ࡱ>  bjbj <((P6P6P6P6P6d6d6d6864:d6t;(X(PXPXPXLZ\]dlnnnnnn$AP6^ Z@LZ^^P6P6PXPX___^RP6PXP6PXl_^l__$'sv PXp#ϝl^҇X0l *_dL,P6J^^_^^^^^_X^^^^^^^^^^^^^^^^( 5:  XYZ COMPANY IATF 16949 QUALITY MANUAL  HYPERLINK "http://www.qsinnovations.com/Page25.html" Order Quality Manual DATE: REVISION 01  UNCONTROLLED COPY  CONTROLLED COPY Serial # _________ Issued To: ___________________________ Date: ___________ SAMPLE Note: This sample manual only contains partial text therefore, the numbering is not consecutive. Table of Contents  TOC \o "1-4" \f \h \z \t "Body Text Indent,1"   HYPERLINK \l "_Toc477252743" Introduction  PAGEREF _Toc477252743 \h 8  HYPERLINK \l "_Toc477252744" 1.0 Scope  PAGEREF _Toc477252744 \h 9  HYPERLINK \l "_Toc477252745" 1.1 Products and services  PAGEREF _Toc477252745 \h 9  HYPERLINK \l "_Toc477252746" 1.2 Applicability  PAGEREF _Toc477252746 \h 9  HYPERLINK \l "_Toc477252747" 1.3 Quality policy statement  PAGEREF _Toc477252747 \h 10  HYPERLINK \l "_Toc477252748" 2.0 Company history and contact information  PAGEREF _Toc477252748 \h 11  HYPERLINK \l "_Toc477252749" 3.0 Terms and definitions  PAGEREF _Toc477252749 \h 11  HYPERLINK \l "_Toc477252750" 4.0 Context of the organization  PAGEREF _Toc477252750 \h 12  HYPERLINK \l "_Toc477252751" 4.1 Understanding the organization and its context  PAGEREF _Toc477252751 \h 12  HYPERLINK \l "_Toc477252752" 4.2 Understanding the needs and expectations of interested parties  PAGEREF _Toc477252752 \h 12  HYPERLINK \l "_Toc477252753" 4.3 Determining the scope of the quality management system  PAGEREF _Toc477252753 \h 13  HYPERLINK \l "_Toc477252754" 4.3.1 Determining the scope of the quality management system - supplemental  PAGEREF _Toc477252754 \h 13  HYPERLINK \l "_Toc477252755" 4.3.2 Customer-specific requirements  PAGEREF _Toc477252755 \h 13  HYPERLINK \l "_Toc477252756" 4.4 Quality management system and its processes  PAGEREF _Toc477252756 \h 13  HYPERLINK \l "_Toc477252757" 4.4.1.1 Conformance of products and processes  PAGEREF _Toc477252757 \h 17  HYPERLINK \l "_Toc477252758" 4.4.1.2 Product safety  PAGEREF _Toc477252758 \h 17  HYPERLINK \l "_Toc477252759" 5.0 Leadership  PAGEREF _Toc477252759 \h 17  HYPERLINK \l "_Toc477252760" 5.1 Leadership and commitment  PAGEREF _Toc477252760 \h 17  HYPERLINK \l "_Toc477252761" 5.1.1 General  PAGEREF _Toc477252761 \h 17  HYPERLINK \l "_Toc477252762" 5.1.1.1 Corporate responsibility  PAGEREF _Toc477252762 \h 18  HYPERLINK \l "_Toc477252763" 5.1.1.2 Process effectiveness and efficiency  PAGEREF _Toc477252763 \h 18  HYPERLINK \l "_Toc477252764" 5.1.1.3 Process owners  PAGEREF _Toc477252764 \h 19  HYPERLINK \l "_Toc477252765" 5.1.2 Customer focus  PAGEREF _Toc477252765 \h 19  HYPERLINK \l "_Toc477252766" 5.2 Policy  PAGEREF _Toc477252766 \h 19  HYPERLINK \l "_Toc477252767" 5.2.1 Establishing the quality policy  PAGEREF _Toc477252767 \h 19  HYPERLINK \l "_Toc477252768" 5.2.2 Communicating the quality policy  PAGEREF _Toc477252768 \h 20  HYPERLINK \l "_Toc477252769" 5.3 Organizational roles, responsibilities and authorities  PAGEREF _Toc477252769 \h 20  HYPERLINK \l "_Toc477252770" 5.3.1 Organizational roles, responsibilities, and authorities supplemental  PAGEREF _Toc477252770 \h 22  HYPERLINK \l "_Toc477252771" 5.3.2 Responsibility and authority for product requirements and corrective actions  PAGEREF _Toc477252771 \h 22  HYPERLINK \l "_Toc477252772" 5.4 Management responsibilities  PAGEREF _Toc477252772 \h 22  HYPERLINK \l "_Toc477252773" 5.5 Management representative  PAGEREF _Toc477252773 \h 23  HYPERLINK \l "_Toc477252774" 6.0 Planning  PAGEREF _Toc477252774 \h 24  HYPERLINK \l "_Toc477252775" 6.1 Actions to address risk and opportunities  PAGEREF _Toc477252775 \h 24  HYPERLINK \l "_Toc477252776" 6.1.1  PAGEREF _Toc477252776 \h 24  HYPERLINK \l "_Toc477252777" 6.1.2  PAGEREF _Toc477252777 \h 24  HYPERLINK \l "_Toc477252778" 6.1.2.1 Risk analysis  PAGEREF _Toc477252778 \h 25  HYPERLINK \l "_Toc477252779" 6.1.2.2 Preventive action  PAGEREF _Toc477252779 \h 25  HYPERLINK \l "_Toc477252780" 6.1.2.3 Contingency plans  PAGEREF _Toc477252780 \h 25  HYPERLINK \l "_Toc477252781" 6.2 Quality objectives and planning to achieve them  PAGEREF _Toc477252781 \h 27  HYPERLINK \l "_Toc477252782" 6.2.1 General  PAGEREF _Toc477252782 \h 27  HYPERLINK \l "_Toc477252783" 6.2.2 Planning to