Quality Management System - For Auditor PDF

Template Document Number : QSC04-014 Rev.00 Template Document Control: Prepared by: GGM, Approved by: RBM Date of Implementation: December 14, 2020 QUALITY MANAGEMENT SYSTEM (ISO 9001:2015 and IA...

Template Document Number : QSC04-014 Rev.00 Template Document Control: Prepared by: GGM, Approved by: RBM Date of Implementation: December 14, 2020 QUALITY MANAGEMENT SYSTEM (ISO 9001:2015 and IATF 16949:2016) Document Control: Prepared by: JCM Approved by: RBM Date of Implementation: Document Number and Revision No.: Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 1  AGENDA OR OBJECTIVE A. For the Trainee: ❑ To understand the requirement of ISO 9001:2015 and IATF 16949:2016 Standards B. For the Company: ❑ To maintain compliance to ISO 9001:2015 and IATF 16949:2016 Standards Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 2  COURSE OUTLINE I. Introduction in Quality Management System, II. ISO 9001:2015 and IATF 16949:2016 Requirements Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 3  TRAINING METHOD The trainer will deliver the training through: Lecture Question and Answer Short Quiz Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 4  Part I: Introduction in Quality Management System Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 5 Introduction in QMS, ISO 9001:2015 and IATF 16949:2016 What is Quality Management System (QMS)? Quality Management System (QMS) is defined as a structured system that documents processes, procedures, and responsibilities for continuously delivering high-quality products and services that meet regulatory and customer requirement. Source: https://www.simplerqms.com/quality/qms/what-is/ Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 6 Introduction in QMS, ISO 9001:2015 and IATF 16949:2016 Types of Quality Management System (QMS) There are different types of quality management systems. In selecting the right QMS will depends on industry, quality requirements, and other factors. The most common quality management systems standards used across the different industries are: QMS Standards Applicable Organization ISO 9001 All industries ISO 22000 Food Industry ISO 27001 IT Industry ISO 13485 Medical Industry IATF 16949 Automotive Industry For Nicera, we are using both ISO 9001 and IATF 16949 Standards. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 7 Goal of Quality Management System Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 8 Introduction in QMS, ISO 9001:2015 and IATF 16949:2016 Who developed ISO 9001 and IATF 16949? ISO – is an independent, non- IATF – is a group of automotive governmental international manufacturers which aims at providing organization with a membership improved quality products to automotive of 169 national standard bodies. customers worldwide. IATF has the following - Founded on 23 February 1947. members: 9 vehicle manufacturers (OEM), 5 - ISO has 25,009 international vehicle manufacturers respective trade standards covering almost associations. aspect of technology, IATF was founded in 1996. management & manufacturing. IATF has created five (5) Oversight offices - It is headquartered in Geneva, located in France, Germany, Italy, United Switzerland. Kingdom and United States of America Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 9 Introduction in QMS, ISO 9001:2015 and IATF 16949:2016 Top reasons why we need to be certified to ISO 9001 and IATF 16949 ✓ To comply to customer requirement ✓ To have a better Quality Management System Customer Customer Requirements Requirements Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 10  Part II: ISO 9001:2015 and IATF 16949:2016 Requirements Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 12  CLAUSES: 1. Scope Clauses that are auditable by certifying body (i.e. 2. Normative Reference SGS) 3. Terms and Definition ISO and IATF clauses are in PDCA cycle 4. Context of the organization PLAN– 4.0, 5.0, 6.0, 7.0 DO – 8.0 5. Leadership CHECK – 9.0 ACT – 10.0 6. Planning 7. Support 8. Operation 9. Performance Evaluation 10. Improvement Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 13  1. Scope -> This section defines the scope of ISO 9001:2015 and IATF 16949:2016 standard. For ISO 9001:2015 This standard specifies requirement for a QMS when an organization: needs to demonstrate its compliance to customer and other requirements. aims to enhance customer satisfaction For IATF 16949:2016 This automotive QMS standard specifies requirement for: Design and development, Production, Assembly, installation and service of automotive related products Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 13  4. Context of the Organization 4.1 Understanding the organization and its context → The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system. → The organization shall monitor and review information about these external and internal issues. Example of Internal Issues: Example of External Issues: ▪ High absences ▪ Global Shortage of materials ▪ High Turnover rate ▪ High prices of materials ▪ Low competency skills of staff ▪ Increase quality issues from Case Suppliers ▪ Deteriorated machine performance ▪ Inventory reduction of customer ▪ High cases of human lapse ▪ Frequent change of Customer Requirement ▪ Insufficient manpower ▪ Delayed response from Head office ▪ Delayed manpower sourcing ▪ Forex Fluctuation Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 14  4. Context of the Organization 4.2 Understanding the needs and expectations of interested parties → Due to their effect or potential effect on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine: ✓ the interested parties that are relevant to the quality management system; ✓ the requirements of these interested parties that are relevant to the quality management system. → The organization shall monitor and review information about these interested parties and their relevant requirements. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 15  4. Context of the Organization 4.3 Determining the scope of the quality management system → The organization shall determine the boundaries and applicability of the quality management system to establish its scope. → The scope of the organization’s QMS shall be available and be maintained as documented information. 4.3.1 Determine the supporting functions, whether on-site or remote. 4.3.2 Customer Specific Requirements (CSR) shall be evaluated and included in the scope of the organization’s QMS. 4.4 Quality management system and its processes 4.4.1 The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 16  4. Context of the Organization 4.4.1.1 Conformance of Products and Processes → The organization shall ensure conformance of all products and processes, including service parts and those that are outsourced, to all applicable customer, statutory and regulatory requirement. 4.4.1.2 Product Safety → The organization shall have documented processes for the management of product-safety related products and manufacturing processes. 4.4.2 To the extent necessary, the organization shall: maintain documented information to support the operation of its processes; retain documented information to have confidence that the processes are being carried out as planned. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 17  5. Leadership 5.1 Leadership and commitment 5.1.1 General → Top management shall demonstrate leadership and commitment with respect to the QMS. 5.1.1.1 Corporate Responsibility → The organization shall define and implement corporate responsibility policies, including at a minimum: an anti-bribery policy, an employee code of conduct, an ethics escalation policy (whistle-blowing policy) 5.1.1.2 Process Effectiveness and Efficiency → Top management shall review the effectiveness and efficiency of the QMS to evaluate and improve the organization’s QMS. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 18  5. Leadership 5.1.1.3 Process Owners → Top management shall identify process owners who are responsible for the managing the organization’s process and related outputs. Process owners shall understand their roles and be competent to perform those roles. 5.1.2 Customer Focus → Top management shall demonstrate leadership and commitment with respect to customer focus by ensuring that: ✓ Customer and applicable statutory & regulatory requirements are determined, understood and consistently met; ✓ the risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed; ✓ the focus on enhancing customer satisfaction is maintained. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 19  5. Leadership 5.2 Policy 5.2.1 Top management shall establish, implement and maintain a quality policy. 5.2.2 The quality policy shall be: ✓ available and be maintained as documented information; ✓ be communicated, understood and applied within the organization; ✓ be available to relevant interested parties, as appropriate. 5.3 Organizational Roles, Responsibilities and Authorities → Top management shall ensure that the responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 20  5. Leadership 5.3.1 Organizational Roles, Responsibilities & Authorities- Supplemental → Top management shall assign personnel with the responsibility and authority to ensure the customer requirements are met. These assignments shall be documented. 5.3.2 Responsibility and Authority for Product Requirements and Corrective Actions → Top management shall ensure that: ✓ Personnel responsible for conformity to product requirements have the authority to stop shipment and stop production to correct quality problems. ✓ Personnel with authority and responsibility for corrective actions are promptly informed of products or process that do not conform to requirements. ✓ Production operations across all shifts are staffed with personnel in charge of, or delegated responsibility for, ensuring conformity to product requirements. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 21  6. Planning 6.1 Actions to address risks and opportunities 6.1.1 The organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks & opportunities that need to be addressed. 6.1.2 The organization shall plan actions to address these risks and opportunities. Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services. 6.1.2.1 Risk Analysis → The organization shall include in its risk analysis, at a minimum, lesson learned from product recalls, product audit, field returns and repair, complaints, scrap and rework. → The organization shall retain documented information as evidence of the result of risk analysis. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 22  6. Planning 6.1.2.2 Preventive Action → The organization shall determine and implement action(s) to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the severity of the potential issues. → The organization shall establish a process to lessen the impact of negative effects of risk. 6.1.2.3 Contingency Plan The organization shall: ✓ Identify and evaluate internal and external risk to all manufacturing process and infrastructure equipment essential to maintain production output to ensure that customer requirements are met; ✓ Define contingency plan according to risk and impact to the customer. ✓ Prepare contingency plans for continuity of supply. ✓ Periodically test the contingency plans for effectiveness. ✓ Document the contingency plans and retain documented information describing any revision(s), including the person who authorized the change(s). Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 23  6. Planning 6.2 Quality Objectives and Planning to achieve them 6.2.1 The organization shall establish quality objectives at relevant functions, levels and processes needed for the QMS. The quality objectives shall be: a) be consistent with the quality policy; b) be measurable; c) take into account applicable requirements; d) be relevant to conformity of products and services and to enhancement of customer satisfaction; e) be monitored; f) be communicated; g) be updated as appropriate. The organization shall maintain documented information on the quality objectives. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 24  6. Planning 6.2.2 When planning how to achieve its quality objectives, the organization shall determine: ✓ what will be done; ✓ what resources will be required; ✓ who will be responsible; ✓ when it will be completed; ✓ how the results will be evaluated 6.2.2.1 Quality Objectives and Planning to achieve them- Supplemental → Top Management shall ensure that quality objectives to meet customer requirements are defined, established, and maintained for relevant functions, processes, and levels throughout the organization. → The results of the organization’s review regarding interested parties and their relevant requirements shall be considered when the organization establishes its annual (at a minimum) quality objectives and related performance target (internal and external) Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 25  6. Planning 6.3 Planning of Changes When the organization determines the need for changes to the QMS, the changes shall be carried out in a planned manner. The organization shall consider: ✓ the purpose of the changes and their potential consequences; ✓ the integrity of the quality management system; ✓ the availability of resources; ✓ the allocation or reallocation of responsibilities and authorities. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 26  7. Support 7.1 Resources 7.1.1 General → The organization shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the QMS. 7.1.2 People → The organization shall determine and provide the persons necessary for the effective implementation of its QMS and for the operation and control of its processes. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 27  7. Support 7.1.3 Infrastructure → The organization shall determine, provide and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services. NOTE: Infrastructure can include buildings and associated utilities, equipment (including hardware & software), information and communication technology. 7.1.3.1 Plant, Facility, and Equipment Planning → The organization shall use a multidisciplinary approach including risk identification and risk mitigation methods for developing and improving plant, facility, and equipment plans. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 28  7. Support 7.1.4 Environment for the Operation of the Process → The organization shall determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services. NOTE: A suitable environment can be a combination of human and physical factors, such as: ✓ Social (e.g. non-discriminatory, calm, non-confrontational), ✓ Psychological (e.g. stress-reducing, burnout prevention, emotionally protective); ✓ Physical (e.g. temperature, heat, humidity, light, airflow, hygiene, noise) 7.1.4.1 Environment for the Operation of the Process- Supplemental → The organization shall maintain it’s premises in a state of order, cleanliness, and repair that is consistent with the product and manufacturing process needs. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 29  7. Support 7.1.5 Monitoring and Measuring Resources 7.1.5.1 General → The organization shall determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements. → The organization shall ensure that the resources provided: ✓ are suitable for the specific type of monitoring and measurement activities being undertaken; ✓ are maintained to ensure their continuing fitness for their purpose. → The organization shall retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources. 7.1.5.1.1 Measurement System Analysis → Statistical studies shall be conducted to analyse the variation present in the results of each type of inspection, measurement, and test equipment system identified in the control plan. NOTE: Prioritization of MSA studies should focus on critical or special product or process characteristics. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 30  7. Support 7.1.5.2 Measurement Traceability When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results, measuring equipment shall be: ✓ calibrated or verified at specified intervals, or prior to use; ✓ identified in order to determine their status; ✓ safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results. 7.1.5.2.1 Calibration/Verification Records → The organization shall have a documented process for managing calibration/verification records. → Records of the calibration/ verification activity for all gauges and measuring and test equipment needed to provide evidence of conformity to internal requirements, legislative and regulatory requirements, and customer-defined requirements shall be retained. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 31  7. Support 7.1.5.3 Laboratory Requirements 7.1.5.3.1 Internal laboratory → An organization's internal laboratory facility shall have a defined scope that includes its capability to perform the required inspection, test, or calibration services. → The laboratory shall specify and implement, as a minimum, requirements for adequacy of the laboratory technical procedures, competency of the laboratory personnel, testing of the product; capability to perform these services correctly, traceable to the relevant process standard, customer requirements, if any; 7.1.5.3.2 External Laboratory → External/commercial/independent laboratory facilities used for inspection, test, or calibration services by the organization shall have a defined laboratory scope that includes the capability to perform the required inspection, test, or calibration, and either the laboratory shall be accredited to ISO/IEC 17025 or its national equivalent by an accreditation body. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 32  7. Support 7.1.6 Organizational Knowledge → The organization shall determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services. This knowledge shall be maintained and be made available to the extent necessary. → Organizational knowledge can be based on: Internal Sources: knowledge gained from experience; lessons learned from failures and successful projects; the results of improvements in processes, products and services. External Sources: conferences; gathering knowledge from customers or external providers. 