IECQ PUBLICATION QC IEC Quality Assessment System for Electronic Components (IECQ System)

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1 QC Edition IECQ PUBLICATION IEC Quality Assessment System for Electronic Components (IECQ System) Hazardous Substance Process Management System Requirements (HSPM) QC :2012(E)

2 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2012 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or 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.: , rue de Varembé Fax: CH-1211 Geneva 20 Switzerland About the IEC The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes International Standards for all electrical, electronic and related technologies. About IEC publications The 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 - The 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 It also gives information on projects, replaced and withdrawn publications.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/justpublished Stay up to date on all new IEC publications. Just Published details all new publications released. Available on-line and also once a month by . Electropedia - The world's leading online dictionary of electronic and electrical terms containing more than 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/csc If you wish to give us your feedback on this publication or need further assistance, please contact the Customer Service Centre: csc@iec.ch.

3 QC Edition IECQ PUBLICATION IEC Quality Assessment System for Electronic Components (IECQ System) Hazardous Substance Process Management System Requirements (HSPM) INTERNATIONAL ELECTROTECHNICAL COMMISSION PRICE CODE Q

4 2 QC IEC:2012(E) CONTENTS FOREWORD Scope General Application Normative references Terms and definitions Hazardous Substance Process Management System General requirements Documentation requirements Management responsibility Management commitment Customer focus HSF policy Planning Responsibility, authority and communication Management review Resource management Provision of resources Human resources Infrastructure Work environment Product realization Planning of HSF process and product realization Customer-related process Design and development Purchasing of HSF products Production and service provision Control of monitoring and measuring devices for HSF characteristic Measurement, analysis and improvement General Monitoring and measurement Control of HSF nonconforming product Analysis of HSF data Improvement of hazardous substance process management system Bibliography... 17

5 QC IEC:2012(E) 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION Hazardous Substance Process Management System Requirements (HSPM) FOREWORD This 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 3 rd edition of IECQ QC has been prepared in response to feedback from application of the 2 nd Edition. Changes included in this 3 rd 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 regulations IECQ QC , 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 of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of 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.

6 4 QC 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 replaces the second edition from 1 July The transition arrangements for IECQ HSPM Certification according to this edition are detailed in IECQ MC/257/INF. This edition of QC :2012 clarifies how organizations can use IECQ QC 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 :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 :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 IECQ MC/238/CA Report on MC Consultation IECQ MC/255/R

7 QC IEC:2012(E) 5 Hazardous Substance Process Management System Requirements (HSPM) 1 Scope 1.1 General This 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 Application In 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 references The 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 Requirements 3 Terms and definitions For purposes of this Specification, the following terms and definitions apply. HS Hazardous 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 environment HSF Hazardous Substances Free refers to the reduction or elimination of any HS hazardous characteristic of product Refers to one of the quality characteristic of products, which characterizes hazardous substances and their contents within the product Information services provider Refers 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.

8 6 QC IEC:2012(E) Structure for the achievement of Hazardous Substance Free operations Customer requirements for HSF Statutory and regulatory requirements for HSF WEEE, RoHS, EPA, ISO 14001, etc. Contract Review to ensure capability Design review to determine conformance to HSF requirements Document design aspects and impacts that are controlled per the organization's list of HSF materials Operations Organization Plan for the management of HSF Document policies and objectives evidencing the organization's commitment to HSF conformity. Document the process for ensuring compliance to customer requirements of HSF conformity. HSF Materials process Management HSF Manufacturing process controls HSF Supply Chain process controls HSF Quality Assurance processes Document Processes for the receiving, storage, segregation and shipping of parts or products throughout the organization, its subsidiaries and suppliers. Document controls of all processes for the manufacture, supply or repair of parts or products throughout the organization, its subsidiaries and suppliers. Document processes for approval of suppliers and HSF compliance control in the procurement of all parts and/or products used Document the sequence of review and approval of all processes used to produce parts or products. This applies to Suppliers of parts and Subcontractors of assemblies. Document the assessment and control of corrective actions taken on nonconformities throughout the organization's, its suppliers and subcontractor's operations Document the process for determining compliance to stated HSF policies and objectives. This model illustrates the minimum requirements of this standard, but does not show processes at a detailed level

