ISO 15189 and ISO 22870 Documentation Kit

The contents of the document kit which we offer include more than 110 document files as listed below:

1. ISO 15189 – ISO 22870 Manual – sample copy of the quality manual for ISO 15189 and ISO 22870 standard. It describes how all requirements of ISO 15189 and ISO 22870 standard requirements. It covers a list of procedures as well as an overview of the organization and covers tier1 of ISO 15189 and ISO 22870 documents.
2. Mandatory Procedures (31 procedures) – Sample copies of mandatory quality procedures as per ISO 15189 and ISO 22870 are provided, which cover all the details like purpose, scope, responsibility, how procedure is followed as well as the list of exhibits, reference documents, and formats.
3. Standard operation procedures (07 SOPs) – It covers sample standard operating procedures covering all the specific practice areas and provides details for the operation of the training organization.
4. Exhibits (06 exhibits): – It covers 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, etc. as per. ISO 15189 and ISO 22870.
5. Blank sample formats for all the departments (60 sample formats) – It covers sample copy of blank forms required to maintain records as well as establish control and make a system in the organization. The samples given are as a guide and not compulsory to follow and the organization is free to change the same to suit its own requirements.
6. Job description (06 job descriptions)- Sample copies of job description as per ISO 15189 and ISO 22870 are provided. The list of the sample job descriptions provided in the kit is given below.
7. ISO 15189 and ISO 22870 Audit checklist (more than 250 questions) – It covers sample audit questions based on all the ISO 15189 and ISO 22870 requirements. It helps the auditor to make their own audit checklist for quick and perfect auditing to ensure all the ISO 15189 and ISO 22870 requirements are fulfilled by the organization. A total of more than 500 questions are prepared on the basis of ISO 15189 and ISO 22870.
8. Sample Risk Assessment Sheet – A ready-to-use risk assessment sheet is given in the editable form to prepare the risk document for the organization. It is given in an excel format and can be used as a template.
9. ISO 15189 and ISO 22870 Compliance Matrix – This compliance matrix contains ISO 15189 and ISO 22870 requirement wise list of documented information for easy reference of users and to understand how this system is made.

The ISO 15189 is the international standard that specifies the quality management system requirements for medical laboratories; While ISO 22870 gives specific requirements applicable to point-of-care testing (POCT) and is used by medical laboratories in accordance with the ISO 15189 standard.

Documented information package:

Our documentation kit contains sample documents required for ISO 15189 and ISO 22870 certification as listed below. All documents are in MS-Word/Excel files and you can edit them. You can make changes as per your organization’s need and within few days your entire documents with all necessary controls will be ready. In the ISO 15189 and ISO 22870, documented information (procedures, etc.) are required a few places only. But for making the system better, we have provided many editable templates from which a user can select templates as per their own requirement and make some minor changes in them to make
own system. Two types of documented information are provided in this kit, as listed below:

1. Maintain documented information (Scope, Manual, etc.)
2. Retain documented information (Forms / Templates)

Under the main directories, further files are provided in MS Word/excel document as per the details given below.

1. Quality Manual:

It covers sample copy of quality manual for ISO 15189 and ISO 22870 standard. It describes how all requirement of ISO 15189 and ISO 22870 standard requirements. It covers list of procedures as well as overview of organization and covers tier1 of ISO 15189 and ISO 22870 documents.

Content:

Section – 1

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 Organisation and management responsibility
   4.2 Quality management system
   4.3 Document control
   4.4 Service agreements
   4.5 Examination by referral laboratories
   4.6 External services and supplies
   4.7 Advisory services
   4.8 Resolution of complaints
   4.9 Identification and controls of nonconformities
   4.10 Corrective action

4.11 Preventive action
4.12 Continual improvement
4.13 Control of records (quality and technical records)
4.14 Evaluation and audits (internal audit)
4.15 Management review

5. Technical Requirements
5.1 Personnel
5.2 Accommodation and environmental conditions
5.3 Laboratory equipment, reagents and consumables
5.4 Pre–examination processes and procedures
5.5 Examination processes and procedures
5.6 Ensuring quality of examination results (Assuring the quality of examination processes and procedures)
5.7 Post–examination processes and procedures
5.8 Reporting of results
5.9 Release of results
5.10 Laboratory information management

2. Quality Procedures (31 procedures):

Sample copies of mandatory quality procedures as per ISO 15189 and ISO 22870 are provided, which cover all the details like purpose, scope, responsibility, how procedure is followed as well as the list of exhibits, reference documents and formats. The list of sample procedures provided in the kit is given below.

