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1 A customer concession or deviation permit shall be obtained prior to further processing whenever the product or manufacturing process is different from that which is currently approved

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2 A documented information to control external processes shall be maintained

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3 A documented internal audit process shall be established

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4 A documented procedure to define product acceptance criteria shall be maintained

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5 A documented procedure to establish a defined scope of the internal laboratory shall be maintained

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6 A documented procedure to establish and implement control plans shall be maintained

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7 A documented procedure to plan realization processes shall be maintained

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8 A documented procedure to solve problems shall be maintained

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9 A documented process and criteria to evaluate supplier performance shall be established

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10 A documented process describing the review, distribution and implementation of all customer engineering standards and specifications shall be established

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11 A documented process for disposition of nonconforming product shall be established

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12 A documented process for identifying training needs shall be established and maintained

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13 A documented process for managing calibration and verifications records shall be established

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14 A documented process for problem solving shall be established

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15 A documented process for repair confirmation in accordance with the control plan shall be established

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16 A documented process for rework confirmation in accordance with the control plan shall be established

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17 A documented process for the management of product-safety related products and manufacturing processes shall be established

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18 A documented process to control and react to changes that impact product realization shall be established

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19 A documented process to determine the use of appropriate error-proofing devices shall be established

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20 A documented process to identify outsourced processes and to select the types and extent of controls shall be established

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21 A documented process to motivate employees shall be maintained

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22 A documented process to verify that internal auditors are competent shall be established

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23 A documented supplier selection process shall be established

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24 A documented total productive maintenance system shall be developed, implemented and maintained

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25 A layout inspection and a functional verification shall be performed for each product as specified in the control plans

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26 A list of qualified internal auditors shall be maintained

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27 A member of the management shall be appointed as management representative

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28 A multidisciplinary approach shall be used including risk identification and risk mitigation methods for developing and improving plant, facility and equipment plans

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29 A multidisciplinary approach shall be used to conduct an analysis to determine if it is feasible that the organization’s manufacturing processes are capable of consistently producing product that meets all the engineering and capacity requirements specified by the customer

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30 A multidisciplinary approach shall be used to establish, document and implement the process for identifying special characteristics

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31 A process for communication of information on service activities is established, implemented and maintained

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32 A process for continual improvement shall be established

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33 A process for quality assurance for products with internally developed embedded software shall be established

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34 A process to ensure the quality of externally provided processes, products and services shall be established

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35 A process to lessen the impact of negative effects of risk shall be established

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36 A product approval process shall be established, implemented and maintained

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37 A prototype program and control plan shall be established, when required by the customer

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38 A record retention policy shall be defined, documented and implemented

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39 A register to determine the risks when selecting suppliers shall be maintained

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40 A risk management process shall be established

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41 A second-party audit process shall be included in supplier management

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42 A system for production tooling management shall be established and implemented

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43 A warranty management process shall be implemented, when the organization is required to provide warranty for their products

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44 Acceptance criteria shall be defined

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45 Actions to eliminate the causes of potential nonconformities shall be determined and implemented

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46 All design changes after initial product approval shall be evaluated

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47 All manufacturing processes shall be audited over each three-year calendar period

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48 All QMS processes shall be audited over each three-year calendar period

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49 An action plan shall be documented and implemented when customer performance objectives are not met

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50 An external laboratory shall have a defined scope

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51 An identification and traceability process shall be implemented

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52 An internal laboratory shall have a defined scope

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53 An inventory management system to optimize turns over time and ensure stock rotation shall be used

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54 Appropriate use of statistical tools shall be determined

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55 Conformance of all products and processes shall be ensured to customer, statutory and regulatory requirements

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56 Contingency plans shall be defined

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57 Control plans shall be developed at the system, subsystem, component or material level

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58 Corporate responsibility policies, including an anti-bribery policy, an employee code of conduct and an ethics escalation policy shall be defined and implemented

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59 Customer complaints and field failures shall be analyzed

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60 Customer requirements for designation, approval documentation and control of special characteristics shall be met

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61 Customer satisfaction shall be monitored through continual evaluation of internal and external performance indicators

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62 Customer-specific requirements shall be included in the scope of the QMS

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63 Design and development planning shall include all interested parties

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64 Design and development validation shall be performed

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65 Documented evidence of customer-authorized waivers shall be retained

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66 Documented information that demonstrates that all employees are aware of their impact on product quality and are aware of the importance of their activities shall be retained

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67 Documents of external origin shall be approved

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68 Infrastructure needed to achieve product conformity shall be monitored

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69 Job set-ups shall be verified

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70 Lessons learned from product recalls, product audits, field returns and repairs, complaint, scrap and rework shall be included in the risk analysis

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71 Management review shall be conducted at least once every year

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72 Manufacturing process design input requirements shall be identified, documented and reviewed

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73 On-the-job training shall be provided

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74 Personnel responsible for product conformity shall have the authority to stop shipment

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75 Personnel with authority and responsibility for corrective action shall be promptly informed of products or processes that do not conform to requirements

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76 Personnel with product design responsibility shall be competent

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77 Personnel with the responsibility and authority to ensure that customer requirements are met shall be assigned

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78 Planning for product realization shall include customer product requirements and technical specifications, logical requirements, manufacturing feasibility, project planning and acceptance criteria

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79 Process effectiveness, including periodic re-evaluation relative to risk, shall be maintained

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80 Process mapping shall be established and documented

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81 Process owners shall be identified

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82 Product design input requirements shall be identified, documented and reviewed

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83 Product realization and support processes shall be reviewed to evaluate and improve their effectiveness and efficiency

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84 Product scheduling shall ensure meeting customer requirements, such as Just-In-Time production

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85 Product with unidentified or suspect status shall be classified and controlled as nonconforming product

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86 Products, materials or services, when specified by the customer, shall be purchased from customer-directed sources

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87 Quality objectives needed to meet customer requirements shall be defined, established and maintained

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88 Requirements for products and services shall include recycling, environmental impact and identified characteristics

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89 Risk analysis methodology (such as FMEA) shall be used to assess risks in the rework process prior to a decision to rework the product

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90 Risk analysis methodology (such as FMEA) shall be used to assess risks in the repair process prior to a decision to repair the product

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91 Service centres shall comply with applicable requirements

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92 Standardized work documents shall be communicated and understood, legible, presented in the language understood by the personnel and accessible

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93 Statistical studies shall be conducted

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94 Suppliers of automotive product-related software or automotive products with embedded software shall implement and maintain a process for software quality assurance for their products

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95 Suppliers of automotive products and services shall develop, implement and improve a QMS certified to ISO 9001

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96 The competence of the auditors undertaking the second-party audits shall be demonstrated

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97 The confidentiality of customer-contracted products and projects under development shall be ensured

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98 The control of monitoring and measuring equipment shall be determined

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99 The internal audit program shall be established

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100 The language agreed with the customer shall be used for written and verbal communication

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101 The manufacturing process design output shall be documented in a manner that enables verification against input requirements

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102 The planned arrangements for initial release of products and services shall encompass product and service

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103 The premises shall be maintained in a state of order and cleanliness shall be respected

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104 The process that manages the use of alternate control methods shall be documented

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105 The product design output shall be capable of being verified and validated against product design input requirements

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106 The QMS shall be documented and include a quality manual

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107 The quality manual shall be validated by top management

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108 The reaction plan indicated in the control plan shall be initiated for characteristics that are either not statistically capable or are unstable

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