijzing naar eventuele tekortkomingen:

EN ISO 15189: 2022 § 5: Structural and governance requirements

Normelement 2022	Normelement 2012	Omschrijving	Evaluatie
5.1	4.1.1.2	Legal entity
5.1		Legal entity: Laboratory or organization – entity – legally responsible
5.2	4.1.1.4	Laboratory director
5.2.1		Laboratory director competence: Person or persons – specified qualification, competence, delegated authority, responsibility, and resources
5.2.2		Laboratory director responsibilities: Implementation – risk management – systematically identified and addressed – documented duties and responsibilities
5.2.3		Delegation of duties: Selected duties or responsibilities – to qualified and competent personnel – documented – ultimate responsibility
5.3	4.1.1.1 – 4.1.2.2 - 4.1.2.3 - 4.2.2.2 – 4.7	Laboratory activities
5.3.1		General: Specify and document the range – activities – sites – claim conformity – excludes externally provided laboratory activities on an ongoing basis
5.3.2		Conformance with requirements: Meet requirements – this document – users – regulatory authorities – recognition – complete range
5.3.3		Advisory activities: Appropriate laboratory advice and interpretation - communicating with laboratory users - choice and use of examinations - professional judgments - effective utilization – advising
5.4	4.1.2.5 –4.1.2.6 - 4.1.2.7 – 4.2.2.1 - 4.2.2.2	Structure and authority
5.4.1		General: Define – parent organization – relationships - responsibility -authority - lines of communication and interrelationship – all personnel – procedures – consistent application - validity
5.4.2		Quality management: Personnel - authority and resources – duties – MS – deviations – actions – reporting - effectiveness
5.5	4.1.2.2 - 4.1.2.3 – 4.1.2.4 – 4.14.7	Objectives and policies
5.5		Objectives and policies: Needs and requirements – good professional practice – examinations – intended use – conform – measurable objectives - consistent with policies – integrity – changes – quality indicators – monitor performance
5.6	4.2.1 – 4.11 - 4.16.6	Risk management
5.6		Risk management: Processes for identifying risks – develop actions – evaluated – effectiveness - modified

Belangrijkste bekeken documenten:

Algemene beschrijving van de vaststellingen inclusief de verwijzing naar eventuele tekortkomingen:

EN ISO 15189: 2022 § 6: Resource requirements

Normelement 2022	Normelement 2012	Omschrijving	Evaluatie
6.1	4.1.1.4 - 4.1.2.1	General
6.1		General: Available – personnel – facilities – equipment – reagents – consumables – support services – manage and perform activities
6.2	4.1.1.3 - 4.1.1.4 - 4.1.2.1 - 4.1.2.7 - 5.1.1 - 5.1.2 - 5.1.3 - 5.1.4 - 5.1.5 - 5.1.6 -5.1.8 - 5.1.9	Personnel
6.2.1		General: Sufficient number – competent personnel - impartially – ethical – accordance management system - communication - introduction programme
6.2.2		Competence requirements: Specify competence requirements each function – ensure and manage competency – documented information
6.2.3		Authorization: Authorization personnel
6.2.4		Continuing education and professional development: Programme – all personnel – suitability – periodically reviewed
6.2.5		Personnel records: Procedures – retain records – competence requirements – position descriptions - (re)training – authorization – monitoring

Belangrijkste bekeken documenten:

Algemene beschrijving van de vaststellingen inclusief de verwijzing naar eventuele tekortkomingen:

Normelement 2022	Normelement 2012	Omschrijving	Evaluatie
6.3	5.2.1 – 5.2.2 – 5.2.3 – 5.2.4 – 5.2.5 – 5.2.6	Facilities and environmental conditions
6.3.1		General: Suitable – pre-examination sites – other sites – POCT Specify – monitor – record
6.3.2		Facility controls: Implementation – records – monitoring – periodically reviewed - control of access – prevention (cross)contamination – safety – maintenance
6.3.3		Storage facilities: Storage space – prevention cross contamination and deterioration – hazardous materials
6.3.4		Personnel facilities: Toilet – drinking water – storage – space personnel activities
6.3.5		Sample collection facilities: Enable collection – privacy, comfort patients – separate space reception and collection - first aid

