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Đây là bản tiêu chuẩn ISO 9001 phiên bản mới nhất, ban hành năm 2015. Bản song ngữ Anh Việt.Một số điểm chính của tài liệu này:Bản ISO 9001:2015 tuân theo cấu trúc cao cấp mới và bao gồm 10 mục chính:1. Phạm vi2. Tiêu chuẩn trích dẫn3. Thuật ngữ và định nghĩa4. Bối cảnh của tổ chức5. Sự lãnh đạo6. Hoạch định7. Nguồn lực hỗ trợ8. Vận hành9. Đánh giá thực hiện10. Cải tiếnTóm tắt những thay đổi căn bảnBản mới này được xây dựng với mục đích giúp tiêu chuẩn có thể được áp dụng dễ dàng hơn cho tất cả ngành công nghiệp dịch vụ khác nhau. Vì thế, khi đề cập về những giá trị mang đến cho khách hàng trong bộ tiêu chuẩn, thuật ngữ “Sản Phẩm” đã được thay thế bằng “Sản phẩm và Dịch Vụ”. Bối cảnh của tổ chức Cơ cấu khung mới và những điểm chính ban hành trong Phụ Lục SL, Phụ Lục 2 đã giới thiệu 2 điều khoản mới liên quan đến bối cảnh của tổ chức:4.1 Hiểu rõ tổ chức và Bối cảnh tổ chức4.2 Nắm bắt những nhu cầu và mong muốn của những bênquan tâmHai điều khoản mới này yêu cầu mọi tổ chức phải xác địnhnhững vấn đề và nhu cầu có thể tác động đến quá trình hoạchđịch xây dựng hệ thống quản lý chất lượng, những vấn đề nàycó thể sử dụng làm dữ liệu đầu vào cho công tác phát triển hệthống quản lý chất lượng. Một trong những phương pháp tiếpcận và quản lý doanh nghiệp hiệu quả mới nhất hiện nay lànắm bắt tất cả những nhu cầu của các bên liên quan...
TIÊU CHU N QU C T * INTERNATIONAL STANDARD ISO 9001:2015 Xu t b n l n Fifth edition H TH NG QU N LÝ CH T L NG − CÁC YÊU C U QUALITY MANAGEMENT SYSTEMS – REQUIREMENTS HÀ N I – 2015 ISO 9001 : 2015 © VNPI v1.2 ISO 9001 : 2015 M cl c L i gi i thi u 0.1 Khái quát 0.2 Các nguyên t c qu n lý ch t l ng 0.3 Ti p c n theo trình 0.4 Quan h v i tiêu chu n h th ng qu n lý khác 11 Ph m vi áp d ng 13 Tài li u vi n d n 13 Thu t ng đ nh ngh a 13 B i c nh c a t ch c 14 4.1 Hi u t ch c b i c nh c a t ch c 14 4.2 Hi u nhu c u mong đ i c a bên quan tâm 14 4.3 Xác đ nh ph m vi c a h th ng qu n lý ch t l ng 14 4.4 H th ng qu n lý ch t l ng trình c a h th ng 15 S lãnh đ o 16 5.1 S lãnh đ o cam k t 16 5.2 Chính sách ch t l ng 17 5.3 Vai trò, trách nhi m quy n h n t ch c 18 Ho ch đ nh 18 6.1 Hành đ ng gi i quy t r i ro c h i 18 6.2 M c tiêu ch t l ng ho ch đ nh đ đ t đ c m c tiêu 19 6.3 Ho ch đ nh s thay đ i 20 H tr 20 7.1 Ngu n l c 20 7.2 N ng l c 23 7.3 Nh n th c 23 7.4 Trao đ i thông tin 23 7.5 Thông tin đ c l p v n b n 23 i u hành 25 8.1 Ho ch đ nh ki m soát u hành 25 8.2 Yêu c u đ i v i s n ph m d ch v 26 8.3 Thi t k phát tri n s n ph m d ch v 27 8.4 Ki m soát s n ph m d ch v bên cung c p 30 8.5 S n xu t cung c p d ch v 32 8.6 Chuy n giao s n ph m d ch v 34 8.7 Ki m sốt đ u khơng phù h p 35 ánh giá k t qu ho t đ ng 35 9.1 Theo dõi, đo l ng, phân tích đánh giá 35 9.2 ánh giá n i b 37 9.3 Xem xét c a lãnh đ o 37 10 C i ti n 38 10.1 Khái quát 38 10.2 S không phù h p hành đ ng kh c ph c 39 10.3 C i ti n liên t c 40 Ph l c A 41 Ph l c B 49 Tài li u tham kh o 57 © VNPI v1.2 ISO 9001 : 2015 L i nói đ u Tiêu chu n ISO 9001:2015 T ch c Tiêu chu n hóa qu c t (ISO) ban hành ngày 15-9-2015 thay th ISO 9001:2008 B n d ch tiêu chu n ISO 9001:2015 Vi n N ng su t Vi t Nam th c hi n nh m cung c p thông tin tham kh o cho chuyên gia nh ng ng i quan tâm VI N N NG SU T VI T NAM Vietnam National Productivity Institute Nghiên c u ki n ngh sách v nâng cao n ng su t Cung c p d ch v t v n đào t o v c i ti n n ng su t ch t l Making tomorrow better than today Hà N i S Hoàng Qu c Vi t, C u Gi y, Hà N i Tel: 04.37561501 - Fax: 04.37561502 Website: www.vnpi.vn - Email: vnpi@vnpi.vn www.facebook.com/nangsuatvietnam C quan th c hi n ch ng trình, d Châu Á (APO) t i Vi t Nam N ng 12 Chi L ng, Toà nhà c Long (T ng 2) Qu n H i Châu, TP N ng Tel: 0511.3582925 - Fax: 0511.3582926 E-mail: vnpidn@vnpi.vn ng án c a T ch c N ng su t TP H Chí Minh 64-66 M c nh Chi, ph ng akao Qu n 1, TP H Chí Minh Tel: 08.39104561 - Fax: 08.39104170 E-mail: vnpihcm@vnpi.vn © VNPI v1.2 ISO 9001 : 2015 L i gi i thi u Introduction 0.1 Khái quát 0.1 General Ch p nh n áp d ng h th ng qu n lý ch t l m t quy t đ nh chi n l c c a m t t ch c đ c i ti n k t qu ho t đ ng t ng th cung c n n t ng v ng ch c cho sáng ki n phát tri v ng ng có th pm t nb n The adoption of a quality management system is a strategic decision for an organization that can help to improve its overall performance and provide a sound basis for sustainable development initiatives Nh ng l i ích ti m n ng đ t ch c tri n khai th c hi n m t h th ng qu n lý ch t l ng d a Tiêu chu n qu c t là: The potential benefits to an organization of implementing a quality management system based on this International Standard are: a) kh n ng đ cung c p s n ph m d ch v đáp ng yêu c u khách hàng yêu c u lu t đ nh ch đ nh thích h p; a) the ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements; b) t o u ki n cho c lòng c a khách hàng; hài b) facilitating opportunities to enhance customer satisfaction; c) gi i quy t r i ro c h i k t h p v i b i c nh m c tiêu c a t ch c; c) addressing risks and opportunities associated with its context and objectives; d) kh n ng đ ch ng minh s phù h p v i yêu c u h th ng qu n lý ch t l ng quy đ nh d) the ability to demonstrate conformity to specified quality management system requirements Tiêu chu n qu c t có th đ c s d ng b i bên bên bên t ch c This International Standard can be used by internal and external parties Tiêu chu n qu c t không nh m d n đ n nhu c uv : It is not the intent of this International Standard to imply the need for: h i nâng cao s s đ ng nh t c u trúc c a h th ng uniformity in the structure of different quality qu n lý ch t l ng khác nhau; management systems; s đ ng nh t c a h th ng tài li u theo c u trúc alignment of documentation to the clause u kho n c a Tiêu chu n qu c t này; structure of this International Standard; vi c s d ng thu t ng c th chu n qu c t t ch c c a Tiêu the use of the specific terminology of this International Standard within the organization Các yêu c u c a h th ng qu n lý ch t l ng đ c quy đ nh Tiêu chu n qu c t b sung cho yêu c u đ i v i s n ph m d ch v The quality management system requirements specified in this International Standard are complementary to requirements for products and services Tiêu chu n qu c t s d ng cách ti p c n trình, k t h p chu trình Plan- Do-Check-Act (PDCA) t d a r i ro This