general general (ISO 17025:2005, 5.1)(ISO 17025:2005, 5.1)

personnel personnel (ISO 17025:2005, 5.2)(ISO 17025:2005, 5.2)

accommodation and accommodation and environmentenvironment(ISO 17025:2005, 5.31)(ISO 17025:2005, 5.31)

Technical requirements:Technical requirements:

The Laboratory ProcessThe Laboratory Process

LaboratoryLaboratory

ReportReport

SampleSample

Technical requirementsTechnical requirements

LaboratoryLaboratory

In generalIn general Factors influencing the Factors influencing the

correctness and reliability of the correctness and reliability of the tests performedtests performed

SampleSample

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Factors determine correctness Factors determine correctness and reliability of the testsand reliability of the tests

Human factorsHuman factors Acomodation and Acomodation and

environmental conditionsenvironmental conditions Test and calibration Test and calibration

methods, method validationmethods, method validation EquipmentEquipment Measurement traceabilityMeasurement traceability SamplingSampling Handling test itemsHandling test items

PersonnelPersonnel (ISO 17025:2005, 5.2)(ISO 17025:2005, 5.2)

Management requirements to Management requirements to personnel -1 personnel -1 (ISO 17025: 2005, 4.1)(ISO 17025: 2005, 4.1)

Laboratory have managerial and technical Laboratory have managerial and technical personnel (irrespective of other responsibilities) personnel (irrespective of other responsibilities) who have the authority and resources needed to who have the authority and resources needed to carry out their duties and carry out their duties and to identify the to identify the occurrence of departures from the quality occurrence of departures from the quality system and initiate actions if required system and initiate actions if required

Free from any undue internal and external Free from any undue internal and external pressures and influences pressures and influences

Management requirements to Management requirements to personnel -2 personnel -2 (ISO 17025 ; 2005,4.1)(ISO 17025 ; 2005,4.1)

Protection of the customers confidential Protection of the customers confidential informationinformation

Specify responsibilities, authority and Specify responsibilities, authority and interrelations of all personnel which interrelations of all personnel which activities can influence the quality of the activities can influence the quality of the resultresult

Appropropriate supervision of testing staff Appropropriate supervision of testing staff and trainees and trainees

Management requirements to Management requirements to personnel - 3 personnel - 3 (ISO 17025:2005, 4.1)(ISO 17025:2005, 4.1)

Technical management which has overall Technical management which has overall responsibility for operations and provision of responsibility for operations and provision of resources needed to ensure required quality of resources needed to ensure required quality of operationsoperations

Quality manager: irrespective of other duties has Quality manager: irrespective of other duties has defined responsibility and authority ensuring the defined responsibility and authority ensuring the management system is implemented and management system is implemented and followed at all times, has direct access to the followed at all times, has direct access to the highest level of management highest level of management

Management requirements to Management requirements to personnel - 4 personnel - 4 (ISO 17025: 2005,4.1)(ISO 17025: 2005,4.1)

Appoint deputies for key managerial Appoint deputies for key managerial personnelpersonnel

Ensure that personnel is aware of Ensure that personnel is aware of relevance and importance of their activitiesrelevance and importance of their activities

Top management shall ensure proper Top management shall ensure proper communication processes are established communication processes are established regarding effectiveness of the regarding effectiveness of the management system management system

Technical requirements to Technical requirements to personnel -1 personnel -1 (ISO 17025:2005, 5.2)(ISO 17025:2005, 5.2)

Laboratory management shall ensure the competence of Laboratory management shall ensure the competence of personnel for operation specific equipment, perform personnel for operation specific equipment, perform tests, evaluate results, sign test reportstests, evaluate results, sign test reports

Personnel responsible for opinions and interpretation at Personnel responsible for opinions and interpretation at reports have relevant knowledge of technology including reports have relevant knowledge of technology including legislation, understanding significance of deviations legislation, understanding significance of deviations

Training programme: Management formulates goals for Training programme: Management formulates goals for education, training and skills of personnel. Needs are education, training and skills of personnel. Needs are identified and training programme is evaluated.identified and training programme is evaluated.

Personnel -2 Personnel -2 (ISO 17025:2005, 5.2)(ISO 17025:2005, 5.2)

Job descriptions Job descriptions minimal responsibilities with respect to minimal responsibilities with respect to

performing tests, planning and evaluation performing tests, planning and evaluation of tests, reporting opinions and of tests, reporting opinions and interpretations, method modification and interpretations, method modification and validation new methods.validation new methods.

Expertise and experience requiredExpertise and experience required Qualification and training programmesQualification and training programmes Managerial dutiesManagerial duties

Personnel - 3 Personnel - 3 (ISO 17025:2005, 5.2)(ISO 17025:2005, 5.2)

Authorization to perform particular types of Authorization to perform particular types of sampling, tests, issuing tests reports, to sampling, tests, issuing tests reports, to give opinions and interpretations, give opinions and interpretations, operation of particularly types of operation of particularly types of equipmentequipment

Authorization of specified tasks is done Authorization of specified tasks is done including date on which it is confirmed and including date on which it is confirmed and registrated and readily availableregistrated and readily available

Requirements to personnel are registratedRequirements to personnel are registrated

Accommodation and environmental Accommodation and environmental conditions conditions (ISO17025:2005, 5.3)(ISO17025:2005, 5.3)

Laboratory facilities will facilitate correct Laboratory facilities will facilitate correct performance of the tests and are documentedperformance of the tests and are documented

Monitor, control and record conditions as Monitor, control and record conditions as required by relevant specifications (biological required by relevant specifications (biological sterility, dust, humidity temperature, electrical sterility, dust, humidity temperature, electrical supply etc.) supply etc.)

Attention for access to certain test areas, good Attention for access to certain test areas, good housekeeping and effective separation of housekeeping and effective separation of incompatible activities incompatible activities