ISO 15189 Certification Documents - Ahmedabad

The ISO 15189:2022 Documentation Kit is a comprehensive tool designed to assist medical laboratories in developing a documented quality management system and assessing their competence by ISO 15189 requirements. This kit includes a quality manual, procedures, SOPs, exhibits, and forms to establish a good working system. The kit includes a quality manual, 34 procedures, eight editable exhibits, seven standard operating procedures, 62 editable forms and templates, a job description, an ISO 15189 audit checklist, and a sample risk assessment and opportunity sheet. The ISO 15189:2022 document compliance matrix provides a requirement-wise list of documented information references for easy reference. The kit is written in simple English and provided in an editable.doc format, making it easy to edit and meet the demands of updated system requirements.

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