International Standard employs the process approach, which incorporates the Plan-Do-CheckAct (PDCA) cycle and risk-based thinking Cách ti p c n trình cho phép t ch c l p k ho ch trình t ng tác c a chúng The process approach enables an organization to plan its processes and their interactions Chu trình PDCA cho phép t ch c đ m b o r ng q trình c a t ch c có đ ngu n l c đ c qu n The PDCA cycle enables an organization to ensure that its processes are adequately resourced and © VNPI v1.2 ISO 9001 : 2015 lý đ y đ , c h i đ c i ti n đ th c hi n c xác đ nh managed, and that opportunities for improvement are determined and acted on T d a r i ro cho phép t ch c xác đ nh y u t có th làm cho trình c a t ch c h th ng qu n lý ch t l ng c a t ch c ch ch kh i k t qu d ki n, đ đ a bi n pháp ki m sốt phịng ng a nh m gi m thi u tác đ ng tiêu c c t n d ng t i đa c h i chúng xu t hi n (xem kho n A.4) Risk-based thinking enables an organization to determine the factors that could cause its processes and its quality management system to deviate from the planned results, to put in place preventive controls to minimize negative effects and to make maximum use of opportunities as they arise (see Clause A.4) Vi c đáp ng m t cách n đ nh yêu c u h ng đ n nhu c u mong đ i t ng lai đ t m t thách th c đ i v i t ch c m t môi tr ng ngày n ng đ ng ph c t p đ t đ c m c tiêu này, t ch c có th c n v n d ng hình th c c i ti n, bên c nh vi c kh c ph c c i ti n liên t c, ch ng h n nh thay đ i mang tính đ t phá, đ i m i tái c c u Consistently meeting requirements and addressing future needs and expectations poses a challenge for organizations in an increasingly dynamic and complex environment To achieve this objective, the organization might find it necessary to adopt various forms of improvement in addition to correction and continual improvement, such as breakthrough change, innovation and re-organization Trong Tiêu chu n qu c t đ c s d ng: này, m u câu sau In this International Standard, the following verbal forms are used: "ph i" ch m t yêu c u; “shall” indicates a requirement; "nên" ch m t khuy n ngh ; “should” indicates a recommendation; "nó th " ch m t s cho phép; “may” indicates a permission; "có th làm" ch m t kh n ng/m t n ng l c “can” indicates a possibility or a capability Thông tin đ c đánh d u "CHÚ THÍCH" h d n đ hi u ho c làm rõ yêu c u liên quan Information marked as “NOTE” is for guidance in understanding or clarifying the associated requirement 0.2 Các nguyên t c qu n lý ch t l ng ng 0.2 Quality management principles Tiêu chu n qu c t đ c d a nguyên t c qu n lý ch t l ng đ c mô t ISO 9000 Các mô t bao g m m t di n gi i c a m i nguyên t c, lý t i nguyên t c r t quan tr ng đ i v i t ch c, m t s ví d v l i ích g n li n v i nguyên t c ví d n hình c a hành đ ng đ nâng cao hi u l c th c hi n c a t ch c áp d ng nguyên t c This International Standard is based on the quality management principles described in ISO 9000 The descriptions include a statement of each principle, a rationale of why the principle is important for the organization, some examples of benefits associated with the principle and examples of typical actions to improve the organization’s performance when applying the principle Các nguyên t c qu n lý ch t l The quality management principles are: h customer focus; ng vào khách hàng; s lãnh đ o; s cam k t c a m i ng ti p c n theo trình; ng là: leadership; i; engagement of people; process approach; © VNPI v1.2 ISO 9001 : 2015 c i ti n; improvement; đ a quy t đ nh d a b ng ch ng; evidence-based decision making; qu n lý m i quan h relationship management 0.3 Ti p c n theo trình 0.3 Process approach 0.3.1 Khái quát 0.3.1 General Tiêu chu n qu c t khuy n khích vi c v n d ng cách ti p c n theo trình tri n khai, th c hi n c i ti n tính hi u l c c a h th ng qu n lý ch t l ng, nâng cao s hài lịng c a khách hàng thơng qua đáp ng yêu c u c a khách hàng Yêu c u c th đ c xem thi t y u cho vi c áp d ng cách ti p c n theo q trình đ c mơ t u 4.4 This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements Specific requirements considered essential to the adoption of a process approach are included in 4.4 Vi c hi u rõ qu n lý q trình có m i t ng tác v i nh m t h th ng góp ph n vào tính hi u l c hi u qu c a t ch c vi c đ t đ c k t qu mong đ i Cách ti p c n cho phép t ch c ki m soát m i quan h s ph thu c l n gi a trình h th ng, k t qu ho t đ ng t ng th c a t ch c có th đ c nâng cao Understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its intended results This approach enables the organization to control the interrelationships and interdependencies among the processes of the system, so that the overall performance of the organization can be enhanced Cách ti p c n theo trình bao g m vi c xác đ nh qu n lý m t cách có h th ng qúa trình, m i t ng tác c a chúng, đ đ t đ c k t qu d đ nh phù h p v i sách ch t l ng đ nh h ng chi n l c c a t ch c The process approach involves the systematic definition and management of processes, and their interactions, so as to achieve the intended results in accordance with the quality policy and strategic direction of the organization Qu n lý trình h th ng nh m t t ng th có th đ t đ c b ng cách s d ng chu trình PDCA (xem 0.3.2) v i t p trung t ng th vào t d a r i ro (xem 0.3.3) nh m t n d ng c h i ng n ng a k t qu không mong mu n Management of the processes and the system as a whole can be achieved using the PDCA cycle (see 0.3.2) with an overall focus on risk-based thinking (see 0.3.3) aimed at taking advantage of opportunities and preventing undesirable results Vi c áp d ng cách ti p c n theo trình h th ng qu n lý ch t l ng cho phép: The application of the process approach in a quality management system enables: a) hi u rõ nh t quán vi c đáp ng yêu c u; b) vi c xem xét trình v m t giá tr gia t ng; c) đ t đ c k t qu ho t đ ng c a trình m t cách hi u l c; d) c i ti n trình d a vi c đánh giá d li u thông tin a) understanding and consistency in meeting requirements; b) the consideration of processes in terms of added value; c) the achievement of effective process performance; d) improvement of processes based on evaluation of data and information © VNPI v1.2 ISO 9001 : 2015 Hình cho th y bi u đ c a m i trình cho th y s t ng tác c a y u t c a trình Vi c theo dõi đo l ng m ki m soát, m c n thi t đ ki m soát, c th đ i v i m i trình