DIN ISO 22006-2012 Quality management systems - Guidelines for the application of ISO 9001 2008 to crop production (ISO 22006 2009)《质量管理系统 ISO 9001-2008应用到农产品的指南(ISO 22006-2009)》.pdf

1、February 2012 Translation by DIN-Sprachendienst.English price group 28No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).I

2、CS 03.120.10; 67.020!$yXh“1865369www.din.deDDIN ISO 22006Quality management systems Guidelines for the application of ISO 9001:2008 to crop production(ISO 22006:2009)English translation of DIN ISO 22006:2012-02Qualittsmanagementsysteme Anleitung fr die Anwendung von ISO 9001:2008 im Pflanzenanbau (I

3、SO 22006:2009)Englische bersetzung von DIN ISO 22006:2012-02Systmes de management de la qualit Lignes directrices pour lapplication de lISO 9001:2008 pour la production des rcoltes(ISO 22006:2009)Traduction anglaise de DIN ISO 22006:2012-02www.beuth.deDocument comprises pagesIn case of doubt, the Ge

4、rman-language original shall be considered authoritative.7401.12 A comma is used as the decimal marker. Contents Page National foreword .3 National Annex NA (informative) Bibliography .3 Introduction .4 0.1 General 7 0.2 Process approach 8 0.3 Relationship with ISO 9004210 0.4 Compatibility with oth

5、er management systems .11 1 Scope 12 1.1 General 12 1.2 Application 13 2 Normative references 13 3 Terms and definitions13 4 Quality management system 17 4.1 General requirements 17 4.2 Documentation requirements .19 5 Management responsibility.24 5.1 Management commitment 24 5.2 Customer focus 24 5

6、.3 Quality policy25 5.4 Planning 25 5.5 Responsibility, authority and communication 26 5.6 Management review .28 6 Resource management .29 6.1 Provision of resources 29 6.2 Human resources .30 6.3 Infrastructure 31 6.4 Work environment .32 7 Product realization .33 7.1 Planning of product realizatio

7、n 33 7.2 Customer-related processes 34 7.3 Design and development 37 7.4 Purchasing .40 7.5 Production and service provision 42 7.6 Control of monitoring and measuring equipment 46 8 Measurement, analysis and improvement 47 8.1 General 47 8.2 Monitoring and measurement 48 8.3 Control of nonconformin

8、g product 51 8.4 Analysis of data 52 8.5 Improvement 52 Annex A (informative) Typical crop processes and sub-processes .55 Annex B (informative) Cross references between ISO 22000:20056and ISO 22006:2009 65 Annex C (informative) Correspondence between ISO 14001:20043and ISO 22006:2009 .70 Bibliograp

9、hy 74 2 DIN ISO 22006:2012-02 National foreword This standard has been prepared by Technical Committee ISO/TC 34 “Food products” (Secretariat: AFNOR, France), WG 12 “Application of ISO 9001:2000 in the agriculture” (Secretariat: USA). The responsible German body involved in its preparation was the N

10、ormenausschuss Lebensmittel und landwirtschaftliche Produkte (Food and Agricultural Products Standards Committee), Working Committees NA 057-02-02 AA Lebensmittelsicherheit Management-Systeme and NA 057-02-02-02 AK Management-systeme fr die Landwirtschaft. The text of ISO 22006:2009 “Quality managem

11、ent systems Guidelines for the application of ISO 9001:2008 to crop production” has been adopted without any modification. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. DIN and/or DKE shall not be held responsible for identifyin

12、g any or all such patent rights. The DIN Standard corresponding to the International Standard referred to in this document is as follows: ISO 9000 DIN EN ISO 9000 National Annex NA (informative) Bibliography DIN EN ISO 9000:2005, Quality management systems Fundamentals and vocabulary DIN EN ISO 9001

13、:2008, Quality management systems Requirements DIN EN ISO 9004:2009, Managing for the sustained success of an organization A quality management approach DIN EN ISO 14001:2004, Environmental management systems Requirements with guidance for use DIN EN ISO 19011, Guidelines for quality and/or environm

