What is a Quality Management System and Why do We Need it?

What is ISO?

The International Organization for Standardization (ISO), is an international agency of standards and guidelines used for measuring quality in the manufacturing and service industries. If you buy from China, this will be very important to you.

Essentially, ISO provides quality management system (QMS) standards to ensure companies are able to meet and deliver on their promises. ISO is a system meant to help organizations start, apply, supervise and measure ways to increase and maintain performance. Essentially, helping them more effectively deliver on their promises.

What does a QMS cover?

Oftentimes, when entrepreneurs buy from China, suppliers will seduce them into thinking they can cover your product ISO standards, when in reality they may cover the ISO standards you require, but for a different product. Truth is, ISO certification does not guarantee product quality. ISO only certifies the processes that make the product are documented and executed in a quality manner.

A QMS should cover some of the points below:

Record keeping
Organization structure
Employee responsibilities
Process to provide services or products
How continuity is preserved during staff changes
Procedure to manage employees and conduct business
System to ensure employees receive the information they need
Detailed objectives, like keeping defects below a certain percent
Training programs and standard operating procedures (to make sure employees know how to perform their work duties)

What Types of Quality Management Systems are Used in China

The most common QMS structure used in China, by far, is ISO 9001. Essentially ISO 9001 is considered the very minimum quality standards a company can expect to apply in regards to QMS. Depending on your product, other QMS standards may be more relevant and applicable.

Below are just a few examples taken from the ISO website. More QMS standard information can be found on their site below:

Quality

Number	Title
ISO 9001:2015	Quality management systems — Requirements
ISO 10004:2012	Quality management — Customer satisfaction — Guidelines for monitoring and measuring
ISO 13485:2016	Medical devices — Quality management systems — Requirements for regulatory purposes

Safety and Security

Number	Title
ISO 10377:2013	Consumer product safety — Guidelines for suppliers
ISO 10393:2013	Consumer product recall — Guidelines for suppliers
ISO/CD 22000	Food safety management systems — Requirements for any organization in the food chain
ISO/DIS 34001.3	Security management system — Fraud countermeasures and controls
ISO/DTS 34700	Animal welfare management — General requirements and guidance for organizations in the food supply chain
ISO/DIS 45001	Occupational health and safety management systems — Requirements with guidance for use
ISO/IEC 80079-34:2011	Explosive atmospheres — Part 34: Application of quality systems for equipment manufacture

General Management

Number	Title
ISO/DIS 37001	Anti-bribery management systems
ISO 55001:2014	Asset management — Management systems — Requirements

Health and Medical

Number	Title
ISO 13485:2016	Medical devices — Quality management systems — Requirements for regulatory purposes

Environment and Energy

Number	Title
ISO 14001:2015	Environmental management systems — Requirements with guidance for use
ISO 14004:2016	Environmental management systems — General guidelines on implementation
ISO 14006:2011	Environmental management systems — Guidelines for incorporating Eco design

Environment and Energy

Number	Title
ISO 14298:2013	Graphic technology — Management of security printing processes
ISO 15378:2015	Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
ISO/AWI 41001	Facilities Management — integrated Management System — Requirements [with Guidance for Use]

Services

Number	Title
ISO/IEC 20000-1:2011	Information technology — Service management — Part 1: Service management system requirements
ISO 21101:2014	Adventure tourism — Safety management systems — Requirements
ISO 24518:2015	Activities relating to drinking water and wastewater services — Crisis management of water utilities

Information Technology

Number	Title
ISO/IEC 27001:2013	Information technology — Security techniques — Information security management systems — Requirements
ISO/IEC 90003:2014	Software engineering — Guidelines for the application of ISO 9001:2008 to computer software
ISO/IEC 20000-1:2011	Information technology — Service management — Part 1: Service management system requirements

What is a Quality Management System and Why do We Need it?

What is ISO?

What does a QMS cover?

A QMS should cover some of the points below:

What Types of Quality Management Systems are Used in China

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