s khác tùy thu c vào r i ro liên quan Figure gives a schematic representation of any process and shows the interaction of its elements The monitoring and measuring check points, which are necessary for control, are specific to each process and will vary depending on the related risks đ ng TR C SAU Hình — S đ bi u di n y u t c a m t trình Figure — Schematic representation of the elements of a single process 0.3.2 Chu trình PDCA 0.3.2 Plan-Do-Check-Act cycle Chu trình PDCA có th áp d ng cho t t c trình cho t ng th H th ng qu n lý ch t l ng Hình minh h a i u kho n t đ n 10 có th nhóm theo chu trình PDCA The PDCA cycle can be applied to all processes and to the quality management system as a whole Figure illustrates how Clauses to 10 can be grouped in relation to the PDCA cycle Chu trình PDCA có th mô t ng n g n nh sau: The PDCA cycle can be briefly described as follows: © VNPI v1.2 ISO 9001 : 2015 Plan: thi t l p m c tiêu c a h th ng Plan: establish the objectives of the system and trình, ngu n l c c n đ t o k t qu phù h p v i yêu c u c a khách hàng sách c a t ch c; xác đ nh gi i quy t r i ro c h i; Do: th c hi n h ng m c ho ch đ nh; its processes, and the resources needed to deliver results in accordance with customers’ requirements and the organization’s policies, and identify and address risks and opportunities; Check: giám sát (khi có th ) đo l ng Do: implement what was planned; trình s n ph m, d ch v đ u Check: monitor and (where applicable) measure processes and the resulting products theo sách, m c tiêu yêu c u and services against policies, objectives, báo cáo k t qu ; requirements and planned activities, and report Act: th c hi n bi n pháp c i ti n k t qu the results; ho t đ ng c n thi t Act: take actions to improve performance, as necessary c a c a Hình – S đ c u trúc Tiêu chu n qu c t theo chu trình PDCA © VNPI v1.2 ISO 9001 : 2015 Figure - Representation of the structure of this International Standard in the PDCA cycle 0.3.3 T d a r i ro T d a r i ro (xem m c A.4) thi t y u đ đ t đ c tính hi u l c h th ng qu n lý ch t l ng Khái ni m t d a r i ro đ c ng m đ nh phiên b n tr c c a Tiêu chu n qu c t bao g m, ví d , th c hi n hành đ ng phịng ng a đ lo i b s khơng phù h p ti m n, phân tích b t k s không phù h p x y ra, hành đ ng đ ng n ng a s tái di n phù h p v i nh h ng c a s không phù h p 0.3.3 Risk-based thinking Risk-based thinking (see Clause A.4) is essential for achieving an effective quality management system The concept of risk-based thinking has been implicit in previous editions of this International Standard including, for example, carrying out preventive action to eliminate potential nonconformities, analysing any nonconformities that occur, and taking action to prevent recurrence that is appropriate for the effects of the nonconformity đáp ng yêu c u c a Tiêu chu n qu c t này, t ch c c n l p k ho ch th c hi n hành đ ng đ gi i quy t r i ro c h i Vi c gi i quy t c nh ng r i ro c h i s t o c s đ t ng tính hi u l c c a h th ng qu n lý ch t l ng, đ t đ c k t qu c i thi n ng n ng a tác đ ng tiêu c c To conform to the requirements of this International Standard, an organization needs to plan and implement actions to address risks and opportunities Addressing both risks and opportunities establishes a basis for increasing the effectiveness of the quality management system, achieving improved results and preventing negative effects C h i có th phát sinh nh k t qu c a m t tình hu ng thu n l i đ đ t k t qu mong mu n, ví d , Opportunities can arise as a result of a situation favourable to achieving an intended result, for 10 © VNPI v1.2 ISO 9001 : 2015 b) M t th a thu n v i m t công ty liên k t; c) Các trình đ c thuê đ n m t nhà cung c p bên ngồi Th ngu n bên ngồi ln có đ c tính c t y u c a m t d ch v , u s có nh t m t ho t đ ng c n đ c th c hi n t i giao di n gi a bên cung c p t ch c Các bi n pháp ki m soát đ c yêu c u v i s cung c p t bên ngồi có th khác nhi u tùy thu c vào b n ch t c a s n ph m d ch v T ch c ph i áp d ng ti p c n qu n lý r i ro đ xác đ nh hình th c m c đ c a ho t đ ng ki m soát t ng ng nhà cung c p bên s n ph m d ch v đ c cung c p t bên ngồi c th 44 © VNPI v1.2 ISO 9001 : 2015 Annex A (informative) Clarification of new structure, terminology and concepts A.1 Structure and terminology The clause structure (i.e clause sequence) and some of the terminology of this edition of this International Standard, in comparison with the previous edition (ISO 9001:2008), have been changed to improve alignment with other management systems standards There is no requirement in this International Standard for its structure and terminology to be applied to the documented information of an organization’s quality management system The structure of clauses is intended to provide a coherent presentation of requirements, rather than a model for documenting an organization’s policies, objectives and processes The structure and content of documented information related to a quality management system can often be more relevant to its users if it relates to both the processes operated by the organization and information maintained for other purposes There is no requirement for the terms used by an organization to be replaced by the terms used in this International Standard to specify quality management system requirements Organizations can choose to use terms which suit their operations (e.g using “records”, “documentation” or “protocols” rather than “documented information”; or “supplier”, “partner” or “vendor” rather than “external provider”) Ta ble A.1 shows the major differences in terminology between this edition of this International Standard and the previous edition Table A.1 — Major differences in terminology between ISO 9001:2008 and ISO 9001:2015 ISO 9001:2008 ISO 9001:2015 Products Products and services Exclusions Not used (See Clause A.5 for clarification of applicability) Management representative Not used (Similar responsibilities and authorities are assigned but no requirement for a single management representative) Documentation, quality manual, documented procedures, records Documented information Work environment Environment for the operation of processes Monitoring and measuring equipment Monitoring and measuring resources Purchased product Externally provided products and services Supplier External provider A.2 Products and services ISO 9001:2008 used the term “product” to include all output categories This edition of this International Standard uses “products and services” “Products and services” include all output categories (hardware, services, software and processed materials) The specific inclusion of “services” is intended to highlight the differences between products and services in the application of some requirements The characteristic of services is that at least part of the output is realized © VNPI v1.2 45 ISO 9001 : 2015 at the interface with the customer This means, for example, that conformity to requirements cannot necessarily be confirmed before service delivery In most cases, products and services are used together Most outputs that organizations provide to customers, or are supplied to them by external providers, include both products and services For example, a tangible or intangible product can have some associated service or a service can have some associated tangible or intangible product A.3 Understanding the needs and expectations of interested parties Subclause 4.2 specifies requirements for the organization to determine the interested parties that are relevant to the quality management system and the requirements of those interested parties However, 4.2 does not imply extension of quality management system requirements beyond the scope of this International Standard As stated in the scope, this International Standard is applicable where an organization needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and aims to enhance customer satisfaction There is no requirement in this International Standard for the organization to consider interested parties where it has decided that those parties are not relevant to its quality management system It is for the organization to decide if a particular requirement of a relevant interested party is relevant to its quality management system A.4 Risk-based thinking The concept of risk-based thinking has been implicit in previous editions of this International Standard, e.g through requirements for planning, review and improvement This International Standard specifies requirements for the organization to understand its context (see 4.1) and determine risks as a basis for planning (see 6.1) This represents the application of risk-based thinking to planning and implementing quality management system processes (see 4.4) and will assist in determining the extent of documented information One of the key purposes of a quality management system is to act as a preventive tool Consequently, this International Standard does not have a separate clause or subclause on preventive action The concept of preventive action is expressed through the use of risk-based thinking in formulating quality management system requirements The risk-based thinking applied in this International Standard has enabled some reduction in prescriptive requirements and their replacement by performance-based requirements There is greater flexibility than in ISO 9001:2008 in the requirements for processes, documented information and organizational responsibilities Although 6.1 specifies that the organization shall plan actions to address risks, there is no requirement for formal methods for risk management or a documented risk management process Organizations can decide whether or not to develop a more extensive risk management methodology than is required by this International Standard, e.g through the application of other guidance or standards Not all the processes of a quality management system represent the same level of risk in terms of the organization’s ability to meet its objectives, and the effects of uncertainty are not the same for all organizations Under the requirements of 6.1, the organization is responsible for its application of risk- based thinking and the actions it takes to address risk, including whether or not to retain documented information as evidence of its determination of risks A.5 Applicability This International Standard does not refer to “exclusions” in relation to the applicability of its requirements to the organization’s quality management system However, an organization can review the applicability of 46 © VNPI v1.2 ISO 9001 : 2015 requirements due to the size or complexity of the organization, the management model it adopts, the range of the organization’s activities and the nature of the risks and opportunities it encounters The requirements for applicability are addressed in 4.3, which defines conditions under which an organization can decide that a requirement cannot be applied to any of the processes within the scope of its quality management system The organization can only decide that a requirement is not applicable if its decision will not result in failure to achieve conformity of products and services A.6 Documented information As part of the alignment with other management system standards, a common clause on “documented information” has been adopted without significant change or addition (see 7.5) Where appropriate, text elsewhere in this International Standard has been aligned with its requirements Consequently, “documented information” is used for all document requirements Where ISO 9001:2008 used specific terminology such as “document” or “documented procedures”, “quality manual” or “quality plan”, this edition of this International Standard defines requirements to “maintain documented information” Where ISO 9001:2008 used the term “records” to denote documents needed to provide evidence of conformity with requirements, this is now expressed as a requirement to “retain documented information” The organization is responsible for determining what documented information needs to be retained, the period of time for which it is to be retained and the media to be used for its retention A requirement to “maintain” documented information does not exclude the possibility that the organization might also need to “retain” that same documented information for a particular purpose, e.g to retain previous versions of it Where this International Standard refers to “information” rather than “documented information” (e.g in 4.1: “The organization shall monitor and review the information about these external and internal issues”), there is no requirement that this