IECQ-QC080000_2012_en

QC 080000Edition 3.0 2012-05IECQ PUBLICATIONHazardous Substance Process Management System Requirements (HSPM)Q C 080000:2012(E )IEC Quality Assessment System for Electronic Components (IECQ System)THIS PUBLICATION IS COPYRIGHT PROTECTEDCopyright © 2012 IEC, Geneva, SwitzerlandAll rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any formor by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either IEC or IEC's member National Committee in the country of the requester.If you have any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or your local IEC member National Committee for further information.IEC Central Office Tel.: +41 22 919 02 113, rue de Varembé Fax: +41 22 919 03 00CH-1211 Geneva 20 info@iec.chSwitzerland www.iec.chAbout the IECThe International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes International Standards for all electrical, electronic and related technologies.About IEC publicationsThe technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the latest edition, a corrigenda or an amendment might have been published.Useful links:IEC publications search - www.iec.ch/searchpubThe advanced search enables you to find IEC publications by a variety of criteria (reference number, text, technical committee,…).It also gives information on projects, replaced and withdrawn publications.IEC Just Published - webstore.iec.ch/justpublishedStay up to date on all new IEC publications. Just Published details all new publications released. Available on-line and also once a month by email. Electropedia - The world's leading online dictionary of electronic and electrical terms containing more than 30 000 terms and definitions in English and French, with equivalent terms in additional languages. Also known as the International Electrotechnical Vocabulary (IEV) on-line.Customer Service Centre - webstore.iec.ch/cscIf you wish to give us your feedback on this publication or need further assistance, please contact the Customer Service Centre: csc@iec.ch.QC 080000Edition 3.0 2012-05IECQ PUBLICATIONHazardous Substance Process Management System Requirements (HSPM)INTERNATIONALELECTROTECHNICAL COMMISSIONQPRICE CODEIEC Quality Assessment System for Electronic Components (IECQ System)– 2 – QC 080000 © IEC:2012(E)CONTENTSFOREWORD (3)1Scope (5)1.1General (5)1.2Application (5)2Normative references (5)3Terms and definitions (5)4Hazardous Substance Process Management System (7)4.1General requirements (7)4.2Documentation requirements (7)5Management responsibility (8)5.1Management commitment (8)5.2Customer focus (8)5.3HSF policy (8)5.4Planning (8)5.5Responsibility, authority and communication (8)5.6Management review (9)6Resource management (9)6.1Provision of resources (9)6.2Human resources (9)6.3Infrastructure (10)6.4Work environment (10)7Product realization (10)7.1Planning of HSF process and product realization (10)7.2Customer-related process (11)7.3Design and development (11)7.4Purchasing of HSF products (12)7.5Production and service provision (13)7.6Control of monitoring and measuring devices for HSF characteristic (14)8Measurement, analysis and improvement (14)8.1General (14)8.2Monitoring and measurement (14)8.3Control of HSF nonconforming product (15)8.4Analysis of HSF data (15)8.5Improvement of hazardous substance process management system (16)Bibliography (17)QC 080000 © IEC:2012(E) – 3 –INTERNATIONAL ELECTROTECHNICAL COMMISSION––––––––––––Hazardous Substance Process ManagementSystem Requirements (HSPM)FOREWORDThis publication has been prepared by the Management Committee (MC) of the IECQ.This publication is directly related to Publication IECQ 03-5 containing the Rules of Procedure for the IECQ HSPM Scheme.This IECQ Specification and its requirements are based on the belief that the achievement of Hazardous Substance Free (HSF) products and production processes cannot be realized without an effective integration of management disciplines. This Specification is a supplement to and exists in concert with the ISO 9001 Quality Management System (QMS) framework for the comprehensive, systematic, and transparent management and control of processes pursuant to HSF goals. This 3rd edition of IECQ QC 080000 has been prepared in response to feedback from application of the 2nd Edition. Changes included in this 3rd Edition include:– Recognition of current implementation of the EU RoHS Directive– Inclusion of other relevant EU Directives, e.g. REACH– Provision for use of various national regulationsIECQ QC 080000, originally based on the EIA Standard 954, Electrical and Electronic Components and Products Hazardous Substance Free Standard and Requirements, to serve as guidance for manufacturers in the fulfilment of HSF legal and customer requirements which may include regulatory requirements such as:•Directive 2002/95/EC of the European Parliament and of the Council of 27 January 2003 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS) and its recasted version, 2011/65/EU•Directive 2002/96/EC of the European Parliament and of the Council of 27 January 2003 on Waste Electrical and Electronic Equipment (WEEE) and its recasted version •Regulation (EC) No 1907/2006 of the European Parliament and of the Council of18 December 2006 concerning the Registration, Evaluation, Authorisation and Restrictionof Chemicals (REACH)•Directive 94/62/EC of the European Parliament and Council of 20 December 1994 on packaging and packaging waste•Directive 2006/66/EC of the European Parliament and of the Council of 6 September 2006 on batteries and accumulators and waste batteries and accumulators and repealing Directive 91/157/EEC•Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys•Directive 2000/53/EC of the European Parliament and of the Council of 18 September 2000 on end-of-life vehicles•The Consumer Product Safety Improvement Act (CPSIA) of 2008 of U.S.A •Administration on Control of Pollution by Electronic and Electrical Products of China etc., or their adaptation and updated version thereafter.– 4 – QC 080000 © IEC:2012(E) NOTE Legislation exists or is pending in a number of jurisdictions around the world that will require the elimination of a specified list of hazardous substances (HS), including lead, mercury, cadmium, hexavalent chromium, poly-brominated biphenyls (PBB), and poly-brominated diphenyl ethers (PBDE) etc., or notification of substances of very high concerns, from a wide range of products. As a result, producers and users of electrical and electronic components must be able to know that their products either are hazardous-substance free (HSF); or, if the products are not HSF, the quantitative amounts of HS that are present.The processes used to identify, control, quantify, and report the HS content in an electrical or electronic component, or an element thereof, must be defined and understood in sufficient detail to assure all concerned parties of the HSF status of a product. The processes must be appropriately documented and conducted in a controlled and consistent manner, to facilitate verification of compliance to applicable requirements and regulations; to allow efficient and effective compliance checks; that it can be implemented by producers and users in many different locations; and to allow harmonization of compliance and enforcement methods. Above all, they must minimize technical barriers to the trade of products around the world.This third edition of IECQ QC 080000 replaces the second edition from 1 July 2012. The transition arrangements for IECQ HSPM Certification according to this edition are detailed in IECQ MC/257/INF.This edition of QC 080000:2012 clarifies how organizations can use IECQ QC 080000 to manage their hazardous substances other than just emphasizing the removal and avoiding restricted substances in the products. Advantages of the new edition include:•The QC 080000:2012 not only includes requirements on restricting hazardous substances in products, it also includes management requirements on working with hazardous substances. These management requirements will enable an organization to put in place processes to accommodate other hazardous substances directives and regulations other than RoHS. New requirements in the re-casted RoHS such as compliance assessment, preparation of technical file, preparation of self-declaration, use of markings, change control, product recall, and the information communication within the supply chain in REACH, etc. can now be managed through these new requirements in QC 080000:2012. •Better alignment and consistency with ISO 9001:2008 in terms of terminology and wordings to facilitate an organization’s incorporation of the IECQ HSPM requirements into their existing management system.•Remove the ambiguity and clarify the intention of some requirements in the 2005 version.The text of this publication is based on the following documents:Document Report on MC ConsultationIECQ MC/238/CA IECQ MC/255/RQC 080000 © IEC:2012(E) – 5 –Hazardous Substance Process ManagementSystem Requirements (HSPM)1 Scope1.1 GeneralThis Specification is intended for use by•manufacturers, suppliers, repairers, and maintainers of products to develop processes to identify, control, quantify, and report the amounts of HS in the products they manufacture or supply; and•customers and users of the products to know the HSF status of a product, and to understand the processes by which it is determined.This Specification defines the requirements for establishing processes to identify and control the introduction of hazardous substances (HS) into its products. In the event that hazardous substances are introduced into the products, this Specification defines the requirements for implementing processes to test, analyze, or otherwise ascertain the HS content, and to make it available to the customer. Documented processes shall be within the organization’s business and quality management systems.The requirements of this Specification are in addition to those contained within ISO 9001.1.2 ApplicationIn principle, all requirements of this International Specification are intended to be applicable to all organizations in Electrical and Electronic sectors. Organizations in other sectors may also adopt this specification for the management of hazardous substances.2 Normative referencesThe