Documentation Kit for ISO 15189:2022 Accreditation
ISO 15189:2022 documents kit contains more than 120 editable MS-Word files. These editable documents address all the elements of medical laboratory accreditation
Content of Documentation Kit for ISO 15189:2022 Accreditation
The editable ISO 15189 Documentation kit has more than 120 editable files for requirements for the medical laboratory quality management system. The fourth edition of the ISO 15189 standard has been published in December 2022. The ISO 15189:2022 standard edition has been completely revised and aligned with ISO/IEC 17025 standard. Among other major changes like the increased emphasis on risk throughout the standard, the latest standard includes the requirements for point of care testing (POCT), which were earlier specified in the ISO 22870 standard. This kit includes the following ready-to-use templates, which can accelerate the documentation process for ISO 15189 accreditation.
- Quality Manual - 01 editable file to define how ISO 15189:2022 system is implemented.
- Quality Procedures - Total 34 procedures in word format for various departments.
- Exhibits - Total 08 editable exhibits in word format to follow while implementing an effective system.
- Standard Operating Procedures - Total 07 SOPs for collection, operation and testing process and used as reference documents.
- Blank Formats /Templates - Total 62 editable forms and templates for various departments of medical laboratories to fill up records and learn system requirements.
- Job description: It covers sample copy of job descriptions.
- ISO 15189 Audit Checklist - More than 500 audit questions to verify the implemented quality management system and add effectiveness in the medical laboratory accreditation.
- Sample Risk Assessment and Opportunity Sheet: 01 editable file to cover sample copy-filled risk assessment and opportunity sheet as per the ISO 15189 standard.
- ISO 15189:2022 document compliance matrix: The ISO 15189:2022 requirement wise list of documented information reference of this kit is given in compliance matrix for ready reference to user to understand how this system is made.
Features of the Product
- Written in simple English.
- Prepared in .docx format and accessible with MS Word 2007 and later version.
- Documents are user compatible, easy to learn, and easy to use.
- Anyone can view DEMO of the list of iso 15189 documents that help to take the decision to purchase this documentation kit.
- It contains manual, quality procedures, SOPs, exhibits, and formats which are a complete set of documentation.
- A very useful tool for iso 15189 consultant.
- Defines the baseline system that satisfies requirements for medical laboratory as well as covers ISO 15189:2022 principles.
- Minimizes excessive paperwork.
- Most compatible for QMS implementation in medical laboratories in the USA, UK, Europe, and Asia.
- User-friendly and easy to learn as well as modifiable to make its own documents.
- Designed under the guidance of experienced consultants.
How This Product is 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 .docx 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 15189 consultant as well as improve the system.
- Audit checklist for iso 15189 accreditation is given with more than 500 internal audit questions, which is useful to train all the employees for an accreditation audit.
More Details
The standard ISO 15189:2022 is developed for use by medical laboratories in developing their quality management systems and assessing their own competence. The ISO 15189 standard's fourth edition was published in December 2022. The ISO 15189:2022 standard edition has been totally revised and is now in accordance with the ISO/IEC 17025 standard. The current standard incorporates the standards for point of care testing (POCT), which were previously established in the ISO 22870 standard, among other notable modifications such as the increased emphasis on risk throughout the standard. 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.
The editable ISO 15189:2022 Documentation which includes quality manual, procedures, SOPs, forms, audit checklists, etc., is a primary requirement for conforming to the competence of medical laboratories. The documentation kit designed by Global Manager Group contains ready-to-use sample documents like ISO 15189 manual, procedures, standard operating procedures, formats, forms, Job description, Sample Risk Assessment & Opportunity Sheet and templates as well as more than 500 questions in the audit checklist, etc., which cover all documented information required for ISO 15189:2022 accreditation. The overall aim of this documentation kit for medical laboratories is to give confidence to the laboratory customers (patients / corporate customers/ hospitals etc.), regulating authorities, and accreditation bodies that are associated with the medical laboratory as well as for iso 15189 consultant. The key advantage of the ISO 15189 certification documents kit is its user compatibility. It is a globally used documentation tool available with easy editing features and compatible with clause-wise requirements. All the documents covered in more than 120 MS Word files are editable and written in simple English. The users can update sample document templates as per their organization’s working system and create their own documents for their company in just a couple of man-days.
Method of Delivery of ISO 15189 Documentation Kit
The ISO 15189 documents for requirements for medical laboratory quality management system can be purchased through a secure online transaction. Soft-copy of the total ISO 15189 accreditation documentation kit shall be delivered online after 12 hours of confirmation of payment. After the purchase of our product online via a secure payment gateway, we give the username and password with a download link to the buyer for easy download of the purchased product from our server.
Note: All the documents are editable and all rights of using them at one site will be given to the buyers. They will be given rights for changing the company name, logo, etc. as per their company’s system requirements.
This product kit softcopy is now on sale. This product is delivered by download from server/ E-mail.
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