SZNS ISO 22870:2006 Point-of-care testing (POCT) – Requirements for quality and competence

E109.46

This standard gives specific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO 15189. The requirements of this standard apply when POCT is carried out in hospital, clinic and by a healthcare organization providing ambulatory care.

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Description

This standard gives specific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO 15189. The requirements of this standard apply when POCT is carried out in hospital, clinic and by a healthcare organization providing ambulatory care.

TABLE OF CONTENTS

Contents Page
1   Scope 1
2    Normative references 1
3    Terms and definitions 1
4    Management requirements 1
4.1   Organization and management 1
4.2   Quality management system 2
4.3   Document control 3
4.4   Review of contracts 3
4.5   Examination by referral laboratories 3
4.6   External services and supplies 3
4.7   Advisory services 3
4.8   Resolution of complaints 3
4.9   Identification and control of nonconformities 3
4.10 Corrective action 4
4.11 Preventive action 4
4.12 Continual improvement 5
4.13 Quality and technical records 5
4.14 Internal audits 5
4.15 Management review 5
5 Technical requirements 5
5.1   Personnel 5
5.2   Accommodation and environmental conditions 7
5.3   Laboratory equipment 7
5.4   Pre-examination procedures 7
5.5   Examination procedures 7
5.6   Assuring the quality of examination procedures 8
5.7   Post-examination procedure 8
5.8   Reporting of results 8
Bibliography 10

Additional information

Format

PDF, Hardcopy