Annex SL Cấu trúc cấp cao của Hệ thống quản lý ISO High level structure

Cấu trúc cấp cao theo quan điểm mới của ISO giành cho các hệ thống quản lý. Hight Level Structure Risk base thinking Tiêu chuẩn này quy định cấu trúc nền tảng cho các tiêu chuẩn sẽ được phát hành bởi ISO Tổ chức tiêu chuẩn hoá quốc tế

ISO/IEC Directives, Part 1, Consolidated ISO Supplement, 2015 Appendix (normative) ‹‰ŠŽ‡˜‡Ž•–”—…–—”‡ǡ‹†‡–‹…ƒŽ…‘”‡–‡š–ǡ…‘‘–‡”•ƒ†…‘”‡†‡ϐ‹‹–‹‘•       –Š‡ †‡–‹…ƒŽ –‡š– ’”‘’‘•ƒŽ•ǡ  α ƒ  †‹•…‹’Ž‹‡ •’‡…‹ϐ‹… “—ƒŽ‹ϐ‹‡” ȋ‡Ǥ‰Ǥ ‡‡”‰›ǡ ”‘ƒ† –”ƒˆϐ‹…•ƒˆ‡–›ǡ•‡…—”‹–›ǡˆ‘‘†•ƒˆ‡–›ǡ•‘…‹‡–ƒŽ•‡…—”‹–›ǡ‡˜‹”‘‡–ǡ“—ƒŽ‹–›Ȍ–Šƒ–‡‡†•–‘„‡‹•‡”–‡†Ǥ Ž—‡‹–ƒŽ‹…‹œ‡†–‡š–‹•‰‹˜‡ƒ•ƒ†˜‹•‘”›‘–‡•–‘•–ƒ†ƒ”†•†”ƒˆ–‡”• Introduction   ’‡…‹ϔ‹…–‘–Š‡†‹•…‹’Ž‹‡Ǥ Scope   ’‡…‹ϔ‹…–‘–Š‡†‹•…‹’Ž‹‡Ǥ Normative references   Žƒ—•‡‹–Ž‡•ŠƒŽŽ„‡—•‡†Ǥ’‡…‹ϔ‹…–‘–Š‡†‹•…‹’Ž‹‡Ǥ ͵Ǥ‡”•ƒ††‡ϐ‹‹–‹‘•   ͷŽƒ—•‡‹–Ž‡•ŠƒŽŽ„‡—•‡†Ǥ‡”•ƒ††‡ϔ‹‹–‹‘•ƒ›‡‹–Š‡”„‡™‹–Š‹–Š‡ •–ƒ†ƒ”†‘”‹ƒ•‡’ƒ”ƒ–‡†‘…—‡–Ǥ‘”‡ˆ‡”‡…‡‘‘–‡”•ƒ†‘”‡†‡ϔ‹‹–‹‘•ή†‹•…‹’Ž‹‡•’‡…‹ϔ‹… ‘‡•ǤŠ‡ƒ””ƒ‰‡‡–‘ˆ–‡”•ƒ††‡ϔ‹‹–‹‘••ŠƒŽŽ„‡ƒ……‘”†‹‰–‘–Š‡…‘…‡’–•›•–‡•‘ˆ‡ƒ…Š•–ƒ†ƒ”†Ǥ ‘”–Š‡’—”’‘•‡•‘ˆ–Š‹•†‘…—‡–ǡ–Š‡ˆ‘ŽŽ‘™‹‰–‡”•ƒ††‡ϐ‹‹–‹‘•ƒ’’Ž›Ǥ   ͸Š‡ˆ‘ŽŽ‘™‹‰–‡”•ƒ††‡ϔ‹‹–‹‘•…‘•–‹–—–‡ƒ‹–‡‰”ƒŽ’ƒ”–‘ˆ–Š‡Dz…‘‘ –‡š–dzˆ‘”ƒƒ‰‡‡–•›•–‡••–ƒ†ƒ”†•Ǥ††‹–‹‘ƒŽ–‡”•ƒ††‡ϔ‹‹–‹‘•ƒ›„‡ƒ††‡†ƒ•‡‡†‡†Ǥ‘–‡• ƒ›„‡ƒ††‡†‘”‘†‹ϔ‹‡†–‘•‡”˜‡–Š‡’—”’‘•‡‘ˆ‡ƒ…Š•–ƒ†ƒ”†Ǥ   ͹–ƒŽ‹…•–›’‡‹ƒ†‡ϔ‹‹–‹‘‹†‹…ƒ–‡•ƒ…”‘••Ǧ”‡ˆ‡”‡…‡–‘ƒ‘–Š‡”–‡”†‡ϔ‹‡† in this clause, and the number reference for the term is given in parentheses   ͺŠ‡”‡–Š‡–‡š–Dzdzƒ’’‡ƒ”•–Š”‘—‰Š‘—––Š‹•…Žƒ—•‡ǡ–Š‡ƒ’’”‘’”‹ƒ–‡”‡ˆ‡”‡…‡ •Š‘—Ž† „‡ ‹•‡”–‡† †‡’‡†‹‰ ‘ –Š‡ …‘–‡š– ‹ ™Š‹…Š –Š‡•‡ –‡”• ƒ† †‡ϔ‹‹–‹‘• ƒ”‡ „‡‹‰ ƒ’’Ž‹‡†Ǥ ‘” ‡šƒ’Ž‡ǣDzƒ‘„Œ‡…–‹˜‡dz…‘—Ž†„‡•—„•–‹–—–‡†ƒ•Dzƒ‹ˆ‘”ƒ–‹‘•‡…—”‹–›‘„Œ‡…–‹˜‡dzǤ 3.1 organization ’‡”•‘‘”‰”‘—’‘ˆ’‡‘’Ž‡–Šƒ–Šƒ•‹–•‘™ˆ—…–‹‘•™‹–Š”‡•’‘•‹„‹Ž‹–‹‡•ǡƒ—–Š‘”‹–‹‡•ƒ†”‡Žƒ–‹‘ships to achieve its ‘„Œ‡…–‹˜‡• (3.8) ‘–‡ͳ–‘‡–”›ǣ Š‡…‘…‡’–‘ˆ‘”‰ƒ‹œƒ–‹‘‹…Ž—†‡•ǡ„—–‹•‘–Ž‹‹–‡†–‘•‘Ž‡Ǧ–”ƒ†‡”ǡ…‘’ƒ›ǡ…‘”’‘”ƒ–‹‘ǡϐ‹”ǡ ‡–‡”’”‹•‡ǡƒ—–Š‘”‹–›ǡ’ƒ”–‡”•Š‹’ǡ…Šƒ”‹–›‘”‹•–‹–—–‹‘ǡ‘”’ƒ”–‘”…‘„‹ƒ–‹‘–Š‡”‡‘ˆǡ™Š‡–Š‡”‹…‘”’‘”ƒ–‡†‘” ‘–ǡ’—„Ž‹…‘”’”‹˜ƒ–‡Ǥ 3.2 interested party (preferred term) stakeholder (admitted term) person or organizationȋ͵ǤͳȌ–Šƒ–…ƒƒˆˆ‡…–ǡ„‡ƒˆˆ‡…–‡†„›ǡ‘”’‡”…‡‹˜‡‹–•‡Žˆ–‘„‡ƒˆˆ‡…–‡†„›ƒ†‡…‹•‹‘ ‘”ƒ…–‹˜‹–› © ISO/IEC 2015 – All rights reserved 127 ISO/IEC Directives, Part 1, Consolidated ISO Supplement, 2015 3.3 requirement ‡‡†‘”‡š’‡…–ƒ–‹‘–Šƒ–‹••–ƒ–‡†ǡ‰‡‡”ƒŽŽ›‹’Ž‹‡†‘”‘„Ž‹‰ƒ–‘”› ‘–‡ͳ–‘‡–”›ǣ Dz ‡‡”ƒŽŽ› ‹’Ž‹‡†dz ‡ƒ• –Šƒ– ‹– ‹• …—•–‘ ‘” …‘‘ ’”ƒ…–‹…‡ ˆ‘” –Š‡ ‘”‰ƒ‹œƒ–‹‘ ƒ† ‹–‡”‡•–‡†’ƒ”–‹‡•–Šƒ––Š‡‡‡†‘”‡š’‡…–ƒ–‹‘—†‡”…‘•‹†‡”ƒ–‹‘‹•‹’Ž‹‡†Ǥ ‘–‡ʹ–‘‡–”›ǣ •’‡…‹ϐ‹‡†”‡“—‹”‡‡–‹•‘‡–Šƒ–‹••–ƒ–‡†ǡˆ‘”‡šƒ’Ž‡‹†‘…—‡–‡†‹ˆ‘”ƒ–‹‘Ǥ 3.4 management system set of interrelated or interacting elements of an organizationȋ͵ǤͳȌ–‘‡•–ƒ„Ž‹•Špolicies (3.7) and ‘„Œ‡…–‹˜‡• (3.8) and processesȋ͵ǤͳʹȌ–‘ƒ…Š‹‡˜‡–Š‘•‡‘„Œ‡…–‹˜‡• ‘–‡ͳ–‘‡–”›ǣ ƒƒ‰‡‡–•›•–‡…ƒƒ††”‡••ƒ•‹‰Ž‡†‹•…‹’Ž‹‡‘”•‡˜‡”ƒŽ†‹•…‹’Ž‹‡•Ǥ ‘–‡ʹ–‘‡–”›ǣ Š‡•›•–‡‡Ž‡‡–•‹…Ž—†‡–Š‡‘”‰ƒ‹œƒ–‹‘ǯ••–”—…–—”‡ǡ”‘Ž‡•ƒ†”‡•’‘•‹„‹Ž‹–‹‡•ǡ’Žƒ‹‰ and operation ‘–‡͵–‘‡–”›ǣ Š‡ •…‘’‡ ‘ˆ ƒ ƒƒ‰‡‡– •›•–‡ ƒ› ‹…Ž—†‡ –Š‡ ™Š‘Ž‡ ‘ˆ –Š‡ ‘”‰ƒ‹œƒ–‹‘ǡ •’‡…‹ϐ‹… ƒ† ‹†‡–‹ϐ‹‡† ˆ—…–‹‘• ‘ˆ –Š‡ ‘”‰ƒ‹œƒ–‹‘ǡ •’‡…‹ϐ‹… ƒ† ‹†‡–‹ϐ‹‡† •‡…–‹‘• ‘ˆ –Š‡ ‘”‰ƒ‹œƒ–‹‘ǡ ‘” ‘‡ ‘” ‘”‡ ˆ—…–‹‘•ƒ…”‘••ƒ‰”‘—’‘ˆ‘”‰ƒ‹œƒ–‹‘•Ǥ 3.5 top management ’‡”•‘‘”‰”‘—’‘ˆ’‡‘’Ž‡™Š‘†‹”‡…–•ƒ†…‘–”‘Ž•ƒorganization (3.1) at the highest level ‘–‡ͳ–‘‡–”›ǣ ‘’ ƒƒ‰‡‡– Šƒ• –Š‡ ’‘™‡” –‘ †‡Ž‡‰ƒ–‡ ƒ—–Š‘”‹–› ƒ† ’”‘˜‹†‡ ”‡•‘—”…‡• ™‹–Š‹ –Š‡ ‘”‰ƒ‹œƒ–‹‘Ǥ ‘–‡ʹ–‘‡–”›ǣ ˆ –Š‡ •…‘’‡ ‘ˆ –Š‡ management system ȋ͵ǤͶȌ …‘˜‡”• ‘Ž› ’ƒ”– ‘ˆ ƒ ‘”‰ƒ‹œƒ–‹‘ǡ –Š‡ –‘’ ƒƒ‰‡‡–”‡ˆ‡”•–‘–Š‘•‡™Š‘†‹”‡…–ƒ†…‘–”‘Ž–Šƒ–’ƒ”–‘ˆ–Š‡‘”‰ƒ‹œƒ–‹‘Ǥ 3.6 effectiveness ‡š–‡––‘™Š‹…Š’Žƒ‡†ƒ…–‹˜‹–‹‡•ƒ”‡”‡ƒŽ‹œ‡†ƒ†’Žƒ‡†”‡•—Ž–•ƒ…Š‹‡˜‡† 3.7 policy intentions and direction of an organizationȋ͵ǤͳȌǡƒ•ˆ‘”ƒŽŽ›‡š’”‡••‡†„›‹–•top management (3.5) 3.8 objective ”‡•—Ž––‘„‡ƒ…Š‹‡˜‡† ‘–‡ͳ–‘‡–”›ǣ ‘„Œ‡…–‹˜‡…ƒ„‡•–”ƒ–‡‰‹…ǡ–ƒ…–‹…ƒŽǡ‘”‘’‡”ƒ–‹‘ƒŽǤ ‘–‡ʹ–‘‡–”›ǣ „Œ‡…–‹˜‡• …ƒ ”‡Žƒ–‡ –‘ †‹ˆˆ‡”‡– †‹•…‹’Ž‹‡• ȋ•—…Š ƒ• ϐ‹ƒ…‹ƒŽǡ Š‡ƒŽ–Š ƒ† •ƒˆ‡–›ǡ ƒ† ‡˜‹”‘‡–ƒŽ‰‘ƒŽ•Ȍƒ†…ƒƒ’’Ž›ƒ–†‹ˆˆ‡”‡–Ž‡˜‡Ž•ȋ•—…Šƒ••–”ƒ–‡‰‹…ǡ‘”‰ƒ‹œƒ–‹‘Ǧ™‹†‡ǡ’”‘Œ‡…–ǡ’”‘†—…–ƒ† process (3.12)) ‘–‡͵–‘‡–”›ǣ ‘„Œ‡…–‹˜‡…ƒ„‡‡š’”‡••‡†‹‘–Š‡”™ƒ›•ǡ‡Ǥ‰Ǥƒ•ƒ‹–‡†‡†‘—–…‘‡ǡƒ’—”’‘•‡ǡƒ‘’‡”ƒ–‹‘ƒŽ …”‹–‡”‹‘ǡƒ•ƒ‘„Œ‡…–‹˜‡ǡ‘”„›–Š‡—•‡‘ˆ‘–Š‡”™‘”†•™‹–Š•‹‹Žƒ”‡ƒ‹‰ȋ‡Ǥ‰Ǥƒ‹ǡ‰‘ƒŽǡ‘”–ƒ”‰‡–ȌǤ ‘–‡Ͷ–‘‡–”›ǣ –Š‡…‘–‡š–‘ˆƒƒ‰‡‡–•›•–‡•ǡ‘„Œ‡…–‹˜‡•ƒ”‡•‡–„›–Š‡‘”‰ƒ‹œƒ–‹‘ǡ…‘•‹•–‡– ™‹–Š–Š‡’‘Ž‹…›ǡ–‘ƒ…Š‹‡˜‡•’‡…‹ϐ‹…”‡•—Ž–•Ǥ 128 © ISO/IEC 2015 – All rights reserved ISO/IEC Directives, Part 1, Consolidated ISO Supplement, 2015 3.9 risk ‡ˆˆ‡…–‘ˆ—…‡”–ƒ‹–› ‘–‡ͳ–‘‡–”›ǣ ‡ˆˆ‡…–‹•ƒ†‡˜‹ƒ–‹‘ˆ”‘–Š‡‡š’‡…–‡†Ȅ’‘•‹–‹˜‡‘”‡‰ƒ–‹˜‡Ǥ ‘–‡ʹ–‘‡–”›ǣ …‡”–ƒ‹–›‹•–Š‡•–ƒ–‡ǡ‡˜‡’ƒ”–‹ƒŽǡ‘ˆ†‡ϐ‹…‹‡…›‘ˆ‹ˆ‘”ƒ–‹‘”‡Žƒ–‡†–‘ǡ—†‡”•–ƒ†‹‰‘” ‘™Ž‡†‰‡‘ˆǡƒ‡˜‡–ǡ‹–•…‘•‡“—‡…‡ǡ‘”Ž‹‡Ž‹Š‘‘†Ǥ ‘–‡͵–‘‡–”›ǣ ‹•‹•‘ˆ–‡…Šƒ”ƒ…–‡”‹œ‡†„›”‡ˆ‡”‡…‡–‘’‘–‡–‹ƒŽDz‡˜‡–•dzȋƒ•†‡ϐ‹‡†‹ —‹†‡͹͵ǣʹͲͲͻǡ ͵ǤͷǤͳǤ͵Ȍƒ†Dz…‘•‡“—‡…‡•dzȋƒ•†‡ϐ‹‡†‹ —‹†‡͹͵ǣʹͲͲͻǡ͵Ǥ͸ǤͳǤ͵Ȍǡ‘”ƒ…‘„‹ƒ–‹‘‘ˆ–Š‡•‡Ǥ ‘–‡Ͷ–‘‡–”›ǣ ‹• ‹• ‘ˆ–‡ ‡š’”‡••‡† ‹ –‡”• ‘ˆ ƒ …‘„‹ƒ–‹‘ ‘ˆ –Š‡ …‘•‡“—‡…‡• ‘ˆ ƒ ‡˜‡– ȋ‹…Ž—†‹‰ …Šƒ‰‡•‹…‹”…—•–ƒ…‡•Ȍƒ†–Š‡ƒ••‘…‹ƒ–‡†DzŽ‹‡Ž‹Š‘‘†dzȋƒ•†‡ϐ‹‡†‹ —‹†‡͹͵ǣʹͲͲͻǡ͵Ǥ͸ǤͳǤͳȌ‘ˆ‘……—””‡…‡Ǥ 3.10 competence ƒ„‹Ž‹–›–‘ƒ’’Ž›‘™Ž‡†‰‡ƒ†•‹ŽŽ•–‘ƒ…Š‹‡˜‡‹–‡†‡†”‡•—Ž–• 3.11 documented information ‹ˆ‘”ƒ–‹‘”‡“—‹”‡†–‘„‡…‘–”‘ŽŽ‡†ƒ†ƒ‹–ƒ‹‡†„›ƒorganizationȋ͵ǤͳȌƒ†–Š‡‡†‹—‘ which it is contained ‘–‡ͳ–‘‡–”›ǣ ‘…—‡–‡†‹ˆ‘”ƒ–‹‘…ƒ„‡‹ƒ›ˆ‘”ƒ–ƒ†‡†‹ƒǡƒ†ˆ”‘ƒ›•‘—”…‡Ǥ ‘–‡ʹ–‘‡–”›ǣ ‘…—‡–‡†‹ˆ‘”ƒ–‹‘…ƒ”‡ˆ‡”–‘ǣ — the management systemȋ͵ǤͶȌǡ‹…Ž—†‹‰”‡Žƒ–‡†processes (3.12); Ȅ‹ˆ‘”ƒ–‹‘…”‡ƒ–‡†‹‘”†‡”ˆ‘”–Š‡‘”‰ƒ‹œƒ–‹‘–‘‘’‡”ƒ–‡ȋ†‘…—‡–ƒ–‹‘ȌǢ Ȅ‡˜‹†‡…‡‘ˆ”‡•—Ž–•ƒ…Š‹‡˜‡†ȋ”‡…‘”†•ȌǤ 3.12 process •‡–‘ˆ‹–‡””‡Žƒ–‡†‘”‹–‡”ƒ…–‹‰ƒ…–‹˜‹–‹‡•™Š‹…Š–”ƒ•ˆ‘”•‹’—–•‹–‘‘—–’—–• 3.13 performance ‡ƒ•—”ƒ„Ž‡”‡•—Ž– ‘–‡ͳ–‘‡–”›ǣ ‡”ˆ‘”ƒ…‡…ƒ”‡Žƒ–‡‡‹–Š‡”–‘“—ƒ–‹–ƒ–‹˜‡‘”“—ƒŽ‹–ƒ–‹˜‡ϐ‹†‹‰•Ǥ ‘–‡ʹ–‘‡–”›ǣ ‡”ˆ‘”ƒ…‡ …ƒ ”‡Žƒ–‡ –‘ –Š‡ ƒƒ‰‡‡– ‘ˆ ƒ…–‹˜‹–‹‡•ǡ processes ȋ͵ǤͳʹȌǡ ’”‘†—…–• ȋ‹…Ž—†‹‰ •‡”˜‹…‡•Ȍǡ•›•–‡•‘”organizations (3.1) 3.14 outsourceȋ˜‡”„Ȍ ƒ‡ƒƒ””ƒ‰‡‡–™Š‡”‡ƒ‡š–‡”ƒŽorganizationȋ͵ǤͳȌ’‡”ˆ‘”•’ƒ”–‘ˆƒ‘”‰ƒ‹œƒ–‹‘ǯ•ˆ—…–‹‘ or process (3.12) ‘–‡ͳ–‘‡–”›ǣ  ‡š–‡”ƒŽ ‘”‰ƒ‹œƒ–‹‘ ‹• ‘—–•‹†‡ –Š‡ •…‘’‡ ‘ˆ –Š‡ management system ȋ͵ǤͶȌǡ ƒŽ–Š‘—‰Š –Š‡ ‘—–•‘—”…‡†ˆ—…–‹‘‘”’”‘…‡••‹•™‹–Š‹–Š‡•…‘’‡Ǥ 3.15 monitoring †‡–‡”‹‹‰–Š‡•–ƒ–—•‘ˆƒ•›•–‡ǡƒprocessȋ͵ǤͳʹȌ‘”ƒƒ…–‹˜‹–› ‘–‡ͳ–‘‡–”›ǣ ‘†‡–‡”‹‡–Š‡•–ƒ–—•ǡ–Š‡”‡ƒ›„‡ƒ‡‡†–‘…Š‡…ǡ•—’‡”˜‹•‡‘”…”‹–‹…ƒŽŽ›‘„•‡”˜‡Ǥ © ISO/IEC 2015 – All rights reserved 129 ISO/IEC Directives, Part 1, Consolidated ISO Supplement, 2015 3.16 measurement processȋ͵ǤͳʹȌ–‘†‡–‡”‹‡ƒ˜ƒŽ—‡ 3.17 audit •›•–‡ƒ–‹…ǡ‹†‡’‡†‡–ƒ††‘…—‡–‡†processȋ͵ǤͳʹȌˆ‘”‘„–ƒ‹‹‰ƒ—†‹–‡˜‹†‡…‡ƒ†‡˜ƒŽ—ƒ–‹‰‹– ‘„Œ‡…–‹˜‡Ž›–‘†‡–‡”‹‡–Š‡‡š–‡––‘™Š‹…Š–Š‡ƒ—†‹–…”‹–‡”‹ƒƒ”‡ˆ—Žϐ‹ŽŽ‡† ‘–‡ͳ–‘‡–”›ǣ ƒ—†‹–…ƒ„‡ƒ‹–‡”ƒŽƒ—†‹–ȋϐ‹”•–’ƒ”–›Ȍ‘”ƒ‡š–‡”ƒŽƒ—†‹–ȋ•‡…‘†’ƒ”–›‘”–Š‹”†’ƒ”–›Ȍǡ ƒ†‹–…ƒ„‡ƒ…‘„‹‡†ƒ—†‹–ȋ…‘„‹‹‰–™‘‘”‘”‡†‹•…‹’Ž‹‡•ȌǤ ‘–‡ʹ–‘‡–”›ǣ ‹–‡”ƒŽƒ—†‹–‹•…‘†—…–‡†„›–Š‡‘”‰ƒ‹œƒ–‹‘‹–•‡Žˆǡ‘”„›ƒ‡š–‡”ƒŽ’ƒ”–›‘‹–•„‡ŠƒŽˆǤ ‘–‡͵–‘‡–”›ǣ Dz—†‹–‡˜‹†‡…‡dzƒ†Dzƒ—†‹–…”‹–‡”‹ƒdzƒ”‡†‡ϐ‹‡†‹ͳͻͲͳͳǤ 3.18 conformity ˆ—Žϐ‹Ž‡–‘ˆƒ”‡“—‹”‡‡– (3.3) 3.19 nonconformity ‘Ǧˆ—Žϐ‹Ž‡–‘ˆƒ”‡“—‹”‡‡– (3.3) 3.20 corrective action ƒ…–‹‘–‘‡Ž‹‹ƒ–‡–Š‡…ƒ—•‡‘ˆƒnonconformityȋ͵ǤͳͻȌƒ†–‘’”‡˜‡–”‡…—””‡…‡ 3.21 continual improvement ”‡…—””‹‰ƒ…–‹˜‹–›–‘‡Šƒ…‡performance (3.13) Context of the organization 4.1 Understanding the organization and its context Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ†‡–‡”‹‡‡š–‡”ƒŽƒ†‹–‡”ƒŽ‹••—‡•–Šƒ–ƒ”‡”‡Ž‡˜ƒ––‘‹–•’—”’‘•‡ƒ†–Šƒ– ƒˆˆ‡…–‹–•ƒ„‹Ž‹–›–‘ƒ…Š‹‡˜‡–Š‡‹–‡†‡†‘—–…‘‡ȋ•Ȍ‘ˆ‹–•ƒƒ‰‡‡–•›•–‡Ǥ 4.2 Understanding the needs and expectations of interested parties Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ†‡–‡”‹‡ǣ Ȅ –Š‡‹–‡”‡•–‡†’ƒ”–‹‡•–Šƒ–ƒ”‡”‡Ž‡˜ƒ––‘–Š‡ƒƒ‰‡‡–•›•–‡Ǣ Ȅ –Š‡”‡Ž‡˜ƒ–”‡“—‹”‡‡–•‘ˆ–Š‡•‡‹–‡”‡•–‡†’ƒ”–‹‡•Ǥ 4.3 Determining the scope of the XXX management system Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ†‡–‡”‹‡–Š‡„‘—†ƒ”‹‡•ƒ†ƒ’’Ž‹…ƒ„‹Ž‹–›‘ˆ–Š‡ƒƒ‰‡‡–•›•–‡–‘ ‡•–ƒ„Ž‹•Š‹–••…‘’‡Ǥ Š‡†‡–‡”‹‹‰–Š‹••…‘’‡ǡ–Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ…‘•‹†‡”ǣ Ȅ –Š‡‡š–‡”ƒŽƒ†‹–‡”ƒŽ‹••—‡•”‡ˆ‡””‡†–‘‹ͶǤͳǢ Ȅ –Š‡”‡“—‹”‡‡–•”‡ˆ‡””‡†–‘‹ͶǤʹǤ 130 © ISO/IEC 2015 – All rights reserved ISO/IEC Directives, Part 1, Consolidated ISO Supplement, 2015 Š‡•…‘’‡•ŠƒŽŽ„‡ƒ˜ƒ‹Žƒ„Ž‡ƒ•†‘…—‡–‡†‹ˆ‘”ƒ–‹‘Ǥ 4.4 XXX management system Š‡ ‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ ‡•–ƒ„Ž‹•Šǡ ‹’Ž‡‡–ǡ ƒ‹–ƒ‹ ƒ† …‘–‹—ƒŽŽ› ‹’”‘˜‡ ƒ  ƒƒ‰‡‡– •›•–‡ǡ‹…Ž—†‹‰–Š‡’”‘…‡••‡•‡‡†‡†ƒ†–Š‡‹”‹–‡”ƒ…–‹‘•ǡ‹ƒ……‘”†ƒ…‡™‹–Š–Š‡”‡“—‹”‡‡–•‘ˆ –Š‹•–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†Ȁ–Š‹•’ƒ”–‘ˆȀ–Š‹•‡…Š‹…ƒŽ’‡…‹ϐ‹…ƒ–‹‘Ǥ Leadership 5.1 Leadership and commitment ‘’ƒƒ‰‡‡–•ŠƒŽŽ†‡‘•–”ƒ–‡Ž‡ƒ†‡”•Š‹’ƒ†…‘‹–‡–™‹–Š”‡•’‡…––‘–Š‡ƒƒ‰‡‡– •›•–‡„›ǣ Ȅ ‡•—”‹‰ –Šƒ– –Š‡  ’‘Ž‹…› ƒ†  ‘„Œ‡…–‹˜‡• ƒ”‡ ‡•–ƒ„Ž‹•Š‡† ƒ† ƒ”‡ …‘’ƒ–‹„Ž‡ ™‹–Š –Š‡ •–”ƒ–‡‰‹…†‹”‡…–‹‘‘ˆ–Š‡‘”‰ƒ‹œƒ–‹‘Ǣ Ȅ ‡•—”‹‰ –Š‡ ‹–‡‰”ƒ–‹‘ ‘ˆ –Š‡  ƒƒ‰‡‡– •›•–‡ ”‡“—‹”‡‡–• ‹–‘ –Š‡ ‘”‰ƒ‹œƒ–‹‘ǯ• „—•‹‡••’”‘…‡••‡•Ǣ Ȅ ‡•—”‹‰–Šƒ––Š‡”‡•‘—”…‡•‡‡†‡†ˆ‘”–Š‡ƒƒ‰‡‡–•›•–‡ƒ”‡ƒ˜ƒ‹Žƒ„Ž‡Ǣ Ȅ …‘—‹…ƒ–‹‰ –Š‡ ‹’‘”–ƒ…‡ ‘ˆ ‡ˆˆ‡…–‹˜‡  ƒƒ‰‡‡– ƒ† ‘ˆ …‘ˆ‘”‹‰ –‘ –Š‡  ƒƒ‰‡‡–•›•–‡”‡“—‹”‡‡–•Ǣ Ȅ ‡•—”‹‰–Šƒ––Š‡ƒƒ‰‡‡–•›•–‡ƒ…Š‹‡˜‡•‹–•‹–‡†‡†‘—–…‘‡ȋ•ȌǢ Ȅ †‹”‡…–‹‰ƒ†•—’’‘”–‹‰’‡”•‘•–‘…‘–”‹„—–‡–‘–Š‡‡ˆˆ‡…–‹˜‡‡••‘ˆ–Š‡ƒƒ‰‡‡–•›•–‡Ǣ Ȅ ’”‘‘–‹‰…‘–‹—ƒŽ‹’”‘˜‡‡–Ǣ Ȅ •—’’‘”–‹‰‘–Š‡””‡Ž‡˜ƒ–ƒƒ‰‡‡–”‘Ž‡•–‘†‡‘•–”ƒ–‡–Š‡‹”Ž‡ƒ†‡”•Š‹’ƒ•‹–ƒ’’Ž‹‡•–‘–Š‡‹” ƒ”‡ƒ•‘ˆ”‡•’‘•‹„‹Ž‹–›Ǥ  ‡ˆ‡”‡…‡ –‘ Dz„—•‹‡••dz ‹ –Š‹• –‡”ƒ–‹‘ƒŽ –ƒ†ƒ”†Ȁ–Š‹• ’ƒ”– ‘ˆ  Ȁ–Š‹• ‡…Š‹…ƒŽ ’‡…‹ϐ‹…ƒ–‹‘…ƒ„‡‹–‡”’”‡–‡†„”‘ƒ†Ž›–‘‡ƒ–Š‘•‡ƒ…–‹˜‹–‹‡•–Šƒ–ƒ”‡…‘”‡–‘–Š‡’—”’‘•‡•‘ˆ–Š‡‘”‰ƒ‹œƒ–‹‘ǯ• existence 5.2 Policy ‘’ƒƒ‰‡‡–•ŠƒŽŽ‡•–ƒ„Ž‹•Šƒ’‘Ž‹…›–Šƒ–ǣ ƒȌ ‹•ƒ’’”‘’”‹ƒ–‡–‘–Š‡’—”’‘•‡‘ˆ–Š‡‘”‰ƒ‹œƒ–‹‘Ǣ „Ȍ ’”‘˜‹†‡•ƒˆ”ƒ‡™‘”ˆ‘”•‡––‹‰‘„Œ‡…–‹˜‡•Ǣ …Ȍ ‹…Ž—†‡•ƒ…‘‹–‡––‘•ƒ–‹•ˆ›ƒ’’Ž‹…ƒ„Ž‡”‡“—‹”‡‡–•Ǣ †Ȍ ‹…Ž—†‡•ƒ…‘‹–‡––‘…‘–‹—ƒŽ‹’”‘˜‡‡–‘ˆ–Š‡ƒƒ‰‡‡–•›•–‡Ǥ Š‡’‘Ž‹…›•ŠƒŽŽǣ Ȅ „‡ƒ˜ƒ‹Žƒ„Ž‡ƒ•†‘…—‡–‡†‹ˆ‘”ƒ–‹‘Ǣ Ȅ „‡…‘—‹…ƒ–‡†™‹–Š‹–Š‡‘”‰ƒ‹œƒ–‹‘Ǣ Ȅ „‡ƒ˜ƒ‹Žƒ„Ž‡–‘‹–‡”‡•–‡†’ƒ”–‹‡•ǡƒ•ƒ’’”‘’”‹ƒ–‡Ǥ © ISO/IEC 2015 – All rights reserved 131 ISO/IEC Directives, Part 1, Consolidated ISO Supplement, 2015 5.3 Organizational roles, responsibilities and authorities ‘’ƒƒ‰‡‡–•ŠƒŽŽ‡•—”‡–Šƒ––Š‡”‡•’‘•‹„‹Ž‹–‹‡•ƒ†ƒ—–Š‘”‹–‹‡•ˆ‘””‡Ž‡˜ƒ–”‘Ž‡•ƒ”‡ƒ••‹‰‡† ƒ†…‘—‹…ƒ–‡†™‹–Š‹–Š‡‘”‰ƒ‹œƒ–‹‘Ǥ ‘’ƒƒ‰‡‡–•ŠƒŽŽƒ••‹‰–Š‡”‡•’‘•‹„‹Ž‹–›ƒ†ƒ—–Š‘”‹–›ˆ‘”ǣ ƒȌ ‡•—”‹‰ –Šƒ– –Š‡  ƒƒ‰‡‡– •›•–‡ …‘ˆ‘”• –‘ –Š‡ ”‡“—‹”‡‡–• ‘ˆ –Š‹• –‡”ƒ–‹‘ƒŽ –ƒ†ƒ”†Ȁ–Š‹•’ƒ”–‘ˆȀ–Š‹•‡…Š‹…ƒŽ’‡…‹ϐ‹…ƒ–‹‘Ǣ „Ȍ ”‡’‘”–‹‰‘–Š‡’‡”ˆ‘”ƒ…‡‘ˆ–Š‡ƒƒ‰‡‡–•›•–‡–‘–‘’ƒƒ‰‡‡–Ǥ Planning 6.1 Actions to address risks and opportunities Š‡’Žƒ‹‰ˆ‘”–Š‡ƒƒ‰‡‡–•›•–‡ǡ–Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ…‘•‹†‡”–Š‡‹••—‡•”‡ˆ‡””‡†–‘ ‹ͶǤͳƒ†–Š‡”‡“—‹”‡‡–•”‡ˆ‡””‡†–‘‹ͶǤʹƒ††‡–‡”‹‡–Š‡”‹••ƒ†‘’’‘”–—‹–‹‡•–Šƒ–‡‡†–‘„‡ ƒ††”‡••‡†–‘ǣ Ȅ ‰‹˜‡ƒ••—”ƒ…‡–Šƒ––Š‡ƒƒ‰‡‡–•›•–‡…ƒƒ…Š‹‡˜‡‹–•‹–‡†‡†‘—–…‘‡ȋ•ȌǢ Ȅ ’”‡˜‡–ǡ‘””‡†—…‡ǡ—†‡•‹”‡†‡ˆˆ‡…–•Ǣ Ȅ ƒ…Š‹‡˜‡…‘–‹—ƒŽ‹’”‘˜‡‡–Ǥ Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ’Žƒǣ ƒȌ ƒ…–‹‘•–‘ƒ††”‡••–Š‡•‡”‹••ƒ†‘’’‘”–—‹–‹‡•Ǣ „Ȍ Š‘™–‘ǣ Ȅ ‹–‡‰”ƒ–‡ƒ†‹’Ž‡‡––Š‡ƒ…–‹‘•‹–‘‹–•ƒƒ‰‡‡–•›•–‡’”‘…‡••‡•Ǣ Ȅ ‡˜ƒŽ—ƒ–‡–Š‡‡ˆˆ‡…–‹˜‡‡••‘ˆ–Š‡•‡ƒ…–‹‘•Ǥ 6.2 XXX objectives and planning to achieve them Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ‡•–ƒ„Ž‹•Š‘„Œ‡…–‹˜‡•ƒ–”‡Ž‡˜ƒ–ˆ—…–‹‘•ƒ†Ž‡˜‡Ž•Ǥ Š‡‘„Œ‡…–‹˜‡••ŠƒŽŽǣ ƒȌ „‡…‘•‹•–‡–™‹–Š–Š‡’‘Ž‹…›Ǣ „Ȍ „‡‡ƒ•—”ƒ„Ž‡ȋ‹ˆ’”ƒ…–‹…ƒ„Ž‡ȌǢ …Ȍ –ƒ‡‹–‘ƒ……‘—–ƒ’’Ž‹…ƒ„Ž‡”‡“—‹”‡‡–•Ǣ †Ȍ „‡‘‹–‘”‡†Ǣ ‡Ȍ „‡…‘—‹…ƒ–‡†Ǣ ˆȌ „‡—’†ƒ–‡†ƒ•ƒ’’”‘’”‹ƒ–‡Ǥ Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ”‡–ƒ‹†‘…—‡–‡†‹ˆ‘”ƒ–‹‘‘–Š‡‘„Œ‡…–‹˜‡•Ǥ Š‡’Žƒ‹‰Š‘™–‘ƒ…Š‹‡˜‡‹–•‘„Œ‡…–‹˜‡•ǡ–Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ†‡–‡”‹‡ǣ Ȅ ™Šƒ–™‹ŽŽ„‡†‘‡Ǣ Ȅ ™Šƒ–”‡•‘—”…‡•™‹ŽŽ„‡”‡“—‹”‡†Ǣ Ȅ ™Š‘™‹ŽŽ„‡”‡•’‘•‹„Ž‡Ǣ 132 © ISO/IEC 2015 – All rights reserved ISO/IEC Directives, Part 1, Consolidated ISO Supplement, 2015 Ȅ ™Š‡‹–™‹ŽŽ„‡…‘’Ž‡–‡†Ǣ Ȅ Š‘™–Š‡”‡•—Ž–•™‹ŽŽ„‡‡˜ƒŽ—ƒ–‡†Ǥ Support 7.1 Resources Š‡ ‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ †‡–‡”‹‡ ƒ† ’”‘˜‹†‡ –Š‡ ”‡•‘—”…‡• ‡‡†‡† ˆ‘” –Š‡ ‡•–ƒ„Ž‹•Š‡–ǡ ‹’Ž‡‡–ƒ–‹‘ǡƒ‹–‡ƒ…‡ƒ†…‘–‹—ƒŽ‹’”‘˜‡‡–‘ˆ–Š‡ƒƒ‰‡‡–•›•–‡Ǥ 7.2 Competence Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽǣ Ȅ †‡–‡”‹‡–Š‡‡…‡••ƒ”›…‘’‡–‡…‡‘ˆ’‡”•‘ȋ•Ȍ†‘‹‰™‘”—†‡”‹–•…‘–”‘Ž–Šƒ–ƒˆˆ‡…–•‹–• performance; Ȅ ‡•—”‡ –Šƒ– –Š‡•‡ ’‡”•‘• ƒ”‡ …‘’‡–‡– ‘ –Š‡ „ƒ•‹• ‘ˆ ƒ’’”‘’”‹ƒ–‡ ‡†—…ƒ–‹‘ǡ –”ƒ‹‹‰ǡ ‘” experience; Ȅ ™Š‡”‡ƒ’’Ž‹…ƒ„Ž‡ǡ–ƒ‡ƒ…–‹‘•–‘ƒ…“—‹”‡–Š‡‡…‡••ƒ”›…‘’‡–‡…‡ǡƒ†‡˜ƒŽ—ƒ–‡–Š‡‡ˆˆ‡…–‹˜‡‡•• ‘ˆ–Š‡ƒ…–‹‘•–ƒ‡Ǣ Ȅ ”‡–ƒ‹ƒ’’”‘’”‹ƒ–‡†‘…—‡–‡†‹ˆ‘”ƒ–‹‘ƒ•‡˜‹†‡…‡‘ˆ…‘’‡–‡…‡Ǥ  ’’Ž‹…ƒ„Ž‡ƒ…–‹‘•…ƒ‹…Ž—†‡ǡˆ‘”‡šƒ’Ž‡ǡ–Š‡’”‘˜‹•‹‘‘ˆ–”ƒ‹‹‰–‘ǡ–Š‡‡–‘”‹‰‘ˆǡ‘”–Š‡”‡Ǧ ƒ••‹‰‡–‘ˆ…—””‡–Ž›‡’Ž‘›‡†’‡”•‘•Ǣ‘”–Š‡Š‹”‹‰‘”…‘–”ƒ…–‹‰‘ˆ…‘’‡–‡–’‡”•‘•Ǥ 7.3 Awareness ‡”•‘•†‘‹‰™‘”—†‡”–Š‡‘”‰ƒ‹œƒ–‹‘ǯ•…‘–”‘Ž•ŠƒŽŽ„‡ƒ™ƒ”‡‘ˆǣ Ȅ –Š‡’‘Ž‹…›Ǣ Ȅ –Š‡‹” …‘–”‹„—–‹‘ –‘ –Š‡ ‡ˆˆ‡…–‹˜‡‡•• ‘ˆ –Š‡  ƒƒ‰‡‡– •›•–‡ǡ ‹…Ž—†‹‰ –Š‡ „‡‡ϐ‹–• ‘ˆ ‹’”‘˜‡†’‡”ˆ‘”ƒ…‡Ǣ Ȅ –Š‡‹’Ž‹…ƒ–‹‘•‘ˆ‘–…‘ˆ‘”‹‰™‹–Š–Š‡ƒƒ‰‡‡–•›•–‡”‡“—‹”‡‡–•Ǥ 7.4 Communication Š‡ ‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ †‡–‡”‹‡ –Š‡ ‹–‡”ƒŽ ƒ† ‡š–‡”ƒŽ …‘—‹…ƒ–‹‘• ”‡Ž‡˜ƒ– –‘ –Š‡  ƒƒ‰‡‡–•›•–‡ǡ‹…Ž—†‹‰ǣ Ȅ ‘™Šƒ–‹–™‹ŽŽ…‘—‹…ƒ–‡Ǣ Ȅ ™Š‡–‘…‘—‹…ƒ–‡Ǣ Ȅ ™‹–Š™Š‘–‘…‘—‹…ƒ–‡Ǣ Ȅ Š‘™–‘…‘—‹…ƒ–‡Ǥ 7.5 Documented information 7.5.1 General Š‡‘”‰ƒ‹œƒ–‹‘ǯ•ƒƒ‰‡‡–•›•–‡•ŠƒŽŽ‹…Ž—†‡ǣ ƒȌ †‘…—‡–‡† ‹ˆ‘”ƒ–‹‘ ”‡“—‹”‡† „› –Š‹• –‡”ƒ–‹‘ƒŽ –ƒ†ƒ”†Ȁ–Š‹• ’ƒ”– ‘ˆ  Ȁ–Š‹• ‡…Š‹…ƒŽ’‡…‹ϐ‹…ƒ–‹‘Ǣ © ISO/IEC 2015 – All rights reserved 133 