14、ental management systems auditing DIN EN ISO 22000:2005, Food safety management systems Requirements for any organization in the food chain DIN ISO/TS 22003, Food safety management systems Requirements for bodies providing audit and certification of food safety management systems DIN ISO/TS 22004, F

15、ood safety management systems Guidance on the application of ISO 22000:2005 DIN EN ISO 22005, Traceability in the feed and food chain General principles and basic requirements for system design and implementation 3 DIN ISO 22006:2012-02 Introduction This International Standard gives guidelines to as

16、sist crop-producing farm operations in the application of ISO 9001:20081. In the context of this International Standard, a quality management system (QMS) is about how a farm operation is managed. The ultimate goal of implementing ISO 9001:20081in a farm operation should be a combination of improved

17、 performance, financial results, and customer confidence and satisfaction. Farmers should focus on what is practical and work to implement a QMS with these results in mind. QMSs are built from existing activities and should not cause excessive paperwork or lack of flexibility. QMSs are not just for

18、large farm operations. The guidelines given in this International Standard are also relevant to small farm operations. Adjustments in implementation and interpretation of this International Standard may be needed in small farm operations. While there may be effort involved in the implementation of I

19、SO 9001:20081, the ultimate goal is to achieve net benefits. This International Standard specifies a set of activities that need to be included; however, it does not specify how to carry them out. Listing all of the farm operation activities on a flow diagram aids in determining whether they fit tog

20、ether well or whether some aspects need to be changed to make the processes work better. ISO 90011and ISO 90043are based on eight management principles customer focus, leadership, involvement of people, process approach, system approach to management, continual improvement, factual approach to decis

21、ion-making, and mutually beneficial supplier relationships all of which can be used to improve the performance of the farm operation. This International Standard does not include requirements specific to other management systems such as those particular to food safety, the environment or occupationa

22、l health and safety, and does not imply that a farm operation is obliged to implement management systems for food safety, the environment or occupational health and safety. The complexity of documents, records, training, etc. depends on: a) the number of people working or involved in the farm operat

23、ion, both on a permanent and seasonal basis; b) necessary skills or competencies to perform tasks; c) complexity of processes; d) number of distinct processes; e) types and complexity of tools and equipment used. A QMS on its own does not lead to improvement of work processes or product or service q

24、uality. It is a means to achieve the objectives of the farm operation. A schematic diagram of QMSs in food supply chains is given in Figure 1. 4 Quality management systems Guidelines for the application of ISO 9001:2008 to crop production DIN ISO 22006:2012-02 Genetics (seed, root stock)Fertilizers

25、and chemicalsGrowers (producers)Elevator,cooperative,conditionerIntermediate ingredient processorFood manufacturerInput suppliersProduction agricultureFirst buyerIntermediary processors handlers distributorsFood manufacturer and distribution chainISO 9001ISO 9001 using this International Standardas

26、guidance and/or ISO 22000 if necessary Consumer Distributor 226aISO 9001 using ISO 15161and/or ISO 22000 if necessary 2 56aNOTE ISO 9001:20081and ISO 22000:20056can be used for certification. This International Standard and ISO 15161:20014are not intended for certification purposes. a The requiremen

27、ts specified in ISO 220006include those of a hazard analysis critical control plan (HACCP). Figure 1 Example: quality management system in food supply chains 5 DIN ISO 22006:2012-02 The guidance provided clarifies the clause of the International Standard which it follows. Examples have been used whe

28、rever possible to aid in understanding the requirements. Effective communications and familiarity with all parts of the farm operation may be all that is needed. When reading ISO 9001:20081, certain words and phrases have particular significance or meaning. Explanations of some of the more important

29、 of these are given below. shall Whenever this word occurs, there is an obligation to fulfil a requirement in order to demonstrate an effective QMS. should/may These words are not to be interpreted as requirements, but as recommendations or permissions. appropriate This word means that the organizat

30、ion can decide how the requirements apply to the farm operation. In some cases, the organization may decide that the guidance does not apply to the farm operation (see the exclusions in 1.2). NOTE In this International Standard, “appropriate” and “suitable” are also used to indicate where such decis