List of Quality Procedures

1. Procedure for Receipt, handling, storage and disposal of samples in line with the legal requirements
2. Establishment and review of agreements for providing medical laboratory services to its customers / patients
3. Purchasing
4. Identification and control of non–conformities
5. Preventive action
6. Control of documents
7. Management of complaints or other feedback received from clinicians, patients, laboratory staff or other parties
8. Internal audit
9. Selecting and evaluating referral laboratories and consultants
10. Corrective action
11. Personnel and training
12. Selection, purchasing and management of equipment
13. Control of records
14. Calibration of equipment
15. Management review
16. Safe handling, transport, storage and use of equipment to prevent its contamination or deterioration
17. Pre–examination process
18. Transportations of samples
19. Facility maintenance and environment
20. Pre–examination handling, preparation and storage
21. Ensuring the quality of examination results
22. Identification, collection, retention, indexing, access, storage, maintenance and safe disposal of clinical samples
23. Release of examination results
24. Risk assessment
25. Reception, storage, acceptance testing and inventory management of reagents and consumables
26. Collection and handling of primary samples
27. Sample receipt
28. Validation of examination procedures
29. Review of examination results
30. Reporting the results
31. Confidentiality of patient’s information

3. Exhibits (06 exhibits):

It covers 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 etc. as per. ISO 15189 and ISO 22870.

List of Exhibits

1. Skill requirements
2. Codification system
3. Calibration periodicity
4. Secrecy rules
5. Recommended conditions for sample collection, transport and storage for conventional cytogenetic analysis
6. Minimum retention period for identified records

4. Standard operation procedures (07 SOPs):

It covers sample standard operating procedures covering all the specific practice areas and provides details for operation of training organization.

List of SOPs

1. SOP for Collection and transportation of sample
2. SOP for Specimen acceptance & rejection criteria
3. SOP for Treatment and disposal of biomedical waste
4. SOP for Housekeeping
5. SOP for Use of PPE and personal safety
6. SOP for Examination by lateral flow method
7. SOP for Examination of COVID–19 by CT Value

5. Blank sample formats for all the departments (60 sample formats)

It covers sample copy of blank forms required to maintain records as well as establish control and make system in the organization. The samples given are as a guide and not compulsory to follow and organization is free to change the same to suit own requirements.

List of blank formats

1. Sample collection register
2. Sample disposal register
3. PPE kit and consumable disposal register
4. Request for examination
5. Customer feedback form
6. Complaint register
7. Complaint report
8. Inward register
9. Equipment history card
10. Preventive maintenance schedule
11. Equipment wise preventive maintenance checkpoints
12. Control of nonconformity work report
13. Housekeeping report
14. Result of suspected case of Influenza (category C)
15. Line List for Reporting by the laboratories
16. Goods inward register
17. Gate pass
18. Stock register
19. Master list and Distribution list of documents
20. Corrective action report
21. Change Note
22. Quality objectives (key performance indicator)
23. Master List of Records
24. Internal audit non–conformity report
25. Audit Plan / Schedule
26. Clause wise document wise audit review report
27. Preventive Action Report
28. Purchase order
29. Calibration status of equipment
30. Indent (purchase requisition)
31. Audit Observation Report
32. Approved vendor list
33. Supplier registration form
34. Inspection report
35. Supplier evaluation form
36. Evaluation for Referral Lab
37. Four Year Plan for Quality Control
38. IQC Analysis report
39. ILC Analysis report
40. Critical consumables
41. Environment condition monitoring report
42. Daily Medical facility and collection Centre checklist
43. Method validation report
44. In-house calibration report
45. Immunization report
46. Circular – MRM Agenda
47. Minutes of management review meeting
48. Periodic document review report
49. Improvement log
50. Confidentiality agreement
51. Risk assessment and opportunity sheet
52. Training calendar
53. Training report
54. Induction training report
55. Job description and specification
56. Skill matrix
57. Appointment letter
58. Competence assessment report
59. Employee competence report
60. Management system training effectiveness report

6. Job description (06 job description)

Sample copies of job description as per ISO 15189 and ISO 22870 are provided. The list of sample job description provided in the kit is given below.

List of Job description

1. Job description for Director
2. Job description for Quality Manager
3. Job description for Technical Manager
4. Job description for Lab Technicians / Microbiologist
5. Job description for Sampling Technicians / Sample collection person
6. Job description for Receptionist / sample receiver

7. ISO 15189 and ISO 22870 Audit checklist (more than 250 questions)

It covers sample audit questions based on all the ISO 15189 and ISO 22870 requirements. It helps the auditor to make own audit checklist for quick and perfect auditing to ensure all the ISO 15189 and ISO 22870 requirements are fulfilled by the organization. A total of more than 500 questions are prepared on the basis of ISO 15189 and ISO 22870.

8. Sample Risk Assessment Sheet

A ready-to-use risk assessment sheet is given in editable form to prepare the risk document for the organization. It is given in an excel format and can be used as a template.

9. ISO 15189 and ISO 22870 Compliance Matrix

This compliance matrix contains ISO 15189 and ISO 22870 requirement wise list of documented information for easy reference of users and to understand how this system is made