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ISO 15189:2007
1. Introduction to ISO 15189 ISO 15189:2007 Medical laboratories- Particular requirements for quality and competence 3/24/2010
2. Introduction: In the following slides ISO 15189:2007 standard is paraphrased and reworded for the training purpose. Refer to the standard to the actual text. This second edition cancels and replaces the first edition (ISO 15189:2003) in order to align it more closely with the second edition of ISO/IEC17025. 3/24/2010
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5. It has its origins in two ISO Standards âŠISO 9001 and ISO 170253/24/2010
6. ISO 15189âŠâŠThe history Defining Quality asâŠâŠ âŠâŠ âThe degree to which a set of inherent characteristics fulfills requirementsâ Defining Competence asâŠ. âŠâŠâA demonstrated ability to apply knowledge and skillsâ 3/24/2010
10. Why standards? Theyâre important in international trade to eliminate barriers. They facilitate trade through enhanced product quality and reliability at reduced costs. To be recognized internationally. 3/24/2010
11. Why quality? To improve patient care. To be consistent & focus on process. To assure safety of clients & customers. For better customer satisfaction. For continuous improvement 3/24/2010
12. Benefits of ISO15189 More focus on patient safety & report test results Emphasizes on the total service of a medical laboratory (consultation, turn around time, cost etc.) Addresses ethics and information needs of the medical laboratory Be recognized as a competent laboratory worldwide. 3/24/2010
24. Facilities and safetyThere are relationships between these QSE called âprocess mapâ ISO 15189 has 23 QSE 3/24/2010
25. process map: ORGANISATION & MANAGEMENT RESPONSIBILITY 4.1Organization and management responsibility 4.15 Management review 4.4 Service agreements QUALITY MANAGEMENT SYSTEM 4.2 Quality management system 4.3 Document control 4.13 Control of records Act Plan EVALUATION & CONTINUAL IMPROVEMENT 4.8 Resolution of Complaints 4.9 Identification and control of non conformities 4.10 Corrective action 4.11 Preventative action 4.12 Continual improvement 4.14 Evaluation and Internal audits 5.6 Ensuring the quality of results (in part) RESOURCE MANAGEMENT 5.1 Personnel 5.2 Accommodation and environmental conditions 5.3 Laboratory equipment, reagents and materials 5.9 Management of information systems 4.6 External supplies and services EXAMINATION PROCESSES Pre examination processes 4.5 Examination by referral laboratories 5.4 Pre examination processes Examination processes 5.5 Examination processes 5.6 Ensuring the quality of results (in part) Post examination processes 4.7 Advisory services 5.7 Post examination processes 5.8 Reporting results User Satisfaction or dissatisfaction User Requirements Check Do Report Request PROCESS INPUTS OUTPUTS 3/24/2010
26. Key Clauses in ISO 15189:2007 Organization & Management Quality Management System Resource Management Pre-examination procedures Examination Procedures Post-examination procedures Corrective & Preventive Action Continual Improvement 3/24/2010
27. Difference between ISO 15189 &9000: ISO 9001 certificate provides confidence about the laboratoryâs quality management system. Therefore ISO 15189 is a measure of both technical competence and quality management and is the most appropriate process for laboratories use. 3/24/2010
34. 4.1 Organization and Management The personnel responsible for patient care. medical lab or organization shall be legally identifiable. Medical lab services shall be designed to meet needs of patients and all clinical Responsibilities & authorities shall be defined. Lab management shall be responsible for the design, implementation, maintenance and improvement of the QMS. 3/24/2010
35. 4.1 Organization and Management Policies, processes, programmes, procedures and work instructions shall be documented and communicated to all relevant personnel. The QMS shall include, but not limited to, internal quality control and participation in interlaboratory comparisons such as external quality assessment schemes. 3/24/2010
36. 4.1 Organization and Management Quality policy shall be stated per Lab director and readily available to appropriate personnel. Quality policy shall be documented in a quality manual. Quality policy shall include: the scope of service of the lab, the objectives of the QMS. Labâs commitment to good practice, the quality of its examinations, and compliance with the QMS. 3/24/2010
37. 4.2 Quality management system Quality manual shall describe the structure of the documentation used in the QMS. Roles & responsibilities of technical management & quality manager shall be defined in the manual. Lab management shall establish, implement and document a preventive maintenance and calibration programmes of instruments, reagents and analytical system. 3/24/2010
