Records Required to Meet ISO Standard
Providing a list of records and their formats necessary to comply with ISO Standard requirements. The list includes various documents related to communication, agreements, corrective actions, quality indicators, training, employee records, equipment maintenance, and more. The formats approved for use can be utilized as is or customized to suit individual lab needs. The content is complemented with linked images showing additional details.
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Presentation Transcript
Dr Neeraj as has kindly provided the list the records (with their formats) necessary to meet the requirements of the ISO Standard These r part of the courses This format has been applied . The formats approved The labs may use these formats or The lab may keep add to the list Delete not applicable ..
S.No S.No. . Document Name Document Name CLAUSE CLAUSE Communication with staff 4.1 1 2 Document Distribution Record 4.3 3 Revision History of Documents 4 Service Agreement Deviation Form 4.4 5 Agreement-Part Time Consultants 6 Ref Lab Evaluation Format 4.5 7 Sample outsourced format 8 Advisory Services Format 4.7 9 Internal Complaint Format 4.8 10 Feedback Form Patient 11 Daily Non conformance Report 4.9
S.No S.No. . Document Name Document Name CLAUSE CLAUSE Corrective action form 4.10 12 13 Preventive Action Form 4.11 Continual Improvement Form 14 4.12 Quality Indicators 15 Turn Around Time 16 Audit Schedule 17 4.14 Audit Nonconformance Report 18 Internal Audit Report 19 20 Risk Assessment Form 21 Management Review Minutes 4.15
S.No S.No. . Document Name Document Name CLAUSE CLAUSE 22 23 24 Confidentiality Agreement Employee health record Induction Training Format 25 Annual Training Plan 26 Training need identification 27 Meeting / Training Attendance Sheet 5.1 28 Training Questionnaire 29 Incident / Accident Record 30 Employee training record 31 Employee Suggestion Form 32 Employee competency assessment form
S.No S.No. . Document Name Document Name CLAUSE CLAUSE 31 Employee Performance Appraisal Form 5.1 32 Employee personnel record 33 Employee Joining Letter Temperature / Humidity Record Format 34 Housekeeping schedule 35 5.2 Toilet Cleaning Schedule 36 37 Waste Disposal Record 38 Equipment service log 39 Maintenance Schedule Equipment 5.3 40 Decontamination Schedule Equipment
S.No S.No. . Document Name Document Name CLAUSE CLAUSE 41 42 Verification Format Equipment 5.3 Lot Verification format New Kit Test Requisition Form Sample Rejection record 43 5.4 44 5.4 45 5.5 Validation & Verification Record External QC corrective action record 46 5.6 47 Internal QC corrective action record 5.7 Sample Discard Record Format 48 49 50 Report Error Log 5.9 Critical / Alert Value Information Record Format 5.9 51 Software Validation & Verification 52 Charges Record 5.10 53 Maintenance Record
FORMS AND FORMATS Prepared by Quality Manager Issued By Approved By Quality Manager Lab Director Name & Address of the Laboratory
INTERNAL AUDIT PLAN Type of Audit Horizontal Vertical P Planned C Conducted NC NCR Closed NP Next Planned JAN 201 FEB 201 MAR 201 APR 201 MAY 201 JUN 201 JULY 201 AUG 201 SEP 201 OCT 201 NOV 201 DEC 201 DEPARTMENT Lab Management Reception Sample Collection Stores & Purchase Reporting / I.T Maintenance Housekeeping Clinical Biochemistry Hematology Clinical Pathology Serology
P Planned C Conducted NC NCR Closed NP Next Planned JAN 201 FEB 201 MAR 201 APR 201 MAY 201 JUN 201 JULY 201 AUG 201 SEP 201 OCT 201 NOV 201 DEC 201 Area//Activity Lab Management Reception Sample Collection Stores & Purchase Reporting / I.T Maintenance Housekeeping Clinical Biochemistry Hematology Clinical Pathology Serology