achieve quality objectives  PAGEREF _Toc477252783 \h 27  HYPERLINK \l "_Toc477252784" 6.2.2.1 Quality objectives and planning to achieve them - supplemental  PAGEREF _Toc477252784 \h 27  HYPERLINK \l "_Toc477252785" 6.2.3 Classification of quality objectives  PAGEREF _Toc477252785 \h 28  HYPERLINK \l "_Toc477252786" 6.2.4 Key initiatives  PAGEREF _Toc477252786 \h 28  HYPERLINK \l "_Toc477252787" 6.3 Planning of changes  PAGEREF _Toc477252787 \h 28  HYPERLINK \l "_Toc477252788" 7.0 Support  PAGEREF _Toc477252788 \h 29  HYPERLINK \l "_Toc477252789" 7.1 Resources  PAGEREF _Toc477252789 \h 29  HYPERLINK \l "_Toc477252790" 7.1.1 General  PAGEREF _Toc477252790 \h 29  HYPERLINK \l "_Toc477252791" 7.1.1.1 Responsibilities for determination of required resources  PAGEREF _Toc477252791 \h 30  HYPERLINK \l "_Toc477252792" 7.1.1.2 Provision of resources  PAGEREF _Toc477252792 \h 30  HYPERLINK \l "_Toc477252793" 7.1.2 People  PAGEREF _Toc477252793 \h 30  HYPERLINK \l "_Toc477252794" 7.1.3 Infrastructure  PAGEREF _Toc477252794 \h 30  HYPERLINK \l "_Toc477252795" 7.1.3.1 Plant, facility, and equipment planning  PAGEREF _Toc477252795 \h 30  HYPERLINK \l "_Toc477252796" 7.1.4 Environment for the operation of processes  PAGEREF _Toc477252796 \h 31  HYPERLINK \l "_Toc477252797" 7.1.4.1 Environment for the operation of processes supplemental  PAGEREF _Toc477252797 \h 31  HYPERLINK \l "_Toc477252798" 7.1.4.2 Personnel safety to achieve product quality  PAGEREF _Toc477252798 \h 32  HYPERLINK \l "_Toc477252799" 7.1.5 Monitoring and measuring resources  PAGEREF _Toc477252799 \h 32  HYPERLINK \l "_Toc477252800" 7.1.5.1 General  PAGEREF _Toc477252800 \h 32  HYPERLINK \l "_Toc477252801" 7.1.5.2 Measurement traceability  PAGEREF _Toc477252801 \h 33  HYPERLINK \l "_Toc477252802" 7.1.5.3 Laboratory requirements  PAGEREF _Toc477252802 \h 34  HYPERLINK \l "_Toc477252803" 7.1.6 Organizational knowledge  PAGEREF _Toc477252803 \h 35  HYPERLINK \l "_Toc477252804" 7.2 Competence  PAGEREF _Toc477252804 \h 35  HYPERLINK \l "_Toc477252805" 7.2.1 General  PAGEREF _Toc477252805 \h 35  HYPERLINK \l "_Toc477252806" 7.2.2 Competence, awareness and training  PAGEREF _Toc477252806 \h 36  HYPERLINK \l "_Toc477252807" 7.2.2.1 Competence on-the-job training  PAGEREF _Toc477252807 \h 36  HYPERLINK \l "_Toc477252808" 7.2.3 Internal auditor competency  PAGEREF _Toc477252808 \h 36  HYPERLINK \l "_Toc477252809" 7.2.4 Second-party auditor competency  PAGEREF _Toc477252809 \h 37  HYPERLINK \l "_Toc477252810" 7.3 Awareness  PAGEREF _Toc477252810 \h 37  HYPERLINK \l "_Toc477252811" 7.3.1 Awareness supplemental  PAGEREF _Toc477252811 \h 38  HYPERLINK \l "_Toc477252812" 7.3.2 Employee motivation and empowerment  PAGEREF _Toc477252812 \h 38  HYPERLINK \l "_Toc477252813" 7.4 Communication  PAGEREF _Toc477252813 \h 38  HYPERLINK \l "_Toc477252814" 7.4.1 General  PAGEREF _Toc477252814 \h 38  HYPERLINK \l "_Toc477252815" 7.4.2 Internal communication  PAGEREF _Toc477252815 \h 39  HYPERLINK \l "_Toc477252816" 7.4.3 External communication  PAGEREF _Toc477252816 \h 39  HYPERLINK \l "_Toc477252817" 7.5 Documented information  PAGEREF _Toc477252817 \h 39  HYPERLINK \l "_Toc477252818" 7.5.1 General  PAGEREF _Toc477252818 \h 39  HYPERLINK \l "_Toc477252819" 7.5.1.1 Quality management system documentation  PAGEREF _Toc477252819 \h 40  HYPERLINK \l "_Toc477252820" 7.5.1.2 Quality system manual  PAGEREF _Toc477252820 \h 40  HYPERLINK \l "_Toc477252821" 7.5.2 Creating and updating  PAGEREF _Toc477252821 \h 40  HYPERLINK \l "_Toc477252822" 7.5.3 Control of documented information  PAGEREF _Toc477252822 \h 40  HYPERLINK \l "_Toc477252823" 8.0 Operation  PAGEREF _Toc477252823 \h 41  HYPERLINK \l "_Toc477252824" 8.1 Operational planning and control  PAGEREF _Toc477252824 \h 42  HYPERLINK \l "_Toc477252825" 8.1.1 Planning of product and service realization  PAGEREF _Toc477252825 \h 42  HYPERLINK \l "_Toc477252826" 8.1.2 Operational planning and control supplemental  PAGEREF _Toc477252826 \h 43  HYPERLINK \l "_Toc477252827" 8.1.3 Confidentiality  PAGEREF _Toc477252827 \h 43  HYPERLINK \l "_Toc477252828" 8.1.4 Acceptance criteria  PAGEREF _Toc477252828 \h 43  HYPERLINK \l "_Toc477252829" 8.2 Requirements for products and services  PAGEREF _Toc477252829 \h 43  HYPERLINK \l "_Toc477252830" 8.2.1 Customer communication  PAGEREF _Toc477252830 \h 