The Process Control, Design and Planning Stage of ISO 15189:2012 Management System Standard: an Implementation Update: Suppleme
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The process control, design and planning stage of ISO 15189:2012 management system standard: an implementation update: supplementary material Dennis Mok and Sharfuddin Chowdhury Table S1. Selected international organisations (n = 28) providing relevant guidance documents in support of the implementation of process control, design and planning stage of ISO 15189:2012. Organisations Classification (n = 28) (Type A to Type F) European Committee for Standardization (CEN) D European Committee for Electrotechnical Standardization (CENELEC) D International Commission on Illumination (CIE) C Cooperative on International Traceability in Analytical Chemistry (CITAC) F Eurachem F Health Level Seven International (HL7) F International Atomic Energy Agency (IAEA) B International Agency for Research on Cancer (IARC) E International Air Transport Association (IATA) B International Commission on Non‑Ionizing Radiation Protection (ICNIRP) D International Commission on Occupational Health (ICOH) B International Council for Standardization in Haematology (ICSH) C International Electrotechnical Commission (IEC) C Institute of Electrical and Electronics Engineers (IEEE) F International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) B International Health Terminology Standards Development C Organisation (IHTSDO)* International Laboratory Accreditation Cooperation (ILAC) F International Labour Organization (ILO) B International Organization for Standardization (ISO) B International Social Security Association (ISSA) B International Solid Waste Association (ISWA) B International Union of Pure and Applied Chemistry (IUPAC) B Organisation for Economic Co‑operation and Development (OECD) C International Organization of Legal Metrology (OIML) B Transparency International (TI) F United Nations Economic Commission for Europe (UNECE) E World Health Organization (WHO) B WHO Regional Office for Europe (WHO/Europe) E * International Health Terminology Standards Development Organisation trades as SNOMED International. Descriptions (1, pp. xv‑xxi): Type A: federation of international organisations: includes ≥ three international organisations; management and policy‑making organs reflect a well‑balanced geographical distribution. Type B: universal membership organisation: from either ≥ 60 countries or ≥ 30 countries in ≥ two continents and with a well‑balanced geographical distribution; management and policy‑making organs reflect a well‑balanced geographical distribution. Type C: intercontinental membership organisation: from ≥ 10 countries in ≥ two continents with a well‑balanced geographical distribution; management and policy‑making organs reflect a well‑balanced geographical distribution. Type D: regionally defined membership organisation: from ≥ three countries within one continental or sub‑continental region; management and policy‑making organs reflect a well‑balanced geographical distribution. Type E: organisation emanating from places, persons or other bodies: no criteria for membership; reference to, and to some degree limited by, another international organisation, or a person, or a place. Type F: organisation having a special form: no criteria for membership; structure is non‑formal, unconventional or unusual. Type G: internationally‑oriented national organisation: no criteria for membership; management and policy‑making organs reflect participation of only one country or two countries; formal links with ≥ one other international organisation. Table S2. Recommended guidance documents associated with the process control, design and planning stage of ISO 15189:2012. Subclauses Organisations References (n = 27) (n = 116) (n = 237) CITAC and Guide to quality in analytical chemistry: an aid to accreditation, 3rd edn (2, p. 27) Eurachem 4.6 ISO 37500:2014 Guidance on outsourcing (3) ISO ISO/TS 22318:2015 Societal security — Business continuity management — Guidelines for supply chain continuity (4) CITAC and 5.1.2 Guide to quality in analytical chemistry: an aid to accreditation, 3rd edn (2, p. 17) Eurachem CITAC and 5.1.3 Guide to quality in analytical chemistry: an aid to accreditation, 3rd edn (2, p. 17) Eurachem EN 149:2001+A1:2009 Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking (5) EN 166:2001 Personal eye protection - Specifications (6) EN ISO 361:2015 Basic ionizing radiation symbol (7) EN ISO 374‑1:2016+A1 Protective gloves against dangerous chemicals and micro‑organisms - Part 1: terminology and performance requirements for chemical risks (8) EN ISO 374‑5:2016 