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Quality Managegment Systems

Quality Managegment Systems

Dec 06, 2017

Particular requirements for the application of ISO9001:2015 for automotive production And relevant service part organizations.

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1. Scope

This standard provides the requirements for the following requirements: the requirements of the quality management system:

A) it needs to be confirmed that it has the ability to provide products and services that meet the requirements of the customer and apply the requirements of the laws and regulations.

B) through the effective application of the system, including the process of continuous improvement of the system, and the requirements to meet the requirements and applicable laws and regulations of the customer,

The aim is to enhance customer satisfaction.

All requirements specified in this standard are universal and are intended to be applicable to organizations of various types, different sizes, and the provision of different products and services.


Note 1: in this standard, the term "product" or "service" is only applicable to products and services expected to be provided to customers or customers.

Note 2: the requirements of laws and regulations may be called statutory requirements.


This technical specification is combined with ISO9001:2015, which stipulates the requirement of quality management system, which is used for the design and development of automobile related products, and is also suitable for installation and service when related.

This technical specification is applicable to the manufacturing site of the production and / or maintenance parts organized by the customer. Support functions, whether they are on-site or outside, such as design center, company headquarters and distribution center, are part of the on-site audit because they support the scene, but they cannot be independently certified by this standard.

This technical specification can be applied to the whole automobile supply chain.


2. Normative reference files

The following documents are essential to the application of this standard. All date reference documents, only this version is applicable to this standard.

The latest version of a reference document without a date, including all the revisions, is applicable to this criterion.

The basis and terminology of ISO9000:2015 quality management system.


3, terms and definitions

This standard uses the terms and definitions in ISO9000:2015.

The definition and definition of the 3.1 automobile industry.

This document uses the terms and definitions given in ISO9000:2015 and below.


3.1.1 control plan control plan

A description of the formation of the system and process required for the control of the product.


3.1.2 has a design responsibility organization design responsible organization.

An organization with the right to establish a new product specification, or to change the existing product specifications.


Note: this responsibility includes the test and verification of the design performance within the scope of the customer's prescribed application.


3.1.3 error proofing

The design and development of the product and manufacturing process that does not prevent the manufacture of unqualified products.


3.1.4 Laboratory

A facility for testing, testing, or calibrating, including, but not limited to, chemical, metallographic, dimensional, physical, electrical, or reliability tests.

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3.1.5 laboratory scope 

Controlled documents, including:

- the laboratory is qualified for the specific test, evaluation and calibration;

A list of equipment used to carry out the above activities;

- a list of the methods and standards for the activities mentioned above.


3.1.6 manufacturing

The following process or process:

- production materials;

- production or maintenance parts;

- assembly;

Heat treatment, welding, spray paint, electroplating and other surface treatment.


3.1.7 foreseeable maintenance

Activity based on process data, by predicting possible failure modes to avoid maintenance problems.


3.1.8  prevention maintenance 

The measures planned to eliminate the failure of the equipment and the reasons for the external interruption of production as an output of the design of the manufacturing process.


3.1.9   premium freight

An additional cost or cost that occurs outside the contracted delivery of the contract. Note: may be caused by method, quantity, planned or delayed delivery.


3.1.10   remotelocation

A site that supports the site and does not exist in the process of production.


3.1.11  site

A place where a value-added manufacturing process is occurring.


3.1.12  special characteristic

It may affect the safety of the product or the compliance, coordination, function, performance, or the product characteristics or manufacturing process parameters of the compliance, function, performance, or subsequent process of the product.


4, organization environment

4.1 understanding the organization and its environment

The organization should determine the external and internal factors related to its purpose and strategic direction and influence its quality management system to achieve its expected results.

The organization should monitor and review the relevant information of these internal and external factors.


Note 1: these factors may be positive or negative or should be considered.

Note 2: we can promote the understanding of external situations by considering the laws, regulations, technology, competition, market, culture, social and economic factors from different countries, regions, or locals.