43  HYPERLINK \l "_Toc477252831" 8.2.1.1 Customer communication supplemental  PAGEREF _Toc477252831 \h 44  HYPERLINK \l "_Toc477252832" 8.2.2 Determining the requirements related to products and services  PAGEREF _Toc477252832 \h 44  HYPERLINK \l "_Toc477252833" 8.2.2.1 Determining the requirements for products and services supplemental  PAGEREF _Toc477252833 \h 44  HYPERLINK \l "_Toc477252834" 8.2.3 Review of requirements related to products and services  PAGEREF _Toc477252834 \h 45  HYPERLINK \l "_Toc477252835" 8.2.3.1 Review of requirements related to products and services supplemental  PAGEREF _Toc477252835 \h 45  HYPERLINK \l "_Toc477252836" 8.2.3.2 Customer- designated special characteristics  PAGEREF _Toc477252836 \h 45  HYPERLINK \l "_Toc477252837" 8.2.3.3 Organization manufacturing feasibility  PAGEREF _Toc477252837 \h 45  HYPERLINK \l "_Toc477252838" 8.2.4 Changes to requirements for products and services  PAGEREF _Toc477252838 \h 46  HYPERLINK \l "_Toc477252839" 8.3 Design and development of products and services  PAGEREF _Toc477252839 \h 46  HYPERLINK \l "_Toc477252840" 8.3.1 General  PAGEREF _Toc477252840 \h 46  HYPERLINK \l "_Toc477252841" 8.3.1.1 Design and development of products and services supplemental  PAGEREF _Toc477252841 \h 47  HYPERLINK \l "_Toc477252842" 8.3.2 Design and development planning  PAGEREF _Toc477252842 \h 47  HYPERLINK \l "_Toc477252843" 8.3.2.1 Design and development planning supplemental  PAGEREF _Toc477252843 \h 47  HYPERLINK \l "_Toc477252844" 8.3.2.2 Product design skills  PAGEREF _Toc477252844 \h 48  HYPERLINK \l "_Toc477252845" 8.3.2.3 Development of products with embedded software  PAGEREF _Toc477252845 \h 49  HYPERLINK \l "_Toc477252846" 8.3.3 Design and development inputs  PAGEREF _Toc477252846 \h 49  HYPERLINK \l "_Toc477252847" 8.3.3.1 Product design input  PAGEREF _Toc477252847 \h 49  HYPERLINK \l "_Toc477252848" 8.3.3.2 Manufacturing process design input  PAGEREF _Toc477252848 \h 50  HYPERLINK \l "_Toc477252849" 8.3.3.3 Special characteristics  PAGEREF _Toc477252849 \h 51  HYPERLINK \l "_Toc477252850" 8.3.4 Design and development controls  PAGEREF _Toc477252850 \h 51  HYPERLINK \l "_Toc477252851" 8.3.4.1 General  PAGEREF _Toc477252851 \h 51  HYPERLINK \l "_Toc477252852" 8.3.4.2 Design and development review  PAGEREF _Toc477252852 \h 51  HYPERLINK \l "_Toc477252853" 8.3.4.3 Design and development validation  PAGEREF _Toc477252853 \h 52  HYPERLINK \l "_Toc477252854" 8.3.4.4 Prototype programme  PAGEREF _Toc477252854 \h 53  HYPERLINK \l "_Toc477252855" 8.3.4.5 Product approval process  PAGEREF _Toc477252855 \h 53  HYPERLINK \l "_Toc477252856" 8.3.5 Design and development outputs  PAGEREF _Toc477252856 \h 53  HYPERLINK \l "_Toc477252857" 8.3.5.1 Design and development outputs supplemental  PAGEREF _Toc477252857 \h 53  HYPERLINK \l "_Toc477252858" 8.3.5.2 Manufacturing process design output  PAGEREF _Toc477252858 \h 54  HYPERLINK \l "_Toc477252859" 8.3.6 Design and development changes  PAGEREF _Toc477252859 \h 55  HYPERLINK \l "_Toc477252860" 8.3.6.1 Design and development changes supplemental  PAGEREF _Toc477252860 \h 55  HYPERLINK \l "_Toc477252861" 8.4 Control of externally provided processes, products and services  PAGEREF _Toc477252861 \h 55  HYPERLINK \l "_Toc477252862" 8.4.1 General  PAGEREF _Toc477252862 \h 56  HYPERLINK \l "_Toc477252863" 8.4.1.1 General - supplemental (under control of externally provided processes, products and services)  PAGEREF _Toc477252863 \h 56  HYPERLINK \l "_Toc477252864" 8.4.1.2 Supplier selection process  PAGEREF _Toc477252864 \h 56  HYPERLINK \l "_Toc477252865" 8.4.1.3 Customer-Directed Sources (also known as DirectedBuy)  PAGEREF _Toc477252865 \h 57  HYPERLINK \l "_Toc477252866" 8.4.2 Type and extent of control  PAGEREF _Toc477252866 \h 57  HYPERLINK \l "_Toc477252867" 8.4.2.1 Type and extent of control supplemental  PAGEREF _Toc477252867 \h 58  HYPERLINK \l "_Toc477252868" 8.4.2.2 Statutory and regulatory requirements  PAGEREF _Toc477252868 \h 58  HYPERLINK \l "_Toc477252869" 8.4.2.3 Supplier quality management system development  PAGEREF _Toc477252869 \h 58  HYPERLINK \l "_Toc477252870" 8.4.2.4 Supplier monitoring  PAGEREF _Toc477252870 \h 59  HYPERLINK \l "_Toc477252871" 8.4.2.5 Verification of purchased product  PAGEREF _Toc477252871 \h 61  HYPERLINK \l "_Toc477252872" 