Belangrijkste bekeken documenten:

Algemene beschrijving van de vaststellingen inclusief de verwijzing naar eventuele tekortkomingen:

Normelement 2022	Normelement 2012	Omschrijving	Evaluatie
6.4	5.3.1.1 – 5.3.1.2 – 5.3.1.3 – 5.3.1.4 – 5.3.1.5 – 5.3.1.6 – 5.3.1.7	Equipment
6.4.1		General: Processes – proper functioning – prevent contamination or deterioration
6.4.2		Equipment requirements: access – outside permanent control – requirements met – uniquely labelled/identified – register – maintain and replace equipment – ensure quality of results
6.4.3		Equipment acceptance procedure: Verify – specified acceptability criteria – achieving measurement accuracy/uncertainty
6.4.4		Equipment instructions for use: Safeguards – prevent unintended adjustments – trained/authorized/competent personnel – instructions available – used as specified
6.4.5		Equipment maintenance and repair: Preventive maintenance programmes – records – (safe) working condition – out of service – decontaminate – space for repairs - personal protective equipment
6.4.6		Equipment adverse incident reporting: Investigated – reported – procedure – manufacturer recall
6.4.7		Equipment records: Records – available – lifespan equipment

Belangrijkste bekeken documenten:

Algemene beschrijving van de vaststellingen inclusief de verwijzing naar eventuele tekortkomingen:

Normelement 2022	Normelement 2012	Omschrijving	Evaluatie
6.5	5.3.1.4 – 5.3.1.5	Equipment calibration and metrological traceability
6.5.1		General: Specify requirements
6.5.2		Equipment calibration: Procedure – conditions – records – verification – correction factors – risk
6.5.3		Metrological traceability of measurements results: Documented – unbroken chain of calibrations – traceability - SI – other means – genetic reference sequences – qualitative methods – consistent identification

Belangrijkste bekeken documenten:

Algemene beschrijving van de vaststellingen inclusief de verwijzing naar eventuele tekortkomingen:

Normelement 2022	Normelement 2012	Omschrijving	Evaluatie
6.6	5.3.2.1 – 5.3.2.2 – 5.3.2.3 – 5.3.2.4 – 5.3.2.5 – 5.3.2.6 – 5.3.2.7	Reagents and consumables
6.6.1		General: Processes
6.6.2		Reagents and consumables – receipt and storage: Storage – manufacturer specification – monitor environmental conditions – verify adequacy receiving facility
6.6.3		Reagents and consumables – acceptance testing: Verify performance – each reagent/new formulation/new lot/shipment – before use/before release results
6.6.4		Reagents and consumables – inventory management: Establish inventory management system – segregate accepted from not inspected or accepted
6.6.5		Reagents and consumables – instruction for use: Instructions – available- used according manufacturer specifications
6.6.6		Reagents and consumables – adverse incident reporting: Investigated - reported - procedure – manufacturer recall
6.6.7		Reagents and consumables – records: Records of performance – in-house additional information

Belangrijkste bekeken documenten:

Algemene beschrijving van de vaststellingen inclusief de verwijzing naar eventuele tekortkomingen:

Normelement 2022	Normelement 2012	Omschrijving	Evaluatie
6.7	4.4.1 – 4.4.2	Service agreements
6.7.1		Agreements with laboratory users: Procedure – informed of changes – records of reviews
6.7.2		Agreements with POCT operators: Service agreements - Specify and communicate responsibilities and authorities
6.8	4.5.1 – 4.5.2 – 4.6	Externally provided products and services
6.8.1		General: Ensure – externally provided products and services – suitable - Collaborate other departments or functions
6.8.2		Referral laboratories and consultants: Communicate -requirements for procedures/examinations/reports, management critical results, personnel qualifications –referring laboratory responsible – list
6.8.3		Review and approval of externally provided products and services: Procedures – records – define, review and approve requirements - criteria qualification, selection, evaluation - referral of samples – conform requirements before use – actions from evaluations

