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ISO 15189:2012 Documentation Kit for Accreditation
ISO 15189:2012 documents kit contains more than 170 editable files. These editable documents address all the elements of medical laboratory accreditation.
- A Manual
- Required Procedures
- Formats
- Sample Filled Forms
| Release Date |
2022 |
|---|---|
| Standard |
ISO 15189 |
| Total Documents |
100+ |
Original price was: $650.00.$550.00Current price is: $550.00.
- Publisher: ISO Basics
- Language: English
- Developer: Inhouse Consultant
- Application Required: MS Word, MS Excel
Description
Procedures and formats provided in the documentation kit, can help in fine-tuning the processes and establish better control for system establishment for reference material producers.
Content of Documentation Kit for ISO 15189:2012 Accreditation
The ISO 15189 Documentation kit has a total of 170 editable files for requirements for the medical laboratory quality management system. This kit includes the following ready-to-use templates, which can accelerate the documentation process for ISO 15189 accreditation.
- Sample ISO 15189 Manual – 01 editable file to define how ISO 15189:2012 system is implemented.
- Mandatory Procedures – Total 30 procedures in word format for various departments.
- Standard Operating Procedures – Total 40 SOPs for collection, operation and testing process and used as reference documents.
- Exhibits – Total 06 editable exhibits in word format to follow while implementing an effective system.
- Readymade Formats – Total 94 editable forms and templates for various departments of medical laboratories to fill up records and learn system requirements.
- ISO 15189 Audit Checklist – More than 350 audit questions to verify the implemented quality management system and add effectiveness in the medical laboratory accreditation.
The standard ISO 15189:2012 is developed for use by medical laboratories in developing their quality management systems and assessing their own competence. ISO 15189 certification can be also used for confirming or recognizing the competence of medical laboratories by laboratory customers (patients / corporate customers/ hospitals etc.), regulating authorities and accreditation bodies.
Documentation:-
Our document kit is having sample documents required for ISO 15189:2012 certification as listed below. You need to study it do necessary changes as per your company need and within 4 days your entire editable documents with all necessary details are ready and many medical laboratories are accredited globally in 1st trial with the help of our documents from any kind of stringent accreditation assessment.
Under this directory further files are made in word Document as per the details listed below. All the documents are related to any kind of medical laboratories.
Under this directory further files are made in word Document as per the details listed below. All the documents are related to any kind of medical laboratories.
1. Quality Manual:
It covers sample copy of quality manual for medical laboratory. It describes how all requirement of ISO 15189:2012. It covers list of procedures as well as overview of medical laboratories and
covers tier1 of ISO 15189:2012 documents.
(A) Table of Contents
1. Cover page, Table of contents, amendment record sheet and glossary of terms (abbreviation)
2 Authorization statement and laboratory profile
3 Control and distribution
Section – 2
4. Management Requirements
4.1 to 4.15 Management Requirements
5. Technical Requirements
5.1 to 5.10 Technical Requirements
Annexure
ANX–1 List of quality procedures
Note The amendment number given above is at the time of issue of this manual. If any page is amended then latest amendment number of such pages is recorded in amendment record sheet and on the table of content given above.
covers tier1 of ISO 15189:2012 documents.
(A) Table of Contents
1. Cover page, Table of contents, amendment record sheet and glossary of terms (abbreviation)
2 Authorization statement and laboratory profile
3 Control and distribution
Section – 2
4. Management Requirements
4.1 to 4.15 Management Requirements
5. Technical Requirements
5.1 to 5.10 Technical Requirements
Annexure
ANX–1 List of quality procedures
Note The amendment number given above is at the time of issue of this manual. If any page is amended then latest amendment number of such pages is recorded in amendment record sheet and on the table of content given above.
2. Procedures (31 Procedures):
It covers sample copy of mandatory procedures covering all the details of ISO 15189:2012standard.