8.4.3 Information for external providers  PAGEREF _Toc477252872 \h 61  HYPERLINK \l "_Toc477252873" 8.4.3.1 Purchasing information  PAGEREF _Toc477252873 \h 61  HYPERLINK \l "_Toc477252874" 8.4.3.2 Information for external providers supplemental  PAGEREF _Toc477252874 \h 62  HYPERLINK \l "_Toc477252875" 8.5 Production and service provision  PAGEREF _Toc477252875 \h 62  HYPERLINK \l "_Toc477252876" 8.5.1 Control of production and service provision  PAGEREF _Toc477252876 \h 62  HYPERLINK \l "_Toc477252877" 8.5.1.1 Control plan  PAGEREF _Toc477252877 \h 63  HYPERLINK \l "_Toc477252878" 8.5.1.2 Standardized work operator instructions and visual standards  PAGEREF _Toc477252878 \h 64  HYPERLINK \l "_Toc477252879" 8.5.1.3 Verification of job set-ups  PAGEREF _Toc477252879 \h 64  HYPERLINK \l "_Toc477252880" 8.5.1.4 Verification after shutdown  PAGEREF _Toc477252880 \h 64  HYPERLINK \l "_Toc477252881" 8.5.1.5 Total productive maintenance  PAGEREF _Toc477252881 \h 64  HYPERLINK \l "_Toc477252882" 8.5.1.6 Management of production tooling and manufacturing, test, inspection tooling and equipment  PAGEREF _Toc477252882 \h 65  HYPERLINK \l "_Toc477252883" 8.5.1.7 Production scheduling  PAGEREF _Toc477252883 \h 66  HYPERLINK \l "_Toc477252884" 8.5.1.8 Validation of processes for production and service provision  PAGEREF _Toc477252884 \h 66  HYPERLINK \l "_Toc477252885" 8.5.2 Identification and traceability  PAGEREF _Toc477252885 \h 67  HYPERLINK \l "_Toc477252886" 8.5.2.1 Identification and traceability supplemental  PAGEREF _Toc477252886 \h 67  HYPERLINK \l "_Toc477252887" 8.5.3 Property belonging to customers or external providers  PAGEREF _Toc477252887 \h 68  HYPERLINK \l "_Toc477252888" 8.5.4 Preservation  PAGEREF _Toc477252888 \h 68  HYPERLINK \l "_Toc477252889" 8.5.4.1 Preservation supplemental  PAGEREF _Toc477252889 \h 68  HYPERLINK \l "_Toc477252890" 8.5.5 Post-delivery activities  PAGEREF _Toc477252890 \h 69  HYPERLINK \l "_Toc477252891" 8.5.5.1 Feedback of information from service  PAGEREF _Toc477252891 \h 69  HYPERLINK \l "_Toc477252892" 8.5.5.2 Service agreement with customer  PAGEREF _Toc477252892 \h 69  HYPERLINK \l "_Toc477252893" 8.5.6 Control of changes  PAGEREF _Toc477252893 \h 70  HYPERLINK \l "_Toc477252894" 8.5.6.1 Control of changes supplemental  PAGEREF _Toc477252894 \h 70  HYPERLINK \l "_Toc477252895" 8.6 Release of products and services  PAGEREF _Toc477252895 \h 71  HYPERLINK \l "_Toc477252896" 8.6.1 Release of products and services supplemental  PAGEREF _Toc477252896 \h 71  HYPERLINK \l "_Toc477252897" 8.6.2 Layout inspection and functional testing  PAGEREF _Toc477252897 \h 72  HYPERLINK \l "_Toc477252898" 8.6.3 Appearance items  PAGEREF _Toc477252898 \h 72  HYPERLINK \l "_Toc477252899" 8.6.4 Verification and acceptance of conformity of externally provided products and services  PAGEREF _Toc477252899 \h 72  HYPERLINK \l "_Toc477252900" 8.6.5 Statutory and regulatory conformity  PAGEREF _Toc477252900 \h 73  HYPERLINK \l "_Toc477252901" 8.6.6 Acceptance criteria  PAGEREF _Toc477252901 \h 73  HYPERLINK \l "_Toc477252902" 8.7 Control of nonconforming outputs  PAGEREF _Toc477252902 \h 73  HYPERLINK \l "_Toc477252903" 8.7.1.1 Customer authorization for concession  PAGEREF _Toc477252903 \h 74  HYPERLINK \l "_Toc477252904" 8.7.1.2 Control of nonconforming product customer specified process  PAGEREF _Toc477252904 \h 74  HYPERLINK \l "_Toc477252905" 8.7.1.3 Control of suspect product  PAGEREF _Toc477252905 \h 74  HYPERLINK \l "_Toc477252906" 8.7.1.4 Control of reworked product  PAGEREF _Toc477252906 \h 74  HYPERLINK \l "_Toc477252907" 8.7.1.5 Control of repaired product  PAGEREF _Toc477252907 \h 75  HYPERLINK \l "_Toc477252908" 8.7.1.6 Customer notification  PAGEREF _Toc477252908 \h 75  HYPERLINK \l "_Toc477252909" 8.7.1.7 Nonconforming product disposition  PAGEREF _Toc477252909 \h 75  HYPERLINK \l "_Toc477252910" 9.0 Performance evaluation  PAGEREF _Toc477252910 \h 75  HYPERLINK \l "_Toc477252911" 9.1 Monitoring, measurement, analysis, and evaluation  PAGEREF _Toc477252911 \h 76  HYPERLINK \l "_Toc477252912" 9.1.1 General  PAGEREF _Toc477252912 \h 76  HYPERLINK \l "_Toc477252913" 9.1.1.1 Monitoring and measurement of manufacturing processes  PAGEREF _Toc477252913 \h 76  HYPERLINK \l "_Toc477252914" 9.1.1.2 Identification of statistical tools  PAGEREF _Toc477252914 \h 77  HYPERLINK \l "_Toc477252915" 9.1.1.3 Application of statistical concepts  PAGEREF _Toc477252915 \h 77  HYPERLINK \l "_Toc477252916" 9.1.2 Customer satisfaction  PAGEREF _Toc477252916 \h 77  HYPERLINK \l "_Toc477252917" 9.1.2.1 Customer satisfaction supplemental  PAGEREF _Toc477252917 \h 78  HYPERLINK \l "_Toc477252918" 9.1.3 Analysis and evaluation  PAGEREF _Toc477252918 \h 78  HYPERLINK \l "_Toc477252919" 9.1.3.1 Prioritization  PAGEREF _Toc477252919 \h 79  HYPERLINK \l "_Toc477252920" 9.2 Internal audit  PAGEREF _Toc477252920 \h 79  HYPERLINK \l "_Toc477252921" 9.2.1.1 Internal audit program  PAGEREF _Toc477252921 \h 80  HYPERLINK \l "_Toc477252922" 9.2.1.2 Quality management system audit  PAGEREF _Toc477252922 \h 80  HYPERLINK \l "_Toc477252923" 9.2.1.3 Manufacturing process audit  PAGEREF _Toc477252923 \h 81  HYPERLINK \l "_Toc477252924" 9.2.1.4 Product audit  PAGEREF _Toc477252924 \h 81  HYPERLINK \l "_Toc477252925" 9.3 Management review  PAGEREF _Toc477252925 \h 81  HYPERLINK \l "_Toc477252926" 9.3.1 General  PAGEREF _Toc477252926 \h 81  HYPERLINK \l "_Toc477252927" 9.3.1.1 Management review supplemental  PAGEREF _Toc477252927 \h 81  HYPERLINK \l "_Toc477252928" 9.3.2 Management review inputs  PAGEREF _Toc477252928 \h 81  HYPERLINK \l "_Toc477252929" 9.3.2.1 Management review inputs supplemental  PAGEREF _Toc477252929 \h 82  HYPERLINK \l "_Toc477252930" 9.3.3 Management review outputs  PAGEREF _Toc477252930 \h 82  HYPERLINK \l "_Toc477252931" 9.3.3.1 Management review outputs supplemental  PAGEREF _Toc477252931 \h 83  HYPERLINK \l "_Toc477252932" 10.0 Improvement  PAGEREF _Toc477252932 \h 83  HYPERLINK \l "_Toc477252933" 10.1 General  PAGEREF _Toc477252933 \h 83  HYPERLINK \l "_Toc477252934" 10.2 Nonconformity and corrective action  PAGEREF _Toc477252934 \h 83  HYPERLINK \l "_Toc477252935" 10.2.1  PAGEREF _Toc477252935 \h 84  HYPERLINK \l "_Toc477252936" 10.2.2  PAGEREF _Toc477252936 \h 84  HYPERLINK \l "_Toc477252937" 10.2.3 Problem solving  PAGEREF _Toc477252937 \h 84  HYPERLINK \l "_Toc477252938" 10.2.4 Error-proofing  PAGEREF _Toc477252938 \h 85  HYPERLINK \l "_Toc477252939" 10.2.5 Warranty management systems  PAGEREF _Toc477252939 \h 85  HYPERLINK \l "_Toc477252940" 10.2.6 Customer complaints and field failure test analysis  PAGEREF _Toc477252940 \h 86  HYPERLINK \l "_Toc477252941" 10.3 Continual improvement  PAGEREF _Toc477252941 \h 86  HYPERLINK \l "_Toc477252942" 10.3.1 Continual improvement supplemental  PAGEREF _Toc477252942 \h 86  HYPERLINK \l "_Toc477252943" Inspection and Test Procedure  PAGEREF _Toc477252943 \h 88  HYPERLINK \l "_Toc477252944" Corrective and Preventive Action Procedure  PAGEREF _Toc477252944 \h 92  Introduction XYZ Company recognizes its responsibility as a manufacturer of quality products/provider of quality services. To this end, XYZ Company has developed and documented a quality management system. The quality management system complies with the international standard IATF 16949:2016, Automotive Quality Management System Standard. The quality management system is commonly referred to as the quality system or QMS. This Quality Manual applies to sites of the organization where customer-specified parts, for production and/or service, are manufactured, supporting functions, whether on-site or remote and throughout the entire automotive supply chain. The purpose of this manual is to provide comprehensive evidence to all customers, suppliers and employees of what specific controls are implemented to ensure product/service quality. This manual also governs the creation of quality related documented information. It will be revised, as necessary, to reflect the quality system currently in use. It is issued on a controlled copy basis to all internal functions affected by the quality management system and on an uncontrolled copy basis to customers and suppliers. It may be issued to customers on a controlled copy basis upon customer request. This manual is divided into ten main sections. Sections 4-10 are modeled on the sectional organization of the IATF 16949:2016 standard. Sections are further subdivided into several subsections representing main quality system elements or activities. __________________________________ (Name), President 4.4.1.1 Conformance of products and processes XYZ Company ensures that all products and processes conform to all applicable customer, regulatory, statutory requirements, and expectations of all interested parties. This includes outsourced processes and parts for services. For details, refer to the Risk Management Procedure, Process Control Procedure, Inspection and Test Procedure, Purchasing Procedure, Servicing Procedure, Internal Audits Procedure, and Management Review Procedure. 