QMS Qualitäts-Management-Systeme. Key Points Regarding ISO/ TS 16949: 2009 If you have further questions let us know. We are ready to help.

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1 Key Points Regarding ISO/ TS 16949: 2009 If you have further questions let us know. We are ready to help. Heribert Nuhn QMS Germany D Strassenhaus Deutschland Tel.: Fax.: Mobil: Heribert.Nuhn@Nuhn-QMS.de FMEA RGA/ APQP ISO/ TS VDA 2/ PPAP Internal Auditor Awareness ISO/ TS : 2009 E 1 8D 5- Why DVP

2 International Automotive Task Force (IATF) Ass. Nazionale Fra Industrie Automobilistiche (ANFIA/ I) Comité des Constr. Français d Automobiles (CCFA/ F) Féd. des Ind. des Equipements pour Véhicule (FIEV/ F) Society of Motor Manufactures and Traders (SMMT/ UK) Verband der Automobilindustrie (VDA) Chrysler/ Ford/ GM PSA Peugeot Citroën, Renault Awareness ISO/ TS : 2009 E 2

3 ISO/ TS 16949: 2009 US & German QS-9000 APQP + CP PPAP FMEA MSA SPC QSA Bibliography QMS Automotive - Industry VDA 6.1 VDA 4.3 VDA 2 VDA 4.2 VDA Awareness ISO/ TS : 2009 E 3

4 Foreword boxed text is original ISO 9001: 2008 text sector-specific supplemental requirements are outside the boxes shall : indicates a requirement should : indicates a recommendation NOTE : for guidance or clarification of requirement such as : suggestions for guidance only changes from ISO 2001 to 2008 are unlined Annex A (Control Plan) forms a normative part of TS Awareness ISO/ TS : 2009 E 4

5 Contents 0 Introduction 1 Scope 2 Normative Reference 3 Terms and Definitions 4 Quality Management System 5 Management Responsibility Awareness ISO/ TS : 2009 E 5

6 Contents 6 Resource Management 7 Product Realization 8 Measurement, Analysis and Improvement Annex Phases of the Control Plan Elements of the Control Plan Bibliography Awareness ISO/ TS : 2009 E 6

7 Remarks for Certification The certification to this Technical Specification, including customer-specific requirements if any, is recognized by the customer members of IATF when achieved according to the IATF certification scheme ("Rules for achieving IATF recognition"). Details can be obtained at the addresses of the local oversight offices of the IATF (IAOB, VDA-QMC, IATF-France, ANFIA, SMMT) Awareness ISO/ TS : 2009 E 7

8 0 Introduction QMS 0.1 General Quality Management Systems (QMS) a strategic decision of the organization design and implementation of QMS influenced by: environment and associated changes and risks varying needs particular objectives of the organization products provided processes employed size and structure of the organization Awareness ISO/ TS : 2009 E 8

9 0 Introduction QMS 0.1 General uniformity in structure of QMS and documentation is not intended by this International ISO/ TS 16949: 2009 can be used to assess the organizations ability by internal or external parties (customers, certification bodies) to meet customer requirements statutory and regulatory requirements applicable to product and organizations own requirements Awareness ISO/ TS : 2009 E 9

10 0 Introduction QMS 0.2 Process Approach promotes the adoption of a process approach when developing implementing and improving effectiveness of QMS to enhance customer satisfaction by meeting customer requirements Awareness ISO/ TS : 2009 E 10

11 0 Introduction QMS 0.2 Process Approach for an organization to function effectively and efficiently, it has to identify and manage numerous linked activities. an activity using resources, and managed in order to enable the transformation of inputs into outputs, is considered as a process Awareness ISO/ TS : 2009 E 11

12 0 Introduction QMS 0.2 Process Approach the application of a system of processes within an organization together with the identification and interactions of these processes and their management to produce the desired outcome, can be referred to as the "process approach". an advantage of the process approach is the ongoing control of processes (systems like BSC, BOS, MOS, QOS) Awareness ISO/ TS : 2009 E 12

13 0 Introduction QMS 0.2 Process Approach emphasizes: understanding and meeting requirements the need to consider processes in terms of added value obtaining results of process performance and effectiveness and continual improvement of processes based on objective measurement Awareness ISO/ TS : 2009 E 13

14 0 Introduction QMS 0.2 Process Approach Plan-Do-Check-Act can be applied to all processes: (Plan-Do-Check-Act, PDAC see Deming) Plan: establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organizations policies Do: implement the processes Check: monitor and measure processes and product against policies, objectives and requirements for the product and report the results Act: take action to continually improve process performance Awareness ISO/ TS : 2009 E 14

15 Continual Improvement of the QMS QMS Interested parties Resource Management Management Responsibility Measurement analysis and improvement Interested parties Satisfaction Requirement Input Product realization Product Output Management Processes Supporting Processes Awareness ISO/ TS : 2009 E 15

