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

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When you buy from China, Quality Should be a Priority for Both the Buyer and the Supplier.

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.

iso-9001

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 Quality Measurements Systems are available when you buy China goods?

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:
https://www.iso.org/iso/mss-list

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

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