Belangrijkste bekeken documenten:

Algemene beschrijving van de vaststellingen inclusief de verwijzing naar eventuele tekortkomingen:

EN ISO 15189: 2022 § 7: Process requirements

Normelement 2022	Normelement 2012	Omschrijving	Evaluatie
7.1	4.2.1 - 4.11 - 4.14.6	General
7.1		General: Potential risks – residual risk – mitigation process – monitoring & evaluation – opportunities to improve - framework
7.2	4.4.1 - 5.4.1 – 5.4.2 -5.4.3 – 5.4.4.1 – 5.4.4.2 – 5.4.4.3 – 5.4.5 – 5.4.6 – 5.4.7	Pre-examination processes
7.2.1		General: Procedures - accessible
7.2.2		Laboratory information for patients and users: Available info – sufficiently detailed – locations, opening hours and contact info – procedures for requesting and collection – scope & time – advisory services – patient consent – factors – complaint process
7.2.3		Requests for providing laboratory examinations: 7.2.3.1 General agreement – sufficient info – unequivocal traceability – requester – examinations – advice 7.2.3.2 Oral requests procedure – documented confirmation – given time
7.2.4		Primary sample collection and handling: 7.2.4.1 General procedures – available info – deviation – potential risk and impact – periodically review 7.2.4.2 Information for pre-collection activities info and instructions – patient preparation – type and amount – order – special timing – clinical info – labelling for unequivocal identification – criteria for acceptance and rejection 7.2.4.3 Patient consent informed consent – special procedures – patient’s best interest 7.2.4.4 Instructions for collection activities safe, accurate and clinically appropriate – verification of identity – meeting pre-examination requirements – collection – labelling & unequivocal link – identity person collecting & collection date/time – separating and dividing – stabilization and storage conditions – safe disposal
7.2.5		Sample transportation: Instructions – packaging – time between collection and receipt – temperature interval – specific requirements – integrity – health risk – notification & action – periodically evaluate
7.2.6		Sample receipt: 7.2.6.1 Sample receipt procedure Unequivocal traceability – criteria for acceptance and rejection – date and time of receipt – identity person receiving – evaluation by authorized personnel – urgent samples – original sample 7.2.6.2 Sample acceptance exceptions Process – compromised samples – incorrect identification – sample instability – incorrect storage/handling temperature – inappropriate containers – insufficient sample volume – acceptance – final report – nature – advising caution
7.2.7		Pre-examination handling, preparation, and storage: 7.2.7.1 Sample protection Procedures – appropriate facilities – securing 7.2.7.2 Criteria for additional examinations requests Time limits 7.2.7.3 Sample stability Time specified and monitored

Belangrijkste bekeken documenten:

Algemene beschrijving van de vaststellingen inclusief de verwijzing naar eventuele tekortkomingen:

Normelement 2022	Normelement 2012	Omschrijving	Evaluatie
7.3	4.9 - 4.14.2 - 5.5.1.1 – 5.5.1.2 – 5.5.1.3 – 5.5.1.4 – 5.5.2 - 5.5.3 – 5.6.1 – 5.6.2.1 – 5.6.2.2 – 5.6.2.3 – 5.6.3.1 – 5.6.3.2 – 5.6.3.3 – 5.6.3.4 – 5.6.4	Examination process
7.3.1		General: Methods validated for intended use – performance specifications – up to date and readily available – follow established procedures – identity recorded – periodically evaluate examinations – clinically appropriate
7.3.2		Verification of examination methods: Procedure – before introducing – performance specifications – extent of verification – authorized and competent personnel – review – repeat verification when revision – records
7.3.3		Validation of examination methods: Laboratory designed/developed methods – use outside intended scope – modified validated methods – as extensive as necessary – confirm specific requirements – intended use – extent – authorized and competent personnel for review – changes - records
7.3.4		Evaluation of measurement uncertainty: Evaluated and maintained – compare – documented – regular review – where MU not possible/irrelevant – available – inquiries – sources – qualitative results – verification/validation
7.3.5		Biological reference intervals and clinical decision limits: Defined and communicated – periodical review – changes - characteristic
7.3.6		Documentation of examination procedures: Extent necessary – consistent application – language – available – abbreviated document – product instructions – validated change – implications – document control
7.3.7		Ensuring the validity of examination results: 7.3.7.1 General Procedure – monitoring validity – recorded – trends and shifts – planned and reviewed 7.3.7.2 Internal quality control (IQC) IQC procedure – specified criteria – intended clinical application – lot-to-lot reagent or calibrator variation – third-party IQC material - fit for intended purpose – stability – matrix – close to patient samples – clinically relevant challenge – if not available – frequency – recorded data – trends and shifts – IQC data review – acceptability criteria – regular intervals – timeframe – prevent the release – IQC fails 7.3.7.3 External quality assessment (EQA) Monitor performance – procedure – personnel who routinely perform – EQA’s programme(s) selected – target values – if not available or suitable – EQA data review – acceptability criteria – time frame – appropriate action – clinical impact 7.3.7.4 Comparability of examination results: Different methods or equipments – different sites – procedure – record the results – periodically review – impact – inform users

Belangrijkste bekeken documenten:

Algemene beschrijving van de vaststellingen inclusief de verwijzing naar eventuele tekortkomingen:

Normelement 2022	Normelement 2012	Omschrijving	Evaluatie
7.4	4.5.2 - 4.13 – 5.4.7 - 5.7.1 – 5.7.2 - 5.8.1 – 5.8.2 – 5.8.3 - 5.9.1 – 5.9.2 - 5.9.3	Post-examination processes
7.4.1		Reporting of results: 7.4.1.1 General Accurately, clearly, unambiguously – in accordance with examination procedure – info for interpretation of results – procedure for delay – retaining of all associated info 7.4.1.2 Results review and release Review – prior to release - authorized personnel – evaluation – responsibility – procedure 7.4.1.3 Critical results reports Critical decision limits – notification – documented actions – escalation procedure 7.4.1.4 Special considerations for results Simplified reporting – all info available – preliminary report – records for oral reporting – accuracy of communication – special counseling – use of anonymized results 7.4.1.5 Automated selection, review, release and reporting of results Procedure – specified criteria – validated criteria – review – verification after change – results for manual review – rapid suspension 7.4.1.6 Requirements for reports Documented reason for omission – patient identification – laboratory – user – primary sample – examinations – method – results and units – biological reference intervals – clinical decision limits – R&D examinations – identification review and authorization – preliminary results – critical results – end 7.4.1.7 Additional information for reports Time primary sample collection – time of report release – examinations by referral laboratory including name – consultants – interpretation and comments – sample quality and suitability – discrepancies – misinterpretation 7.4.1.8 Amendments to reported results Procedure – reason – additional document or data transfer – awareness – completely new report – record when no capture of revision
7.4.2		Post-examination handling of samples Time length – conditions – identification – additional examinations – storing – located and retrieved - discarting

Belangrijkste bekeken documenten:

Algemene beschrijving van de vaststellingen inclusief de verwijzing naar eventuele tekortkomingen:

Normelement 2022	Normelement 2012	Omschrijving	Evaluatie
7.5	4.9	Nonconforming work
7.5		Nonconforming work: Process – laboratory activities – examination results – responsibilities and authorities – specified actions – halting examinations – evaluation of clinical significance – decision – revision when necessary – resumption – corrective actions - records