38. 4.3 Document control The lab shall define and maintain procedures to control all documents. The lab shall maintain their controlled document and shall define their retention period. All documents issued to lab personnel shall be reviewed and approved by authorized personnel prior to issue. 3/24/2010
39. 4.3 Document control Procedures shall be adopted to ensure that : Only current authorized versions of appropriate documents are available for active use. Obsolete documents are promptly removed from all points of use. Documents are periodically reviewed, revised when necessary, and approved by authorized personnel. 3/24/2010
40. 4.3 Document control Procedures are established to describe how changes to documents are to be made and controlled. All documents relevant to QMS shall be uniquely identified with title, current version number or revision number, authority for issue, etc⊠3/24/2010
41. 4.4 Review of Contracts Procedures/policies shall be established for review of contracts. Records of reviews, including any significant changes and pertinent discussions, shall be maintained. 3/24/2010
42. 4.5Examinations by referral laboratories The lab shall have an effective procedure for selection and evaluation of referral laboratories. The lab shall maintain a register of all referral labs that it uses. The referring lab and not the referral lab shall be responsible for ensuring that examination results are provided to the requestor. 3/24/2010
43. 4.6External services and supplies The lab shall have a procedure for the selection and use of purchased consumable supplies and equipment that affect the quality of its services. There shall be criteria and procedures for inspection, acceptance/rejection and storage of consumable materials. 3/24/2010
44. 4.6 External services and supplies Purchased equipments and consumable supplies shall not be used until they have been verified as complying with requirements and pre-defined specifications. The lab shall evaluate suppliers and shall maintain records of these evaluations and list those approved. 3/24/2010
45. 4.7Advisory services Appropriate lab pro staff shall provide advices to the patient on choice of examinations and use of the services. There should be regular meetings of pro staff with the clinical staff regarding the use of lab services. 3/24/2010
46. 4.8 Resolution of complaints The lab shall have a procedure to deal with customer complaints and feedback. Records of complaints, root cause analysis, corrective actions and preventive actions shall be maintained. 3/24/2010
47. 4.9 Identification & control of nonconformities The lab shall have a policy or procedure to control any aspect of its examinations that does not conform with requirements. It shall ensure that: Personnel responsible for problem resolution are designated. Corrective action taken immediately. Examinations are halted and reports withheld. 3/24/2010
48. 4.10 Corrective action A procedure for corrective action shall explain how to find the true root cause of the non conformity, which will lead to preventive actions. Corrective action shall be appropriate to the magnitude of the problem and commensurate with possible risks. Lab management shall monitor corrective action and ensure that they have been effective. 3/24/2010
49. 4.11 Preventive action Action plans shall be developed to prevent occurrence of nonconformity. Preventive action shall be taken as an opportunity for improvement Preventive action is a pro-active process rather than a reaction to a nonconformity. 3/24/2010
50. 4.12 Continual improvement Lab management shall implement quality indicators for monitoring the labâs contribution to patient care. All operational procedures shall be systematically reviewed by lab management to identify any potential sources of nonconformance or other opportunities for improvement. Action plans for improvement shall be developed, implemented and documented. 3/24/2010
51. 4.13 Quality & technical records The lab shall establish and implement policies and procedure for Identification, indexing, access, storage and overall control of quality records. Records shall be legible and stored such that they are retrievable. Records shall be stored in a suitable environment to prevent damage, loss or unauthorized access. 3/24/2010
52. 4.13 Quality & technical records The lab shall have a policy that defines the retention time for quality & technical records. Retention times vary with the type and nature of record. Records may include but not limited to: 3/24/2010
53. 4.14 Internal audits The lab shall have procedures and policies for internal audits schedule, frequency, methodology and required documentation. Internal audits of the QMS shall be conducted once every twelve month. Both managerial & technical system shall be subject for audit. 3/24/2010
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55. Results of the review shall be documented and shall result into action plans, objectives and goals.