INTERNAL AUDIT PLAN JAN 2016 MAR 201 APR 201 MAY 201 JUN 201 JULY 201 AUG 201 SEP 201 OCT 201 NOV 201 DEC 201 Area/Activity Lab Management Reception Sample Collection Stores & Purchase Reporting / I.T Maintenance Housekeeping Clinical Biochemistry Hematology Clinical Pathology Serology
AUDIT SCHEDULE FROM Q Mgr TO All Concerned DATE DEPARTMENT DATE TIME AUDITOR AUDITEE Sign Lab Management Reception Sample Collection Stores & Purchase Reporting / I.T Maintenance Housekeeping Clinical Biochemistry Hematology Clinical Pathology Serology
AUDIT NON CONFORMANCE REPORT FORMAT DEPTT AUDITOR AUDITEE DATE DETAILS OF N C R CLAUSE / DOCUMENT VIOLATION: NONCONFORMANCE: MINOR MAJOR OBSERVATION Sign of Auditor ROOT CAUSE CORRECTIVE / PREVENTIVE ACTION PROPOSED Sign of Auditee TARGET DATE RESPONSIBILITY Corrective action status check CLOSURE VERIFICATION CLOSURE - ACCEPTED NOT ACCEPTED SIGN & REMARKS OF QMR / LEAD AUDITOR STATUS Compliant Repeated After 1 month After 3 months After 6 months After 9 months
INTERNAL AUDIT REPORT Internal Audit No (As per 15189:2012 Standards) Date of Audit Name of Auditors Department 1 2 3 Areas Audited S No. Date of Audit Auditor 1 Lab Management 2 Reception 3 Sample Collection 4 Stores & Purchase 5 Reporting / I.T 6 Maintenance 7 Housekeeping 8 Clinical Biochemistry 9 Hematology 10 Clinical Pathology 11 Serology
5 Total No. of Nonconformance Clause / Procedure Violation No. of NC Target Date S No. Department Responsibility 1 2 3 4
6 Verification of Corrective Action taken by Q Mgr S No . 1 2 3 4 5 Department No. of NC s Closure Verification Remarks Date Status 7 AUDIT REMARKS
MANAGEMENT REVIEW MINUTES REPORT NO. PLACE TIME: From ______ to _______ hrs DATE OF MEETING: PERSON ATTENDED SIGN PERSON ATTENDED SIGN Medical Director I/C Biochemistry Lab Director I/C Hematology Quality Manager I/C Clinical Pathology I/C Reporting I/C Serology I/C Reception I/C Sample Collection
MINUTES OF MRM POINTWISE Action Taken , If Any S No Responsibility / Target Date Action Verified By AGENDA POINTS DISCUSSED a Periodic review of requests, and suitability of procedures and sample requirements Assessment of user feedback Staff suggestions Internal audits Risk Management Use of Quality Indicators Review by external organizations Results of participation in inter-laboratory comparison programmes (PT/EQA) Monitoring and resolution of complaints Performance of suppliers Identification and control of nonconformities Results of continual improvement including current status of corrective actions and preventive actions Follow up actions from previous management reviews Changes in volume and scope of work, personnel and premises that could affect the quality management system b c d e f g h i j k l m n o Recommendation for improvement, including technical requirements
DAILY NON CONFORMANCE REPORT MONTH Date.. Department Management Administration Sample Collection Area Sample Processing Area Sample Testing Area Reporting / IT Done By
Management: Administration: Maintenance, Stores Sample Testing Area: Pathology, Serology, Microbiology Category of Nonconformance 1 Customer Complaint, 3 Product Quality 5 Environment Related, 7Staff Related, 9 Sampling Related, Any Non conformance repeated after taking corrective action in the past ? Lab Director / TM / Q Mgr Reception, Housekeeping / BMW, Biochemistry, Hematology, Clinical 2 4 Service Quality, 6 Equipment Related, 8 Housekeeping 10 Others (Pl Specify) Procedure Violation YES NO