Protective gloves against dangerous chemicals and micro‑organisms - Part 5: terminology and performance requirements for micro‑organism risks (ISO 374‑5:2016) (9) EN 405:2001+A1:2009 Respiratory protective devices - Valued filtering half masks to protect against particles - Requirements, testing, marking (10) CEN EN 407:2004 Protective gloves against thermal risks (heat and/or fire) (11) † EN 420:2003+A1:2009 Protective gloves - General requirements and test methods (12) EN 421:2010 Protective gloves against ionizing radiation and radioactive contamination (13) EN 511:2006 Protective gloves against cold (14) EN 840-6:2012 Mobile waste and recycling containers - Part 6: safety and health requirements (15) EN 14387:2004+A1:2008 Respiratory protective devices - Gas filter(s) and combined filter(s) - Requirements, testing, marking (16) EN ISO 13688:2013 Protective clothing ‑ General requirements (ISO 13688:2013) (17) EN ISO 19238:2014 Radiological protection - Performance criteria for service laboratories performing 5.1.4 biological dosimetry by cytogenetics (18) EN ISO 20345:2011 Personal protective equipment ‑ Safety footwear (ISO 20345:2011) (19) EN 60825-1:2014 Safety of laser products - Part 1: equipment classification and requirements (IEC 60825‑1:2014) (20) EN 61010-1:2010+A1:2019+AC:2019-04 Safety requirements for electrical equipment for measurement, control, and laboratory use ‑ Part 1: general requirements (IEC 61010‑1:2010+A1:2019) (21) EN 61508‑1:2010 Functional safety of electrical/electronic/programmable electronic safety‑related CENELEC systems ‑ Part 1: general requirements (IEC 61508‑1:2010) (22) ‡ EN 61508‑2:2010 Functional safety of electrical/electronic/programmable electronic safety‑related systems ‑ Part 2: requirements for electrical/electronic/programmable electronic safety related systems (IEC 61508‑2:2010) (23) EN 61508‑3:2010 Functional safety of electrical/electronic/programmable electronic safety‑related systems ‑ Part 3: software requirements (IEC 61508‑3:2010) (24) EN 62471:2008 Photobiological safety of lamps and lamp systems (IEC 62471:2006, modified) (25) International basic safety standards for protection against ionizing radiation and for the safety of IAEA radiation sources (26) Creating a safe and healthy workplace: a guide to occupational health and safety for entrepreneurs, ICOH owners and managers (27) IEC 60825‑1:2014 Safety of laser products – Part 1: equipment classification and requirements, 3rd edn (28) IEC 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: general requirements, 3rd edn (29) IEC 61010-1:2010/COR1:2011 Corrigendum 1 – Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: general requirements, 3rd edn (30) IEC 61010-1:2010/COR2:2013 Corrigendum 2 – Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: general requirements, 3rd edn (31) IEC 61010-1:2010/AMD1:2016 Amendment 1 – Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: general requirements, 3rd edn (32) IEC 61010-2‑081:2019 Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 2‑081: particular requirements for automatic and semi‑automatic IEC laboratory equipment for analysis and other purposes, 3rd edn (33) § IEC 61010-2‑101:2018 Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 2‑101: particular requirements for in vitro diagnostic (IVD) medical equipment, 3rd edn (34) IEC 61508‑1:2010 Functional safety of electrical/electronic/programmable electronic safety‑related systems – Part 1: general requirements, 2nd edn (35) IEC 61508‑2:2010 Functional safety of electrical/electronic/programmable electronic safety‑related systems – Part 2: requirements for electrical/electronic/programmable electronic safety related systems, 2nd edn (36) IEC 61508‑3:2010 Functional safety of electrical/electronic/programmable electronic safety‑related systems – Part 3: software requirements, 2nd edn (37) IEC 62471:2006 Photobiological safety of lamps and lamp systems (38) Ambient factors in the workplace (39) ILO Safety in the use of chemicals at work (40) The use of lasers in the workplace: a practical guide (41) ISO 361:1975 Basic ionizing radiation symbol (42) ISO 374-1:2016 Protective gloves against dangerous chemicals and micro‑organisms — Part 1: terminology and performance requirements for chemical risks (43) ISO 374-1:2016/Amd.1:2018 Amendment 1 — Protective gloves against dangerous chemicals and micro‑organisms — Part 1: terminology and performance requirements for chemical risks (44) ISO 374-5:2016 Protective gloves against dangerous chemicals and micro‑organisms — Part 5: terminology and performance requirements for micro‑organisms risks (45) ISO 3864‑1:2011 Graphical symbols — Safety colours and safety signs