information is to be documented In such situations, the organization can decide whether or not it is necessary or appropriate to maintain documented information A.7 Organizational knowledge In 7.1.6, this International Standard addresses the need to determine and manage the knowledge maintained by the organization, to ensure the operation of its processes and that it can achieve conformity of products and services Requirements regarding organizational knowledge were introduced for the purpose of: a) safeguarding the organization from loss of knowledge, e.g through staff turnover; failure to capture and share information; b) encouraging the organization to acquire knowledge, e.g learning from experience; mentoring; benchmarking A.8 Control of externally provided processes, products and services All forms of externally provided processes, products and services are addressed in 8.4, e.g whether © VNPI v1.2 47 ISO 9001 : 2015 through: a) purchasing from a supplier; b) an arrangement with an associate company; c) outsourcing processes to an external provider Outsourcing always has the essential characteristic of a service, since it will have at least one activity necessarily performed at the interface between the provider and the organization The controls required for external provision can vary widely depending on the nature of the processes, products and services The organization can apply risk-based thinking to determine the type and extent of controls appropriate to particular external providers and externally provided processes, products and services 48 © VNPI v1.2 ISO 9001 : 2015 Ph l c B (Tham kh o) Các tiêu chu n qu c t khác v qu n lý ch t l ng H th ng qu n lý ch t l ng phát tri n b i ISO/TC 176 Các tiêu chu n qu c t đ c mô t ph l c đ c phát tri n b i ISO/TC 176 nh m cung c p thông tin h tr cho t ch c áp d ng Tiêu chu n qu c t này, cung c p ch d n cho t ch c l a ch n ti n t i xa h n yêu c u c a Tiêu chu n Ch d n ho c yêu c u bao g m tài li u li t kê ph l c không b sung, ho c u ch nh, yêu c u c a Tiêu chu n qu c t B ng B.1 th hi n m i liên h gi a tiêu chu n v i nh ng u kho n liên quan c a Tiêu chu n Ph l c không bao g m vi c tham chi u đ n tiêu chu n h th ng qu n lý ch t l v c c th đ c phát tri n b i ISO/TC 176 Tiêu chu n qu c t m t ba tiêu chu n đ ng cho l nh c phát tri n b i ISO/TC 176 ISO 9000 H th ng qu n lý ch t l ng – C s t v ng cung c p n n t ng c t y u cho s th u hi u th c hi n m t cách thích h p v i tiêu chu n qu c t Các nguyên t c qu n lý ch t l ng đ c mô t chi ti t ISO 9000 đ c xem xét đ n phát tri n Tiêu chu n qu c t Các nguyên t c không ph i nh ng yêu c u, nh ng t o thành n n t ng c a yêu c u đ c đ a Tiêu chu n ISO 9000 c ng đ nh rõ thu t ng , đ nh ngh a khái ni m đ c s d ng Tiêu chu n qu c t ISO 9001 (Tiêu chu n qu c t này) đ nh rõ yêu c u h ng ch y u đ n cung c p ni m tin vào s n ph m d ch v cung c p b i t ch c nâng cao th a mãn khách hàng Vi c th c hi n thích h p c ng mong mu n mang đ n l i ích khác cho t ch c, nh c i ti n trao đ i thông tin n i b , s th u hi u ki m soát t t h n trình c a t ch c ISO 9004 Qu n lý cho s thành công b n v ng c a m t t ch c – Ti p c n qu n lý ch t l ng cung c p ch d n cho nh ng t ch c mu n ti n t i xa h n yêu c u c a tiêu chu n qu c t đ gi i quy t ch đ ph m vi r ng h n mà có th d n đ n c i ti n hi u qu ho t đ ng t ng th c a t ch c ISO 9004 bao g m ch d n v ph ng pháp t đánh giá đ m t t ch c có th đánh giá m c đ phát tri n c a H th ng qu n lý ch t l ng c a Các tiêu chu n qu c t đ c tóm t t d i có th cung c p s h tr cho t ch c xác l p ho c tìm ki m s c i ti n v h th ng qu n lý ch t l ng, trình ho t đ ng c a ISO 10001 Qu n lý ch t l ng – S th a mãn khách hàng – S th a mãn c a khách hàng – H ng d n v quy ph m đ o đ c đ i v i t ch c cung c p ch d n đ m t t ch c xác đ nh xem s cung c p cho th a mãn khách hàng đáp ng nhu c u mong đ i c a khách hàng Vi c s d ng tiêu chu n có th nâng cao ni m tin c a khách hàng vào m t t ch c c i ti n s th u hi u c a khách hàng v nh ng u có th đ i t t ch c, v y, gi m thi u kh n ng c a s hi u nh m u n i ISO 10002 Qu n lý ch t l ng – S th a mãn c a khách hàng – H ng d n v gi i quy t u n i trong t ch c cung c p ch d n v trình x lý u n i thông qua nh n gi i quy t nhu c u mong đ i c a i n i x lý m i u n i nh n đ c Tiêu chu n cung c p m t trình u n i m , hi u qu d s d ng, bao g m vi c đào t o nhân s Tiêu chu n c ng cung c p ch d n cho doanh nghi p nh © VNPI v1.2 49 ISO 9001 : 2015 ISO 10003 Qu n lý ch t l ng – S th a mãn c a khách hàng – H ng d n gi i quy t tranh ch p bên t ch c cung c p ch d n cho vi c gi i quy t m t cách hi u qu hi u l c tranh ch p bên đ i v i u n i liên quan đ n s n ph m Gi i quy t tranh ch p cung c p m t cách th c đ n bù t ch c không kh c ph c đ c m t u n i n i b Ph n l n u n i đ c x lý thành công t ch c, không c n đ n th t c đ i kháng ISO 10004 Qu n lý ch t l ng – S th a mãn c a khách hàng – H ng d n theo dõi đo l ng cung c p ch d n cho hành đ ngnâng cao th a mãn c a khách hàng nh n di n c h i cho vi c c i ti n s n ph m, trình đ c tính có giá tr v i khách hàng Các hành đ ng nh v y có th c s trung thành c a khách hàng giúp gi khách hàng ISO 10005 H th ng qu n lý ch t l ng – H ng d n k ho ch ch t l ng cung c p ch d n v thi t l p s d ng k ho ch ch t l ng nh m t công c g n k t yêu c u c a trình, s n ph m, d án ho c h p đ ng v i ph ng th c th c hi n côn vi c th c hành h tr trình t o s n ph m Các l i ích c a thi t l p k ho ch ch t l ng nâng cao ni m tin r ng yêu c u s đ c đáp ng, trình đ c ki m soát đ ng l c mà u có th t o cho nh ng ng i liên quan ISO 10006 H th ng qu n lý ch t l ng – H ng d n qu n lý ch t l ng d án t nh đ n l n, t đ n gi n đ n ph c t p, t d án riêng l đ n m t ph n c Các ch d n đ c s d ng b i nhân s qu n lý d án nh ng n i c n đ áp d ng th c hành bao g m danh m c tiêu chu n v h ISO 10007 H th ng qu n lý ch t l ng – H ng d n qu n lý c u hình h tr t ch c áp d ng qu n lý c u hình cho đ i v i đ nh h ng k thu t hành chu trình s ng c a s n ph m Qu n lý c u hình có th đ c s d ng đ đáp ng yêu c u v nh n bi t truy v t s n ph m quy đ nh b i Tiêu chu n qu c t ISO 10008 Qu n lý ch t l ng – S th a mãn c a khách hàng – H m i n t gi a doanh nghi p v i ng i tiêu dùng cung c p ch d th c hi n m t h th ng giao d ch n t gi a doanh nghi p v i ng hi u l c hi u qu , th cung c p c s cho khách hàng có đ nâng cao kh n ng c a t ch c th a mãn khách hàng