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2026-04-15 E.Enkh-Aldar MNS ISO 13485:2021 Medical Devices Quality Management System Requirements for Regulatory Purposes

MNS ISO 13485:2021 Medical Devices Quality Management System Requirements for Regulatory Purposes

ISO 13485 / IAF MD 9:2023 Annex D Аудитын хугацаа/Аудит өдөр (IAF MD 9:2023 Хавсралт D)					ISO 13485 / IAF MD 9:2023 Annex D Аудитын хугацаа (IAF MD 9:2023 Хавсралт D)
Хамгийн бага ажилтны тоо	Өндөр эрсдэл	Дунд эрсдэл	Бага эрсдэл	Хязгаарлагдмал хамрах хүрээ	Хамгийн бага ажилтны тоо	Өндөр эрсдэл	Дунд эрсдэл	Бага эрсдэл	Хязгаарлагдмал хамрах хүрээ
1-5	3	2.5	2.5	2.5	4,200,000	4,200,000	3,500,000	3,500,000	3,500,000
6-10	3.5	3	3	3	4,900,000	4,900,000	4,200,000	4,200,000	4,200,000
11-15	4.5	3.5	3	3	6,300,000	6,300,000	4,900,000	4,200,000	4,200,000
16-25	5.5	4.5	3.5	3	7,700,000	7,700,000	6,300,000	4,900,000	4,200,000
26-45	7	5.5	4	3	9,800,000	9,800,000	7,700,000	5,600,000	4,200,000
46-65	8	6	4.5	3.5	11,200,000	11,200,000	8,400,000	6,300,000	4,900,000
66-85	9	7	5	3.5	12,600,000	12,600,000	9,800,000	7,000,000	4,900,000
86-125	11	8	5.5	4	15,400,000	15,400,000	11,200,000	7,700,000	5,600,000
126-175	12	9	6	4.5	16,800,000	16,800,000	12,600,000	8,400,000	6,300,000
176-275	13	10	7	5	18,200,000	18,200,000	14,000,000	9,800,000	7,000,000
276-425	15	11	8	5.5	21,000,000	21,000,000	15,400,000	11,200,000	7,700,000
426-625	16	12	9	6	22,400,000	22,400,000	16,800,000	12,600,000	8,400,000
626-875	17	13	10	6.5	23,800,000	23,800,000	18,200,000	14,000,000	9,100,000
876-1175	19	15	11	7	26,600,000	26,600,000	21,000,000	15,400,000	9,800,000
1176-1550	20	16	12	7.5	28,000,000	28,000,000	22,400,000	16,800,000	10,500,000
1551-2025	21	17	12	8	29,400,000	29,400,000	23,800,000	16,800,000	11,200,000