16 0 Introduction QMS 0.3 Relationship with ISO 9004 compliments ISO Compatibility with other management systems enhances compatibility with other systems, does not include requirements of these systems like environmental management occupational health and safety requirements financial management or risk management Awareness ISO/ TS : 2009 E 16

17 0 Introduction QMS 0.5 Goal for ISO/ TS develop QMS for continuous improvement emphasizing defect prevention reduction of variation reduction of waste in the supply chain fundamental requirements for a QMS including customer-specific requirements avoiding multiple audits Awareness ISO/ TS : 2009 E 17

18 1 Scope QMS 1.1 General demonstrate the ability to consistently provide product that meets customer requirements and applicable statutory and regulatory requirements Awareness ISO/ TS : 2009 E 18

19 1 Scope QMS 1.1 General ISO/ TS aims to enhance customer satisfaction through effective application of the system including processes for continual improvement assurance of conformity to customer requirements and applicable statutory and regulatory requirements Awareness ISO/ TS : 2009 E 19

20 1 Scope QMS 1.1 General this Technical Specification in conjunction with ISO 9001: 2008 defines the QMS requirements for automotive related products in design and development production installation and service applicable to all sites, where customer-specified parts,for production and/ or service, are manufactured Awareness ISO/ TS : 2009 E 20

21 1 Scope QMS 1.1 General supporting functions, on-site or remote form part of the site audit as they support the site design centers corporate headquarters distribution centers supporting functions can not obtain stand-alone certification Awareness ISO/ TS : 2009 E 21

22 1 Scope QMS 1.2 Application all requirements of this International Standard are generic and intended to be applicable to all organizations, regardless of type and size of organization or type of product provided where requirements cannot be applied due to the nature of the organization or product, this can be considered for exclusion conformity to ISO/ TS, if exclusions relate to clause Awareness ISO/ TS : 2009 E 22

23 2 Normative References QMS for dated references, only cited edition applies changes should be checked for undated references the latest edition applies Awareness ISO/ TS : 2009 E 23

24 3 Terms and Definitions QMS Supplier Organization Customer "Organization" refers to the entity that this International Standard applies to "Supplier" replaces the term "sub-supplier" product can always include service Awareness ISO/ TS : 2009 E 24

25 3.1 Terms and Definitions for the Automotive Industry Laboratory Scope controlled document containing specific tests, evaluations and calibrations that a laboratory inspection is qualified to perform a list of the equipment which it uses to perform the above and a list of methods and standards to which it performs the above Awareness ISO/ TS : 2009 E 25

26 3.1 Terms and Definitions for the Automotive Industry Special Product Characteristics product characteristics production process characteristics, having influence on safety compliance with government regulations fit function and performance mounting Awareness ISO/ TS : 2009 E 26

27 3.1 Terms and Definitions for the Automotive Industry Remote Location location that supports sites and at which nonproduction processes occur Error Proofing product and manufacturing process design and development to prevent manufacture of nonconforming product Awareness ISO/ TS : 2009 E 27

28 3.1 Terms and Definitions for the Automotive Industry Laboratory facility for inspection test or calibration that may include, but is not limited to, chemical, metallurgical, dimensional, physical, electrical or reliability testing Awareness ISO/ TS : 2009 E 28

29 3.1 Terms and Definitions for the Automotive Industry Design Responsible Organization organization with authority to establish a new or change an existing product specification to include testing and verification Awareness ISO/ TS : 2009 E 29

30 3.1 Terms and Definitions for the Automotive Industry Manufacturing process of making or fabricating production materials production or service parts heat treating, welding, painting, plating or other finishing services Awareness ISO/ TS : 2009 E 30

31 3.1 Terms and Definitions for the Automotive Industry Control Plan documented description of the systems and processes required for controlling product (Annex A) Control plans for: Prototyp, Pre-Launch, Production: general data product control (product-related special characteristics) process control (process-related special characteristics) methods (measurement technique, error-proofing, sample size, frequency, control method) reaction plan, corrective action Awareness ISO/ TS : 2009 E 31

32 3.1 Terms and Definitions for the Automotive Industry Site location at which value added manufacturing processes occur Awareness ISO/ TS : 2009 E 32

33 3.1 Terms and Definitions for the Automotive Industry Predictive Maintenance activities, based on process data to prevent maintenance problems Preventive Maintenance planned activities based on data prepared during the product development process to prevent maintenance problems Awareness ISO/ TS : 2009 E 33

34 3.1 Terms and Definitions for the Automotive Industry Premium Freight extra costs for charges incurred by method quality unscheduled or late deliveries Awareness ISO/ TS : 2009 E 34

