Global Consultancy & training company for certification documents, system training, and management training. Quality, Environmental, OH&S, ISMS, HSE certification, Hospital accreditation, Laboratory accreditation…

Medical Laboratory Certification –

ISO 15189:2022 Documentation Consultancy

We are offering ISO 15189:2022 Documentation consultancy for medical laboratories quality management system implementation and certification. With our consultancy, globally many medical laboratories have developed their own quality management system (QMS) documentation and have successfully achieved ISO 15189 accreditation. The ISO 15189 standard’s most recent fourth edition was published in December 2022. Complete changes were made to the ISO 15189:2022 standard version to bring it into compliance with the ISO/IEC 17025 standard. The most recent standard incorporates the requirements for point of care testing (POCT), which were previously established in the ISO 22870 standard, among other significant changes like the increased emphasis on risk throughout the standard. Our team of experienced ISO 15189 consultants guides medical laboratories in system implementation, documentation and training process as well as assessment of their own competency, which helps in effective implementation of quality management system, and hence, quick ISO 15189:2022 accreditation. Our QMS consultants help medical laboratories in establishing and implementing a management system that ensures quality of testing services and compliance to the ISO 15189:2022 standard and requirements of customers and various global regulators.

D135 – ISO 15189:2022 Documents Kit with Manual, Procedures, Templates – $ 649

Demo

Our company has introduced ISO 15189:2022 Documentation Kit for medical laboratory accreditation as per the most recent revised standard requirements, which can be used as a ready-reference tool to complete the ISO 15189 documentation process. This readymade documentation kit will help medical laboratories in developing a documented quality management system and assessing their own competence in accordance with ISO 15189 requirements and finally achieve ISO 15189 accreditation from a recognized accreditation body anywhere in the world. During preparation of ISO 15189 documentation, medical laboratories need to prepare a ISO 15189 quality manual, procedures, SOPs, exhibits and forms to establish a good working system. Our experienced team of QMS consultants have designed sample documents to help medical laboratories and consultants in establishing an effective documentation for quick ISO 15189:2022 accreditation.

Contents of ISO 15189:2022 Documentation Kit for Medical Laboratories Accreditation

This ISO 15189:2022 Documentation Kit contains all sample documents that a medical laboratory needs to establish an effective quality management system and assess its competence to consistently deliver technically valid test results. The documents of this kit include:

• ISO 15189:2022 Manual – This is basically a quality manual for medical laboratories.
• ISO 15189 Procedures – Total 34 procedures in word format for various departments.
• Exhibits – Total 08 editable exhibits in word format to add effectiveness in system implementation.
• 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 a 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.

The entire ISO 15189 documentation kit is written in simple English and provided in editable .doc format, so that just with minimal editing your documents will be ready. The complete set of documents for ISO 15189 QMS with easy editing features compatible with system requirements can be purchased from us. Our documentation kit is a very effective tool to learn and implement QMS documentation completely and meet the demands of the updated system requirements.

Benefits of Using Our ISO 15189:2022 Documentation Kit for Medical Laboratory Accreditation

• It helps medical laboratories in implementing ISO 15189 system and getting benefits of accreditation in day to day operations.
• Users can easily amend and change the templates as per their working system and create their own quality documents quickly.
• Saves much time and cost in document preparation. It gives 100% value for money to customers.
• ISO 15189 Procedures and formats provided in this documentation kit can help in fine-tuning the processes and establish better control over quality management system of medical laboratories
• Ready-to-use documents in .doc format reduce your time in documentation process.
• Documents are useful in training staff on QMS requirements, as well as assessing their competence.
• This kit takes care for all the sections and sub-sections of ISO 15189:2022, which gives better confidence and improves the system.
• Effective tool to create ISO 15189 manual, procedures, records and audit checklists for quick certification.

Why ISO 15189 Manual and Procedures are Important?

Though all documents of this kit are vital for medical laboratories to implement QMS and achieve ISO 15189 accreditation, ISO 15189 Manual and procedures are considered the most important for Medical laboratory’s Quality management system. These documents constitute the basic two tiers of ISO 45001 documentation system. ISO 15189 Manual describes about the scope, company profile, organization structure as well as details of system implementation in accordance with requirements of ISO 15189:2022 standard. ISO 15189 Manual also provides an overview of processes followed in order to fulfill QMS requirements as per ISO 15189:2022.

ISO 15189 Procedures provide detailed method of meeting requirements of the QMS and relevant clauses of the ISO 15189:2022 standard. These procedures are also important because they support operation of processes to establish confidence in the QMS of medical laboratories.