ISO 15189 and ISO 22870 Documentation Kit with Manual, Procedures, Templates
ISO 15189:2022 and ISO 22870:2016 integrated documents kit contains more than 110 editable MS-Word files. These editable documents address all the elements of medical laboratory accreditation and point-of-care testing
Content of ISO 15189 and ISO 22870 Documentation Kit with Manual, Procedures, Templates
The contents of the document kit which we offer include more than 110 document files as listed below:
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Features of the Product
- Total ISO 15189 and ISO 22870 documents are in plain English and easy to understand the documentation process.
- A soft-copy of an editable ISO 15189 and ISO 22870 documentation kit is provided that saves much time.
- It is easy to learn and user-friendly and comply with all ISO 15189:2022 and ISO 22870:2016 requirements.
- Good learning materials for establishing good environmental and quality management systems.
- It is been verified and evaluated at various levels during system implementation by our team and more than 1000 hours are spent in preparation of such a readymade documentation kit.
- Our products are highly sold globally and used by many multinational companies, which got total customer satisfaction as well as value for money.
How This Product is Useful
- The user can very easily modify the templates according to their products and create the documents for their organization within 3 days.
- The kit takes care of all the sections and sub-sections of ISO 15189 and ISO 22870 standards and helps you to establish a better system.
- Save much time and cost in document preparation.
- Our products are highly sold across the globe and are used by many multinational companies. They have got total satisfaction as well as experienced value for money.
- In the preparation of the documentation kit, our team has verified and evaluated the entire content at various levels. More than 1000 hours have been spent in the preparation of this documentation kit.
More Details
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. The requirements of ISO 22870 apply when a POCT is performed in a hospital, clinic, and by a healthcare organization providing ambulance care. This document package is addressing the requirement of revised ISO 15189 and ISO 22870 standards and covers quality manual, Quality Procedures, blank forms, Standard Operating Procedures, sample risk templates, Exhibits, ISO 15189 and ISO 22870 Audit checklist, etc, in editable word templates. The editable ISO 15189 and ISO 22870 documents are designed by the experienced team of a consultant by sending more than 1000 hours in document preparation. Our consulting team has prepared documents conforming to the requirements of ISO 15189 and ISO 22870, are used globally by many clients from the USA, UK, Middle East, Europe, and Asia, and already get certified from leading certifying bodies.
Method of Delivery of ISO 15189 and ISO 22870 Documentation Kit
After the purchase of our ISO 15189:2022 and ISO 22870:2016 documentation package - we are sending an email with username and password within 12 to 24 hours for the online delivery of our products via download from our FTP server.
This product kit softcopy is now on sale. This product is delivered by download from server/ E-mail.
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