giúp gi m thi ISO 10012 H th ng qu n lý đo l ng – Các yêu c u đ i v i trình đo l ng thi t b đo l ng cung c p ch d n cho vi c qu n lý trình đo l ng vi c xác nh n v m t đo l ng v i thi t b đo đ c s d ng đ xác nh n ch ng t s tuân th v i yêu c u v đo l ng Tiêu chu n quy đ nh yêu c u qu n lý ch t l ng c a m t h th ng qu n lý đo l ng nh m đ m b o yêu c u v đo l ng đ c đáp ng ISO/TR 10013 H ng d n v tài li u c a h th ng qu n lý ch t l ng cung c p ch d n v vi c phát tri n trì tài li u c n thi t cho m t h th ng qu n lý ch t l ng Tiêu chu n có th đ c s d ng đ v n b n hóa h th ng qu n lý nh ng h th ng danh m c tiêu chu n h th ng qu n lý c a ISO, VD: h th ng qu n lý môi tr ng h th ng qu n lý an toàn ISO 10014 Qu n lý ch t l ng – H ng d n v hi n th c hóa l i ích kinh t tài đ c dành cho lãnh đ o c p cao Tiêu chu n cung các h ng d n cho hi n th c hóa l i ích v kinh t tìa thông qua vi c áp d ng nguyên t c qu n lý ch t l ng Tiêu chu n thúc đ y vi c áp d ng nguyên t c qu n lý l a ch n ph ng pháp công c cho phép s thành công b n v ng c a t ch c ISO 10015 Qu n lý ch t l 50 ng – H án áp d ng v i d a danh m c d án m b o r ng t ch c c a th ng qu n lý c a ISO ng d n cho giao d ch th ng n v cách th c mà t ch c có th i tiêu (B2C ETC) dùng m t cách c s tin t ng h n v i B2C ECT, u u n i tranh ch p ng d n v đào t o cung c p h ng d n h tr t ch c gi i © VNPI v1.2 ISO 9001 : 2015 quy t v n đ liên quan đ n đào t o Tiêu chu n có th đ c áp d ng b t k s ch d n đ c yêu c u đ di n gi i s tham chi u đ n “giáo d c” “đào t o” dan m c tiêu chu n v h th ng qu n lý c a ISO B t k s tham chi u đ n “đào t o” đ u bao g m m i hình th c giáo d c đào t o ISO/TR 10017 Ch d n v công c th ng kê cho ISO 9001:2000 gi i thích công c th ng kê phát sinh b i s bi n thiên có th quan sát đ c di n bi n c a trình đ u ra, th m chí u ki n t ng nh n đ nh Các công c th ng kê cho phép s d ng m t cách t t h n d li u nh m h tr trình quy t đ nh, v y giúp c i ti n liên t c ch t l ng c a s n ph m, trình nh m đ t đ c s th a mãn c a khách hàng ISO 10018 Qu n lý ch t l ng – H ng d n v s tham gia c a m i ng i n ng l c cung c p h ng đ tác đ ng đ n s tham gia c a m i ng i n ng l c M t h th ng qu n lý ch t l ng ph thu c vào s tham gia c a nh ng ng i có n ng l c cách th c mà h đ c đ a vào tích h p t ch c i u tr ng y u ph i xác đ nh, phát tri n đánh giá tri th c, k n ng, hành vi môi tr ng làm vi c đ c yêu c u ISO 10019 H ng d n cho vi c l a ch n t v n h th ng qu n lý ch t l ng s d ng d ch v t v n cung c p ch d n cho vi c l a ch n t v n h th ng qu n lý ch t l ng s d ng d ch v c a h Tiêu chu n cung c p ch d n v trình đánh giá n ng l c c a m t t ch c t v n h th ng qu n lý cung c p s tin t ng r ng nhu c u mong đ i c a t ch c đ i v i d ch v t v n đ c đáp ng ISO 19011 H ng d n đánh giá h th ng qu n lý cung c p ch d n v qu n lý ch ng trình đánh giá, ho ch đ nh th c hi n m t cu c đánh giá h th ng qu n lý, c ng nh n ng l c đánh giá chuyên gia đánh giá đoàn đánh giá Tiêu chu n d ki n áp d ng v i đánh giá viên, t ch c áp d ng h th ng qu n lý, t ch c c n th c hi n đánh giá h th ng qu n lý © VNPI v1.2 51 ISO 9001 : 2015 B ng B.1 M i quan h gi a tiêu chu n qu c t v qu n lý ch t l ng h th ng qu n lý ch t l ng v i u kho n c a Tiêu chu n qu c t Đi u kho n tiêu chu n qu c t Tiêu chu n qu c t khác 10 ISO 9000 T tc T tc T tc T tc T tc T tc T tc ISO 9004 T tc T tc T tc T tc T tc T tc T tc ISO 10001 8.2.2, 8.5.1 9.1.2 ISO 10002 8.2.1, 9.1.2 ISO 10003 9.1.2 ISO 10004 9.1.2, 9.1.3 ISO 10005 ISO 10006 T tc 5.3 6.1, 6.2 T tc T tc 9.1 10.2 T tc T tc T tc T tc T tc T tc T tc T tc T tc T tc T tc T tc ISO 10007 ISO 10008 8.5.2 T tc T tc T tc T tc ISO 10012 7.1.5 ISO/TR 10013 7.5 ISO 10014 T tc T tc T tc ISO 10015 ISO 10019 T tc 7.2 ISO/TR 10017 ISO 10018 T tc T tc 6.1 7.1.5 T tc T tc 9.1 T tc T tc T tc 8.4 ISO 19011 CHÚ THÍCH T t c th hi n r ng t t c u kho n ph u kho n đ liên quan đ n Tiêu chu n qu c t khác 52 10.2.1 9.2 c đ c p c a Tiêu chu n qu c t đ u © VNPI v1.2 ISO 9001 : 2015 Annex B (informative) Other International Standards on quality management and quality management systems developed by ISO/TC 176 The International Standards described in this annex have been developed by ISO/TC 176 to provide supporting information for organizations that apply this International Standard, and to provide guidance for organizations that choose to progress beyond its requirements Guidance or requirements contained in the documents listed in this annex not add to, or modify, the requirements of this International Standard Table B.1 shows the relationship between these standards and the relevant clauses of this International Standard This annex does not include reference to the sector-specific quality management system standards developed by ISO/TC 176 This International Standard is one of the three core standards developed by ISO/TC 176 ISO 9000 Quality management systems — Fundamentals and vocabulary provides an essential background for the proper understanding and implementation of this International Standard The quality management principles are described in detail in ISO 9000 and have been taken into consideration during the development of this International Standard These principles are not requirements in themselves, but they form the foundation of the requirements specified by this International Standard ISO 9000 also defines the terms, definitions and concepts used in this International Standard ISO 9001 (this International Standard) specifies requirements aimed primarily at giving confidence in the products and services provided by an organization and thereby enhancing customer satisfaction Its proper implementation can also be expected to bring other organizational benefits, such as improved internal communication, better understanding and control of the organization’s processes ISO 9004 Managing for the sustained success of an organization — A quality management approach provides guidance for organizations that choose to progress beyond the requirements of this International Standard, to address a broader range of topics that can lead to improvement of the organization’s overall performance ISO 9004 includes guidance on a self-assessment methodology for an organization to be able to evaluate the level of maturity of its quality management system The International Standards outlined below can provide assistance to organizations when