following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 9001, Quality Management Systems – Requirements3 Terms and definitionsFor purposes of this Specification, the following terms and definitions apply.HSHazardous Substance refers to any substances regulated by applicable legal or customer requirements as to prohibit, restrict, reduce its use or notify it existence, which will inherently do harm to human health or the safety of environmentHSFHazardous Substances Free refers to the reduction or elimination of any HShazardous characteristic of productRefers to one of the quality characteristic of products, which characterizes hazardous substances and their contents within the productInformation services providerRefers to an entity or organization that analyzes, monitors, or provides information for use in conjunction with designing, procuring, manufacturing, maintaining or supporting products for which the HS content should be known.– 6 – QC 080000 © IEC:2012(E) Structure for the achievement of Hazardous Substance Free operationsThis model illustrates the minimum requirements of this standard,but does not show processes at a detailed levelQC 080000 © IEC:2012(E) – 7 –4 Hazardous Substance Process Management SystemThe requirements of ISO 9001 shall apply along with the additional requirements of this specification.4.1 General requirements4.1.1 GeneralEach organization shall include in its ISO 9001 mandated quality management system the procedures, documentation, and process management practices necessary to achieve HSF product and production processes.The organization shalla) identify and document all hazardous substances contained or will potentially be introducedinto products,b) identify the specific processes to be managed relevant to its HSF goals and theirapplication throughout the organization,c) determine the interdependence and interaction of these processes and develop anappropriate HSF process management plan,d) establish criteria upon which to objectively determine the effectiveness of theorganization’s HSF process management,e) ensure the availability of resources and information needed to support effective HSFprocess management,f) monitor, measure and analyze these processes, andg) implement actions to ensure continuous process improvement in achieving HSF.4.1.2 Relationship with ISO 9001The intention of this document is that HSF process management is to be congruent with the elements of ISO 9001 international Standard.4.1.3 OutsourcingWhere an organization chooses to outsource any process that affects its products’ HSF characteristic, and accept into its operations the product of processes outside its own operations, the organization shall ensure management of and control over such processes. 4.2 Documentation requirements4.2.1 GeneralThe quality management system documentation shall includea) statements of HSF policy and objectives with inclusion of a timeline for elimination of useof all hazardous substances, as appropriate,b) in the organization’s quality manual a section on the HSF process management plan andobjectives and reference to HSF documented procedures,c) documented procedures as required by the organization’s HSF process management planwith control of all such documents executed as required by section 4.2.3 of the ISO 9001 international Standard,d) records of the organization’s HSF process management performance with control of allsuch documents executed as required by section 4.2.4 of the ISO 9001 international Standard,e) HSF documents or records specified by legal requirements or customer requirements,f) a list of all hazardous substances contained in or will potentially be introduced intoproducts.– 8 – QC 080000 © IEC:2012(E) 5 Management responsibility5.1 Management commitmentTop management shall provide evidence of its commitment to the development and implementation of practices consistent with achieving HSF products and production processes and the continuous improvement of such bya) communicating to the organization the importance of meeting customer as well asstatutory and regulatory requirements on HS management,b) establishing the HSF policy,c) ensuring that HSF objectives are established,d) including HSF in management reviews, ande) providing resources to ensure progress toward HSF products and production processes.5.2 Customer focusTop management shall ensure that customer HSF requirements are determined and met with the aim of customer satisfaction.5.3 HSF policyTop management shall ensure that the HSF policy is appropriate for the purpose of the organization, anda) includes a commitment to comply with requirements and continually improve theeffectiveness of the HSF management practices,b) provides a framework for establishing and reviewing HSF objectives,c) is communicated and understood within the organization, andd) is reviewed for continuing suitability.5.4 Planning5.4.1 HSF objectivesa) Top management shall ensure that HSF objectives are established at relevant functionsand levels within the organization. The HSF objectives shall be measurable and consistent with the HSF policy,b) The HSF objectives shall include