DAILY NON CONFORMANCE REPORT DATE DEPARTMENT DETAILS OF DAILY N C R ROOT CAUSE CORRECTIVE / PREVENTIVE ACTION TAKEN TARGET DATE RESPONSIBILITY CLOSURE VERIFICATION DATE DEPARTMENT DETAILS OF DAILY N C R ROOT CAUSE CORRECTIVE / PREVENTIVE ACTION TAKEN TARGET DATE RESPONSIBILITY CLOSURE VERIFICATION
PREVENTIVE ACTION FORM DATE DEPARTMENT INCHARGE DEPTT PREVENTIVE ACTION SUGGESTED NAME SUGGESTION PREVENTIVE ACTION ACCEPTED NOT ACCEPTED PREVENTIVE ACTION PROPOSED TARGET DATE RESPONSIBILITY ACTION TAKEN VERIFICATION REMARKS OF LAB DIRECTOR
CONTINUAL IMPROVEMENT FORM DATE DEPARTMENT PREVIOUS STATUS IMPROVEMENT BENEFICIARY
QUALITY INDICATORS FOR MONTORING LABORATORYS PERFORMANCE (Year ) MONTH QUALITY INDICATORS 1 2 3 PRE ANALYTICAL FAILURES 4 5 6 7 8 9 10 11 12 13 14 15 Syntax errors during patient registration No. of veni puncture failures No. of Sample Rejections No. of times samples marked URGENT reached late for testing ANALYTICAL FAILURES No. of Re Test on patient / clinician request No. of times alert values not informed to Ref. doctor No. of equipment failures No. of parameters with IQC outside good % CV (Monthly) No. of parameter outside the EQAS acceptable criteria POST ANALYTICAL FAILURES Reports not delivered on time (TAT) No. of reporting errors No. of complaints received from clinicians No. of complaints received from patients / attendants Done By
QUALITY INDICATORS FOR MONTORING LABORATORYS PERFORMANCE (Year ) Quality Indicators - Cumulative Score Month wise QUALITY INDICATORS JAN FEB MAR APR MAY JUN JULY AUG SEP OCT NOV DEC PRE ANALYTICAL FAILURES Syntax errors during patient registration No. of veni puncture failures No. of Sample Rejections No. of times samples marked URGENT reached late for testing ANALYTICAL FAILURES No. of Re Test on patient / clinician request No. of times alert values not informed to Ref. doctor No. of equipment failures No. of parameters with IQC outside good % CV (Monthly) No. of parameter outside the EQAS acceptable criteria POST ANALYTICAL FAILURES Reports not delivered on time (TAT) No. of reporting errors No. of complaints received from clinicians No. of complaints received from patients / attendants Done By
REFERENCE LAB EVALUATION Duration of Performance Evaluation Year Name of Ref Lab January June July December COMPLAINTS AGAINST 1 Delay in Pick up of Samples 2 Non standard method of transportation 3 Wrong Patient / Test Entry 4 Delay in Delivery of Reports 5 Behavior of Ref Lab Staff 6 Errors in billing 7 Improper Communication 8 Refusal to give urgent reports over phone Overall Rating Evaluation Done By Verified By Yearly Performance Rating
CRITERIA OF EVALUATION RATING C 10 or more complaints B 5 or more complaints A Less than 5 complaints ACTION TAKEN A B C Recommend for continuation Suggestion For improvement Warning (Discontinue if the supplier gets two consecutive rating)
INCIDENT / ACCIDENT REPORTING FORMAT Date: Department Person Involved Category of Accident / Incident Please on relevant category Needle Stick Injury Spills & Splashes Falls & Slip Fire Electrical Chemical Infrastructure Physical Others Details of Accident / Incident Root Cause Corrective Action Taken Responsibility Acton Verified By / Date
DOCUMENT DISTRIBUTION RECORD Documents Recd By Quality system Procedures (P&P) Forms and Formats (FR) Equipment Operating Manuals {OM) Kit Inserts Sample Collection Manual Quality Manual (QM) Standard Operating Procedures (SOP s) Issued To Department In-charge LISTS Date Lab Director CopyNo.1 ALL Copy No-1 ALL Copy No.1 ALL Copy No.1 CopyNo.2 Soft copy CopyNo.2 Soft copy Copy No.3&4 CopyNo.2 Soft Copy Copy No.2 Soft Copy ALL CopyNo.2 Soft copy ALL CopyNo.3 Soft copy TM ALL Copy No.2 ALL Q Mgr Copy No.3 NABL Hospital Management Reception Sample Collection Copy no. 5 (Relevant) (Relevant) Copy No.4 (Rate List) (Rate List) Mispa- Nano, Erbachem/Smartlyte / Kit Insert Biochemistry SOP Copy No.4 Biochemistry (Relevant) Hematology SOP Copy No.4 Clinical Pathology SOP Copy No.4 Serology SOP Copy No.4 Hematology (Relevant) XP-100/Kit Insert (Relevant) Kit Insert Clinical Pathology Serology (Relevant) Kit Insert IT / Reporting Maintenance Housekeeping (Relevant) (Relevant) (Relevant)