9 QC IEC:2012(E) 7 4 Hazardous Substance Process Management System The requirements of ISO 9001 shall apply along with the additional requirements of this specification. 4.1 General requirements General Each 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 shall a) identify and document all hazardous substances contained or will potentially be introduced into products, b) identify the specific processes to be managed relevant to its HSF goals and their application throughout the organization, c) determine the interdependence and interaction of these processes and develop an appropriate HSF process management plan, d) establish criteria upon which to objectively determine the effectiveness of the organization s HSF process management, e) ensure the availability of resources and information needed to support effective HSF process management, f) monitor, measure and analyze these processes, and g) implement actions to ensure continuous process improvement in achieving HSF Relationship with ISO 9001 The intention of this document is that HSF process management is to be congruent with the elements of ISO 9001 international Standard Outsourcing Where 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 requirements General The quality management system documentation shall include a) statements of HSF policy and objectives with inclusion of a timeline for elimination of use of all hazardous substances, as appropriate, b) in the organization s quality manual a section on the HSF process management plan and objectives and reference to HSF documented procedures, c) documented procedures as required by the organization s HSF process management plan with control of all such documents executed as required by section of the ISO 9001 international Standard, d) records of the organization s HSF process management performance with control of all such documents executed as required by section 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 into products.

10 8 QC IEC:2012(E) 5 Management responsibility 5.1 Management commitment Top 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 by a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements on HS management, b) establishing the HSF policy, c) ensuring that HSF objectives are established, d) including HSF in management reviews, and e) providing resources to ensure progress toward HSF products and production processes. 5.2 Customer focus Top management shall ensure that customer HSF requirements are determined and met with the aim of customer satisfaction. 5.3 HSF policy Top management shall ensure that the HSF policy is appropriate for the purpose of the organization, and a) includes a commitment to comply with requirements and continually improve the effectiveness of the HSF management practices, b) provides a framework for establishing and reviewing HSF objectives, c) is communicated and understood within the organization, and d) is reviewed for continuing suitability. 5.4 Planning HSF objectives a) Top management shall ensure that HSF objectives are established at relevant functions and 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 of hazardous substances identified and used in processes or products including purchased products HSF planning Top management shall ensure that a) the practices required to achieve HSF are integrated into the quality management system planning and are elements in the quality objectives, and b) the continuity of the HSF effort is maintained as improvements and changes are executed. 5.5 Responsibility, authority and communication Responsibility and authority Top management shall ensure that HSF related responsibilities and authorities are defined and communicated within the organization.

11 QC IEC:2012(E) Management representative Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes a) ensuring that processes, procedures, and practices are established pursuant to achieving HSF goals, b) reporting to top management on the organization s performance pursuant to the HSF plan and needs and recommended improvements in execution, c) ensuring that HSF related requirements and responsibilities are communicated and understood throughout the organization, and d) ensuring the awareness in supplier organizations of their HSF related requirements and responsibilities Internal communication a) Top management shall ensure that the organization s personnel are informed of HSF management requirements and changes, performance effectiveness and issues as relate to the HSF policies and execution plan, and b) Hazardous substances information, including the list of hazardous substance, shall be communicated, as necessary throughout the organization. 5.6 Management review General Top management shall include and report on, during the regular management reviews, activities related to the HSF plan with regards to a) 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 results e) evaluation and feedback from customers on the HS management performance of the organization, f) resources needed for realizing HSF products and processes, and g) improvement plan. 6 Resource management 6.1 Provision of resources The 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 resources General Personnel performing work affecting conformity to HSF product requirements shall be competent on the basis of appropriate education, training, skills and experience.

12 10 QC IEC:2012(E) Competence, training and awareness The organization shall a) determine the necessary competence for personnel performing work affecting conformity to 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 and how they contribute to the achievement of the HSF objectives, and e) maintain appropriate records of education, training, skills and experience. 6.3 Infrastructure The 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), and c) supporting services (such as testing, data computing, communication or information systems). 6.4 Work environment The organization shall determine, provide and maintain the work environment needed to achieve HSF products. 7 Product realization 7.1 Planning of HSF process and product realization The 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 HSF product, c) required verification, validation, monitoring, inspection and test activities specific to the HSF 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 impact on the HSF characteristic of products, e) records needed to provide evidence that the HSF product realization processes and resulting product meet requirements, f) the output of this planning shall be in a form suitable for the organization s method of operations. 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 implemented