4.4.1.2 Product safety XYZ Companys has developed and implemented a Product Safety Management Procedure to manage product safety. Design, manufacturing, and servicing processes further support product safety initiatives. 5.1.1.1 Corporate responsibility XYZ Company promotes an ethical business culture and focuses on maintaining integrity in all of its business activities. To this end, XYZ Company has developed and enforces documented corporate responsibility policies. For details, refer to the Anti-Bribery Policy and Employee Code of Conduct, which also includes an escalation policy. 6.1.2.1 Risk analysis XYZ Company periodically reviews lessons learned from product recalls, product audits, field returns and repairs, complaints, scrap, rework, and includes them in risk analysis. The effectiveness of these actions is evaluated, and actions are integrated in to XYZ Companys quality management system. For details, refer to the Risk Management Procedure. 6.2.4 Key initiatives The management of XYZ Company establishes annual key initiatives, which include quality objectives. The objectives are established via the Management Review Procedure and communicated to all levels of the organization for use in establishing each functions and employees annual key objectives. Quality objectives are measurable, include business performance indicators reflecting requirements for products/services, and are consistent with the quality policy including the commitment to continuous improvement. The use of quality objectives for facilitating continual improvement is explained in the Continual Improvement Procedure. 8.0 Operation 8.1 Operational planning and control 8.1.1 Planning of product and service realization XYZ Company has established and maintains a documented Product and Service Realization Planning Procedure to ensure that processes and sub-processes are conducted under controlled conditions. Planning of the realization processes is consistent with the other requirements of the organizations quality management system. 8.3.2.3 Development of products with embedded software XYZ Company maintains and follows a documented a software quality assurance process for products with internally developed embedded software. XYZ Company uses an appropriate assessment methodology to assess its software development process. 8.4.1 General XYZ Company ensures that the purchasing process is controlled such that purchased products and subcontracted services, which affect product/service quality, conform to specified requirements. 8.4.2.3.1 Automotive product-related software or automotive products with embedded software XYZ Company require suppliers of software-related products, or products with embedded software to maintain software quality assurance process for its products, this includes a software development assessment methodology. The requirements within Section 8.3.2.3 of this manual also apply to XYZ Company suppliers. For details refer to Section 8.3.2.3. Inspection and Test Procedurexe "Inspection and Test Procedure" Receiving Inspection and Test All purchased material which influences the manufacture of, or is intended for use as part of, deliverable products is subject to inspection and/or testing by Receiving Inspection. Upon receipt of products, receiving personnel verify the quantity of delivered units, check marking and identification of packages, and inspect all packages for any signs of tampering or damage. If all these checks and inspections are satisfactory, receiving personnel signs the delivery receipt. If not, any shortages or damages are noted on all copies of the delivery receipts. The received containers are then moved to the designated inspection area, a copy of the purchase order is retrieved, and the packing slips are removed from the containers. Upon opening the containers, the goods are verified against the purchase order and the packing slip, and are