AGREEMENT PART TIME CONSULTANT I, Dr _______________________MD (Path / Micro) agree to visit Global Diagnostic Laboratory, Bhatia Global Hospital & Endosurgery Institute, New Delhi for the following activities between ____ to ___ in the morning and between _____ to ____in the evening or whenever requested during emergency. Monitor the functioning of department / Lab and the staff for various procedures and protocols. Verify the QC for the activity done by the technicians Verify correct documentation and transmission of patient data in microbiology department / lab Verification and Signing of final test reports As a laboratory consultant, I will also use my powers judicially for Controlling of nonconformance in the lab Rejection of samples / results / items found nonconforming Ask for a repeat test wherever required Send the samples to external lab for cross verification if required Follow EQAS and ILC program for necessary corrective actions I also agree to keep all the lab information confidential and will take necessary actions with impartiality and without any internal, external, commercial, financial or any other influences that may adversely affect the quality of work. This agreement will be reviewed as and when the need arises on mutually acceptable basis
RISK ASSESSMENT FORM MONTH Risk Assessed During or Due to Registration Sample - Collection, Processing, Transport & storage Equipment - Operation, Maintenance & Calibration IQC / EQAS - Preparation, Use, Storage & CAPA Reagent - Use & Storage 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 Maintenance - Work Environment, Power Supply & Backup Housekeeping - Cleaning, Dis-infection, disposal Staff - Competence & Training Result / Data - Confidentiality, Transmission, Reporting, Release & Storage Done By
RISK ASSESSMENT FORM DATE NAME OF PERSON RISK IDENTIFIED LOCATION RISK LEVEL: HIGH MODERATE LOW ACTION TAKEN FOR RISK MANAGEMENT ACTION TAKEN BY ACTION EFFECTIVENESS VERIFIED BY DATE NAME OF PERSON RISK IDENTIFIED LOCATION RISK LEVEL: HIGH MODERATE LOW ACTION TAKEN FOR RISK MANAGEMENT ACTION TAKEN BY ACTION EFFECTIVENESS VERIFIED BY
SERVICE AGREEMENT DEVIATION FORMAT Reason for Deviation Patient ID Details of Deviation Action Taken Consent Taken By User s Request Date Eqpt Method Kit Sample Others
ADVISORY SERVICES FORMAT Advise Given To C: Consultant P: Patient A: Attendant Patient Name or ID No Type of Advise Given Details of Advise Given By Date Verified By TYPE OF ADVISE GIVEN 1Choice of examinations 2 Facilities provided by the lab and how to avail the same 3 Delivery of test report4 Addition of examination 5 Choice of test methods 6 Patient preparation requirements 7 Informed Consent 8 Type and volume of sample required for examination 9 Collection methodology examinations on individual clinical cases 13 the results of examinations 14 Consulting on scientific and logistic matters such as instances of failure of sample(s) to meet acceptance criteria 15 10 Clinical indications and limitations of 11 Frequency of requesting the examination 12 Advising 13 Professional judgement on the interpretation of 11 15 Others
