IATF16949:2016 standard is 2016 standard has a lot of major changes, such as adopting new structure, the introduction of risk management consciousness, strengthen the business continuity management (BCM), IATF16949:2016 standard is ISO9001:2015 version of the standard also has many different, such as: to keep the quality manual, program files and the content of the outsourcing party. Here is a brief introduction to the added content of IATF16949:2016.
1, 4.3.2 customer special requirements must be assessed and identified and contained within the scope of the quality management system;
Second, 4.4.1.1 products and process consistency organizations are responsible for the consistency of the product and process, including the service parts and their outsourcing, to ensure that all customer, legal and regulatory requirements are met (see 8.4.2.2);
3, 4.4.1.1 product safety, the organization shall be the process of the management of products and manufacturing processes related to product safety;
4, 4.4.1.2 IATF16949 reserves the outsourcing process;
5, 5.1.1.1 corporate responsibility, the organization shall formulate and implement the code of conduct and ethics (" whistle blower policy ") to ensure the social and environmental performance of the supply chain.
6, 5.3.2 products require compliance and corrective measures, and the quality of the veto;
Risk analysis should be carried out by the risk analysis organization, at least: potential and actual feedback, on-site return and repair, complaint, scrap, and any rework. Note: risk analysis should be based on severity, frequency and detection of customers.
An emergency plan for the BCM business;
Article 9, 7.5.1.2 quality manual, may be a series document;
The preservation organization recorded by the 10 and 7.5.3.2.1 records should be determined, documented, and documented stored procedures. The records shall be in accordance with the requirements of laws, regulations, organizations and customers. Production part approval, tooling records, advanced product quality planning (or equivalent) records, purchase orders and amendments shall keep the length of time, the parts (or components) of production and service in time, plus one calendar year, unless the customer or regulatory agencies shall be formulated separately.
The design and development of the design and development plan - the training organization should identify the process to determine the training needs of the people who are in contact with the customer during the quotation phase, the project development phase, and the production phase. At the appropriate time, the personnel should be trained in the product quality advanced planning (or equivalent) and relevant customer special requirements (CSR). This training record should be provided. Training should be included. But it is not limited to the following: FMEA, manufacturing process control and control plan. In every organization, the person who supports customer manufacturing or design centers should be able to access and use the necessary computer software through the customer's portal platform. Provide customers with special requirements, corrective (or preventive) measures, and the training of computer application in accordance with requirements.
12, 8.3.3.1 product design input, embedded software and phillips curve;
13, 8.3.6.1 design and development changes, for embedded software products, organizations should ensure that the actual configuration parameters of software and hardware are documented and communicated to customers.
14, 8.4.1.2 supplier selection process, increasing business continuity planning (BCM) requirements;
The audit of the embedded software of the product of the product of the 15, 8.4.2.3.1 software;
17th, 8.4.2.5.2 supplier performance development;
Standard operation-operation instruction and visual standards, and covers safety rules;
19, 8.5.1.3 homework is prepared to verify, retain the approval records for the process and product of the process and product in preparation and final confirmation.
20, 8.5.6.1.1 ByPass Control of the ByPass Control.
21st, 8.6.1 release of products and services, the organization shall ensure that verify the arrangement of the product and service requirements whether meet the planning includes the control plan and written documents, whether or not according to the provisions in the control plan.
The customer's license of 22 or 8.7.1.1 shall be maintained by the organization for the duration or quantity of authorization.
Twenty-third and 9.2.2.1 internal audit schemes, when the organization has software development, the audit plan (see appendix D) should include software development capability assessment.
24, 9.3.2.1 administration review input, increased: product consistency; Plan for plant, facility and equipment to ensure manufacturing feasibility (see 7.1.3.1); Customer satisfaction (see 9.1.2); Predictability and preventative maintenance plans; Guarantee performance; Customer scorecard review and so forth.
25, 10.2.5 warranty management;
26, 10.2.5.1 customer complaints and field failure test analysis.
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