77. Plan, set goals and allocate resources appropriate to the medical environment.
78. There shall be staff resources adequate to carry out operations in the lab and other functions of the QMS.
79. Lab management shall authorize personnel to perform particular tasks such as sampling, examination and operation of particular types of equipment.3/24/2010
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81. The competency of each person to perform tasks shall be assessed periodically. Retraining shall occur when necessary.
82. Confidentiality of info and data regarding patients shall be maintained by all personnel.3/24/2010
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84. Lab resources shall be maintained in a functional and reliable condition to support the lab activities.
85. The environment where the primary sample or examinations or both are collected shall be suitable and shall not invalidate test results.3/24/2010
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87. The lab shall monitor, control and record environmental conditions. Attention should be paid to sterility, dust, humidity, electrical supply, temperature, etc⊠as appropriate to the technical activities concerned.3/24/2010
90. Relevant storage space and conditions shall be provided to ensure the continuing integrity of samples, slides, histology blocks, documents, files, manuals, reagents, records, results and supplies.3/24/2010
136. Repeating of tests due to analytical failure or further examinations of same primary sample.3/24/2010
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138. The lab shall monitor the transportation of samples to the lab so that they are transporteda. Within a time frame appropriate to the nature of the requested examinations. b. Within a temperature interval specified in the primary sample collection manual. c. In a manner that ensures safety for the carrier, the public and the lab. 3/24/2010
139. 5.4 Pre-examination procedures Criteria shall be developed and documented for acceptance or rejection of primary samples. All primary samples received shall be recorded in an accession book, worksheet or computer system. The lab shall periodically review its sample volume requirements for phlebotomy to ensure sufficient volume is always taken. The lab shall have a documented procedures for the receipt, labeling, processing and reporting of those primary samples received by the lab. 3/24/2010
140. 5.5 Examination procedures The lab shall use examination procedures which meet the needs of the users of lab services and are appropriate for the examinations. The lab shall use only validated procedures for confirming that the examination procedures are suitable for the intended use. The lab shall record the results obtained and the procedure used for the validation. 3/24/2010
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142. The procedure shall be based on the instructions for use (e.g. package insert) written by the manufacturer provided that they describe the procedure, as it is performed in the lab.3/24/2010
159. The lab shall make its list of current examination procedures, including primary sample requirements, and relevant performance specifications and requirements, available to users of laboratory services.
160. Any planned changes to examination procedures which could influence test results or their interpretation, shall be explained to lab users prior to introduction.3/24/2010
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162. The lab shall determine the uncertainty of results, where relevant and possible. Sources may be related to sampling, sample preparation, calibrators, equipment used, working environment condition of the sample, reference materials, and changes of operator.3/24/2010
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164. Participate in a suitable programme of inte-rlaboratory comparisons;
169. The lab shall participate in inter-laboratory comparisons such as those organizes by external quality assessment schemes.. 3/24/2010
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171. Whenever a formal inter-laboratory comparison is not in place, the lab shall develop a mechanism (such as exchange samples with other labs) for determining the acceptability of procedures not otherwise evaluated. 3/24/2010
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173. The lab shall document, record and, as appropriate, expeditiously act upon results from these comparisons. Problems or deficiencies identified shall be acted upon and records of actions retained. 3/24/2010
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175. Storage of primary sample and other lab samples shall be in accordance with approved policy.
176. Disposal of samples (left over) shall be carried out in accordance with local regulations or recommendations for waste management and/or as per in house policy.3/24/2010
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178. The lab and the requester both are responsible for ensuring report results are received by the appropriate individuals within an agreed-upon time interval.
179. Results shall be legible, without mistakes in transcription and reported to physicians or designated authorized personnel.3/24/2010
195. Copies or files of reported results shall be retained by the lab for prompt retrieval of info and retention time shall be consistent with the requirements regional, local or national.3/24/2010
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197. Turnaround times shall be established and agreed upon between lab management and requesters. There shall be a policy for notifying the requester when an examination is delayed. Turnaround times as well as feedback from clinicians in relation to it shall be monitored, recorded and reviewed by lab management.3/24/2010
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199. The lab shall have written policies regarding the alteration of reports. When altered, the record must show the time, date and name of the person responsible for the change. Original entries shall remain legible when alterations are made.3/24/2010