EMPLOYEE PERSONNEL RECORD NAME DATE OF BIRTH PERMANENT ADDRESS PRESENT ADDRESS TELEPHONE NO. DESIGNATION DEPARTMENT MONTH / YEAR OF JOINING TOTAL PREVIOUS EXPERIENCE (Please give below the details) 1 2 3 4 5 QUALIFICATION I hereby confirm that the details given above are correct to the best of my knowledge and belief. The organization has the right to take any action that they deem fit against any wrong information given by me Please affix your photograph here
EMPLOYEE JOINEE FORM NAME: FATHER S NAME: ADDRESS: PHONE NO. DEPARMENT DESIGNATION SALARY DUTY TIMINGS PROBATION / TRAINING PERIOD SECURITY DEPOSIT: (If Applicable) I agree to the terms and conditions of employment and will abide by all laboratory rules, regulations and procedures. Please affix your photograph here
CONFIDENTIALITY AGREEMENT IT IS HEREBY AGREED that: Iwill work in laboratory Hospital /Lab, New Delhi with full dedication, sincerity and within the framework of professional code of ethics and guidelines given in procedure manual During my association with HOSPITAL/LAB, I will not undertake outside assignments or do private work that may create potential conflict of interest unless otherwise agreed with the management of Hospital/Lab. I will execute all my responsibilities as defined in the procedure manual and will not refuse any other responsibilities given to me by the management during urgent / emergency conditions I will strictly follow all laboratory Rules, Regulation, procedures and instructions as given in various the procedure manual in letter and spirit to avoid potential conflict of interests. I will conduct all my activities with impartiality and without fear from any internal, external, commercial, financial and other pressures that may adversely affect the quality of work I will strictly adhere to all legal and statutory guidelines defined by the Central/ State Government of India and as given in procedure manual I will not do any activity that would diminish the confidence in my competence, impartiality, judgement or operational integrity I will work towards achieving short and long term goals and objectives set by the laboratory I will develop, conduct and participate in staff training programs as per the training plan given by the management or whenever instructed I will not use Hospital /Lab name as surety / guarantee for taking personal loans etc I will maintain strict confidentiality of laboratory and patient information / data I will ensure proper safeguard against damage / loss / misuse of laboratory property directly under my supervision / department Signature of Employee Director Name Signature of Lab Name of the Laboratory
EMPLOYEE HEALTH RECORD Date of Examination Name Weight Height cm Kg Yrs Sex Age Nationality Marital Status History of any significant past illness including: - 1) Psychiatric and neurological disorders (Epilepsy, depression) 2) Allergy 3) Others RESULTS LABORATORY INVESTIGATIONS RESULTS MEDICAL EXAMINATION Eyes Lt. Urine: - Sugar Eyes Rt. Blood Group Color Blindness Haemoglobin Vaccination (Hepatitis) Date of Vaccination Pulse Heart Rate Blood.Pressure 1st Dose Lot No. Expiry Lungs 2nd Dose Lot No. Expiry Lot No. Expiry Chest X-Ray Hernia Venereal Disease 3rd Dose Deformity Anti HhsAg
INDUCTION TRAINING FORMAT Employee Name Designation Date of Joining Department Accompanied By Employee s Sign ACTIVITY COVERED DATE INTRODUCTION Welcome by Quality Manager & introduction with person who will accompany for induction training round Introduction with Lab management Quality Manager Introduction to various departments in-charges and team Brief about lab and management Lab Timings LAB PREMISES ROUND Round of work area Location of toilets Entrance & Exits of building Fire Escapes & Location of fire fighting equipments Quality Manager Layout of departments, equipments and other infrastructure Brief on health & safety issues including vaccination COMMUNICATION Methods, Protocol Quality Manager