examined visually for any signs of damage. The purchase order is stamped RECEIVED and is signed and dated by the receiving inspector. All receiving inspections are logged in the Receiving Inspection Log. On critical parts and components, as determined by the Quality Manager, a precision inspection/test is performed. This type of inspection includes one or more of the following: review of material certificates, supplier inspection records, compliance certificates, and any other relevant documentation delivered with the product receipt of, and evaluation of, statistical data random sampling based on statistical technique specified 100% Inspection/testing if necessary visual inspection to detect any damage or other visible problems performing measurements and testing against specified requirements second or third party assessments or audits of supplier sites, when combined with records of acceptable delivered product quality part evaluation by a designated laboratory another method agreed with the customer Results of such inspection/test, including recording the sample size and actual measurements are recorded on the Inspection/Test & Audit Report Where it is not practical to perform receiving inspection upon receipt, provisions are made to perform source inspection at the suppliers facility. The Quality Manager determines the extent and scope of receiving inspection based on the importance of the item and the suppliers control methods and performance. The Quality Manager may request that suppliers provide objective evidence of conformance (i.e., material certifications, certificates of conformance, test data, first article inspection and SPC data). Objective evidence provided by suppliers may be used as the basis for reducing/waiving receiving and source inspection. Upon acceptance, products are identified with an ACCEPT tag [green sticker] and moved to stock. In the event that product which is designated for receiving inspection is released to production due to urgency, it shall be positively identified and recorded in receiving inspection records. In-process Inspection and Test In-process inspection/testing is conducted to ensure that the product/process conforms to specified requirements. The inspection/testing is normally carried out by production personnel. Random audits of the in-process inspection/testing process are conducted by quality control personnel. The Quality Manager determines the extent and scope of in-process inspection/testing based on the importance of the item, control methods, and previous performance. Final Inspection and Test For acceptance of completed products, final inspection/testing is utilized. This includes a verification of satisfactory receiving and in-process inspections/tests, as well as completion of the remaining inspections/tests to assure that the finished products/processes conform to specified requirements. Products are not released, processes are not approved until all inspection/test activities have been satisfactorily completed and the appropriate documentation is available and authorized. All final inspections are logged in the Final Inspection Log. On critical parts and components, as determined by the Quality Manager, a Final Inspection/Test & Audit Report is completed. XYZ Company ensures the planned arrangement, to verify that the products and service requirements have been satisfied, are aligned with the control plan and are documented as specifies in the control plan. XYZ Company ensures that the planned arrangements for initial release of products and services encompass product or services approval. When changes occur after initial release, XYZ Company ensures that product or services approvals are obtained in accordance with section 8.5.6. A layout inspection and a functional verification to applicable customer engineering material and performance standards is performed for each product as specified in the control plans. The frequency of layout inspections is determined by the customer. Results are available for customer review. The Quality Manager determines the extent and scope of final inspection/testing based on the importance of the item, control methods, and previous performance. Inspection and Test Records Inspection/test records, which show clearly whether the product/process has passed or failed