The IATF16949:2016 standard is the 2009 version of the standard there are many major changes, such as the use of advanced structure, the introduction of new risk management awareness, strengthen business continuity management (BCM), IATF16949:2016 standard is ISO9001:2015 version of the standard there are many different, such as: the quality manual, procedure documents and contract content. The following is a brief introduction to the added content in IATF16949:2016.
1. The special requirements of 4.3.2 customers must be evaluated and identified and included in the scope of the quality management system.
Two, 4.4.1.1 product and process consistency organization is responsible for ensuring product and process consistency, including service parts and outsourcing, ensuring that all customer, legal and regulatory requirements are met (see 8.4.2.2).
Three, 4.4.1.1 product safety, organization should be product safety related products and manufacturing process management to form a document process;
Four, 4.4.1.2 IATF16949 reserves the outsourcing process;
Five, 5.1.1.1 corporate responsibility, behavior criterion and moral promotion policy of the organization shall establish and implement staff code of conduct ("policy" Whistleblower), the purpose is to ensure social and environmental performance of supply chain.
Six, 5.3.2 product requirements of compliance and corrective measures, the quality of the veto;
Seven, 6.1.2.1 risk analysis organization should continue risk analysis, including at least: potential and practical feedback, on-site return and repair, complaints, scrapping, and any rework. Note: risk analysis should be based on the severity, frequency and detection of the impact on the customer.
Eight, 6.1.2.2 emergency plan (increase the content of BCM business continuity);
Nine, 7.5.1.2 quality manual, can be a series of documents;
Ten, the preservation organization of the 7.5.3.2.1 records should be determined, documented and implemented. The control of the records should be in accordance with the requirements of the law, regulations, organizations and customers. Production part approval, tooling records, advanced product quality planning (or equivalent) records, purchase orders and modify the length of time should be kept, namely part (or parts) production and service in time, plus a calendar year, unless the customer or regulatory agencies other provisions.
Eleven, 8.3.2.2 design and development planning, training organization should identify processes to identify training needs for customers who are in contact with customers at the bidding stage, project development stage and production stage. When appropriate, the personnel should be trained in the pre planning (or equal) quality of the product quality (or the same) and the related customer special requirements (CSR). The record of this training should be provided. Training should be included. But it is not limited to the following: FMEA, manufacturing process control and control plans. In every organization, people who can support the customer's manufacturing or design center should be able to access through the customer's portal platform and be able to use the necessary available computer software. Provide customers with special requirements, corrective (or preventive) measures, and computer application related training as required.
Twelve, 8.3.3.1 product design input, embedded software and Phillips curve;
Thirteen, 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.
Fourteen, 8.4.1.2 supplier selection process, increase business continuity planning (BCM) requirements;
Fifteen, 8.4.2.3.1 product embedded software sixteen, 8.4.2.4.1 two party audit;
Seventeen, 8.4.2.5.2 supplier performance development;
Eighteen, 8.5.1.2 standard operations - operation guidance and visual standards, and cover security rules;
Nineteen, the 8.5.1.3 operation is ready to be verified, and the approval records of the process and product are retained with the preparation verification and the first final confirmation.
Twenty, 8.5.6.1.1 bypass control ByPass Control.
Twenty-one, the release of 8.6.1 products and services. The organization shall ensure that the product and service requirements are verified to meet the planned arrangement, including whether the control plan and written documentation are regulated according to the control plan.
Twenty-two, 8.7.1.1 customer charter, the organization should maintain the duration of the authorized or quantitative records.
Twenty-three, 9.2.2.1 internal audit scheme, when the organization has software development, the audit scheme (see Appendix D) should include the evaluation of the software development capability.
Twenty-four, the 9.3.2.1 input to management review, increase product consistency; plant, facility and equipment planning, ensure manufacturing feasibility (see 7.1.3.1); customer satisfaction (see 9.1.2); predictive and preventive maintenance plan; warranty performance; review the content of customer scorecard.
Twenty-five, 10.2.5 warranty management;
Twenty-six, 10.2.5.1 customer complaints and field failure test analysis.