13 QC 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 process Determination of requirements related to the HSF product The organization shall determine a) HSF requirements specified by the customer, b) HSF requirements not stated by the customer but necessary for specified or intended uses, where known, c) HSF statutory and regulatory requirements related to the product, and d) 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 Review of HSF requirements related to the product The 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 that a) product HSF requirements are defined, b) the organization has the ability to meet the defined HSF requirements, and c) records of the results of the HSF review and actions arising from the review shall be kept and maintained Customer communication The organization shall determine and implement effective arrangements for communication with customers in format and channel specified by legal or customer requirements in relation to a) any use of, contamination by or mixing with product or processes that contain hazardous substances, b) any information, records, documents or evidences requested by customer, and c) changes that may have impact on the HSF characteristic of product. 7.3 Design and development HSF design and development planning The 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.

14 12 QC IEC:2012(E) HSF design and development inputs Inputs 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 HSF design and development outputs The 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 HSF design and development review At 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 Design and development verification Verification 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 Design and development validation Validation 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 Control of HSF design and development changes Design 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 products Purchasing process a) The organization shall ensure that purchased product conforms to HSF requirements through 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 supply product in accordance with the organization s HSF requirements. The organization shall establish a list of qualified HSF suppliers and validated HSF purchased products.

15 QC IEC:2012(E) 13 c) Where appropriate, the procurement route of purchased product shall be fully understood and a documented procedure shall be established to outline the procurement activities related to HSF product. d) The organization shall ensure that any HSF purchased product is free from possible contamination by hazardous substance. Any process that has the possibility of contamination by or mixing with hazardous substances shall be fully identified and controlled. e) The organization shall ensure effective control over changes in supply chain Purchasing information a) The organization shall establish and communicate the HSF requirements to suppliers. b) Procurement of hazardous substances shall be clearly identified on the purchase document and upon receipt of the material. c) Without specific approval, the organization shall not purchase products from outside of the list of qualified HSF suppliers and validated HSF purchased products for HSF production Verification of purchased product The organization shall establish and implement the inspection or other activities such as testing necessary for ensuring that purchased product meets specified HSF purchase requirements. a) A documented procedure shall be established and maintained for the inspection and identification of hazardous substances included in purchased products. The hazardous substance shall be identified by the type in the inspection data. b) Included shall be a process to handle an abnormality/nonconformance. c) If the processes are combined with each other, a documented procedure shall be established to differentiate between purchased products. 7.5 Production and service provision Control of HSF production and service provision processes The organization shall plan and carry out HSF production and service provisions under controlled conditions to achieve the HSF characteristic of products. Controlled conditions shall include, as applicable, a) the availability of HSF information that describes the characteristics of the product, b) the availability of HSF work instructions, as necessary, in which processes that have the potential of contamination or mixture are identified and preventive measures documented, c) the validated HSF purchased products for HSF production, d) the suitable HSF equipment, e) the availability and use of HSF monitoring and measuring devices, f) the implementation of HSF monitoring and measurement, and g) the implementation of HSF release, delivery and post-delivery process controls Validation of HSF processes for production and service provision The organization shall validate processes for production and service provision where the HSF characteristic of resulting products cannot be verified by subsequent monitoring or measurement. This includes any processes where HSF deficiencies become apparent only after the product is in use or the service has been delivered.

