ISO 15189:2012 Documentation Consultancy

ISO 15189:2012The ISO/IEC 15189:2012 is a standard for accreditation of medical and clinical laboratories. To achieve ISO 15189 certification, medical laboratories must have to implement quality management system and prepare documents that conform to the requirements of ISO 15189:2012 standard. We offer online ISO 15189 documentation consultancy, in which we collect required information from the clients via e-mail and other digital mediums, and prepare documents accordingly by using our documentation toolkit.

ISO 15189 Documentation - Manual, Procedures, Checklist offers ISO 15189 Documentation Toolkit for accreditation of medical laboratories, which is a set of ready-to-use templates designed as per the latest version of standard requirements. This readymade ISO 15189 documentation kit consists of following ISO 15189 documents:

  • ISO 15189 Manual (01 editable file)
  • ISO 15189 Procedures (30 procedures)
  • Standard Operating Procedures (40 SOPs)
  • Sample Exhibits (06 exhibits)
  • Sample Forms and Templates (94 blank forms)
  • ISO 15189 Audit Checklist (more than 350 questions)

The Ready-to-use ISO 15189 documents for medical laboratories cover sample copy of 15189 manual, ISO 15189 procedures, standard operating procedures, blank and filled formats, as well as ready-to-use ISO 15189 audit checklists, etc., drafted and endorsed to ensure effective accreditation. All the medical lab accreditation ISO 15189 documents are written in plain English and provided in editable word format, which saves time and cost in the process of ISO 15189 documentation, and hence, certification.

Recommended List of Medical Accreditation Documentation Toolkits

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D135 ISO 15189 Documentation Kit for Medical Laboratories download $450
D126 ISO 13485 Documents for Medical Devices - Quality Management System download $399