Contracts Subcontracting Suppliers Complaints Corrective and preventive actions (CAPA) Internal audits Management reviews Management requirements.
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ContractsContracts SubcontractingSubcontracting SuppliersSuppliers ComplaintsComplaints Corrective and preventive actions (CAPA)Corrective and preventive actions (CAPA) Internal auditsInternal audits Management reviewsManagement reviews
Management requirementsManagement requirements::
Review of request tenders and Review of request tenders and contracts -1 contracts -1 (ISO 17025: 2005, 4.4)(ISO 17025: 2005, 4.4)
Policy and procedures requiredPolicy and procedures required Differences between request and the Differences between request and the
contract shall be resolved before work contract shall be resolved before work startsstarts
Relevant discussions with a customer are Relevant discussions with a customer are registrated registrated
Review of request tenders and Review of request tenders and contracts - 2 contracts - 2 (ISO 17025: 2005, 4.4)(ISO 17025: 2005, 4.4)
Contract has to be acceptable for customer and Contract has to be acceptable for customer and laboratory laboratory
In contract procedure:In contract procedure:
Requirements including the method are Requirements including the method are adequately defined, documented and adequately defined, documented and understood understood
Capacity ad resources of laboratory are assuredCapacity ad resources of laboratory are assured How to act in case of deviations How to act in case of deviations
Review of request tenders and Review of request tenders and contracts - 3 contracts - 3 (ISO 17025:2005, 4.4)(ISO 17025:2005, 4.4)
A contract can be a written or oral A contract can be a written or oral agreementagreement
Review of compatibility by earlier work or Review of compatibility by earlier work or proven skills to performproven skills to perform
Subcontracting testsSubcontracting tests (ISO 17025; 2005, 4.5)(ISO 17025; 2005, 4.5)
Documented policy and procedure available Documented policy and procedure available including review of subcontractors (ISO 17025 including review of subcontractors (ISO 17025 accreditation preferred) accreditation preferred)
Contracts with subcontractors are documented Contracts with subcontractors are documented in a registerin a register
Laboratory is also responsible for subcontracted Laboratory is also responsible for subcontracted tests tests
Gain approval of customer for subcontractingGain approval of customer for subcontracting
Suppliers -1 Suppliers -1 (ISO 17025: 2005, 4.6)(ISO 17025: 2005, 4.6)
Policy and procedure for selection and use Policy and procedure for selection and use of supplies and servicesof supplies and services
Procedures for inspection, acceptance and Procedures for inspection, acceptance and storage of suppliesstorage of supplies
Suppliers -2 Suppliers -2 (ISO 17025: 2005, 4.6)(ISO 17025: 2005, 4.6)
Evaluation of suppliers critical for the quality Evaluation of suppliers critical for the quality of test resultsof test results
ServicesServices SubcontractingSubcontracting EquipmentEquipment Reference substancesReference substances ReagentsReagents Critical consumablesCritical consumables
Suppliers - 3 Suppliers - 3 (ISO 17025: 2005, 4.6)(ISO 17025: 2005, 4.6)
Criteria for evaluation of suppliersCriteria for evaluation of suppliers Documentation of evalutionDocumentation of evalution Preventive action in case of poor Preventive action in case of poor
performanceperformance
ComplaintsComplaints
The laboratory shall have a policy and procedure for the resolution of
complaints (ISO 17025:2005, 4.8)
Control of nonconforming testing Control of nonconforming testing work work (ISO 17025; 2005, 4.9)(ISO 17025; 2005, 4.9)
Policy and procedure required for Policy and procedure required for nonconforming work and registrationnonconforming work and registration
Evalution of the significance is made Evalution of the significance is made Correction is taken immediatelyCorrection is taken immediately When necessary customer is notified and When necessary customer is notified and
work recalledwork recalled Authorization of resumption of work is Authorization of resumption of work is
defineddefined
Corrective Actions -1Corrective Actions -1 (ISO 17025; 2005, 4.11)(ISO 17025; 2005, 4.11)
The laboratory shall establish a policy The laboratory shall establish a policy and procedure and shall designate and procedure and shall designate appropriate authorities for implementing appropriate authorities for implementing corrective action when nonconforming corrective action when nonconforming work or departures from the policies and work or departures from the policies and procedures in the quality system or procedures in the quality system or technical operations have been identified.technical operations have been identified.
Corrective actions -2Corrective actions -2
Analyse cause, select and implement Analyse cause, select and implement corrective actions (if necessary audit corrective actions (if necessary audit related activities)related activities)
Document changes resulting form Document changes resulting form corrective actionscorrective actions
Preventive actions Preventive actions (ISO 17025; 2005, 4.12)(ISO 17025; 2005, 4.12)
Needed improvements and potential Needed improvements and potential sources of nonconformities shall be sources of nonconformities shall be identifiedidentified
Pro-active process: elements can be risk Pro-active process: elements can be risk analysis, possibility for quality analysis, possibility for quality improvementimprovement
Internal audits -1 Internal audits -1 (ISO 17025: 2005, 4.12)(ISO 17025: 2005, 4.12)
Verify that laboratory operations continue Verify that laboratory operations continue to comply the requirements of the to comply the requirements of the management system and ISO 17025:2005management system and ISO 17025:2005
Internal audits - 2 Internal audits - 2 (ISO 17025: 2005, 4.12)(ISO 17025: 2005, 4.12)
All elements of the management system have to All elements of the management system have to be audited periodicallybe audited periodically
Audit programme made by Quality manager Audit programme made by Quality manager Carried out by trained and qualified independent Carried out by trained and qualified independent
personnel (if allowed by resources) personnel (if allowed by resources) If audit findings results in doubts about If audit findings results in doubts about
effectiveness of results/processes timely effectiveness of results/processes timely corrective actions are takencorrective actions are taken
Follow up audit activities shall verify undertaken Follow up audit activities shall verify undertaken actions actions
Audits in generalAudits in general
Horizontal audits 1 subject example Horizontal audits 1 subject example personnel and competencepersonnel and competence
Vertical audits following a process through Vertical audits following a process through an organizationan organization
Management reviews Management reviews (ISO 17025: 2005, 4.15)(ISO 17025: 2005, 4.15)
The laboratory’s executive The laboratory’s executive management shall management shall periodically conduct a periodically conduct a review of the laboratory's review of the laboratory's management systemmanagement system
PitfallsPitfalls
Managerial systemManagerial system
BureaucraticBureaucratic
Static systemStatic system
Not flexibleNot flexible
environment
law
permits
license
(local) government storage
acc
om
modati
o
n
personnel
management
Profi
ency
test
ing
Docu
ment
contro
l
samples registration
equipment
calib
ratio
n
validation
refe
rence
st
andard
sAnalyticalmethods
Building a Quality System
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