Note 3: an understanding of the internal situation can be promoted by taking into account the value, culture, knowledge and performance of the organization.



4.2 understand the needs and expectations of the parties concerned

Due to the impact or potential impact of continuous provision of products and services that satisfy customer requirements and applicable laws and regulations, the organization shall determine:

A) the parties concerned with the quality management system;

B) the requirements of the parties concerned with the quality management system;

The organization shall monitor and review information about the parties concerned and their related requirements.



4.2.1   understands the needs and expectations of the parties concerned

The supplementary organizations should respond to the relevant parties and their relevant parties in establishing the annual performance objectives (within and outside) of the quality management system.

The process of trial is considered.


4.3   determine the scope of the quality management system

The organization should define the boundaries and applicability of the quality management system to determine its scope. In determining the scope, the organization should consider:

A) various internal and external factors;

B) the requirements of the parties concerned;

C) the products and services of the organization.

The organization shall implement all the requirements applicable to the scope of the quality management system established by the organization in this standard.

The scope of the organization's quality management system should be maintained as a document forming information. This scope should describe the types of products and services covered.

If the organization considers that the application scope of its quality management system does not apply to some of the requirements of this standard, the reasons should be explained.

Those requirements that are not applicable to the quality management system of an organization can't affect the organization's ability or responsibility to ensure the qualified products and services and enhance customer satisfaction, otherwise, it can't claim to meet this standard.


4.3.1 determine the scope of the quality management system

Complementary support functions, both in the field and outside (such as design centers, company headquarters and distribution centers), should be included in the scope of the quality management system.

The only allowable deletion is only limited to the requirements of product design and development in Clause 8.3. Process design shall not be deleted or deleted. 8.3, the requirements for design and development must be reasonable and keep documentary information.


4.3.2 customer special requirements

The special requirements of the customer must be evaluated and identified and included in the quality management system.


4.4 quality management system and its process

4.4.1 organization shall establish, implement, maintain and continuously improve the quality management system, including the process and interaction required by the quality management system, according to the requirements of this standard. The organization should determine the process required by the quality management system and its application in the organization as a whole, and should:

A) determine the input and expected output required for these processes;

B) determine the order and interaction of these processes

C) identification and application of the required guidelines and methods (including monitoring, measurement and related performance indicators) to ensure the effective operation and control of these processes;

D) determine the resources needed to obtain these processes and ensure their availability;

E) stipulates the responsibility and authority of these processes;

F) to meet the risks and opportunities identified in accordance with the requirements of 6.1;

G) evaluate these processes and implement the required changes to ensure the expected results of these processes.

H) improve the process and quality management system.


4.4.1.1 product and process consistency

The organization is responsible for identifying the consistency of the product and process, including the service and its outsourcing. All customer, legal and regulatory requirements have been met.


4.4.1.1 product safety

The organization shall form a documented process for the management of product safety related products and manufacturing processes, including but not limited to:

A) identification of product safety requirements related to statutory and regulatory requirements;

B) notify the customer of the above requirements;

C) recognition of customer requirements

D) design special approval for FMEA;

E) identification of product safety features;

F) identification and control of safety related features from the point of view of the production and manufacturing of the product;

G) the specially approved control plan and process FMEA;

H) definition of the reaction plan;

I) define the responsibilities, define the upgrade process and information flow, including the highest management and customer notification;

J) the specific training of the relevant personnel involved in the product safety related procedures;

K) changes in the product or process shall be approved before the implementation, including the assessment of the potential impact on the safety of the product and the change of the product;

L) requirements for product safety, including customers' designated sources;

M) at least: the traceability of the whole supply chain;

N) lessons from the introduction of new products.


4.4.1.2 outsourcing process

Organizational selection will affect any process outsourcing that products meet the requirements, organize and deal with any such process in the quality management system, determine the type and degree of control, and ensure the outsourcing process, products and services meet the requirements.