Belangrijkste bekeken documenten:

Algemene beschrijving van de vaststellingen inclusief de verwijzing naar eventuele tekortkomingen:

Normelement 2022	Normelement 2012	Omschrijving	Evaluatie
7.6	5.10.1 – 5.10.2 –5.10.3	Control of data and information management
7.6.1		General: Access to data and info
7.6.2		Authorities and responsibilities for information management: Specified authorities and responsibilities – maintenance – modification – ultimately responsible
7.6.3		Information systems management: Validated & verified – changes – authorized – documented – before implementation – documentation readily available – implemented - cybersecurity – environment – manual recording and transcription – integrity – recording of system failures – calculations and data transfer
7.6.4		Downtime plans: Planned process – automated selection and reporting
7.6.5		Off site management: Off-site – external provider - comply

Belangrijkste bekeken documenten:

Algemene beschrijving van de vaststellingen inclusief de verwijzing naar eventuele tekortkomingen:

Normelement 2022	Normelement 2012	Omschrijving	Evaluatie
7.7	4.8 – 5.4.2	Complaints
7.7.1		Process: Description of the process – tracking and recording – appropriate actions – publicly available
7.7.2		Receipt of complaint: Confirm – resolve – gathering info – acknowledge receipt – outcome – progress reports
7.7.3		Resolution of complaint: Investigation and resolution – discriminatory actions – person not involved - impartiality
7.8	4.1.1.4	Continuity and emergency preparedness planning
7.8		Continuity and emergency preparedness planning: Emergency situations – identification – coordinated strategy – periodically tested – planned response capability – info and training – respond to actual emergency situations - action

Belangrijkste bekeken documenten:

Algemene beschrijving van de vaststellingen inclusief de verwijzing naar eventuele tekortkomingen:

EN ISO 15189: 2022 § 8: Management system requirements

Normelement 2022	Normelement 2012	Omschrijving	Evaluatie
8.1	4.1.2.3 – 4.2.1 – 4.2.2.2 – 5.1.5	General requirements
8.1.1		General: establish, document, implement and maintain a management system – fulfilment requirements this document – responsibilities – objectives and policies – documented information – actions - continual improvement – evaluations and internal audits – management review
8.1.2		Fulfilment of management system requirements: Quality management system – fulfilment requirements clauses 4-7 and 8.2-8.9
8.1.3		Management system awareness: Aware – objectives policies – contribution to effectiveness management system – consequences
8.2	4.1.2.1 – 4.1.2.4 – 4.2.2.1 – 4.2.2.2 – 4.3	Management system documentation
8.2.1		General: establish, document, and maintain objectives and policies – ensure acknowledgement and implementation
8.2.2		Competence and quality: Objectives and policies – address competence, quality and consistent operation
8.2.3		Evidence of commitment: Evidence of commitment – development and implementation management system – continually improvement
8.2.4		Documentation: All documentation, processes, systems and records – included in, referenced from or linked to management system
8.2.5		Personnel access: Access – management system documentation - applicable for responsibilities

Belangrijkste bekeken documenten:

Algemene beschrijving van de vaststellingen inclusief de verwijzing naar eventuele tekortkomingen:

Normelement 2022	Normelement 2012	Omschrijving	Evaluatie
8.3	4.3	Control of management system documents
8.3.1		General: Control – internal and external documents
8.3.2		Control of documents: Uniquely labelled – adequacy – periodically reviewed – available – revision status – protection – obsolete documents – retained
8.4	4.13 – 5.9.3	Control of records
8.4.1		Creation of records: Establish and retain legible records – created – activity – affects quality
8.4.2		Amendment of records: Traced – previous versions- original and amended data – date
8.4.3		Retention of records: Implement procedures – retention times – retrievable examination results – available – legible

Belangrijkste bekeken documenten:

