Document Control Establishment of procedure for document control Maintenance of copies of these documents for defined period Preparation,

review and approval of documents Maintenance of a master list or an equivalent document control mechanism Ensuring availability of current authorised versions Periodic review of documents Removal of invalid or obsolete documents Suitable identification of obsolete documents Unique identification of documents Review of Contracts Review of contracts/ requests for testing Maintenance of records of reviews and requests Review of changes in the requests/ contract

Examination by referral laboratories Selection of referral laboratories and consultants Periodic review of performance Maintenance f register of referral laboratories

External services and supplies Establishment of procedure for purchasing, inspection, acceptance/ rejection and storage Verification of purchased supplies/ services Control of storage of supplies Evaluation of supplies

Advisory services Appointment of laboratory professional staff Resolution of complaints Registering complaints and their resolution

Identification and control of nonconformities Establishment of procedure Evaluation of nonconformances for their recurrence Authorization for release of results

Corrective Action Establishment of procedure for corrective actions Documentation and implementation of changes required resulting from corrective action Monitoring the results of corrective action Auditing the areas of implementation of corrective actions, if needed

Continual Improvement Improvement and development of plans Evaluation of effectiveness of improvements Submission of results of review to management Identification of Quality indicators and monitoring Provision of suitable training opportunities for all lab personnel Quality and technical records Establishment of procedure for control of records Storage and maintenance of records

Defined period of retention of records Maintenance of records for the defined period

Internal Audits Organizing internal audits as per schedule Development of procedure for internal auditing Initiation of corrective actions Submission of results for management review

Management Review Organizing management reviews as per schedule Coverage of agenda for review as per the standard Recording the decisions and follow up

Technical requirements Personnel Defined Organizational structure Maintenance of records of personnel Provision of competent person to direct the lab. Provision of adequate staff resources Training of personnel in quality assurance Authorization of personnel for various activities Establishment of policies and procedures and defining roles of personnel Personnel contd. Ensuring availability of continuing education program

Provision of training to prevent adverse incidents Assessment of competency of the staff during training and periodically Encouraging personnel to take part in regular professional development activities Ensuring confidentiality of patient information

Accommodation and environmental conditions Provision of adequate working place for primary sample collection and examinations sites Ensuring protection of patients, employees and visitors protected from recognised hazards Considerations for patient disabilities, comfort, and privacy for primary sample collection Ensuring suitability of the laboratory design and environment suitable for the tasks Monitor, control and recording of environment conditions Ensuring effective separation between incompatible neighboring areas Ensuring limited access to test areas Ensuring proper communication within the lab. Provision of adequate storage space Ensuring cleanliness and good housekeeping Disposal of hazardous materials Provision of training of personnel on cleanliness Laboratory Equipment Provision of necessary equipment Periodic checking equipment for suitability (Preventive maintenance and calibration) Operation of equipment by authorized personnel

Availability of updated operating instructions Maintenance of equipment in safety Removal of defective equipment from usage Avoiding contamination to the person working and provision of suitable space for repairs Indication of calibration and next due date Recalibration/ re-verification of equipment Ensuring controls for the computerized equpt. Use of correction factors from calibrations Safe guarding equipment Pre-examination Process Ensuring sufficient identification information Adequate instruction for sample collection Adequate primary sample collection manual Primary sample collection manual under doc. control system Ensure primary samples traceable to an identified individual by a request form Monitoring transportation of the samples Pre-examination Process -contd. Periodic review of sample volume requirements Development of procedure for handling of urgent primary samples Acceptance of verbal requests for examinations Examination procedures Use of appropriate examination procedures Ensuring use of validated procedures Availability of test procedures with operators

Ensuring the suitability of the procedures Review of the biological reference intervals Maintaining list of its current examination proc. Explanation of the implication when the laboratory changes an examination procedure Assuring the quality of examination procedures Development of internal QC system Determination of uncertainty in measurements Ensuring periodic calibration of equipment Ensuring participation in inter-lab comparisons Development of mechanism for the acceptability of procedures in the absence of PT Checking validity of tests by different procedures, different equipment or sites Corrections/ corrective actions for unsatisfactory QC results Post-examination process Review the results of examinations and evaluate with the clinical information available Storage of primary samples Suitable disposal of tested samples Reporting of results Ensuring reports in the approved format Transfer of test information to computer Authorization for report generation Ensuring delivery of reports as per agreement Use of accepted vocabulary and syntax Retention of the copies or files of reported results

Notification of physician on alert intervals Extension of this notification to the samples sent to referral laboratories for examination Sending the original report for the results Maintenance of records of actions taken in response to results in the critical intervals Establishment of turnaround time Precaution for transcription of results received from referral laboratories Ensuring correct delivery of results Ensuring adequate controls when results are transmitted through electronic means Control for modification/ alteration of reports Clear identification of revised values, if any