Changes of QC080000:2012 against QC080000:2005Moro Chen 陈庆今2Background for the updating of QC080000:2005Legal requirements are upgraded tremendously •EU REACH•EU recasted RoHS•……Strong industry appeal to upgrading•To improve it for better HS management ，such as 7.1，7.3, etc;•To revise some minor defects for better recognition by industry;•……ISO9001 upgraded from version2000 to version2008•ISO9001 is framework for QC080000;•To align the clauses with those of ISO9001,such as 6.4，7.2，7.4，7.5.4, 7.5.5, etc3Summary of the Main differences between version 2005 and 2012---1 version 2012 is applicable to much more legal requirements•in version 2005, only EU RoHS and WEEE mentioned;•IECQ-HSPM certificate can show compliance with only limited HS-relevant regulations, while version 2012 covers all HS-relevant legal requirements;•Version 2005 concerns mainly limitation requirements on HS within products; HS management requirements provided in some new regulations are not embodied very well, such as–SVHC notification and information communication in EU REACH;–Technical file, compliance assessment, compliancedeclaration, CE marking, internal production control, change management, marking and recall, non-conforming product, corrective measures of RoHS2,–China RoHS marking, voluntary certification, information declaration, etc 4Summary of the Main differences between version 2005 and 2012 ---2Intention of some definitions or clauses clarified , such as:•“restricted substance” deleted; “hazardous substance” used in all clauses under a new definition;•HSs to be identified are those with potential to entering into products rather than all HSs used by the organization;•staff to be competent are those who will have impact on the HSF characteristic of product rather than the product itself;•while planning the product realization, organization need to determine the HSF objective and requirements rather than other quality requirements;•no mandatory requirement on organization any longer to inform potential contamination or mixing to customers;•“traceability” is not only required in case that it is requested but also where appropriate;•In 7.6, to be controlled is not equipment used in HSF processes but for monitoring and measuring HSF characteristic;5Summary of the Main differences between version 2005 and 2012 ---3Some minor defects revised, such as•Definition for “Information service provider”;•“ISO14001, EPA” in the structure chart;• 4.2.1 e);•The incomplete expression in 8.2.1;•……some redundant expressions deleted, such as •definitions of common meaning in such as ISO9000;• 4.1 h)；•“The requirements of ISO9001 shall apply along with the additional requirements below:”at the beginning of many clauses;•7.5.4：adapted into 7.5.5or 8.3.6Summary of the Main differences between version 2005 and 2012---4Consistency between the specification and ISO9001:2008 improved, such as• 6.4 recovered ；•Adapted 7.5.4into 7.5.4，7.5.5with the same theme as ISO9001；•follow the clause structure of ISO9001, such as –Re-structured 7.2 into 7.2.1，7.2.2，7.2.3；–Re-structured 7.4 into 7.4.1，7.4.2，7.4.3.7detailed differences between version 2005 and 2012---1clause No.version 2005Version 2012contents list 4. QUALITYMANAGEMENT SYSTEM No 6.4 4. hazardous substance process management system"6.4 Work environment" added.forword only RoHS and WEEEmentioned much more legistration mentioned suchas RoHS2, REACH, China RoHS,CPSIA, toy directive, battery directive,etc, and WEEE is not mentioned anymore.00. introduction 1 scope1.1 General1 1. scope 1.1 General1.2 Application 82 2 Normative ReferencesISO 9001:2000ISO 10005:1995ISO 10006:1997ISO 19011IEC QC 001002-3AS 9100TL 9000ISO 13485are all referred.2 Normative References only ISO9001 referred.3 3 Terms and Definitionsgive definition forHSHSF Information services provider May Product customer Product manufacturer Product repairer Product supplier Product user Restricted SubstanceShouldShall3. Terms and Definitionsonly give definition forHS,HSF,Hazardous characteristic of product,Information services provider,which are specific for the control of hazardous substances.detailed differences between version 2005 and 2012---294title "Quality Management System"title "Hazardous Substance ProcessManagement System"4.1.1 a)"all hazardous substances in use in the organization""all hazardous substances contained orwill potentially be introduced intoproducts"4.1.1 b)"and their application throughout theorganization" added at the end of thesentence.4.1.1 h)deleted4.1"The requirements of ISO9001 shall apply alongwith the additionalrequirements below:", thesame for clause 4.2, 5.1, 5.4, 5.5, 5.6, 6.1, 6.2, 6.3,7.1, 7.2, 7.3, 7.4, 7.5, 7.6,8.1, 8.2.1, 8.3, 8.4, 8.5.deleted4.2a) deleted;"e) HSF documents or records specified by legal requirements or customerrequirements," is added;numbering is re-ordered;detailed differences between version 2005 and 2012---3105.5.3 a)"HSF management requirements and changes" is requiredto be informed to the organization's personnel too.5.6.1the following points added:a) the suitability and realization of HSF policy and targets,b) the changes of legal and customer’s requirements withrespect to HS management,d) audit results with respect to HSF non-conformity andcorresponding corrective action, including audit results.e) evaluation and feedback from customers on the HSmanagement performance of the organization,f) resources needed for realizing HSF products andprocesses, andg) improvement plan.detailed differences between version 2005 and 2012---4116.3infrastructure related to HS control are listed out as:a) buildings, workspace and associated utilities;b) process equipment and testing equipments (bothhardware and software), andc) supporting services (such as testing, data computing,communication or information systems).6.4none added as follows:6.4 Work environmentThe organization shall determine, provide and maintain thework environment needed to achieve