31、ions are necessary. Also, “adequate” is used to indicate that the actions, decisions, etc. are fully sufficient to fulfil requirements. The ISO 22000 family of documents focuses on food, feed and related supply chains, and at the time of publication includes: ISO 220006, which is a food safety manag

32、ement system standard for the food manufacturing and distribution industries which was developed using HACCP and its prerequisites as a base. ISO 22000 covers the critical control points in the processes of food production, manufacture, and delivery relating to food safety; ISO 151614, which is a gu

33、idance document for the application of ISO 9001:20001for the food and drink industries; ISO/TS 220037, which is a requirement document for organizations that provide food safety audit services; ISO/TS 220048, which gives guidance on the implementation of ISO 22000:2005; ISO/TS 220059, which is inten

34、ded to be a tool for traceability that can be coordinated within the context of a broader management system (such as ISO 9001:20081); ISO 22006 (this International Standard), which is not intended to duplicate the requirements of ISO 22000. Additional documents in the ISO 22000 family are planned. T

35、his International Standard has been designed to explain how ISO 9001:20081applies to crop production (food, feed and non-food crops). This International Standard does not set any requirements, nor does it add to or otherwise change the requirements of ISO 9001:20081. It is intended to provide help i

36、n the application of ISO 9001:20081. This International Standard contains ISO 9001:20081requirements in framed boxes. Guidance paragraphs specific to agricultural crop production follow the requirement boxes and are not intended to be requirements nor are they expected to be applicable to all farm o

37、perations. In addition, help boxes (see example below), highlighted by a grey tint, contain guidance or suggestions and are included in places where they are deemed appropriate. HELP The clauses of ISO 90011are written to be adapted to a wide range of organizational activities and sizes. To aid in t

38、he understanding of ISO 9001:20081within the context of crop production, help boxes have been created. These help boxes are specifically designed to help with selected clauses throughout this International Standard. Help boxes may be of particular value when relating the ISO 9001:20081requirements t

39、o a wide variety of farm operations including those that are large, small, mechanized or labour intensive. Help boxes are highlighted by a gray tint to differentiate them from other text used in this International Standard. 6 DIN ISO 22006:2012-02 This International Standard is consistent with ISO 2

40、20006and ISO/TS 220059requirements; it is not intended to duplicate the requirements of these published documents. This International Standard is not a guidance document for the application of ISO 220006or ISO/TS 220059. This International Standard provides guidance to crop producers to aid in the p

41、reparation for ISO 9001:20081certification or for self-declaration to ISO 9001:20081. Text that is unique to this International Standard does not contain requirements associated with certification and registration. This International Standard is not intended to replace ISO 9004:20092which addresses

42、performance improvement. The use of this International Standard does not require the implementation of ISO 9004:20092. 0.1 General ISO 9001:2008, Quality management systems Requirements The adoption of a quality management system should be a strategic decision of an organization. The design and impl

43、ementation of an organizations quality management system is influenced by a) its organizational environment, changes in that environment, and the risks associated with that environment, b) its varying needs, c) its particular objectives, d) the products it provides, e) the processes it employs, f) i

44、ts size and organizational structure. It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation. The quality management system requirements specified in this International Standard are complementary to requir

45、ements for products. Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement. This International Standard can be used by internal and external parties, including certification bodies, to assess the organizations ability to meet customer, statutory and regu

46、latory requirements applicable to the product, and the organizations own requirements. The quality management principles stated in ISO 9000 and ISO 90042have been taken into consideration during the development of this International Standard. Guidance: ISO 9001:20081specifies requirements for a QMS.

47、 When implementing ISO 9001:20081using the guidelines in this International Standard, the organization should consider and utilize appropriate information e.g. statutory and regulatory requirements, customer requirements, recognized guidelines, Codex Alimentarius Commission (Codex) principles and co

48、des of practices including national, international or sector standards. Processes employed may include: good agricultural practices (GAP) as well as good hygiene practices (GHP) as appropriate to the needs of the farm operation and its customers. This is particularly important for those practices that are generally acceptable for the specific crop, international, national, local regulations or specific customer needs. 7