the defined acceptance criteria, are established and maintained. Nonconforming Material/Products All material/products that are found to be nonconforming are identified and segregated and/or quarantined, and appropriately dispositioned per the Control of Nonconforming Product Procedure. Corrective and Preventive Action Procedurexe "Corrective and Preventive Action Procedure" Initiation of Corrective/Preventive Actions Corrective actions may be requested when a condition, which is adverse to quality or which has the potential for product/process improvement is identified. This includes nonconforming material received from a supplier. Preventive actions may be requested when potential product/process problems are identified. Any employee of the company can initiate a corrective/preventive action request by completing the top portion of the Corrective Action Request (CAR) form, but only the Quality Manager can issue a Supplier Corrective Action Request (SCAR). The Quality Manager records all CARs in the Corrective Action Status Log and SCARs in the Supplier Corrective Action Status Log. Customer Complaints Marketing/Sales is responsible for receiving, processing, and responding to customer complaints. All received customer complaints are recorded in the Customer Complaints Status Log. The Quality Manager evaluates every complaint and when relevant, requests implementation of corrective actions from the responsible function. The Quality Manager, in conjunction with the President and Sales, determines the appropriate customer response. Field failures are handled as described in the Servicing Procedure. Analysis and Approvals A thorough analysis of all related processes, operations, quality records and specifications, which may have contributed to the deficiency, is conducted by the responsible function. The investigation and analysis of the root cause and preventive measures shall be fully documented by the group or individual assigned to the problem. The analysis shall include review of all applicable data and examination of product scrapped or reworked to determine the extent and cause of the problem and analysis of trends in processes or performance of work to prevent nonconformances. Analysis of corrective action and preventive action is used as input into management reviews. At a minimum, the following problem-solving methods are used: problem identification containment root cause identification verification of effectiveness of corrective action Additionally, the following methods may be used: analysis of failure mode capability studies correlation diagrams data collection fish bone diagram (ishikawa diagram) FMEA review histograms pareto analysis probability charts recording with corresponding graphic representations stratification (separation of data and divisions into categories) If a customer-prescribed problem-solving format exists, XYZ Company uses the prescribed format. All problems are evaluated in terms of potential impact on production costs, quality costs, performance, reliability, safety, and customer satisfaction. All problems are classified either minor or major. Resolutions to all corrective and preventive actions are reviewed and approved by the Quality Manager. Where the response is unsatisfactory, the corrective action request is re-issued. The Quality Manager conducts periodic reviews/follow up to determine if the corrective and preventive actions have been implemented and are effective. All department managers handle corrective /preventive actions in priority order. The Quality Manager ensures that all action plans are carried out in a reasonable timeframe relative to the severity of the problem. Preventive Actions When corrective actions are implemented or when a potentially serious nonconformance is identified, similar parts, products, and processes are analyzed to determine the required steps for effective implementation of preventive actions. Records All CARs, SCARs, customer complaints, software problem reports, surveys, returned product and post-production records, incident reports, advisory notices, recall records, and their resolution including their verification, are filed and maintained. The risk management files are updated as appropriate. QUALITY SYSTEMS INNOVATIONS, INC.  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