Algemene beschrijving van de vaststellingen inclusief de verwijzing naar eventuele tekortkomingen:

Normelement 2022	Normelement 2012	Omschrijving	Evaluatie
8.5	4.11 – 4.12 – 4.14.6	Actions to address risks and opportunities for improvement
8.5.1		Identification of risks and opportunities for improvement: Identify – risk and opportunities for improvement
8.5.2		Action on risks and opportunities for improvement: Actions – proportional to potential impact – record decisions and actions – effectiveness
8.6	4.11 – 4.12 – 4.14.3 – 4.14.4	Improvement
8.6.1		Continual improvement: Improve effectiveness – identify opportunities – actions – risk assessments – communicate
8.6.2		Laboratory patients, user and personnel feedback: Seek feedback – analyzed – improvement management system – records – communication
8.7	4.9 – 4.10 – 4.14.8	Nonconformities and corrective actions
8.7.1		Actions when nonconformity occurs: Respond – immediate action – address consequences – determine cause – evaluate need corrective action – implement action – effectiveness – update risks and opportunities – change management system
8.7.2		Corrective action effectiveness: Appropriate to effects – mitigate identified cause
8.7.3		Records of nonconformities and corrective actions: Records – non-conformity – cause – actions – effectiveness

Belangrijkste bekeken documenten:

Algemene beschrijving van de vaststellingen inclusief de verwijzing naar eventuele tekortkomingen:

Normelement 2022	Normelement 2012	Omschrijving	Evaluatie
8.8	4.14.1 – 4.15.4 – 4.14.7	Evaluations
8.8.1		General: Conduct evaluations – planned intervals – meet requirements-
8.8.2		Quality indicators: Monitoring quality indicators – planned – periodically reviewed
8.8.3		Internal audits: Internal audits – planned intervals – provide information on management system – programme
8.9	4.15.1 – 4.14.3 – 4.15.2 – 4.15.4	Management reviews
8.9.1		General: Review - planned intervals- suitability – adequacy - effectiveness
8.9.2		Review input: Recorded – evaluations – previous management review – fulfilment objectives – outcomes evaluations/monitoring – feedback – quality assurance – effectiveness – external providers – interlaboratory comparison – POCT- other
8.9.3		Review output: record decision and action – effectiveness- improvement – provision required resources – any change – time frame – communication to personnel

Belangrijkste bekeken documenten:

Algemene beschrijving van de vaststellingen inclusief de verwijzing naar eventuele tekortkomingen:

EN ISO 15189: 2022 § Annex A: Additional requirements for Point-Of-Care testing

Normelement 2022	Normelement ISO 22870	Omschrijving	Evaluatie
A.1	4.1.1 – 4.1.2.1 – 4.2.2.1– 4.2.2.1 - 4.4 – 5.1.4	General
		General: Additional requirements POCT- responsibilities- selection devices- training – quality assurance – management review
A.2		Governance
		Governance: Responsible- monitor accuracy and quality – service agreements with all locations – clinical approval – POCT areas
A.3		Quality assurance programme
		Quality assurance programme: Person responsible – review – conformity with this document
A.4		Training programme
		Training programme: Person – appointed- develop/implement/maintain training programme

2. Bijkomende eisen van BELAC

Referentie	Evaluatie	Conclusie
BELAC 2-001 (verwijzing accreditatie)
XXXXX 0-000 (accreditatiescope : vast versus flexibel – slapende activiteiten)
XXXXX 0-000 (beleid en leidraden betreffende herleidbaarheid van meetresultaten)
BELAC 0-000 (xxxxxxxxxxxxx-xxxxxxxxxxxx (PT): leidraden deelname en evaluatie van performantie)
BELAC 2-405 NGS (richtlijnen voor NGS analysen voor hematologische en solide tumoren)
XXXXX 0-000 MED (bijkomende wettelijke verplichtingen)

BELAC 6-431(15189) Rev 7-2023 18/18