35 3.1 Terms and Definitions for the Automotive Industry 3.1.XX (4.1 NOTE 2) Outsourced Process an "outsourced process" is a process that the organization needs for its quality management system and which the organization chooses to have performed by an external party Awareness ISO/ TS : 2009 E 35

36 4 Quality Management System 4.1 General Requirements the organization shall establish document implement and maintain a quality management system and continually improve its effectiveness Awareness ISO/ TS : 2009 E 36

37 4 Quality Management System 4.1 General Requirements the organization shall determine processes needed for the Quality Management System and their application throughout the organization determine sequence and interaction of these processes determine criteria and methods to ensure effective operation of these processes and control of these processes Awareness ISO/ TS : 2009 E 37

38 4 Quality Management System 4.1 General Requirements ensure availability of resources and information necessary to support operation and support of processes processes must be monitored, measured where applicable and analyzed implement actions to achieve planned results and continual improvement of these processes Awareness ISO/ TS : 2009 E 38

39 4 Quality Management System 4.1 General Requirements processes shall be managed outsourced processes ensure control type and extend of control to be applied to these processes shall be defined in QMS NOTE 1: Processes needed for outsourced processes include: Management activities, provision of resources, product realization, measurement, analysis and improvement Awareness ISO/ TS : 2009 E 39

40 4 Quality Management System NOTE 2: An "outsourced process" is a process that the organization needs for its quality management system and which the organization chooses to have performed by an external party. NOTE 3: Responsibility for all customer, statutory and regulatory requirements related to outsourced processes General Requirements - Supplemental ensure control over outsourced processes responsibility for all customer requirements Awareness ISO/ TS : 2009 E 40

41 4 Quality Management System 4.2 Documentation Requirements General document quality policy and quality objectives document quality manual document procedures and records documents incl. records determined to be necessary by the organization to ensure the effective planning, operation and control of its processes (4.2.4) Awareness ISO/ TS : 2009 E 41

42 4 Quality Management System General extent of documentation of QMS may differ from one organization to another due to: size of organization type of activities complexity of processes and their interactions competence of personnel Awareness ISO/ TS : 2009 E 42

43 4 Quality Management System Quality Manual establish and maintain QM to define: scope of QMS justification for exclusions (chapter 7 only) document or reference procedures describe interaction between processes in the QMS Awareness ISO/ TS : 2009 E 43

44 4 Quality Management System Control of Documents documents shall be controlled records are a special type of document and shall be controlled according to requirements given in Awareness ISO/ TS : 2009 E 44

45 4 Quality Management System Control of Documents documented procedure to define the controls needed approve adequacy of documents prior to issue review and update as necessary and re-approve ensure changes and current revision status is identified ensure relevant versions are available at point of use ensure documents remain legible and readily identifiable Awareness ISO/ TS : 2009 E 45

46 4 Quality Management System Control of Documents documented procedure to define the controls needed ensure documents of external origin are identified and their distribution controlled prevent the unintended use of obsolete documents apply suitable identification to them if they are retained for any purpose Awareness ISO/ TS : 2009 E 46

47 4 Quality Management System Engineering Specifications establish a process to assure timely review, distribution and implementation of all customer engineering standards/ specifications and changes thereof. timely review shall not exceed 2 weeks maintain record of the date the change is implemented implementation of updated documentation (PPAP) Awareness ISO/ TS : 2009 E 47

48 4 Quality Management System Control of Records records established to provide evidence of conformity to requirements and the effectiveness of operation of the QMS shall be controlled records include customer-specified records Records Retention the control of records shall satisfy statutory, regulatory and customer requirements Awareness ISO/ TS : 2009 E 48

49 QM-System Documentation Progression QM- Manual QM-Procedures Job Instructions Level 1: Defines Approach & Responsibility Level 2: Defines Who, What, When Level 3: Answers How Documentation Level 4: Prompts recording of information Proves effectiveness Awareness ISO/ TS : 2009 E 49

50 5 Management Responsibility 5.1 Management commitment Top Mgmt shall provide evidence of commitment to development and implementation of QMS and continually improving its effectiveness communicate importance of customer as well as statutory and regulatory requirements establish quality policy and quality objectives conduct management reviews ensure availability of resources Awareness ISO/ TS : 2009 E 50

51 5 Management Responsibility Efficiency of processes evaluate product realization processes and supporting processes ensure effectiveness and efficiency 5.2 Customer focus ensure customer requirements are determined customer satisfaction enhanced Awareness ISO/ TS : 2009 E 51

52 5 Management Responsibility 5.3 Quality policy Top Mgmt shall insure that quality policy is appropriate for organization includes commitment to comply with requirements effectiveness of QMS is continually improved a framework for establishing quality objectives is provided is communicated and understood in the organization is reviewed for continuing suitability Awareness ISO/ TS : 2009 E 52