a timeline, as appropriate, for the elimination ofhazardous substances identified and used in processes or products including purchased products.5.4.2 HSF planningTop management shall ensure thata) the practices required to achieve HSF are integrated into the quality management systemplanning and are elements in the quality objectives, andb) the continuity of the HSF effort is maintained as improvements and changes are executed.5.5 Responsibility, authority and communication5.5.1 Responsibility and authorityTop management shall ensure that HSF related responsibilities and authorities are defined and communicated within the organization.QC 080000 © IEC:2012(E) – 9 –5.5.2 Management representativeTop management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includesa) ensuring that processes, procedures, and practices are established pursuant to achievingHSF goals,b) reporting to top management on the organization’s performance pursuant to the HSF planand needs and recommended improvements in execution,c) ensuring that HSF related requirements and responsibilities are communicated andunderstood throughout the organization, andd) ensuring the awareness in supplier organizations of their HSF related requirements andresponsibilities.5.5.3 Internal communicationa) Top management shall ensure that the organization’s personnel are informed of HSFmanagement requirements and changes, performance effectiveness and issues as relate to the HSF policies and execution plan, andb) Hazardous substances information, including the list of hazardous substance, shall becommunicated, as necessary throughout the organization.5.6 Management review5.6.1 GeneralTop management shall include and report on, during the regular management reviews, activities related to the HSF plan with regards toa) the suitability and realization of HSF policy and targets,b) the changes of legal and customer’s requirements with respect to HS management,c) identification, use of hazardous substances,d) HSF nonconformities and corrective actions, including audit resultse) evaluation and feedback from customers on the HS management performance of theorganization,f) resources needed for realizing HSF products and processes, andg) improvement plan.6 Resource management6.1 Provision of resourcesThe organization shall determine and provide the resources needed to implement and maintain HSF processes and products, to continually improve its effectiveness, and to enhance customer satisfaction by meeting customer requirements.6.2 Human resources6.2.1 GeneralPersonnel performing work affecting conformity to HSF product requirements shall be competent on the basis of appropriate education, training, skills and experience.– 10 – QC 080000 © IEC:2012(E) 6.2.2 Competence, training and awarenessThe organization shalla) determine the necessary competence for personnel performing work affecting conformityto HSF product requirements,b) provide training and/or other actions specific to the HSF plan for the identification, use,and elimination of hazardous substances,c) evaluate the effectiveness of the training and/or actions taken,d) ensure that personnel are aware of the relevance and importance of their activities andhow they contribute to the achievement of the HSF objectives, ande) maintain appropriate records of education, training, skills and experience.6.3 InfrastructureThe organization shall determine, provide and maintain the infrastructure needed to achieve conformity to HSF process and product requirements. Infrastructure includes, as applicable,a) buildings, workspace and associated utilities,b) process equipment and testing equipments (both hardware and software), andc) supporting services (such as testing, data computing, communication or informationsystems).6.4 Work environmentThe organization shall determine, provide and maintain the work environment needed to achieve HSF products.7 Product realization7.1 Planning of HSF process and product realizationThe organization shall plan and develop the processes needed for HSF product realization.In planning HSF product realization, the organization shall determine the following, as appropriate,a) HSF objectives and requirements for the product,b) the need to establish processes, documents, and provide resources specific to the HSFproduct,c) required verification, validation, monitoring, inspection and test activities specific to theHSF product and the criteria for product acceptance. This shall include information services providers as appropriate,d) documented procedures or work instructions for processes that will potentially have impacton the HSF characteristic of products,e) records needed to provide evidence that the HSF product realization processes andresulting product meet requirements,f) the output of this planning shall be in a form suitable for the organization’s method ofoperations.The organization shall establish and maintain procedure for changes that will potentially lead to the change of HSF characteristic of products. The organization shall plan and implement verification, validation and approval for such changes, and evaluate the results of