ISO/IEC Directives, Part 1, Consolidated ISO Supplement, 2015 „Ȍ †‘…—‡–‡†‹ˆ‘”ƒ–‹‘†‡–‡”‹‡†„›–Š‡‘”‰ƒ‹œƒ–‹‘ƒ•„‡‹‰‡…‡••ƒ”›ˆ‘”–Š‡‡ˆˆ‡…–‹˜‡‡••‘ˆ –Š‡ƒƒ‰‡‡–•›•–‡Ǥ  Š‡‡š–‡–‘ˆ†‘…—‡–‡†‹ˆ‘”ƒ–‹‘ˆ‘”ƒƒƒ‰‡‡–•›•–‡…ƒ†‹ˆˆ‡”ˆ”‘‘‡‘”‰ƒ‹œƒ–‹‘ –‘ƒ‘–Š‡”†—‡–‘ǣ Ȅ–Š‡•‹œ‡‘ˆ‘”‰ƒ‹œƒ–‹‘ƒ†‹–•–›’‡‘ˆƒ…–‹˜‹–‹‡•ǡ’”‘…‡••‡•ǡ’”‘†—…–•ƒ†•‡”˜‹…‡•Ǣ Ȅ–Š‡…‘’Ž‡š‹–›‘ˆ’”‘…‡••‡•ƒ†–Š‡‹”‹–‡”ƒ…–‹‘•Ǣ — the competence of persons 7.5.2 Creating and updating Š‡…”‡ƒ–‹‰ƒ†—’†ƒ–‹‰†‘…—‡–‡†‹ˆ‘”ƒ–‹‘–Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ‡•—”‡ƒ’’”‘’”‹ƒ–‡ǣ Ȅ ‹†‡–‹ϐ‹…ƒ–‹‘ƒ††‡•…”‹’–‹‘ȋ‡Ǥ‰Ǥƒ–‹–Ž‡ǡ†ƒ–‡ǡƒ—–Š‘”ǡ‘””‡ˆ‡”‡…‡—„‡”ȌǢ Ȅ ˆ‘”ƒ–ȋ‡Ǥ‰ǤŽƒ‰—ƒ‰‡ǡ•‘ˆ–™ƒ”‡˜‡”•‹‘ǡ‰”ƒ’Š‹…•Ȍƒ†‡†‹ƒȋ‡Ǥ‰Ǥ’ƒ’‡”ǡ‡Ž‡…–”‘‹…ȌǢ Ȅ ”‡˜‹‡™ƒ†ƒ’’”‘˜ƒŽˆ‘”•—‹–ƒ„‹Ž‹–›ƒ†ƒ†‡“—ƒ…›Ǥ 7.5.3 Control of documented information ‘…—‡–‡†‹ˆ‘”ƒ–‹‘”‡“—‹”‡†„›–Š‡ƒƒ‰‡‡–•›•–‡ƒ†„›–Š‹•–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”† Ȁ–Š‹•’ƒ”–‘ˆȀ–Š‹•‡…Š‹…ƒŽ’‡…‹ϐ‹…ƒ–‹‘•ŠƒŽŽ„‡…‘–”‘ŽŽ‡†–‘‡•—”‡ǣ ƒȌ ‹–‹•ƒ˜ƒ‹Žƒ„Ž‡ƒ†•—‹–ƒ„Ž‡ˆ‘”—•‡ǡ™Š‡”‡ƒ†™Š‡‹–‹•‡‡†‡†Ǣ „Ȍ ‹–‹•ƒ†‡“—ƒ–‡Ž›’”‘–‡…–‡†ȋ‡Ǥ‰Ǥˆ”‘Ž‘••‘ˆ…‘ϐ‹†‡–‹ƒŽ‹–›ǡ‹’”‘’‡”—•‡ǡ‘”Ž‘••‘ˆ‹–‡‰”‹–›ȌǤ ‘”–Š‡…‘–”‘Ž‘ˆ†‘…—‡–‡†‹ˆ‘”ƒ–‹‘ǡ–Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽƒ††”‡••–Š‡ˆ‘ŽŽ‘™‹‰ƒ…–‹˜‹–‹‡•ǡƒ• ƒ’’Ž‹…ƒ„Ž‡ǣ Ȅ †‹•–”‹„—–‹‘ǡƒ……‡••ǡ”‡–”‹‡˜ƒŽƒ†—•‡Ǣ Ȅ •–‘”ƒ‰‡ƒ†’”‡•‡”˜ƒ–‹‘ǡ‹…Ž—†‹‰’”‡•‡”˜ƒ–‹‘‘ˆŽ‡‰‹„‹Ž‹–›Ǣ — control of changes (e.g version control); — retention and disposition ‘…—‡–‡† ‹ˆ‘”ƒ–‹‘ ‘ˆ ‡š–‡”ƒŽ ‘”‹‰‹ †‡–‡”‹‡† „› –Š‡ ‘”‰ƒ‹œƒ–‹‘ –‘ „‡ ‡…‡••ƒ”› ˆ‘” –Š‡ ’Žƒ‹‰ƒ†‘’‡”ƒ–‹‘‘ˆ–Š‡ƒƒ‰‡‡–•›•–‡•ŠƒŽŽ„‡‹†‡–‹ϐ‹‡†ǡƒ•ƒ’’”‘’”‹ƒ–‡ǡƒ†…‘–”‘ŽŽ‡†Ǥ  ……‡••…ƒ‹’Ž›ƒ†‡…‹•‹‘”‡‰ƒ”†‹‰–Š‡’‡”‹••‹‘–‘˜‹‡™–Š‡†‘…—‡–‡†‹ˆ‘”ƒ–‹‘‘Ž›ǡ‘”–Š‡ ’‡”‹••‹‘ƒ†ƒ—–Š‘”‹–›–‘˜‹‡™ƒ†…Šƒ‰‡–Š‡†‘…—‡–‡†‹ˆ‘”ƒ–‹‘Ǥ Operation 8.1 Operational planning and control DRAFTING INSTRUCTION Clause This subclause heading will be deleted if no additional subclauses are added to Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ’Žƒǡ‹’Ž‡‡–ƒ†…‘–”‘Ž–Š‡’”‘…‡••‡•‡‡†‡†–‘‡‡–”‡“—‹”‡‡–•ǡƒ†–‘ ‹’Ž‡‡––Š‡ƒ…–‹‘•†‡–‡”‹‡†‹͸Ǥͳǡ„›ǣ Ȅ ‡•–ƒ„Ž‹•Š‹‰…”‹–‡”‹ƒˆ‘”–Š‡’”‘…‡••‡•Ǣ — implementing control of the processes in accordance with the criteria; 134 © ISO/IEC 2015 – All rights reserved ISO/IEC Directives, Part 1, Consolidated ISO Supplement, 2015 Ȅ ‡‡’‹‰ †‘…—‡–‡† ‹ˆ‘”ƒ–‹‘ –‘ –Š‡ ‡š–‡– ‡…‡••ƒ”› –‘ Šƒ˜‡ …‘ϐ‹†‡…‡ –Šƒ– –Š‡ ’”‘…‡••‡• Šƒ˜‡„‡‡…ƒ””‹‡†‘—–ƒ•’Žƒ‡†Ǥ Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ…‘–”‘Ž’Žƒ‡†…Šƒ‰‡•ƒ†”‡˜‹‡™–Š‡…‘•‡“—‡…‡•‘ˆ—‹–‡†‡†…Šƒ‰‡•ǡ –ƒ‹‰ƒ…–‹‘–‘‹–‹‰ƒ–‡ƒ›ƒ†˜‡”•‡‡ˆˆ‡…–•ǡƒ•‡…‡••ƒ”›Ǥ Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ‡•—”‡–Šƒ–‘—–•‘—”…‡†’”‘…‡••‡•ƒ”‡…‘–”‘ŽŽ‡†Ǥ Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ†‡–‡”‹‡ǣ Ȅ ™Šƒ–‡‡†•–‘„‡‘‹–‘”‡†ƒ†‡ƒ•—”‡†Ǣ Ȅ –Š‡‡–Š‘†•ˆ‘”‘‹–‘”‹‰ǡ‡ƒ•—”‡‡–ǡƒƒŽ›•‹•ƒ†‡˜ƒŽ—ƒ–‹‘ǡƒ•ƒ’’Ž‹…ƒ„Ž‡ǡ–‘‡•—”‡˜ƒŽ‹† ”‡•—Ž–•Ǣ Ȅ ™Š‡–Š‡‘‹–‘”‹‰ƒ†‡ƒ•—”‹‰•ŠƒŽŽ„‡’‡”ˆ‘”‡†Ǣ Ȅ ™Š‡–Š‡”‡•—Ž–•ˆ”‘‘‹–‘”‹‰ƒ†‡ƒ•—”‡‡–•ŠƒŽŽ„‡ƒƒŽ›•‡†ƒ†‡˜ƒŽ—ƒ–‡†Ǥ Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ”‡–ƒ‹ƒ’’”‘’”‹ƒ–‡†‘…—‡–‡†‹ˆ‘”ƒ–‹‘ƒ•‡˜‹†‡…‡‘ˆ–Š‡”‡•—Ž–•Ǥ Š‡ ‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ ‡˜ƒŽ—ƒ–‡ –Š‡  ’‡”ˆ‘”ƒ…‡ ƒ† –Š‡ ‡ˆˆ‡…–‹˜‡‡•• ‘ˆ –Š‡  ƒƒ‰‡‡– •›•–‡Ǥ 9.2 Internal audit 9.2.1 Š‡ ‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ …‘†—…– ‹–‡”ƒŽ ƒ—†‹–• ƒ– ’Žƒ‡† ‹–‡”˜ƒŽ• –‘ ’”‘˜‹†‡ ‹ˆ‘”ƒ–‹‘ ‘ ™Š‡–Š‡”–Š‡ƒƒ‰‡‡–•›•–‡ǣ ƒȌ …‘ˆ‘”•–‘ǣ Ȅ –Š‡‘”‰ƒ‹œƒ–‹‘ǯ•‘™”‡“—‹”‡‡–•ˆ‘”‹–•ƒƒ‰‡‡–•›•–‡Ǣ Ȅ –Š‡ ”‡“—‹”‡‡–• ‘ˆ –Š‹• –‡”ƒ–‹‘ƒŽ –ƒ†ƒ”†Ȁ–Š‹• ’ƒ”– ‘ˆ  Ȁ–Š‹• ‡…Š‹…ƒŽ ’‡…‹ϐ‹…ƒ–‹‘Ǣ „Ȍ ‹•‡ˆˆ‡…–‹˜‡Ž›‹’Ž‡‡–‡†ƒ†ƒ‹–ƒ‹‡†Ǥ 9.2.2 Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽǣ ƒȌ ’Žƒǡ‡•–ƒ„Ž‹•Šǡ‹’Ž‡‡–ƒ†ƒ‹–ƒ‹ƒƒ—†‹–’”‘‰”ƒ‡ȋ•Ȍ‹…Ž—†‹‰–Š‡ˆ”‡“—‡…›ǡ‡–Š‘†•ǡ ”‡•’‘•‹„‹Ž‹–‹‡•ǡ ’Žƒ‹‰ ”‡“—‹”‡‡–• ƒ† ”‡’‘”–‹‰ǡ ™Š‹…Š •ŠƒŽŽ –ƒ‡ ‹–‘ …‘•‹†‡”ƒ–‹‘ –Š‡ ‹’‘”–ƒ…‡‘ˆ–Š‡’”‘…‡••‡•…‘…‡”‡†ƒ†–Š‡”‡•—Ž–•‘ˆ’”‡˜‹‘—•ƒ—†‹–•Ǣ „Ȍ †‡ϐ‹‡–Š‡ƒ—†‹–…”‹–‡”‹ƒƒ†•…‘’‡ˆ‘”‡ƒ…Šƒ—†‹–Ǣ …Ȍ •‡Ž‡…–ƒ—†‹–‘”•ƒ†…‘†—…–ƒ—†‹–•–‘‡•—”‡‘„Œ‡…–‹˜‹–›ƒ†–Š‡‹’ƒ”–‹ƒŽ‹–›‘ˆ–Š‡ƒ—†‹–’”‘…‡••Ǣ †Ȍ ‡•—”‡–Šƒ––Š‡”‡•—Ž–•‘ˆ–Š‡ƒ—†‹–•ƒ”‡”‡’‘”–‡†–‘”‡Ž‡˜ƒ–ƒƒ‰‡‡–Ǣ ‡Ȍ ”‡–ƒ‹†‘…—‡–‡†‹ˆ‘”ƒ–‹‘ƒ•‡˜‹†‡…‡‘ˆ–Š‡‹’Ž‡‡–ƒ–‹‘‘ˆ–Š‡ƒ—†‹–’”‘‰”ƒ‡ƒ†–Š‡ ƒ—†‹–”‡•—Ž–•Ǥ 9.3 Management review ‘’ ƒƒ‰‡‡– •ŠƒŽŽ ”‡˜‹‡™ –Š‡ ‘”‰ƒ‹œƒ–‹‘ǯ•  ƒƒ‰‡‡– •›•–‡ǡ ƒ– ’Žƒ‡† ‹–‡”˜ƒŽ•ǡ –‘ ‡•—”‡‹–•…‘–‹—‹‰•—‹–ƒ„‹Ž‹–›ǡƒ†‡“—ƒ…›ƒ†‡ˆˆ‡…–‹˜‡‡••Ǥ © ISO/IEC 2015 – All rights reserved 135 ISO/IEC Directives, Part 1, Consolidated ISO Supplement, 2015 Š‡ƒƒ‰‡‡–”‡˜‹‡™•ŠƒŽŽ‹…Ž—†‡…‘•‹†‡”ƒ–‹‘‘ˆǣ ƒȌ –Š‡•–ƒ–—•‘ˆƒ…–‹‘•ˆ”‘’”‡˜‹‘—•ƒƒ‰‡‡–”‡˜‹‡™•Ǣ „Ȍ …Šƒ‰‡•‹‡š–‡”ƒŽƒ†‹–‡”ƒŽ‹••—‡•–Šƒ–ƒ”‡”‡Ž‡˜ƒ––‘–Š‡ƒƒ‰‡‡–•›•–‡Ǣ …Ȍ ‹ˆ‘”ƒ–‹‘‘–Š‡’‡”ˆ‘”ƒ…‡ǡ‹…Ž—†‹‰–”‡†•‹ǣ — nonconformities and corrective actions; Ȅ ‘‹–‘”‹‰ƒ†‡ƒ•—”‡‡–”‡•—Ž–•Ǣ Ȅ ƒ—†‹–”‡•—Ž–•Ǣ †Ȍ ‘’’‘”–—‹–‹‡•ˆ‘”…‘–‹—ƒŽ‹’”‘˜‡‡–Ǥ Š‡ ‘—–’—–• ‘ˆ –Š‡ ƒƒ‰‡‡– ”‡˜‹‡™ •ŠƒŽŽ ‹…Ž—†‡ †‡…‹•‹‘• ”‡Žƒ–‡† –‘ …‘–‹—ƒŽ ‹’”‘˜‡‡– ‘’’‘”–—‹–‹‡•ƒ†ƒ›‡‡†ˆ‘”…Šƒ‰‡•–‘–Š‡ƒƒ‰‡‡–•›•–‡Ǥ Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ”‡–ƒ‹†‘…—‡–‡†‹ˆ‘”ƒ–‹‘ƒ•‡˜‹†‡…‡‘ˆ–Š‡”‡•—Ž–•‘ˆƒƒ‰‡‡–”‡˜‹‡™•Ǥ 10 Improvement 10.1 Nonconformity and corrective action Š‡ƒ‘…‘ˆ‘”‹–›‘……—”•ǡ–Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽǣ ƒȌ ”‡ƒ…––‘–Š‡‘…‘ˆ‘”‹–›ƒ†ǡƒ•ƒ’’Ž‹…ƒ„Ž‡ǣ Ȅ –ƒ‡ƒ…–‹‘–‘…‘–”‘Žƒ†…‘””‡…–‹–Ǣ Ȅ †‡ƒŽ™‹–Š–Š‡…‘•‡“—‡…‡•Ǣ „Ȍ ‡˜ƒŽ—ƒ–‡–Š‡‡‡†ˆ‘”ƒ…–‹‘–‘‡Ž‹‹ƒ–‡–Š‡…ƒ—•‡•‘ˆ–Š‡‘…‘ˆ‘”‹–›ǡ‹‘”†‡”–Šƒ–‹–†‘‡•‘– ”‡…—”‘”‘……—”‡Ž•‡™Š‡”‡ǡ„›ǣ Ȅ ”‡˜‹‡™‹‰–Š‡‘…‘ˆ‘”‹–›Ǣ Ȅ †‡–‡”‹‹‰–Š‡…ƒ—•‡•‘ˆ–Š‡‘…‘ˆ‘”‹–›Ǣ Ȅ †‡–‡”‹‹‰‹ˆ•‹‹Žƒ”‘…‘ˆ‘”‹–‹‡•‡š‹•–ǡ‘”…‘—Ž†’‘–‡–‹ƒŽŽ›‘……—”Ǣ …Ȍ ‹’Ž‡‡–ƒ›ƒ…–‹‘‡‡†‡†Ǣ †Ȍ ”‡˜‹‡™–Š‡‡ˆˆ‡…–‹˜‡‡••‘ˆƒ›…‘””‡…–‹˜‡ƒ…–‹‘–ƒ‡Ǣ ‡Ȍ ƒ‡…Šƒ‰‡•–‘–Š‡ƒƒ‰‡‡–•›•–‡ǡ‹ˆ‡…‡••ƒ”›Ǥ ‘””‡…–‹˜‡ƒ…–‹‘••ŠƒŽŽ„‡ƒ’’”‘’”‹ƒ–‡–‘–Š‡‡ˆˆ‡…–•‘ˆ–Š‡‘…‘ˆ‘”‹–‹‡•‡…‘—–‡”‡†Ǥ Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ”‡–ƒ‹†‘…—‡–‡†‹ˆ‘”ƒ–‹‘ƒ•‡˜‹†‡…‡‘ˆǣ Ȅ –Š‡ƒ–—”‡‘ˆ–Š‡‘…‘ˆ‘”‹–‹‡•ƒ†ƒ›•—„•‡“—‡–ƒ…–‹‘•–ƒ‡Ǣ Ȅ –Š‡”‡•—Ž–•‘ˆƒ›…‘””‡…–‹˜‡ƒ…–‹‘Ǥ 10.2 Continual improvement Š‡ ‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ …‘–‹—ƒŽŽ› ‹’”‘˜‡ –Š‡ •—‹–ƒ„‹Ž‹–›ǡ ƒ†‡“—ƒ…› ƒ† ‡ˆˆ‡…–‹˜‡‡•• ‘ˆ –Š‡  ƒƒ‰‡‡–•›•–‡Ǥ 136 © ISO/IEC 2015 – All rights reserved [...]... (preferred term) stakeholder (admitted term) person or organizationȋ͵ǤͳȌ–Šƒ–…ƒƒˆˆ‡…–ǡ„‡ƒˆˆ‡…–‡†„›ǡ‘”’‡”…‡‹˜‡‹–•‡Žˆ–‘„‡ƒˆˆ‡…–‡†„›ƒ†‡…‹•‹‘ ‘”ƒ…–‹˜‹–› © ISO/ IEC 2015 – All rights reserved 127 ISO/ IEC Directives, Part 1, Consolidated ISO Supplement, 2015 3.3 requirement ‡‡†‘”‡š’‡…–ƒ–‹‘–Šƒ–‹••–ƒ–‡†ǡ‰‡‡”ƒŽŽ›‹’Ž‹‡†‘”‘„Ž‹‰ƒ–‘”› ‘–‡ͳ–‘‡–”›ǣ Dz ‡‡”ƒŽŽ› ‹’Ž‹‡†dz ‡ƒ• –Šƒ– ‹–... ‘–‡Ͷ–‘‡–”›ǣ –Š‡…‘–‡š–‘ˆƒƒ‰‡‡–•›•–‡•ǡ‘„Œ‡…–‹˜‡•ƒ”‡•‡–„›–Š‡‘”‰ƒ‹œƒ–‹‘ǡ…‘•‹•–‡– ™‹–Š–Š‡’‘Ž‹…›ǡ–‘ƒ…Š‹‡˜‡•’‡…‹ϐ‹…”‡•—Ž–•Ǥ 128 © ISO/ IEC 2015 – All rights reserved ISO/ IEC Directives, Part 1, Consolidated ISO Supplement, 2015 3.9 risk ‡ˆˆ‡…–‘ˆ—…‡”–ƒ‹–› ‘–‡ͳ–‘‡–”›ǣ ‡ˆˆ‡…–‹•ƒ†‡˜‹ƒ–‹‘ˆ”‘–Š‡‡š’‡…–‡†Ȅ’‘•‹–‹˜‡‘”‡‰ƒ–‹˜‡Ǥ ‘–‡ʹ–‘‡–”›ǣ …‡”–ƒ‹–›‹•–Š‡•–ƒ–‡ǡ‡˜‡’ƒ”–‹ƒŽǡ‘ˆ†‡ϐ‹…‹‡…›‘ˆ‹ˆ‘”ƒ–‹‘”‡Žƒ–‡†–‘ǡ—†‡”•–ƒ†‹‰‘”... †‡–‡”‹‹‰–Š‡•–ƒ–—•‘ˆƒ•›•–‡ǡƒprocessȋ͵ǤͳʹȌ‘”ƒƒ…–‹˜‹–› ‘–‡ͳ–‘‡–”›ǣ ‘†‡–‡”‹‡–Š‡•–ƒ–—•ǡ–Š‡”‡ƒ›„‡ƒ‡‡†–‘…Š‡…ǡ•—’‡”˜‹•‡‘”…”‹–‹…ƒŽŽ›‘„•‡”˜‡Ǥ © ISO/ IEC 2015 – All rights reserved 129 ISO/ IEC Directives, Part 1, Consolidated ISO Supplement, 2015 3.16 measurement processȋ͵ǤͳʹȌ–‘†‡–‡”‹‡ƒ˜ƒŽ—‡ 3.17 audit •›•–‡ƒ–‹…ǡ‹†‡’‡†‡–ƒ††‘…—‡–‡†processȋ͵ǤͳʹȌˆ‘”‘„–ƒ‹‹‰ƒ—†‹–‡˜‹†‡…‡ƒ†‡˜ƒŽ—ƒ–‹‰‹–... Š‡†‡–‡”‹‹‰–Š‹••…‘’‡ǡ–Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ…‘•‹†‡”ǣ Ȅ –Š‡‡š–‡”ƒŽƒ†‹–‡”ƒŽ‹••—‡•”‡ˆ‡””‡†–‘‹ͶǤͳǢ Ȅ –Š‡”‡“—‹”‡‡–•”‡ˆ‡””‡†–‘‹ͶǤʹǤ 130 © ISO/ IEC 2015 – All rights reserved ISO/ IEC Directives, Part 1, Consolidated ISO Supplement, 2015 Š‡•…‘’‡•ŠƒŽŽ„‡ƒ˜ƒ‹Žƒ„Ž‡ƒ•†‘…—‡–‡†‹ˆ‘”ƒ–‹‘Ǥ 4.4 XXX management system Š‡ ‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ ‡•–ƒ„Ž‹•Šǡ ‹’Ž‡‡–ǡ ƒ‹–ƒ‹... ‹†‡–‹ϐ‹‡† •‡…–‹‘• ‘ˆ –Š‡ ‘”‰ƒ‹œƒ–‹‘ǡ ‘” ‘‡ ‘” ‘”‡ ˆ—…–‹‘•ƒ…”‘••ƒ‰”‘—’‘ˆ‘”‰ƒ‹œƒ–‹‘•Ǥ 3.5 top management ’‡”•‘‘”‰”‘—’‘ˆ’‡‘’Ž‡™Š‘†‹”‡…–•ƒ†…‘–”‘Ž•ƒorganization (3.1) at the highest level ‘–‡ͳ–‘‡–”›ǣ ‘’ ƒƒ‰‡‡– Šƒ• –Š‡ ’‘™‡” –‘ †‡Ž‡‰ƒ–‡ ƒ—–Š‘”‹–› ƒ† ’”‘˜‹†‡ ”‡•‘—”…‡• ™‹–Š‹ –Š‡ ‘”‰ƒ‹œƒ–‹‘Ǥ ‘–‡ʹ–‘‡–”›ǣ ˆ –Š‡ •…‘’‡ ‘ˆ –Š‡ management system ȋ͵ǤͶȌ