53 5 Management Responsibility 5.4 Planning Quality objectives ensure that quality objectives are established at relevant functions and levels within the organization measurable consistent within the quality policy Awareness ISO/ TS : 2009 E 53

54 5 Management Responsibility Quality objectives - supplement define quality objectives and measurements include quality objectives in business plan use quality objectives to deploy quality policy quality objectives should address customer expectations quality objectives should be achievable within a defined time period Awareness ISO/ TS : 2009 E 54

55 5 Management Responsibility Quality management system planning ensure requirements as given in 4.1 are carried out quality objectives are achievable wih the system integrity of QMS is maintained when changes to QMS are planned changes to QMS are implemented Awareness ISO/ TS : 2009 E 55

56 5 Management Responsibility 5.5 Responsibility, authority and communication Responsibility and authority ensure with the organization responsibility and authority are defined and communicated Awareness ISO/ TS : 2009 E 56

57 5 Management Responsibility Responsibility for quality managers with responsibility for corrective action shall be promptly informed of products or processes not conforming to requirements authorized to stop production to correct problems this regulation is valid for all shifts Awareness ISO/ TS : 2009 E 57

58 5 Management Responsibility Management representative Top Management shall appoint a member of the organizations management with responsibility and authority to QMS established, implemented and maintained report on performance of QMS and need for improvement promote awareness of customer requirements throughout the organization NOTE: The responsibility of the management representative can be can include liaison with external parties on matters relating to the QMS Awareness ISO/ TS : 2009 E 58

59 5 Management Responsibility Customer representative designate personnel with responsibility and authority to ensure customer requirements are addressed selection of special characteristics setting quality objectives related training corrective and preventive actions product design and development Awareness ISO/ TS : 2009 E 59

60 5 Management Responsibility Internal communication ensure appropriate communication processes are established communication shall include the effectiveness of the QMS Awareness ISO/ TS : 2009 E 60

61 5 Management Responsibility 5.6 Management review General Top Management shall review QMS in planned intervals to ensure its continuing suitability and adequacy effectiveness to include assessing opportunities for improvement and the need for changes to QMS, including quality policy and objectives records of management reviews shall be maintained Awareness ISO/ TS : 2009 E 61

62 5 Management Responsibility QMS Performance reviews shall include all requirements of QMS performance trends as an essential part of the continual improvement process monitoring quality objectives and regular reporting and evaluation of the cost of poor quality record results to provide evidence of achievement of quality objectives are met as specified in the business plan customer satisfaction with product supplied Awareness ISO/ TS : 2009 E 62

63 5 Management Responsibility Management review input include the following information results of audits customer feedback process performance and product conformity status of preventive and corrective actions follow-up of previous management reviews changes that could effect the QMS recommendations for improvement Awareness ISO/ TS : 2009 E 63

64 5 Management Responsibility Management review - supplement customer satisfaction with product supplied analysis of actual and potential field-failures and their impact on quality safety and environment Awareness ISO/ TS : 2009 E 64

65 5 Management Responsibility Management review output the output from the management review shall include any decisions and actions related to: improvement of the effectiveness of the QMS and its processes improvement of product related to customer requirements resources needed Awareness ISO/ TS : 2009 E 65

66 6 Resource Management QMS 6.1 Resource Management determine and provide the resources needed to implement and maintain QMS continually improve effectiveness of QMS enhance customer satisfaction by meeting customer requirements Awareness ISO/ TS : 2009 E 66

67 6 Resource Management QMS 6.2 Human Resources General personnel performing work affecting conformity to product shall be competent on the basis of : education, training skills experience Awareness ISO/ TS : 2009 E 67

68 6 Resource Management QMS Competence, Training and Awareness determine competence needed for personnel performing work affecting conformity to product requirements training/ other actions to achieve necessary competence evaluate effectiveness of actions taken ensure personnel awareness of relevance and importance of their activities and how they contribute to the achievement of quality objectives maintain appropriate records of training (4.2.4) Awareness ISO/ TS : 2009 E 68

69 6 Resource Management QMS Product Design Skills ensure competence of personnel with product design responsibility skilled in applicable tools and techniques applicable tools shall be identified by the organization Training documented procedures to identify training needs activities affecting conformity to product requirements qualification for specific tasks/ customer satisfaction Awareness ISO/ TS : 2009 E 69

70 6 Resource Management QMS Training on the Job activities affecting product quality for: all new or changed processes temporary personnel or sub-contracted personnel provide on-the job training ensure personnel is informed about consequences of defects for customer product and processes Awareness ISO/ TS : 2009 E 70

71 6 Resource Management QMS Employee Motivation and Empowerment process to motivate employees to achieve quality objectives and make continual improvements create an environment to promote innovation promote quality an technological awareness throughout the whole organization measure personnel awareness of relevance and importance of their activities and how they contribute to the achievement of quality objectives Awareness ISO/ TS : 2009 E 71

72 6 Resource Management QMS 6.3 Infrastructure as needed for conformity with product requirements buildings, workspace, associated utilities process equipment (hardware and software) supporting services (transport, communication or information systems) plant, facilities and layout plans flow charts (transport/ material handling) value added use of floor space contingency plans Awareness ISO/ TS : 2009 E 72

73 6 Resource Management QMS 6.4 Work Environment necessary environment needed to achieve conformity to product requirement product safety minimizing potential risk for employees, especially design and development process production process cleanliness as needed for product and production process Awareness ISO/ TS : 2009 E 73

74 7 Product Realization QMS 7.1 Planning of Product Realization (Organization) 7.2 Customer-related Processes (Sales/ Marketing) 7.3 Design and Development (Product and Process) 7.4 Purchasing 7.5 Production and Service Provision 7.6 Control of Monitoring and Measuring Equipment Awareness ISO/ TS : 2009 E 74

75 7.1 Planning of Product Realization plan and develop necessary processes consistent with requirements other processes of QMS determine as appropriate quality goals and requirements for product if needed install processes prepare documentation provide resources Awareness ISO/ TS : 2009 E 75

76 7.1 Planning of Product Realization as appropriate, define the following product specific activities verification and validation control testing acceptance criteria documentation (4.2.4), records providing evidence that the realization processes and resulting product meet requirements Awareness ISO/ TS : 2009 E 76

77 7.1 Planning of Product Realization The output of this shall be in a form suitable for the organization s method of operations Note: A document specifying the processes of the quality management system and the resources applied to a specific product, project or contract can be referred to as a quality plan Awareness ISO/ TS : 2009 E 77

78 7.1 Planning of Product Realization Planning of Product Realization - Supplemental include in quality plan customer requirements and references to its technical specifications Acceptance Criteria define acceptance criteria approved by customer (where required) attribute data sampling: zero defects Awareness ISO/ TS : 2009 E 78

79 7.1 Planning of Product Realization Confidentiality for products and projects under development including related product information Change Control install a process to control and react to design changes evaluate effects of changes verify and validate prior to production implementation Awareness ISO/ TS : 2009 E 79

80 7.1 Planning of Product Realization Change Control proprietary designs have have additional requirements impact on form, fit, function, performance, durability review and evaluate with customer verification and identification required any changes affecting customer requirements require notification of customer (prior) approval of customer applies to product and process changes Awareness ISO/ TS : 2009 E 80

81 7.2 Customer-related Processes Determination of Requirements related to the Product requirements to the product specified by the customer including requirements for delivery and post-delivery activities Awareness ISO/ TS : 2009 E 81

82 7.2 Customer-related Processes Determination of Requirements Related to the Product requirements not stated by the customer but necessary for specified or intended use, where known statutory and regulatory requirements any additional requirements determined by the customer Awareness ISO/ TS : 2009 E 82

83 7.2 Customer-related Processes Note including: product related servicing recycling, environmental requirements and specifics resulting from the organizations knowledge concerning product and production processes regulatory, safety and environmental regulations for handling, storage or final disposal of product Awareness ISO/ TS : 2009 E 83

84 7.2 Customer-related Processes Customer defined Special Characteristics document compliance with customer requirements regarding definition documentation controlling Awareness ISO/ TS : 2009 E 84

85 7.2 Customer-related Processes Review of Requirements Related to the Product prior to commitment to supply submission of tender acceptance of contracts or orders acceptance of changes of contracts or orders Awareness ISO/ TS : 2009 E 85

86 7.2 Customer-related Processes Review of Requirements Related to the Product prior to commitment to supply, ensure product requirements are defined requirements differing from those previously expressed are resolved organization has ability to meet the defined requirements record and maintain results (4.2.4) of reviews and actions taken Awareness ISO/ TS : 2009 E 86

87 7.2 Customer-related Processes Review of Requirements Related to the Product where the customer provides no documented statement of requirements, the customer requirements shall be confirmed by the organization before acceptance special situations: catalog, advertising material, internet sales where requirements are changed the organization shall amend relevant documents make relevant personnel aware of changes Awareness ISO/ TS : 2009 E 87

88 7.2 Customer-related Processes Review of Requirements Related to the Product - Supplement a waiver regarding a complete evaluation shall be approved by the customer Feasibility Commitment as part of contract review, analyze, confirm, document including a risk analysis Awareness ISO/ TS : 2009 E 88

89 7.2 Customer-related Processes Customer Communication determine and implement effective arrangements for communication with customers in relation to: product information enquiries, contracts or order handling, incl. amendments customer feedback, including customer complaints Awareness ISO/ TS : 2009 E 89