they are establishing or seeking to improve their quality management systems, their processes or their activities ISO 10001 Quality management — Customer satisfaction — Guidelines for codes of conduct for organizations provides guidance to an organization in determining that its customer satisfaction provisions meet customer needs and expectations Its use can enhance customer confidence in an organization and improve customer understanding of what to expect from an organization, thereby reducing the likelihood of misunderstandings and complaints ISO 10002 Quality management — Customer satisfaction — Guidelines for complaints handling in organizations provides guidance on the process of handling complaints by recognizing and addressing the needs and expectations of complainants and resolving any complaints received ISO 10002 provides an © VNPI v1.2 53 ISO 9001 : 2015 open, effective and easy-to-use complaints process, including training of people It also provides guidance for small businesses ISO 10003 Quality management — Customer satisfaction — Guidelines for dispute resolution external to organizations provides guidance for effective and efficient external dispute resolutionfor product-related complaints Dispute resolution gives an avenue of redress when organizations not remedy a complaint internally Most complaints can be resolved successfully within the organization, without adversarial procedures ISO 10004 Quality management — Customer satisfaction — Guidelines for monitoring and measuring provides guidelines for actions to enhance customer satisfaction and to determine opportunities for improvement of products, processes and attributes that are valued by customers Such actions can strengthen customer loyalty and help retain customers ISO 10005 Quality management systems — Guidelines for quality plans provides guidance on establishing and using quality plans as a means of relating requirements of the process, product, project or contract, to work methods and practices that support product realization Benefits of establishing a quality plan are increased confidence that requirements will be met, that processes are in control and the motivation that this can give to those involved ISO 10006 Quality management systems — Guidelines for quality management in projects is applicable to projects from the small to large, from simple to complex, from an individual project to being part of a portfolio of projects ISO 10006 is to be used by personnel managing projects and who need to ensure that their organization is applying the practices contained in the ISO quality management system standards ISO 10007 Quality management systems — Guidelines for configuration management is to assist organizations applying configuration management for the technical and administrative direction over the life cycle of a product Configuration management can be used to meet the product identification and traceability requirements specified in this International Standard ISO 10008 Quality management — Customer satisfaction — Guidelines for business-to-consumer electronic commerce transactions gives guidance on how organizations can implement an effective and efficient business-to-consumer electronic commerce transaction (B2C ECT) system, and thereby provide a basis for consumers to have increased confidence in B2C ECTs, enhance the ability of organizations to satisfy consumers and help reduce complaints and disputes ISO 10012 Measurement management systems — Requirements for measurement processes and measuring equipment provides guidance for the management of measurement processes and metrological confirmation of measuring equipment used to support and demonstrate compliance with metrological requirements ISO 10012 provides quality management criteria for a measurement management system to ensure metrological requirements are met ISO/TR 10013 Guidelines for quality management system documentation provides guidelines for the development and maintenance of the documentation necessary for a quality management system ISO/TR 10013 can be used to document management systems other than those of the ISO quality management system standards, e.g environmental management systems and safety management systems ISO 10014 Quality management — Guidelines for realizing financial and economic benefits is addressed to top management It provides guidelines for realizing financial and economic benefits through the 54 © VNPI v1.2 ISO 9001 : 2015 application of quality management principles It facilitates application of management principles and selection of methods and tools that enable the sustainable success of an organization ISO 10015 Quality management — Guidelines for training provides guidelines to assist organizations in addressing issues related to training ISO 10015 can be applied whenever guidance is required to interpret references to “education” and “training” within the ISO quality management system standards Any reference to “training” includes all types of education and training ISO/TR 10017 Guidance on statistical techniques for ISO 9001:2000 explains statistical techniques which follow from the variability that can be observed in the behaviour and results of processes, even under conditions of apparent stability Statistical techniques allow better use of available data to assist in decision making, and thereby help to continually improve the quality of products and processes to achieve customer satisfaction ISO 10018 Quality management — Guidelines on people involvement and competence provides guidelines which influence people involvement and competence A quality management system depends on the involvement of competent people and the way that they are introduced and integrated into the organization It is critical to determine, develop and evaluate the knowledge, skills, behaviour and work environment required ISO 10019 Guidelines for the selection of quality management system consultants and use of their services provides guidance for the selection of quality management system consultants and the use of their services It gives guidance on the process for evaluating the competence of a quality management system consultant and provides confidence that the organization’s needs and expectations for the consultant’s services will be met ISO 19011 Guidelines