ISO/IEC Certification | ISO/IEC Accreditation Standards

ISO 15189:2022 Accreditation Consultancy and Documentation offers complete solution to ISO 15189:2022 Accreditation for medical laboratories. ISO 15189 Accreditation provides recognition to the medical laboratories' competence, including both the management system and technical practices of the laboratory. ISO 15189 accreditation involves an independent assessment of the medical laboratory that includes an examination of personnel’s qualifications and competence, equipment, reagents and supplies, quality assurance, and analytical, pre-analytical, and post-analytical factors. ISO 15189:2022 is a globally used standard for quality and competence of medical laboratories. The latest fourth edition of the ISO 15189 standard has been published in December 2022. The ISO 15189:2022 standard edition has been completely revised and is now in compliance with the ISO/IEC 17025 standard. The current standard includes the requirements for point of care testing (POCT), which were previously established in the ISO 22870 standard, among other notable revisions such as an enhanced emphasis on risk throughout the standard.

ISO 15189:2022 Accreditation Consultancy

We offer ISO 15189:2022 Accreditation consultancy for system implementation, documentation, internal auditing, auditors training, etc. We have rich experience of providing ISO 15189:2022 Accreditation consultancy to a number of medical laboratories by helping them in system implementation, preparation of ISO 15189:2022 documents, including ISO 15189:2022 Manual, as well as conducting training programs on system awareness and auditors training. Our team of ISO 15189:2022 accreditation consultants has rich experience of ISO 15189:2022 accreditation and documentation consultancy. Our services have helped approximately 100 medical laboratories to achieve ISO 15189:2022 accreditation in minimum time and cost.

ISO 15189:2022 Accreditation Documents - Manual, Procedures, Audit Checklist - 649 USD

Well-written and organized ISO 15189:2022 documents are essential for any professional medical laboratory to achieve accreditation. ISO 15189:2022 accreditation documentation must include ISO 15189:2022 manual, ISO 15189:2022 procedures, records, SOPs, formats for technical areas specific to laboratory activities, audit checklist, etc. The overall aim of our ISO 15189:2022 documents is to support medical laboratories in ISO 15189:2022 documentation and give confidence to their customers (patients / corporate customers / hospitals, etc.), regulating authorities and accreditation bodies that are associated with the medical laboratory, as well as ISO 15189 consultants that all the documentation requirements are met by the laboratory. Our ISO 15189:2022 documents cover all the requirements for ISO 15189:2022 accreditation. Our ISO 15189:2022 manual, ISO 15189:2022 audit checklist and ISO 15189:2022 procedures are provided in editable format. They are also useful for auditors and consultants as the primary source of documentation to carry out the process of assessment.

What do ISO 15189:2022 Accreditation Documents Include?

The ISO 15189:2022 documents for medical laboratory’s accreditation include the following:

1. ISO 15189:2022 Manual
2. ISO 15189:2022 Procedures
3. Exhibits
4. Standard Operating Procedures
5. Blank Formats /Templates
6. Job description
7. ISO 15189 Audit Checklist
8. Sample Risk Assessment and Opportunity Sheet
9. ISO 15189:2022 document compliance matrix


• Written in plain English.
• Editable soft copy of documents is provided
• Easy to learn, user-friendly and complies with all accreditation requirements.
• Developed by a team of experienced ISO 15189:2022 consultants.

Benefits of ISO 15189:2022 Accreditation Documents

• Minimizes excessive paperwork
• Helps in fine-tuning the processes and establishing a good ISO 15189:2022 system.
• Saves much time and cost in document preparation.
• Easily modifiable templates according to your requirements
• Defines the baseline system that satisfies requirements for medical laboratory as well as covers ISO 15189:2022 principles.

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