90 7.2 Customer-related Processes Customer Communication - Supplement the organization shall have the ability to communicate the necessary information, incl. data, in a customer-specified language and format (computer aided design data, electronic data exchange) Awareness ISO/ TS : 2009 E 90

91 7.3 Design and Development Note: The requirements of 7.3 include product and process design and development and focus on error prevention rather than error detection Awareness ISO/ TS : 2009 E 91

92 7.3 Design and Development Design and Development Planning plan and control design and development of product determine design and development phases at appropriate stages evaluate verify, validate responsibilities and authorities Awareness ISO/ TS : 2009 E 92

93 7.3 Design and Development Design and Development Planning the organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility planning output should be updated as appropriate Note: Design and development review, verification and validation as suitable for the product and the organization Awareness ISO/ TS : 2009 E 93

94 7.3 Design and Development Cross-functional Approach development, definition and control of special characteristics development and review of FMEA, including reduction of potential risks (RPN) development and review of Control Plans Prototype, Pre-Launch and Production Control Plan Awareness ISO/ TS : 2009 E 94

95 7.3 Design and Development Design and Development Input determine and maintain records relating to input for product requirements (4.2.4) functional and performance requirements applicable statutory and regulatory requirements information from previous or similar design other requirements, essential for design and development the inputs shall be reviewed for adequacy requirements: complete, unambiguous, not in conflict with each other Awareness ISO/ TS : 2009 E 95

96 7.3 Design and Development Product Design and Development Input determine, document and evaluate requirements such as: special characteristics, identification, traceability, packaging use of information: previous or similar projects, benchmarks, field data product quality goals, durability, reliability, maintainability, cost Awareness ISO/ TS : 2009 E 96

97 7.3 Design and Development Process Design and Development Input determine, document and evaluate requirements such as: results of product design and development targets for productivity, process capability and cost customer requirements lessons learned from previous projects risks and appropriate steps for defect prevention Awareness ISO/ TS : 2009 E 97

98 7.3 Design and Development Special Characteristics special characteristics shall be listed in Production Control Plan use customer-specific definitions and symbols all documents must have the symbol identifying special characteristics as designated by the customer or the organization on drawings, FMEAs, Control Plans, Operator Instructions special characteristics can be product characteristics or process parameters Awareness ISO/ TS : 2009 E 98

99 7.3 Design and Development Design and Development Output provided in a form that enables verification against design and development input must be approved prior to release output shall meet input requirements provide appropriate information for purchasing, production and servicing contain or reference product acceptance criteria specify characteristics of product for safe and proper use Awareness ISO/ TS : 2009 E 99

100 7.3 Design and Development Product Design Output - Supplement shall enable verification and validation Design-FMEA, reliability testing (DVP&SOR) special characteristics for product and specifications defect prevention if applicable product definition, incl. drawings and math. data results of product development evaluations diagnostic guides, if applicable Awareness ISO/ TS : 2009 E 100

101 7.3 Design and Development Manufacturing Process Design Output - Supplement shall enable verification and validation specifications and drawings flow chart for production process or plant layout P-FMEA, Production Control Plan, Operator Instructions acceptance criteria for process sign off quality and reliability data, defect prevention procedures for defining and feedback on product failures Awareness ISO/ TS : 2009 E 101

102 7.3 Design and Development Design and Development Review at suitable stages according to planned arrangements (7.3.1) evaluate ability to meet requirements identify problems and propose necessary actions participants representing functions concerned with stages reviewed records (4.2.4) of results and actions taken shall be maintained Awareness ISO/ TS : 2009 E 102

103 7.3 Design and Development Monitoring for defined design and development phases define measurements analyze and summarize as input for Management Review typical measurables quality risks, cost lead-times, critical paths (milestones) Awareness ISO/ TS : 2009 E 103

104 7.3 Design and Development Design and Development Verification in accordance with planned arrangements (7.3.1) ensure output meets input requirements experiments, tests data, calculations recording (4.2.4) results and necessary actions taken Awareness ISO/ TS : 2009 E 104

105 7.3 Design and Development Design and Development Validation in accordance with planned arrangements (7.3.1) ensure output meets input requirements for intended application intended usage validate prior to delivery or installation recording (4.2.4) results and necessary actions taken Awareness ISO/ TS : 2009 E 105

106 7.3 Design and Development Design and Development Validation - Supplement completed in accordance with customer requirements including customer timing plan Prototype Program prepare prototype program and Prototype Control Plan suppliers, tools and processes: whenever possible as intended for production Awareness ISO/ TS : 2009 E 106

107 7.3 Design and Development Production Process and Product Approval use customer recognized approval process for production process approval and product approval in connection with verification of production process shall be extended to include sub-suppliers Awareness ISO/ TS : 2009 E 107