for auditing management systems provides guidance on the management of an audit programme, on the planning and conducting of an audit of a management system, as well as on the competence and evaluation of an auditor and an audit team ISO 19011 is intended to apply to auditors, organizations implementing management systems, and organizations needing to conduct audits of management systems © VNPI v1.2 55 ISO 9001 : 2015 Table B.1 Relationship between other International Standards on quality management and quality management systems and the clauses of this International Standard Other International Standard Clause in this International Standard 10 ISO 9000 All All All All All All All ISO 9004 All All All All All All All ISO 10001 8.2.2, 8.5.1 9.1.2 ISO 10002 8.2.1, 9.1.2 ISO 10003 9.1.2 ISO 10004 9.1.2, 9.1.3 ISO 10005 ISO 10006 All 5.3 6.1, 6.2 All All 9.1 10.2 All All All All All All All All All All All All ISO 10007 ISO 10008 8.5.2 All All All All ISO 10012 7.1.5 ISO/TR 10013 7.5 ISO 10014 All All All ISO 10015 ISO 10019 ISO 19011 All 7.2 ISO/TR 10017 ISO 10018 10.2.1 All All 6.1 7.1.5 All All 9.1 All All All 8.4 9.2 NOTE All indicates that all the subclauses in the specific clause of this International Standard are related to the other International Standard 56 © VNPI v1.2 Tài li u tham kh o [1] ISO 9004, Qu n lý cho s thành công b n v ng c a m t t ch c – Ti p c n qu n lý ch t l [2] ISO 10001, Qu n lý ch t l ng – S th a mãn khách hàng – S d n v quy ph m đ o đ c đ i v i t ch c [3] ISO 10002, Qu n lý ch t l trong t ch c [4] ISO 10003, Qu n lý ch t l t ch c ng – S th a mãn c a khách hàng – H ng d n gi i quy t tranh ch p bên [5] ISO 10004, Qu n lý ch t l ng – S th a mãn c a khách hàng – H ng d n theo dõi đo l [6] ISO 10005, H th ng qu n lý ch t l ng – H ng d n k ho ch ch t l [7] ISO 10006, H th ng qu n lý ch t l ng – H ng d n qu n lý ch t l [8] ISO 10007, H th ng qu n lý ch t l ng – H ng d n qu n lý c u hình [9] ISO 10008, Qu n lý ch t l ng – S th a mãn c a khách hàng – H m i n t gi a doanh nghi p v i ng i tiêu dùng ng – S [10] ISO 10012, H th ng qu n lý đo l [11] ISO/TR 10013, H th a mãn c a khách hàng – H th a mãn c a khách hàng – H ng ng d n v gi i quy t u n i ng, ng ng d án ng d n cho giao d ch th ng – Các yêu c u đ i v i trình đo l ng d n v tài li u c a h th ng qu n lý ch t l ng ng thi t b đo l ng ng, ng [12] ISO 10014, Qu n lý ch t l ng – H ng d n v hi n th c hóa l i ích kinh t tài chính, [13] ISO 10015, Qu n lý ch t l ng – H ng d n v đào t o [14] ISO/TR 10017, Ch d n v công c th ng kê cho ISO 9001:2000 [15] ISO 10018, Qu n lý ch t l [16] ISO 10019, H v n ng – H ng d n cho vi c l a ch n t v n h th ng qu n lý ch t l [17] ISO 14001, H th ng qu n lý môi tr [18] ISO 19011, H ng d n v s tham gia c a m i ng ng – Các yêu c u h ng s d ng d ch v t ng d n s d ng ng d n đánh giá h th ng qu n lý [19] ISO 31000, Qu n lý r i ro – Nguyên t c h [20] ISO 37500, H i n ng l c ng d n ng d n v thuê [21] ISO/IEC 90003, K thu t ph n m m – H ng d n áp d ng ISO 9001:2008 ph n m m máy tính [22] ISO/IEC 60300-1, Qu n lý đ tin c y – Ph n 1: H ng d n qu n lý áp d ng [23] IEC 61160, Xem xét thi t k , [24] Các nguyên t c qu n lý ch t l ng, ISO [25] S a ch n s d ng b tiêu chu n ISO 9000, ISO [26] ISO 9001 cho doanh nghi p nh - Vi c c n làm [27] Tích h p tiêu chu n h th ng qu n lý, ISO [28] www.iso.org/tc176/sc02/public [29] www.iso.org/tc176/iso9001 Auditing Practices Group Bibliography [1] ISO 9004, Managing for the sustained success of an organization — A quality management approach [2] ISO 10001, Quality management — Customer satisfaction — Guidelines for codes of conduct for organizations [3] ISO 10002, Quality management — Customer satisfaction — Guidelines for complaints handling in organizations [4] ISO 10003, Quality management — Customer satisfaction — Guidelines for dispute resolution external to organizations [5] ISO 10004, Quality management — Customer satisfaction — Guidelines for monitoring and measuring [6] ISO 10005, Quality management systems — Guidelines for quality plans [7] ISO 10006, Quality management systems — Guidelines for quality management in projects [8] ISO 10007, Quality management systems — Guidelines for configuration management [9] ISO 10008, Quality management — Customer satisfaction — Guidelines for business-to-consumer electronic commerce transactions [10] ISO 10012, Measurement management systems — Requirements for measurement processes and measuring equipment [11] ISO/TR 10013, Guidelines for quality management system documentation [12] ISO 10014, Quality management — Guidelines for realizing financial and economic benefits [13] ISO 10015, Quality management — Guidelines for training [14] ISO/TR 10017, Guidance on statistical techniques for ISO 9001:2000 [15] ISO 10018, Quality management — Guidelines on people involvement and competence [16] ISO 10019, Guidelines for the selection of quality management system consultants and use of their services [17] ISO 14001, Environmental management systems — Requirements with guidance for use [18] ISO 19011, Guidelines for auditing management systems [19] ISO 31000, Risk management — Principles and guidelines [20] ISO 37500, Guidance on outsourcing [21] ISO/IEC 90003, Software engineering — Guidelines for the application of ISO 9001:2008 to computer software [22] IEC 60300-1, Dependability management — Part 1: Guidance for management and application [23] IEC 61160, Design review [24] Quality management principles, ISO) [25] Selection and use of the ISO 9000 family of standards, ISO [26] ISO 9001 for Small Businesses — What to do, ISO [27] Integrated use of management system standards, ISO [28] www.iso.org/tc176/sc02/public [29] www.iso.org/tc176/ISO9001AuditingPracticesGroup 58 © VNPI v1.2 ... 57 © VNPI v1.2 ISO 9001 : 2015 L i nói đ u Tiêu chu n ISO 9001:2015 T ch c Tiêu chu n hóa qu c t (ISO) ban hành ngày 15-9-2015 thay th ISO 9001:2008 B n d ch tiêu chu n ISO 9001:2015 Vi n N... n qu c t liên quan đ n ISO 9000 ISO 9004 nh sau: This International Standard relates to ISO 9000 and ISO 9004 as follows: ISO 9000 H th ng qu n lý ch t l ng - C s ISO 9000 Quality management... tr ISO 9001:2008 i di n lãnh đ o v ch t l V n b n, s tay ch t l b n, h s Môi tr ng làm vi c S n ph m đ c mua Nhà cung c p S n ph m ng ng, th t c b ng v n gi a ISO 9001:2008 ISO 9001:2015 ISO 9001:2015