List of procedure
- Procedure for Receipt, handling, storage and disposal of samples in line with the legal requirements
- Procedure for Control of documents
- Procedure for Establishment and review of agreements for providing medical laboratory services to its customers / patients
- Procedure for Selecting and evaluating referral laboratories and consultants
- Procedure for Purchasing
- Procedure for Management of complaints or other feedback received from clinicians, patients, laboratory staff or other parties
- Procedure for Identification and control of non–conformities
- Procedure for Corrective action
- Procedure for Preventive action
- Procedure for Control of records
- Procedure for Internal audit
- Procedure for Management review
- Procedure for Personnel and training
- Procedure for Facility maintenance and environment
- Procedure for Selection, purchasing and management of equipment
- Procedure for Safe handling, transport, storage and use of equipment to prevent its contamination or deterioration
- Procedure for Calibration of equipment
- Procedure for Reception, storage, acceptance testing and inventory management of reagents and consumables
- Procedure for Pre–examination process
- Procedure for Collection and handling of primary samples
- Procedure for Transportations of samples
- Procedure for Sample receipt
- Procedure for Pre–examination handling, preparation and storage
- Procedure for Validation of examination procedures
- Procedure for Ensuring the quality of examination results
- Procedure for Review of examination results
- Procedure for Identification, collection, retention, indexing, access, storage, maintenance and safe disposal of clinical samples
- Procedure for reporting the results
- Procedure for Release of examination results
- Procedure for Confidentiality of patient’s information
- Procedure for Risk analysis
3. Standard operating procedure (40 SOPs):
It covers sample copy of standard operating procedures covering all the details of ISO 15189:2012 standard.
List of standard operating procedure (SOPs)
- Collection & Transport of Specimens for Biochemistry Examinations
- Patient Preparation Instructions
- Needle Stick Injury – Care & Precaution
- Specimen Acceptance & Rejection Criteria
- Treatment and Disposal of Biomedical Waste
- House Keeping Procedure
- Personnel Safety Procedure
- Sample Preparation and Storage
- Sample collection
- Sample rejection
- General departmental procedure
- Quality control procedure
- Equipment maintenance & operating procedure
- Measurement of Uncertainty
- Monitoring Turn-Around-Time
- Critical Alert Level Values / Panic Values
- Repeat Test
- Data backup plan
- Generation of test results
- Housekeeping
- Personal protection and safety
- Treatment and Disposal of Biomedical Waste
- Data backup plan, Linearity and range of testing, Accuracy& Precision
- Equipment calibration plan procedure
- Test procedure – Serum – Alanine Amino TransferaseCobas c501
- Test procedure – Serum – Albumin – Cobas c501
- Test procedure – Serum – Bicarbonate – Cobas c311
- Test procedure – Serum – Bilirubin Total – Cobas c501
- Test procedure – Serum – Calcium – Cobas c501
- Test procedure – Serum – Creatinine – Cobas c501
- Test procedure – Serum – GGT – Cobas c501
- Test procedure – Serum – Glucose – Cobas c501
- Test procedure – Serum – HDL Cholesterol – Cobas c311
- Test procedure – Serum – Phosphours – Cobas c501
- Test procedure – Serum – Aspartate Amino Transferase – Cobas c501
- Test procedure – Serum – TGL – Cobas c501
- Test procedure – Serum – Total Cholesterol – Cobas c501
- Test procedure – Serum – Total Protein – Cobas c501
- Test procedure – Serum – Urea – Cobas c501
- Test procedure – Serum – Uric Acid – Cobas c501
4. Exhibits (06 Exhibits):
It covers sample copy of exhibits covering all the details of ISO 15189:2012 standard.
List of Exhibits
- Skill Requirements
- Codification System
- Calibration Periodicity
- Secrecy Rules
- Recommended conditions for sample collection, transport and storage for conventional cytogenetic analysis
- Minimum retention period for identified records
5. Blank Formats (94 Formats):
It covers sample copy of blank forms required to maintain records as well as establish control and make system in the medical laboratories. The samples given are as a guide and not compulsory to follow and medical laboratories is free to change the same to suit own requirements.