108 7.3 Design and Development Control of Design and Development Changes identify and maintain records as appropriate: evaluate, verify, validate approval before implementation evaluate effects on constituent (storage) parts and product already delivered recording (4.2.4) results and necessary actions taken Awareness ISO/ TS : 2009 E 108

109 7.4 Purchasing QMS Purchasing Process ensure purchased product conforms to specified purchase requirements type and extend of control applied to supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product Awareness ISO/ TS : 2009 E 109

110 7.4 Purchasing QMS Purchasing Process evaluate and select suppliers based on their ability to supply products in accordance with the organizations requirements establish criteria for selection, evaluation and reevaluation maintain records (4.2.4) of evaluations and any necessary actions arising from the evaluation Awareness ISO/ TS : 2009 E 110

111 7.4 Purchasing QMS Statutory and Regulatory Conformity applicable to all products and materials Suppler QMS Development min. requirement conformity to ISO 9001: 2008 prioritization of development by importance of supplier Customer-approved Sources where specified purchasing from approved sources organization has responsibility for purchased product Awareness ISO/ TS : 2009 E 111

112 7.4 Purchasing QMS Purchasing Information describe product to be purchased, incl. where adequate: requirements for approval of product, procedures and equipment requirements for qualification of personnel quality management system requirements assure adequacy of specified purchase requirements prior to communication to customer Awareness ISO/ TS : 2009 E 112

113 7.4 Purchasing QMS Verification of Purchased Product establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements intended verification arrangements at the supplier s premises and method of product release must be stated in purchasing information Awareness ISO/ TS : 2009 E 113

114 7.4 Purchasing QMS Incoming Product Conformity to Requirements one or more of the following methods receipt or evaluation of statistical data receiving inspection/ testing assessments or audits of supplier sites by second or third party coupled with records of acceptable delivered product conformity part evaluation by designated laboratory another method agreed with customer Awareness ISO/ TS : 2009 E 114

115 7.4 Purchasing QMS Supplier Monitoring supplier performance shall be monitored by conformity of delivered product to requirements customer disruptions including field returns delivery schedule performance (premium freight) special status customer notification relatd to quality or delivery issues promote supplier monitoring of the performance of their manufacturing process Awareness ISO/ TS : 2009 E 115

116 7.5 Production and Service Provision Control of Production and Service Provision plan and carry out under controlled conditions: availability of information describing the characteristics of the product availability of work instruction use of suitable equipment availability of monitoring and measuring devices implementation (all of the above) implementation of product release, delivery, post-delivery Awareness ISO/ TS : 2009 E 116

117 7.5 Production and Service Provision Production Control Plan for system, subsystem, component, material including bulk material information generated by D-/ P-FMEA for pre-launch and production phase format and information needed see Appendix reaction plan up-date as appropriate approval by customer (special characteristics, if applicable) Awareness ISO/ TS : 2009 E 117

118 7.5 Production and Service Provision Operator Work Instructions written work instructions for processes effecting product quality available at work station using information from quality management plan Production Control Plan product realization process Awareness ISO/ TS : 2009 E 118

119 7.5 Production and Service Provision Verification of Job Sep-ups job set-ups to be verified whenever performed initial run of job material changeover job change work instructions shall be available for set-up personnel, use statistical methods where applicable last-off part comparisons are recommended Awareness ISO/ TS : 2009 E 119

120 7.5 Production and Service Provision Preventive/ Predictive Maintenance determine for facilities needed for key processes provide resources effective, planned, preventive maintenance system planned activities packaging and conservation of facilities availability of spare parts record, evaluate and develop goals for maintenance improve effectiveness and efficiency of production equipment Awareness ISO/ TS : 2009 E 120

121 7.5 Production and Service Provision Management of Production Tooling provide resources for tool and gauge design, fabrication and verification establish and implement tool management maintenance and repair facilities and personnel storage and recovery set-up, tool change for perishable tools tool design modification documentation, change level tool modification and revision to documentation tool identification, defining the status, such as production, repair, disposal Awareness ISO/ TS : 2009 E 121

122 7.5 Production and Service Provision Management of Production Tooling implement a system to monitor if any work is outsourced Note: This requirement applies also for tools needed or service parts Production Scheduling production schedule to meet customer requirements (like JiT) system with access at key stages, order driven Awareness ISO/ TS : 2009 E 122

123 7.5 Production and Service Provision Feedback of Information from Service communicate information on customer service concerns to manufacturing, engineering and design activities Service agreement with customer where there is service agreement, verify effectiveness of any organization services centers any special-purpose tools or measurement equipment the training of service personnel Awareness ISO/ TS : 2009 E 123

124 7.5 Production and Service Provision Validation of Processes for Production and Service Provision validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement and deficiencies become apparent only after product is in use or service has been delivered validation shall demonstrate the ability of processes to achieve planned results Awareness ISO/ TS : 2009 E 124