4.4.2 if necessary, the organization should:

A) maintain the information that forms the file and provide support for the process operation.

B) keep the information of the document to verify that the process is executed as planned.


5,  leading role

5.1  leadership and commitment

5.1.1  General

The top managers should confirm their leadership and commitment to the quality management system through the following aspects:

A) responsibility for the effectiveness of the quality management system;

B) ensure that the quality policy and quality objectives of the quality management system are formulated and consistent with the organizational environment and strategic direction.

C) ensure that the quality management system needs to be integrated into the organizational business process.

D) promote the use of process methods and risk - based thinking;

E) to ensure the resources required for the quality management system;

F) to convey the importance of effective quality management and compliance with the requirements of the quality management system;

G) ensure that the quality management system realizes its expected results;

H) encourage, guide and support employees to contribute to the effectiveness of the quality management system;

I) to promote improvement;

J) support other managers to confirm their leadership in the areas in which they are responsible.


Note: the term "business" used in this standard can be roughly understood as a core activity involving the existence of an organization, whether it is public, private, profitable or non-profit organizations.


5.1.1.1 corporate responsibility

Code of conduct and moral promotion policy of the organization shall establish and implement staff code of conduct (WHISTLEBLOWERPOLICY), the purpose is to ensure social and environmental performance of supply chain.


5.1.1.2 process efficiency

The highest manager should review the process of product implementation and support process to ensure its effectiveness and efficiency. The activities and results of the management review process of the top managers should be included in the management review.


5.1.1.3 process owner

The top manager should determine the process owner, determine its responsibilities, and ensure that they have the ability to execute the process.


5.1.2 focuses on the focus of customers

The top managers should confirm their leadership and commitment to the focus of their customers, through:

A) determine, understand and continue to meet the requirements of the customer and the applicable laws and regulations.

B) identify and respond to the compliance of the products and services, as well as the risks and opportunities to enhance customer satisfaction.

C) keep the focus on enhancing customer satisfaction.


5.2  policy

5.3.1  The formulation of the quality policy

The top managers should formulate, implement and maintain the quality policy. The quality policy should:

A) adapt to the purpose and environment of the organization and support its strategic direction;

B) providing a framework for the development of quality objectives;

C) including the commitment to meet the requirements of the application;

D) includes the commitment to continuously improve the quality management system.


5.2.2  Communication of quality policy

The quality policy should:

A) can be obtained and maintained as a document forming information.

B) access to communication, understanding and application within the organization;

C) may be provided to the relevant party when appropriate.


5.3   The role, responsibility, and authority of an organization

The top manager should ensure that the relevant responsibilities and permissions within the organization are defined, communicated and understood. The top managers should assign duties and powers to:

A) ensure that the quality management system meets the requirements of this standard.

B) ensure that the processes have their expected output;

C) report the performance and improvement opportunities of the reporting quality management system to the top managers.

D) to ensure that the awareness of the focus of attention by the customer is raised throughout the organization.

E) ensure the integrity of the quality management system when planning and implementing changes in the quality management system.


5.3.1  The role, responsibility, and authority of an organization

Top managers should assign personnel to assign responsibilities and authority to ensure that customer requirements are reflected, including the selection of special characteristics, quality objectives and related training, corrective and preventive measures, and product design and development.


5.3.2  The highest manager of product compliance and corrective measures should ensure that:

A) the personnel who ensure the compliance requirements of the product have the right to stop the shipment and stop the production to correct the quality problems.

B) the products or processes that do not meet the requirements should be promptly informed of the personnel with the responsibility and authority of the corrective measures to ensure that they are not compatible.

The product is not transported to the customer and the identification and control of all the potential unqualified products.

C) to maintain documented evidence of these problems and corrective measures and can be provided at the time of request;

D) all crew members are equipped with supervisors or assigned responsibilities to ensure that the product meets the requirements.

E) preserving the documented information of the authorized personnel