7.2 Competence The organization shall: a) determine the necessary competence of person(s) doing work under its control that affects the performance and effectiveness of the QMS; b) ensure that these persons are competent on the basis of appropriate education, training, or experience; c) where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken; d) retain appropriate documented information as evidence of competence. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 33  7. Support 7.2.1 Competence - Supplemental → The organization shall establish and maintain a documented process(es) for identifying training needs including awareness (see 7.3.1) and achieving competence of all personnel performing activities affecting conformity to product and process requirements. → Personnel performing specific assigned tasks shall be qualified, as required, with particular attention to the satisfaction of customer requirements. 7.2.2 Competence-on-the-job training → The organization shall provide on-the-job training for Personnel in any new or modified responsibilities affecting: ✓ conformity to quality requirements, ✓ internal requirements, ✓ regulatory or legislative requirements, this shall include contract or agency personnel. → Persons whose work can affect quality shall be informed about the consequences of nonconformity to customer requirement. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 34  7. Support 7.2.3 Internal Auditor Competency → The organization shall have a documented process(es) to verify that internal auditors are competent, taking into account any customer- specific requirements. For additional guidance on auditor competencies, refer to ISO 19011. → The organization shall maintain a list of qualified internal auditors. 7.2.4 Second-party Auditor Competency → Second-party auditors shall meet customer specific requirements for auditor qualification and demonstrate the minimum following core competencies, including understanding of: ✓ the automotive process approach to auditing; ✓ applicable customer and organization specific requirements; ✓ applicable ISO 9001 and IATF 16949 requirements; ✓ applicable manufacturing process(es) to be audited, Second-Party Auditor including PFMEA and control plan; ✓ applicable core tool requirements related to the scope of the audit; ✓ how to plan, conduct, prepare audit reports, and close out audit findings. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 35  7. Support 7.3 Awareness The organization shall ensure that persons doing work under the organization’s control are aware of: ✓ the quality policy; ✓ relevant quality objectives; ✓ their contribution to the effectiveness of the QMS, including the benefits of Improved performance; ✓ the implications of not conforming with the QMS requirements. 7.3.1 Awareness – Supplemental The organization shall maintain documented information that demonstrates that all employees are aware of ✓ their impact on product quality and; ✓ the importance of their activities in achieving, maintaining, and improving quality, including customer requirements and the risks involved for the customer with non- conforming product. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 36  7. Support 7.3.2 Employee Motivation and Empowerment → The organization shall maintain a documented process(es) to motivate employees to achieve quality objectives, to make continual improvements, and to create an environment that promotes innovation. → The process shall include the promotion of quality and technological awareness throughout the whole organization. 7.4 Communication The organization shall determine the internal and external communications relevant to the QMS, including: ✓ on what it will communicate; ✓ when to communicate; ✓ with whom to communicate; ✓ how to communicate; ✓ who communicates. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 37  7. Support 7.5 Documented Information 7.5.1 General The organization’s QMS shall include: a) documented information required by this International Standard; b) documented information determined by the organization as being necessary for the effectiveness of the QMS. 7.5.1.1 Quality Management System Documentation -> The organization’s QMS shall be documented and include a quality manual, which can be a series of documents. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 38  7. Support 7.5.2 Creating and updating When creating and updating documented information, the organization shall ensure appropriate: a) identification and description (e.g. a title, date, author, or reference number); b) Format (e.g. language, software version, graphics) and media (e.g. paper, electronic); c) review and approval for suitability and adequacy. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 39  7. Support 7.5.3 Control of documented information 7.5.3.1 Documented information required by the QMS and by this International Standard shall be controlled to ensure: a) it is available and suitable for use, where and when it is needed; b) it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity). 7.5.3.2 For the control of documented information, the organization shall address the following activities, as applicable: ✓ distribution, access, retrieval and use; ✓ storage and preservation, including preservation of legibility; ✓ control of changes (version control); ✓ retention and disposition. Documented information of external origin determined by the organization to be necessary for the planning and operation of the QMS shall be identified as appropriate, and be controlled. Documented information retained as evidence of conformity shall be protected from unintended alterations. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 39  7. Support 7.5.3.2.1 Record Retention → The organization shall define, document, and implement a record retention policy. → The control of records shall satisfy statutory, regulatory, organizational, and customer requirements. → Production part approvals, tooling records, product and process design records, purchase orders, or contracts and amendments shall be retained for the length of time that the product is active for production and service requirements, plus one calendar year, unless otherwise specified by the customer or regulatory agency. 7.5.3.2.2 Engineering Specifications → The organization shall have a documented process describing the review, distribution, and implementation of all customer engineering standards/ specifications and related revisions based on customer schedules, as required. → The organization shall retain a record of the date on which each change is implemented in production. Implementation shall include updated documents. → Review should be completed within 10 working days of receipt of notification of engineering standards / specifications changes. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 40  8. Operation 8.1 Operational Planning and Control → The organization shall plan, implement and control the processes (see 4.4) needed to meet the requirements for the provision of products and services, and to implement the actions determined in Clause 6, by: a) determining the requirements for the products and services; b) establishing criteria for: ✓ the processes; ✓ the acceptance of products and services c) determining the resources needed to achieve conformity to the product and service requirements; d) implementing control of the processes in accordance with the criteria; e) determining, maintaining and retaining documented information to the extent necessary: Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 41  8. Operation 8.1.1 Operational Planning and Control – Supplemental → When planning for product realization, the following topics shall be included: ✓ customer product reqmts. and technical specifications; ✓ logistics requirements ✓ manufacturing feasibility; ✓ project planning; ✓ acceptance criteria. → The resources identified in ISO 9001 8.1c), refer to the required verification, validation, monitoring, measurement, inspection, and test activities specific to the product and the criteria for product acceptance. 8.1.2 Confidentiality → The organization shall ensure the confidentiality of customer-contracted products and projects under development, including related product information. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 42  8. Operation 8.2 Requirements for Products and Services 8.2.1 Customer Communication → Communication with customers shall include: ✓ providing information relating to products and services; ✓ handling enquiries, contracts or orders, including changes; ✓ obtaining customer feedback relating to products and services, including customer complaints; ✓ handling or controlling customer property; ✓ establishing specific requirements for contingency actions, when relevant. 8.2.2 Determining the Requirements for Products and Services → When determining the requirements for the products and services to be offered to customers, the organization shall ensure that: a) the requirements for the products and services are defined, including any applicable statutory and regulatory requirements; and those considered necessary by the organization; b) the organization can meet the claims for the products and services it offers. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 43  8. Operation 8.2.2.1 Determining the Requirements for Products and Services- Supplemental → These requirements shall include recycling, environmental impact, and characteristics identified as a result of the organization's knowledge of the product and manufacturing processes. → Compliance to ISO 9001 Section 8.2.2 item a), shall include but not be limited to the following: all applicable government, safety and environmental regulations related to acquisition, storage, handling, recycling, elimination, or disposal of material. 8.2.3 Review of the Requirements for Products and Services 8.2.3.1 The organization shall ensure that it has the ability to meet the requirements for products and services to be offered to customers. The organization shall conduct a review before committing to supply products and services to a customer. The organization shall ensure that contract or order requirements differing from those previously defined are resolved. The customer’s requirements shall be confirmed by the organization before acceptance, when the customer does not provide a documented statement of their requirements. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 44  8. Operation 8.2.3.1.1 Review of the Requirements for Products and Services - Supplemental → The organization shall retain documented evidence of a customer-authorized waiver for the requirements stated in ISO 9001, Section 8.2.3.1, for a formal review. 8.2.3.1.2 Customer-designated Special Characteristics → The organization shall conform to customer requirements for designation, approval documentation, and control of special characteristics. 8.2.3.1.3 Organization Manufacturing Feasibility → The organization shall utilize a multidisciplinary approach 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 of the engineering and capacity requirements specified by the customer. → The organization shall conduct this feasibility analysis for any manufacturing or product technology new to the organization and for any changed manufacturing process or product design. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 45  8. Operation 8.2.3.2 The organization shall retain documented information, as applicable: ✓ on the results of the review; ✓ on any new requirements for the products and services. 8.2.4 Changes to requirements for products and services → The organization shall ensure that relevant documented information is amended, and that relevant persons are made aware of the changed requirements, when the requirements for products and services are changed. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 46  8. Operation 8.3 Design and Development of Products and Services 8.3.1 General → The organization shall establish, implement and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services. 8.3.1.1 Design and Development of Products and Services - Supplemental → The requirements of ISO 9001 8.3.1, shall apply to product and manufacturing process design and development and shall focus on error prevention rather than detection. → The organization shall document the design and development process. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 47  8. Operation 8.3.2 Design and Development Planning → In determining the stages and controls for design and development, the organization shall consider: a) the nature, duration and complexity of the design and development activities; b) the required process stages, including applicable design and development reviews; c) the required design and development verification and validation activities; d) the responsibilities and authorities involved in the design and development process; e) the internal and external resource needs for the design and development of products and services; f) the need to control interfaces between persons involved in the design and development process; g) the need for involvement of customers and users in the design and development process; h) the requirements for subsequent provision of products and services; i) the level of control expected for the design and development process by customers and other relevant interested parties; j) the documented information needed to demonstrate that design and development requirements have been met. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 48  8. Operation 8.3.2.1 Design and Development Planning - Supplemental → The organization shall ensure that design and development planning includes all affected stakeholders within the organization and, as appropriate, its supply chain. → Examples of areas for using such a multidisciplinary approach include but are not limited to the following: ✓ project management (i.e. APQP or VDA-RGA); ✓ product and manufacturing process design activities (i.e. DFM and DFA) ✓ development and review of product design risk analysis (FMEAs), ✓ development and review of manufacturing process risk analysis (i.e. FMEAs, process flows, control plans, and standard work instructions). NOTE: A multidisciplinary approach typically includes the organization’s design, manufacturing, engineering, quality, production, purchasing, supplier, maintenance, and other appropriate functions. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 49  8. Operation 8.3.2.2 Product Design Skills* → The organization shall ensure that Personnel with product design responsibility are competent to achieve design requirements and are skilled in applicable product design tools and techniques. → Applicable tools and techniques shall be identified by the organization. Note: An example of product design skills is the application of digitized mathematically based data. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 50  8. Operation 8.3.2.3 Development of Products with Embedded Software* → The organization shall use a process for quality assurance for their products with internally developed embedded software. → A software development assessment methodology shall be utilized to assess the organization’s software development process. → Using prioritization based on risk and potential impact to the customer, the organization shall retain documented information of a software development capability self-assessment → The organization shall include software development within the scope of their internal audit programme (see Section 9.2.2.1). Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 51  8. Operation 8.3.3 Design and Development Inputs → The organization shall determine the requirements essential for the specific types of products and services to be designed and developed. → The organization shall consider: ✓ functional and performance requirements; ✓ information derived from previous similar design and development activities; ✓ statutory and regulatory requirements; ✓ standards or codes of practice that the organization has committed to implement; ✓ potential consequences of failure due to the nature of the products and services. → Inputs shall be adequate for design and development purposes, complete and unambiguous. Conflicting design and development inputs shall be resolved. → The organization shall retain documented information on design and development inputs. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 52  8. Operation 8.3.3.1 Product Design Input * → The organization shall identify, document, and review product design input requirements as a result of contract review. → Product design input requirements include but are not limited to the following: ✓ product specifications including but not limited to special characteristics (see Section 8.3.3.3); ✓ boundary and interface requirements; ✓ identification, traceability, and packaging; ✓ consideration of design alternatives; ✓ assessment of risks with the input requirements and the organization’s ability to mitigate/manage the risks, including from the feasibility analysis; ✓ targets for conformity to product requirements including preservation, reliability, durability, serviceability, health, safety, environmental, development timing, and cost; ✓ applicable statutory and regulatory requirements of the customer-identified country of destination, if provided; ✓ embedded software requirements. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 53  8. Operation 8.3.3.2 Manufacturing Process Design Input → The organization shall identify, document and review manufacturing process design input requirements including but not limited to the following: a) product design output data including special characteristics; b) targets for productivity, process capability, timing, and cost; c) manufacturing technology alternatives; d) customer requirements, if any; e) experience from previous developments; f) new materials; g) product handling and ergonomic requirements; and h) design for manufacturing and design for assembly. → The manufacturing process design shall include the use of error- proofing methods to a degree appropriate to the magnitude of the problem(s) and commensurate with the risks encountered. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 54  8. Operation 8.3.3.3 Special Characteristics → The organization shall use a multidisciplinary approach to establish, document, and implement its process(es) to identify special characteristics, including those determined by the customer and the risk analysis performed by the organization, and shall include the following: a) documentation of all special characteristics in the product and/or manufacturing documents (as required), relevant risk analysis control plans, and standard work/operator instructions; special characteristics are identified with specific markings and are documented in the manufacturing documents which show the creation of, or the controls required, for these special characteristics; b) development of control and monitoring strategies for special characteristics of products and production processes; c) customer-specified approvals, when required; d) compliance with customer-specified definitions and symbols or the organization’s equivalent symbols or notations. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 55  8. Operation 8.3.4 Design and Development Controls The organization shall apply controls to the design and development process to ensure that: a) the results to be achieved are defined; b) reviews are conducted to evaluate the ability of the results of design and development to meet requirements; c) verification activities are conducted to ensure that the design and development outputs meet the input requirements; d) validation activities are conducted to ensure that the resulting products and services meet the requirements for the specified application or intended use; e) any necessary actions are taken on problems determined during the reviews, or verification and validation activities; f) documented information of these activities is retained. NOTE: Design and development reviews, verification and validation have distinct purposes. They can be conducted separately or in any combination, as is suitable for the products and services of the organization. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 56  8. Operation 8.3.4.1 Monitoring → Measurements at specified stages during the design and development of products and processes shall be defined, analysed, and reported with summary results as an input to management review. → When required by the customer, measurements of the product and process development activity shall be reported to the customer at stages specified, or agreed to, by the customer. NOTE: When appropriate, these measurements may include quality risks, costs, lead times, critical paths, and other measurements. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 57  8. Operation 8.3.4.2 Design and Development Validation → Design and development validation shall be performed in accordance with customer requirements, including any applicable industry and governmental agency-issued regulatory standards. → The timing of design and development validation shall be planned in alignment with customer-specified timing, as applicable. → Where contractually agreed with the customer, this shall include evaluation of the interaction of the organization’s product, including embedded software, within the system of the final customer’s product. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 58  8. Operation 8.3.4.3 Prototype Program* → When required by the customer, the organization shall have a prototype programme and control plan. → The organization shall use, whenever possible, the same suppliers, tooling, and manufacturing processes as will be used in production. → All performance-testing activities shall be monitored for timely completion and conformity to requirements. → When services are outsourced, the organization shall include the type and extent of control in the scope of its QMS to ensure that outsourced services conform to requirements (see ISO 9001, Section 8.4). Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 59  8. Operation 8.3.4.4 Product Approval Process → The organization shall establish, implement, and maintain a product and manufacturing approval process conforming to requirements defined by the customer(s). → The organization shall approve externally provided products and services per ISO 9001 8.4.3 prior to submission of their part approval to the customer. → The organization shall obtain documented product approval prior to shipment, if required by the customer. → Records of such approval shall be retained. Note: Product approval should be subsequent to the verification of the manufacturing process Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 60  8. Operation 8.3.5 Design and Development Outputs → The organization shall ensure that design and development outputs: a) meet the input requirements; b) are adequate for the subsequent processes for the provision of products and services; c) include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria; d) specify the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision. The organization shall retain documented information on design and development outputs. Nicera Confidential: Contains information which is the property of Nicera Philippines Inc. It must not be made available to anyone outside Nicera without its written authorization. Authorized recipient of this information shall not disclose any part to anyone that is not covered by a duly approved written authorization. Nicera may take legal actions against violation of this notice. 61  8. Operation 8.3.5.1 Design and Development Outputs – Supplemental * → The product design output shall be expr