HSF products.detailed differences between version 2005 and 2012---5127.1 a paragraph on change management added as follows:"The organization shall establish and maintain procedurefor changes that will potentially lead to the change of HSFcharacteristic of products. The organization shall plan andimplement verification, validation and approval for suchchanges, and evaluate the results of changes. Changesthat have potential impact on HSF characteristic ofproducts can not be implemented without approval ofcustomers where necessary. Records shall be maintainedfor changes implemented.Note: changes include those within the organization andthose within the supply chain that the organization caninfluence."detailed differences between version 2005 and 2012---6137.2.1 a paragraph added as follows:"The organization shall determine the responsibility andchannel for the collection, delivery and summarization of these requirements, and determine how these requirements apply to its products."7.2.2divided into 7.2.2 and 7.2.3, 7.2.2 C) is moved to 7.2.3 a), and7.2.3 read as:"7.2.3 Customer communicationThe organization shall determine and implement effectivearrangements for communication with customers in format andchannel specified by legal or customer requirements inrelation toa) any use of, contamination by or mixing with product orprocesses that contain hazardous substances,b) any information, records, documents or evidencesrequested by customer, andc) changes that may have impact on the HSF characteristic of product."detailed differences between version 2005 and 2012---7147.3.1"The suitable stage and method shall be determined for thereview, verification and validation of the HSF characteristic ofproduct during design and development." added.7.3.2"Inputs shall include legal and customer requirements onhazardous substance control and be in line with the internalHSF acceptance criteria for HSF product (see 7.1)." added.7.3.3"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 productacceptance criteria.“"a restricted substance" is replaced by "a hazardous substance or processes of risk of contamination by or mixing withhazardous substance"detailed differences between version 2005 and 2012---8157.3.5"Verification shall be performed in accordance with planned arrangements to ensure the HSF characteristicof product and process has met the design anddevelopment input requirements. Methods used forverification shall be determined and validated." added.7.3.6"Validation shall be performed in accordance with plannedarrangements to ensure the compliance of HSFcharacteristic, and the resulting product is capable ofmeeting the requirements for the specified application orintended use, where known.The result of design and development shall be approvedby customer where necessary." added.detailed differences between version 2005 and 2012---9167.4re-phrased to make it more consistent with ISO9001, andthe following requirements are added:"The type and extent of control applied to the supplier andthe purchased product shall be dependent upon the HSFrisk of the purchased product and the ability of thesupplier in HSF management.""The organization shall establish a list of qualified HSFsuppliers and validated HSF purchased products.""The organization shall ensure effective control overchanges in supply chain.""The organization shall establish and communicate theHSF requirements to suppliers.""c) Without specific approval, the organization shall notpurchase products from outside of the list of qualifiedHSF suppliers and validated HSF purchased products forHSF production."detailed differences between version 2005 and 2012---10177.5.1"in which processes that have the potential of contamination or mixture are identified and preventivemeasures documented," added in the end of b);"c) the validated HSF purchased products for HSFproduction," added.7.5.3b)...toprevent combinat ion with HSF product.b) …to prevent HSF product from contamination by ormixing with hazardous substances."e) The organization shall ensure products are affixed with HSF marking and other elements according to legal or customer requirements applicable." added.7.5.4transferred into 7.5.5the whole 7.5.4 added and read as:"7.5.4 Customer propertyThe organization shall exercise care with customerproperty to protect the HSF characteristic while it is underthe organization’s control or being used by organization.The organization shall communicate to customer whereHSF nonconformity identified with customer property."detailed differences between version 2005 and 2012---11187.5.5none the whole 7.5.5 re-wording as:"7.5.5 Preservation of producta) The organization shall protect the HSF characteristicand HSF identification status of product.b) HSF nonconforming materials and products shall besegregated and managed separately.c) The organization shall ensure purchased products arereleased correctly for HSF production.d) Records for storage and releasing of HSFnonconforming products shall be maintained."7.6"c) Measuring equipment for HSF characteristic shall bemanaged to ensure valid results." added.detailed differences between version 2005 and 2012---12198.1adapted to the sub-clauses of 8.1, ISO9001.8.2.1deliberated as:"The organization shall monitor information relating tocustomer and interested party’s perception as to whetherthe organization has met their HSF requirements.Note: Interested Party may include competentauthorities, surveillance authorities, distributors,consumers, authorised representatives, etc., whereapplicable."8.2.2Re-phrased to clarify the intention and align with 90018.2.3Re-phrased to clarify the intention and align with 90018.2.4Re-phrased to clarify the intention and align with 90018.3Re-phrased to clarify the intention and align with 90018.4Re-phrased to clarify the intention and align with 90018.5Re-phrased to clarify the intention and align with 9001detailed differences between version 2005 and 2012---13。
