Quality manual as per iso 15189

A short summary of this paper. Download Download PDF. Translate PDF. Page Sect. Director 2. Lab In charge of respective Sections 3. Quality Manager 4. ISO 2. NABL Specific criteria 3. Regulatory Authorities The HLS is totally dedicated and committed to provide diagnostic services, giving top priority to the quality of the results for all the samples received by laboratory. HLS takes adequate measures to ensure that quality care is given to all patients without showing any discretion.

The services offered by HLS is cost effective and fined tuned to ensure that utmost care is taken so that the results are reliable, accurate and dependable to assure that the results are close to the true value. All the staff members are made to imbibe this philosophy and are part to our endeavor to maintain quality at every level. It is responsibility of all the staff to familiarize themselves with the content of the Quality Manual and comply with the policies and procedures lay down in the manual and associated documents at all times.

Quality manager has the overall responsibility for implementation and control surveillance of Management system. HLS has adequate facilities and technical competence to carry out the tests as mentioned in the Scope of Accreditation as appended to the application form under the clause 2.

This Quality Manual is applicable to the various sections as HLS as mentioned earlier refer Section G for performing the tests as mentioned in the appendix that has been attached to the application from under the clause 2. The Quality manual is for use by HLS in developing their quality, administrative and technical system that governs our operation. Laboratory Clients, Laboratory Clients, Regulatory authorities and accreditation bodies also use it in confirming or recognizing the competence of laboratories.

The regulatory and safety requirements on the operation of laboratories are not covered by this Quality Manual. Our lab shall by comply with the requirements of the International Standard ISO , to operate a Management system for their testing activities.

In addition, certain abbreviations which are used throughout the Quality Manual and other document of Management System are mentioned and decoded in abbreviations. HLS being a clinical testing laboratory considers as customers: 1. Clinical Doctors 2. Walk — in patients Self testing 3. Corporate organizations Health Check 4. He has provided with adequate resources needed to ensure required quality of laboratory operations. HLS has appointed Quality Manager. He has direct access to the Director — HLS.

HLS has documented its policies, process, program, procedure and instructions and has communicated this to all relevant personnel. Policies and objectives of the Quality Management System have been defined in a Quality Policy Statement under the Authority of the Director which has been documented in the Quality Manual.

Laboratory has an established program that ensures regular monitoring, proper calibration and function of instruments, reagents and analytical systems. Respective sections maintain the document for maintenance of equipment that belongs to their section.

The Quality Manual is updated under the authority and responsibility of the Quality Manager. Quality Manager issues these documents to the laboratory personnel. Laboratory personnel are responsible for retaining the authorized editions and removing the obsolete copies.

Quality Manager maintains the distribution list. Any user of the document can propose the amendment; these amendments are reviewed by Technical Manager and approved by the Director. Quality Manager retains a copy of the obsolete Document for records. HLS keeps the stated and implied needs its client uppermost in discharging all contracts made to it. The detailed procedures outlining such reviews are outlined in concerning SOP. In all situations for which the tests are defined in the Directory of services, the method of testing is indicated.

All records of review are maintained which is inclusive of significant changes that is outlined in concerned SOP. HLS shall review and cover investigation that is subcontracted by the Laboratory. HLS informs the Customer of any deviation from the contract If contracts are amended after commencement of work, the changes will be communicated to all personnel concerned. The materials are purchased through on sending an indent form.

The Lab assistant initiates the indent, technical manager approves it. Then the purchase department initiates the purchase activities. On receipt of the material the Lab Assistant shall inspect the material. I the quantity is less, purchase department shall be informed. The detailed procedure for resolution of complaints and other feedback received from clientele, patient or other parties are outlined in complaint register.

The record of complaints and of and of investigations and the corrective actions taken by laboratory is maintained in a register. The Technical Manager verifies the detail of the nonconformity and plan the action to arrest the nonconformity.

Director, Technical Manager takes necessary corrections to arrest the nonconformity. If required, the technical manager will take corrective and preventive actions.

An evaluation is done for the effectiveness of the changes made. Whenever there is scope for improvement, lab management will address it appropriately. IA is carried out by persons whose routine activities are not related to that of the audit area allotted to them.

IA is scheduled at least once in 12 months to cover all areas of the lab. Internal audit will cover and address all elements of the Management system and testing activities. The Quality Manager plans schedules and implements a comprehensive Internal Quality Audits to verify the compliance of it operations and activities to ISO and the requirements of the documented Management System.

This includes informing the client of any deviation from the agreement. This procedure ensures that non-conforming work or problems are corrected, where applicable, and subject to verification after correction to demonstrate conformity. Where required by the agreement, the proposed rectification of non-conforming work or problems is reported for concession to the customer, the end user, regulatory body, or other applicable authority.

The record states whether the method or procedure is fit for the intended use. These factors include contributions from: human factors, accommodation and environmental conditions, test and calibration methods and method validation, equipment, measurement traceability, and handling of test and calibration items.

XYZ Laboratory takes into account these factors in developing test and calibration methods and procedures, in the training and qualification of personnel, and in the selection and calibration of the equipment it uses.

In certain cases it is not possible to undertake metrologically and statistically valid estimations of uncertainty of measurement. In these cases the laboratory attempts to identify all the components of uncertainty and make the best possible estimation, and ensure that the form of reporting does not give an exaggerated impression of accuracy.

Reasonable estimation is based on knowledge of the performance of the method and on the measurement scope, and makes use of previous experience and validation data. The degree of rigor needed in an estimation of uncertainty of measurement depends on factors such as:.

In cases where a well-recognized test method specifies limits to the values of the major sources of uncertainty of measurement and specifies the form of presentation of calculated results, the laboratory is considered to have satisfied the estimation uncertainty of measurement by following the test method and reporting instructions.

The results are normally reported in a test report and include all the information requested by the client and necessary for the interpretation of the test results, and all information required by the method used. Note: Paragraph numbering in the above sample is for illustration purposes only. The numbering in the actual product may differ.

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