Location of Notice Boards Schedule of Team Meetings Protocol of communication over phone KEY POLICIES & PROCEDURES Financial rules & regulations Annual staff review, competency assessments and audits Training Schedule Quality Manager Other employment related policies Staff benefits WORK ETHICS Working hours, Punctuality Lunch Break Leave Policy Quality Manager Absence Complaints & Disciplinary Procedure Pay day, Deductions etc EMPLOYEE DEPARTMENT INDUCTION TRAINING Maintenance
Welcome to the department Introduction to department & department staff Department Functions Key duties & responsibilities QMS & NABL awareness Training on department equipment / procedures Training on Computer, Software and LIS Standard of work expected Conduct Confidentiality Issues Handling complaints Training on department SOP s, Guidelines & Procedures Training on Quality Assurance Department In-charge ACCOMPANIED BY DATE ACTIVITY COVERED Employee sign Department:- Biochemistry/Hematology/serology/clinical pathology Introduction to Equipment QC Procedure EQAS Biological Reference Intervals Critical/Alert Values REMARKS OF QUALITY MANAGER
ANNUAL TRAINING PLAN YEAR S FACULTY JAN FEB MAR APR MAY JUNE JULY AUG SEP OCT NOV DEC TOPIC OF TRAINING No. 1 QMS / NABL Awareness & Update 2 System Documentation 3 QC, EQAS and ILC 4 Good Housekeeping 5 Lab Safety and precautions 6 Fire Safety Precautions during handling of blood and body fluids 7 8 Sample Collection Order of Draw Customer confidentiality and satisfaction 9 10 Biological Reference Range Test Methodology and their utilization 11 12 Test Interferences Critical Values of various test parameters 13 14 Sample Stability and Storage 15 Waste Disposal 16 Equipment operation & maintenance Importance of timely sample collection & delivery of reports 17 18 Others
TRAINING NEED IDENTIFICATION To: Q Mgr The following persons are required to be trained for the following SUBJECT: Approved by Lab Director YES S No Employee Name Designation Reason for Training Requirement NO 1 2 3 4 5 6 7 8 9 10
MEETING / TRAINING ATTENDANCE SHEET Date Topic Faculty Participants S No. Participants Name Designation / Specialty Sign Remarks Marks
EMPLOYEE TRAINING RECORD Name; Department Year *Method of Training Verified by Q Mgr Duration (In Hrs) Results Date Topic of Training * Written Test + training, s/he will be provided retraining on the same 1) Demonstration, 2) Presentation, 3) Assistance, Hands On 4) If the lab staff gets less than 75% marks in the test questionnaire post
EMPLOYEE SUGGESTION FORM Employee Name Date Department: Designation: Details of Suggestion Given Benefits to lab Suggestion If accepted then implementation date Suggestion Review Date Comments Accepted No Accepted Reviewed By Sign of employee Sign of lab director
EMPLOYEE COMPETENCY ASSESSMENT FORM Name Designation Department Applicable to T Technical NT Non Technical S ASSESSMENT DATE Assessment Done By ACTIVITY ASSESSED 1 2 3 4 5 No Equipment Operation & Maintenance Test and Equipment Calibration Equipment De contamination Equipment IQ, OQ & PQ Department SOP s & P&P s Department Documents & Records Test Performance Characteristics Test Verification & Validation Protocols IQC, Analysis & CAPA EQAS / ILC, Analysis & CAPA Alert Values Patient Registration Patient Identification Patient Preparation Order of Sample Draw 1 T, NT 2 3 4 5 6 7 T T T T T, NT T 8 T 9 10 11 12 13 14 15 T T T NT T T T