changes. Changes that have potential impact on HSF characteristic of products can not be implementedQC 080000 © IEC:2012(E) – 11 –without approval of customers where necessary. Records shall be maintained for changes implemented.NOTE Changes include those within the organization and those within the supply chain that the organization can influence.7.2 Customer-related process7.2.1 Determination of requirements related to the HSF productThe organization shall determinea) HSF requirements specified by the customer,b) HSF requirements not stated by the customer but necessary for specified or intendeduses, where known,c) HSF statutory and regulatory requirements related to the product, andd) any additional HSF requirements determined by the organization.The organization shall determine the responsibility and channel for the collection, delivery and summarization of these requirements, and determine how these requirements apply to its products.7.2.2 Review of HSF requirements related to the productThe organization shall review the HSF requirements related to the product. This review shall be conducted prior to the organization’s commitment to supply HSF product to the customer and shall ensure thata) product HSF requirements are defined,b) the organization has the ability to meet the defined HSF requirements, andc) records of the results of the HSF review and actions arising from the review shall be keptand maintained.7.2.3 Customer communicationThe organization shall determine and implement effective arrangements for communication with customers in format and channel specified by legal or customer requirements in relation toa) any use of, contamination by or mixing with product or processes that contain hazardoussubstances,b) any information, records, documents or evidences requested by customer, andc) changes that may have impact on the HSF characteristic of product.7.3 Design and development7.3.1 HSF design and development planningThe organization shall plan and control the design and development of HSF product.In planning the design, the use of any hazardous substance shall be identified in the documentation and a plan for control and eventual replacement/elimination of the part.The suitable stage and method shall be determined for the review, verification and validation of the HSF characteristic of product during design and development.– 12 – QC 080000 © IEC:2012(E) 7.3.2 HSF design and development inputsInputs relating to HSF product requirements shall be determined and records maintained. Inputs shall include legal and customer requirements on hazardous substance control and be in line with the internal HSF acceptance criteria for HSF product (see 7.1).Inputs shall be reviewed for adequacy. HSF requirements shall be complete, unambiguous and not in conflict with each other.7.3.3 HSF design and development outputsThe HSF outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release.Where appropriate, the HSF outputs shall provide appropriate information for customer communication, purchasing, production, product marking, information releasing, and service provision. The outputs shall contain or refer to product acceptance criteria.When the design requires the use of a hazardous substance or processes of risk of contamination by or mixing with hazardous substance, a documented procedure shall be developed for the control, identification, monitoring and measurement of the process/product.7.3.4 HSF design and development reviewAt suitable stages, systematic reviews of the design and development on the HSF characteristic of product and process, including validity of evidences employed, shall be performed in accordance with planned arrangements.7.3.5 Design and development verificationVerification shall be performed in accordance with planned arrangements to ensure the HSF characteristic of product and process has met the design and development input requirements. Methods used for verification shall be determined and validated.7.3.6 Design and development validationValidation shall be performed in accordance with planned arrangements to ensure the compliance of HSF characteristic, and the resulting product is capable of meeting the requirements for the specified application or intended use, where known.The result of design and development shall be approved by customer where necessary.7.3.7 Control of HSF design and development changesDesign and development changes which may lead to the change of HSF characteristic of product shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation.7.4 Purchasing of HSF products7.4.1 Purchasing processa) The organization shall ensure that purchased product conforms to HSF requirementsthrough effective control over purchasing and supply chain. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the HSF risk of the purchased product and the ability of the supplier in HSF management.b) The organization shall evaluate and select suppliers based on their ability to supplyproduct in accordance with the organization’s HSF requirements. The organization shall establish a list of qualified HSF suppliers and validated HSF purchased products.。