List of Formats
- Accident / Incident Record
- Equipment Maintenance Breakdown Record
- Calibration Register – Clinical Chemistry
- PT / EQAS / ILC / corrective action report
- Critical Alert Results Register
- Equipment History Record
- Equipment Maintenance Log
- Housekeeping Record
- Kit in Use Log Form
- LJ chart Template for Lab Mean
- LJ chart Template for Product Insert Mean
- Non Conformance Register
- Record Label
- Repeat Test Result Register
- Sample integrity register
- Sample Rejection Register
- Sample storage and discadal register
- Monitoring STAT
- Monitoring TAT
- Temperature Log Form – Room
- Bleeding Time & Clotting Time Register
- Housekeeping Register
- Non Conformance Register
- Sample Collection Register
- Sample rejection Register
- Sample Rework Register
- Temperature Log Form – Roomn
- Request for examination – serum / fluoride plasma
- Request for examination – urine
- Request for examination – Serum
- Request for examination – whole blood / serum
- Request for examination – whole blood with EDTA
- Customer feedback form
- Complaint register
- Complaint report
- Inward register
- Test Instruction Slips
- Final Test Report
- HIV Consent Form
- Test Amendments Form
- Training Calendar
- Training Report
- Induction training report
- Job Description and Specification
- Skill Matrix
- Confidentiality Agreement
- Appointment Letter
- Employees Competence Report
- ISO 15189 effectiveness check report
- Employee history card
- Immunization report
- Equipment history card
- Preventive maintenance schedule
- Equipment wise preventive maintenance checkpoints
- Disposal of non–conformities
- Purchase order
- Indent (purchase requisition)
- Approved vendor list cum open purchase order
- Supplier registration form
- Open purchase order
- Material specification sheet
- Evaluation for Referral Lab
- Stock register
- Supplier evaluation form
- Four Year Plan for Quality Control
- Re–test plan / execution report
- Z score report
- Uncertainty of Measurement
- Re – Test Analysis
- Critical consumables
- Environment condition monitoring report
- pH Meter Calibration Report
- Inspection report
- Normality record sheet
- Intermediate check report – weighing balance
- Intermediate check report – oven
- Housekeeping checklist
- Checklist for Medical Laboratory Collection Centre / Facility
- Quality control plan method
- Design / Planning of the method validation
- Validation report
- Master List Cum Distribution List of Documents
- Change Note
- Corrective action report
- Master List of Records
- Quality objectives (key performance indicator)
- Audit Plan / Schedule
- Internal audit non–conformity report
- Clause wise document wise audit review report
- Preventive Action Report
- Calibration status of equipment
- Audit Observation Report
- Goods inward register
- Stock register
6. Audit checklist (more than 350 questions)
It covers sample audit questions based on all the ISO 15189 requirements. It helps the auditor to make own audit checklist for quick and perfect auditing to ensure all the ISO 15189 requirements are fulfilled by the medical laboratories.
7. Sample risk template
The ready to use risk template in editable form is given to prepare the risk document for the organization. It is given in excel and can be use as ready to use template.
How useful?
- The users/ iso 15189 consultant can modify readymade templates as per their working system and they can create their own documents for quick accreditation.
- Procedures and formats provided in the documentation kit can help in fine-tuning the processes and establish better control over the management system.
- It saves a lot of time and cost in document preparation. It gives value for money to customers and the number of payback is very low.
- Ready to use templates in .doc format will reduce your time in the documentation process as well as useful in giving training to staff.
- Takes care of all the sections and sub-sections to give better confidence to iso 17065 consultant as well as improve the system.
- Audit checklist for iso 15189 accreditation is given with more than 350 internal audit questions, which is useful to train all the employees for an accreditation audit.
Specification
Overview
| Release Date |
2022 |
|---|---|
| Standard |
ISO 15189 |
| Total Documents |
100+ |
Languages
| Release Date |
2022 |
|---|---|
| Standard |
ISO 15189 |
| Total Documents |
100+ |
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