ISO 15189:2022 — Gap Analysis

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1. Information We Collect

• Profile Information: Name, email, phone, laboratory name and role.
• Assessment Data: Gap analysis responses, scores and notes — localStorage only.

2. Your Rights (UK GDPR)

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3. Contact

ISO Xpert Ltd  |  71-75 Shelton Street, London WC2H 9JQ  |  info@iso-xpert.com

Terms of Use

By using the ISO Xpert ISO 15189 Gap Analysis Tool ("the Tool"), you agree to these Terms.

1. Ownership and Intellectual Property

This Tool is the exclusive intellectual property of ISO Xpert Ltd. All rights reserved.

2. Permitted Use

• Internal, non-commercial gap analysis against ISO 15189:2022.
• Exporting reports for internal laboratory quality records and accreditation preparation.
• Sharing reports within your laboratory or organisation.

3. Disclaimer of Warranties

This Tool is provided "as is" for informational and self-assessment purposes only. ISO Xpert does not warrant that outputs constitute professional laboratory quality management advice. Gap analysis outputs must not be used as a substitute for formal accreditation assessment by a national accreditation body (e.g. UKAS in the UK, DAkkS in Germany, COFRAC in France). Accreditation to ISO 15189:2022 can only be granted by an authorised national accreditation body following an on-site assessment. Laboratory quality decisions — particularly those relating to patient safety, diagnostic accuracy and clinical reporting — must be made by qualified medical and scientific staff.

4. ISO Standards Reference

References to ISO 15189:2022 are for guidance only. This standard replaces ISO 15189:2012 and should be read alongside ISO 17025:2017 for relevant shared technical requirements. The authoritative version must be obtained from ISO or national standards bodies.

5. Patient Safety Notice

Medical laboratory quality has direct implications for patient safety. This tool is designed to support quality improvement activities only. No gap analysis output from this tool should be used to justify clinical or diagnostic decisions, to certify laboratory competence to patients or clinicians, or as evidence of accreditation status.

6. Limitation of Liability

ISO Xpert Ltd shall not be liable for any indirect, incidental or consequential damages arising from use of this Tool.

7. Governing Law

These Terms are governed by the laws of England and Wales.

8. Contact

ISO Xpert Ltd  |  71-75 Shelton Street, London WC2H 9JQ  |  info@iso-xpert.com  |  +44 7853 109840