7.10 Nonconforming work 7.10.1 Does the laboratory have a procedure for dealing with nonconforming work? Does the procedure ensure that: a) The responsibilities and authorities for the management of nonconforming work are defined; b) actions (including halting or repeating of work and withholding of reports, as necessary) are based upon the risk levels established by the laboratory; c) an evaluation is made of the significance of the nonconforming work, including an impact analysis on previous results; d) a decision is taken on the acceptability of the nonconforming work; e) where necessary, the customer is notified and work is recalled; f) the responsibility for authorizing the resumption of work is defined. 7.10.2 To produce Records for Clause 7.10.1 (b) to (f) 7.10.3 Does the laboratory take corrective action when it is found that nonconforming work could recur or that there is doubt about the conformity of the operations laboratory’s with its own management system? 7.11 Control of data and information management 7.11.1 Does the laboratory have access to necessary data and information to perform its laboratory activities? 7.11.2 Does the laboratory validate its laboratory information management systems for functionality and proper functioning of interfaces before introduction? Does the laboratory authorize, document and validate any modifications to its laboratory software? 7.11.3 Is the laboratory information management system a) protected from unauthorized access? b) safeguarded against tampering and loss?
7.10 Nonconforming work 7.10.1 a) b) c) d) e) f) 7.10.2 Does the laboratory have a procedure for dealing with nonconforming work? Does the procedure ensure that: The responsibilities and authorities for the management of nonconforming work are defined; actions (including halting or repeating of work and withholding of reports, as necessary) are based upon the risk levels established by the laboratory; an evaluation is made of the significance of the nonconforming work, including an impact analysis on previous results; a decision is taken on the acceptability of the nonconforming work; where necessary, the customer is notified and work is recalled; the responsibility for authorizing the resumption of work is defined. To produce Records for Clause 7.10.1 (b) to (f) 7.10.3 Does the laboratory take corrective action when it is found that nonconforming work could recur or that there is doubt about the conformity of the laboratory’s operations with its own management system? 7.11 Control of data and information management 7.11.1 Does the laboratory have access to necessary data and information to perform its laboratory activities? 7.11.2 Does the laboratory validate its laboratory information management systems for functionality and proper functioning of interfaces before introduction? Does the laboratory authorize, document and validate any modifications to its laboratory software? 7.11.3 a) b) Is the laboratory information management system protected from unauthorized access? safeguarded against tampering and loss?