16 14 QC IEC:2012(E) HSF identification and traceability a) Where appropriate, the organization shall identify the HSF product by suitable means throughout product realization. b) Processes that include any hazardous substance shall be uniquely identified and controlled to prevent HSF product from contamination by or mixing with hazardous substances. c) The organization shall identify the HSF status of product with respect to monitoring and measurement requirements. d) The organization shall control and record the unique identification of the product where appropriate. e) The organization shall ensure products are affixed with HSF marking and other elements according to legal or customer requirements applicable Customer property The organization shall exercise care with customer property to protect the HSF characteristic while it is under the organization s control or being used by organization. The organization shall communicate to customer where HSF nonconformance identified with customer property Preservation of product a) The organization shall protect the HSF characteristic and HSF identification status of product. b) HSF nonconforming materials and products shall be segregated and managed separately. c) The organization shall ensure purchased products are released correctly for HSF production. d) Records for storage and releasing of HSF nonconforming products shall be maintained. 7.6 Control of monitoring and measuring devices for HSF characteristic a) The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined HSF requirements. b) The organization shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the HSF monitoring and measurement requirements. c) Measuring equipment for HSF characteristic shall be managed to ensure valid results. 8 Measurement, analysis and improvement 8.1 General The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed to a) demonstrate conformity to HSF requirements for product, b) ensure conformity of the hazardous substance process management system, and c) continually improve the effectiveness of the hazardous substance process management system. 8.2 Monitoring and measurement Customer satisfaction The organization shall monitor information relating to customer and interested party s perception as to whether the organization has met their HSF requirements. NOTE Interested Party may include competent authorities, surveillance authorities, distributors, consumers, authorised representatives, etc., where applicable.

17 QC IEC:2012(E) Internal audit The organization shall conduct internal assessments at planned intervals to determine whether the organization s HSF processes conform to the planned arrangements (see 7.1), requirements of this specification and to customer requirements, and are effectively implemented and maintained Monitoring and measurement of processes The organization shall apply suitable methods for monitoring and, where applicable, measurement of the processes that will potentially result in HSF non-conformance, including processes of suppliers/subcontractors and information services providers. How these processes are to be controlled, monitored and measured shall be documented Monitoring and measurement of HSF characteristic of product The organization shall establish a documented procedure to monitor and measure the hazardous substances of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 7.1). Evidence of conformity with acceptance criteria for Hazardous substances shall be maintained. Records shall indicate the person(s) authorizing release of product. Product release and delivery shall not proceed until the required arrangements have been satisfactorily completed. 8.3 Control of HSF nonconforming product The organization shall ensure that products which do not conform to HSF product requirements are identified and controlled to prevent their unintended use or delivery. The organization shall deal with nonconforming product by one or more of the following ways: a) There shall be a clear procedure to handle situations when nonconforming products that contain hazardous substance(s) are detected and to prevent products that contain hazardous substances from being shipped unless otherwise allowed, b) Records of the nature of nonconformities and subsequent actions taken shall be maintained and clearly identified as to what hazardous substance was detected c) When HSF nonconforming product is detected after delivery or use has started, the organization shall take action to notify customers according to contract agreements or company hazardous substance process management policy. 8.4 Analysis of HSF data The organization shall determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the hazardous substance process management system. The analysis of data shall provide information relating to a) customer satisfaction (see 8.2.1), b) conformity to product requirements (see 8.2.4), c) characteristics and trends of processes and products including opportunities for preventive action (see and 8.2.4), and suppliers performance, and d) continuous improvement efforts for the elimination of the all hazardous substances, as applicable.

18 16 QC IEC:2012(E) 8.5 Improvement of hazardous substance process management system Continual improvement The organization shall continually improve the effectiveness of hazardous substance process management system through the use of the quality policy, quality objectives, assessment results, analysis of data, corrective and preventive actions and management review Corrective action for identified HSF nonconformities The organization shall take action to eliminate the cause of HSF nonconformities in order to prevent recurrence. A HSF documented procedure shall be established to define requirements for a) reviewing HSF nonconformities (including customer complaints), b) determining the causes of nonconformities, c) evaluating the need for action to ensure that HSF nonconformities do not recur, d) determining and implementing action needed, e) records of the results of action taken, f) reviewing corrective action taken, and g) reporting the status of all HSF corrective actions for management review.

19 QC IEC:2012(E) 17 Bibliography ISO 10005, Quality Management Guidelines for quality plans ISO 10006, Quality management Guidelines to quality in project management ISO 19011, Guidelines on quality and/or environmental management systems auditing IECQ 03-5, Rules of Procedure Part 5: IECQ HSPM Scheme Hazardous Substance Process Management Requirements AS 9100, Quality Systems Aerospace Model for Quality Assurance in Design, Development, Production, Installation and Servicing TL 9000, Quality Management System (QMS) Requirements ISO 13485, Medical devices Quality management systems System requirements for regulatory purposes ISO/TS 16949, Quality management systems, Automotive Suppliers, Particular requirements for the application of ISO 9001:2008

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