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- The laboratory's management system policies related to quality, including a quality policy statement, shall be defined in a ______ _______
- qualitymanual
- The procedures adopted shall ensure that documents are periodically _____ and, where necessary, revised to ensure continuing suitability and compliance with applicable requirements
- reviewed
- The laboratory shall maintain a register of all _____ that it uses for tests and/or calibrations and a record of the evidence of compliance with this International Standard for the work in question
- subcontractors
- Procedures shall exist for the purchase, _____, and storage of reagents and laboratory consumable materials relevant for the tests and calibrations
- reception
- The laboratory shall ensure that purchased supplies and reagents and consumable materials taht affect the quality of tests and/or calibrations are not used until they have been _____ or otherwise verified as complying with standard specifications or requirements defined in the methods for the tests and/or calibrations concerned
- inspected
- _____ documents for items affecting the quality of laboratory output shall contain data describing the services and supplies ordered
- purchasing
- The laboratory shall be willing to _____ with customers or their representatives in clarifying the customer's request and in monitoring the laboratory's performance in relation to the work performed, provided that the laboratory ensures confidentiality to other customers
- cooperate
- The laboratory shall seek _____, both positive and negative, from its customers
- feedback
- The laboratory shall have a policy and procedure for the resolution of _____ from customers or other parties
- complaints
- The laboratory shall have a policy and procedurs that shall be implemented when any aspect of its testing and/or calibration work, or the results of this work, do not _____ to its own procedures or the agreed requirements of the customer
- conform
- The laboratory shall continually improve the _____ of its management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and the management review
- effectiveness
- The procedure for corrective action shall start with an investigation to determine the _____ _____ of the problem
- rootcause
- Where corrective action is needed, that laboratory shall identify potential corrective actions. It shall select and implement the actions most likely to eliminate the problem and prevent _____
- recurrence
- Corrective actions shall be to a degree appropriate to the _____ and the risk of the problem
- magnitude
- Procedures for _____ actions shall include the initiation of such actions and the application of controls to ensure that they are effective
- preventive
- All records shall be _____ and shall be stored and retained in such a way that they are readily retrievable in facilites that provide a suitable unvironment to prevent damage or deterioration and to prevent loss
- legible
- The laboratory shall have procedures to protect and back-up records stored electronically and to prevent unauthorized access to or _____ of these records
- amendment
- The records for each test or calibration shall contain sufficient information to facilitate, if possible, identification of factors affecting the _____ and to enable the test or calibration to be repeated under conditions as close as possible to the original
- uncertainty
- Observations, data and calculations shall be recorded at the time they are made and shall be _____ to the specific task
- identifiable
- When mistakes occur in _____, each mistake shall be crossed out, not erased, made illegible or deleted, and the correct value entered alongside
- records
- The laboratory shall periodically, and in accordance with a _____ schedule and procedure, conduct internal audits of its activities to verify that its operations continue to comply with the requirements of the management system, including the testing and/or calibration activities
- predetermined
- It is the responsibility of the quality manager to plan and organize _____ as required by the schedule and requested by management
- audits
- Audits shall be carried out by trained and qualified personnel who are, wherever resources permit, _____ of the activity to be audited
- independent
- In accordance with a predetermined schedule and procedure, the laboratory's top management shall periodically conduct a review of the laboratory's _____ system and testing and/or calibration activities to ensure their continuing suitability and effectiveness, and to introduce necessary changes or improvements
- management
- Findings from management reviews and the actions that arise from them shall be _____
- recorded
- The laboratory shall ensure that the _____ conditions do not invalidate the results or adversely affect the required quality of any measurement
- environmental
- The laboratory shall monitor, _____, and record environmental conditions as required by the relevant specifications, methods and procedures or where they influence the quality of the results
- control