ГОСТР ИСО 15189—2015
Библиография
|1]ISO Guide 30. Terms and definitions used in connection with reference materials
(2]ISO 1087-1. Terminology work — Vocabulary — Part 1: Theory and application
(3]ISO 3534-1. Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability
(4] ISO 5725-1, Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles
and definitions
(5]ISO 9000:2005. Quality management systems — Fundamentals and vocabulary
(6]ISO 9001:2008, Quality management systems — Requirements
(7]ISO 15190. Medical laboratories — Requirements for safety
(8] ISO 15194. In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin —
Requirements for certified reference materials and the content of supporting documentation
(9] ISO/IEC 17011. Conformity assessment — General requirements for accreditation bodies accrediting conformity
assessment bodies
(10] ISO/IEC 17043:2010. Conformity assessment — General requirements for proficiency testing
(11] ISO 19011. Guidelines for auditing management systems
(12] ISO/IEC 27001. Information technology — Security techniques — Information security management systems —
Requirements
(13] ISO 27799. Health informatics — Information security management in health using ISO/IEC 27002
(14] 1ЭОЯ5 22367. Medical laboratories — Reduction of error through risk management and continuous improvement
(15] ISO 22870:2006. Point-of-care testing (РОСТ) — Requirements for quality and competence
(16] ISQ1EC 80000 (all parts). Quantities and units
(17] CLSI AUTO08-A: Managing and Validating Laboratory Information Systems. Approved Guideline. CLSI: Wayne,
PA.2006
(18] CLSI AUTO10-A: Autoverification of Clinical Laboratory Test Results; Approved Guideline. CLSI: Wayne. PA..2006
(19] CLSI C03-A4: Preparation and Testing of Reagent ’Water in the Clinical Laboratory — Fourth Edition: Approved
Guideline. CLSI: Wayne. PA.. 2006
(20] CLSI C24-A3: Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions—
Third Edition; Approved Guideline. CLSI: Wayne. PA: 2006
(21] CLSI C28-A3: Defining. Establishing, and Verifying Reference Intervals in the Clinical Laboratory — Third Edition;
Approved Guideline. CLSI: Wayne, PA., 2008
(22] CLSI C54-A: Verification of Comparability of Patient Results within One Health Care System; Approved Guideline.
CLSI: Wayne. PA.. 2008
(23] CLSI EP15-A2. User verification of performance for precision and trueness — Second Edition; Approved Guideline.
CLSI: Wayne. PA.. 2005
(24] CLSI EP17-A: Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline.
CLSI. Wayne PA.. 2004
(25] CLSI GP02-A5: Laboratory Documents: Development and Control — Fifth Edition; Approved Guideline. CLSI:
Wayne. PA.. 2006
(26] CLSI GP09-A: Selecting and Evaluating a Referral Laboratory — Second Edition; Approved Guideline. CLSI: Wayne,
PA.. 1998
(27] CLSI GP16-A3: Urinalysis— Third Edition: Approved Guideline. CLSI: Wayne. PA..2009
(28] CLSI GP17-A2: Clinical Laboratory Safety — Second Edition; Approved Guideline. CLSI: Wayne. PA..2004
(29] CLSI GP18-A2: Laboratory Design — Second Edition; Approved Guideline. CLSI: Wayne. PA.. 2007
(30] CLSI GP21-A3: Training and Competence Assessment—Third Edition: Approved Guideline. CLSI: Wayne. PA. 2009
(31] CLSI GP22-A3; Continual Improvement —Third Edition; Approved Guideline. CLSI: Wayne. PA. 2011
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