125 7.5 Production and Service Provision Validation of Processes for Production and Service Provision establish arrangements for these processes if applicable criteria for review and approval of processes approval of equipment and personnel use of specific methods and processes requirements of records (4.2.4) revalidation Awareness ISO/ TS : 2009 E 125

126 7.5 Production and Service Provision Validation of Processes for Production and Service Provision - Supplemental the requirements of shall apply to all processes for production and service provision Awareness ISO/ TS : 2009 E 126

127 7.5 Production and Service Provision Identification and Traceability where appropriate (not valid for ISO/ TS 16949, ), identify product by suitable means throughout product realization control product status with respect to monitoring and measurement requirements Awareness ISO/ TS : 2009 E 127

128 7.5 Production and Service Provision Note: Inspection and test status is not indicated by the location of product in he production flow,... Alternatives are permitted if the status is clearly identified and documented Identification and Traceability - Supplement the words "Where appropriate" in shall not be applied to ISO/ TS Awareness ISO/ TS : 2009 E 128

129 7.5 Production and Service Provision Customer Property exercise care identify, verify, protect and safeguard if lost, damaged or otherwise found unsuitable for use inform customer and document (4.2.4) Note: customer property can include intellectual property and personal data Customer-owned Production Tooling permanently marked Awareness ISO/ TS : 2009 E 129

130 7.5 Production and Service Provision Preservation of Product preserve product during internal processing and delivery to intended destination preservation includes: identification handling, packaging, storage and protection Awareness ISO/ TS : 2009 E 130

131 7.5 Production and Service Provision Storage and Inventory condition of product in stock shall be assessed in appropriate intervals use inventory management system to optimize inventory turns over time assure stock rotation obsolete product shall be controlled in a similar manner to nonconforming product Awareness ISO/ TS : 2009 E 131

132 7.6 Control of Monitoring and Measuring Equipment determine the monitoring and measurement to be undertaken (7.2.1) determine the monitoring and measurement equipment needed (7.2.1) establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements Awareness ISO/ TS : 2009 E 132

133 7.6 Control of Monitoring and Measuring Equipment establish processes to ensure monitoring and measuring can be carried out: calibrate and or verify at specified intervals or prior to use traceability to national or international standards, record (4.2.4), if other basis is used adjust or re-adjust as necessary have identification to determine calibration status safeguard against adjustments that would invalidate measurement results protect from damage and deterioration Awareness ISO/ TS : 2009 E 133

134 7.6 Control of Monitoring and Measuring Equipment assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements take appropriate action on the equipment and any product affected records (4.2.4) of the results of calibration and verification shall be maintained confirm computer software prior to use Awareness ISO/ TS : 2009 E 134

135 7.6 Control of Monitoring and Measuring Equipment Measurement System Analysis conduct statistical studies to analyze variation for each type of measuring and test equipment use MSA or other method if approved by customer Awareness ISO/ TS : 2009 E 135

136 7.6 Control of Monitoring and Measuring Equipment Calibration or Verification Records equipment identification including referenced standard revisions following engineering changes any out-of-specification readings assessment of impact of out-of-specification condition statement of conformity to specification after calibration/ verification and notification to the customer, if suspect material has been shipped Awareness ISO/ TS : 2009 E 136

137 7.6 Control of Monitoring and Measuring Equipment Laboratory Requirements Internal Laboratory defined scope laboratory scope part of QM-documentation, incl. adequacy of of laboratory procedure competency of personnel testing of product capability to perform these services, incl. traceability review of related records accreditation to ISO/ IEC possible, not mandatory Awareness ISO/ TS : 2009 E 137

138 7.6 Control of Monitoring and Measuring Equipment External Laboratory defined laboratory scope evidence exists either: external laboratory is acceptable to the customer or: accreditation ISO/ IEC or national equivalent Note: Evidence may be demonstrated by customer assessment or customer approved second party Note 2: Where qualified laboratory is not available, calibration services may be performed by the equipment manufacturer Awareness ISO/ TS : 2009 E 138

139 8 Measurement, Analysis and Improvement 8.1 General plan and implement the monitoring, measurement analysis and improvement processes needed to demonstrate conformity of product ensure conformity of QMS continuously improve QMS determine applicable methods (incl. statistical methods) and extend of their use Awareness ISO/ TS : 2009 E 139

140 8 Measurement, Analysis and Improvement Identification of Statistical Methods determine for each process statistical tools include them in the Control Plan define statistical tools during quality planning Knowledge of Basic Statistical Concepts statistical concepts such as variation, control (stability), process capability and over-adjustment shall be understood and utilized throughout the organization Awareness ISO/ TS : 2009 E 140