Customer-centric ISO 9000 Quality Management System Essentials

Every business executive is familiar with the old adage “The customer is always right.” But, is this saying actually correct? Always? Well, the customer usually has a pretty good idea of what they want, or at least what the product functionality and capabilities should be. However, in today’s competitive electronics market, there are typically several different suppliers that can satisfy this end-use requirement. Yet, the final product and the process that creates the PCBAs and electronics can vary a great deal in terms of quality.

The final product and process quality are two different issues with different defining metrics. For example, the quality of a PCBA is measured by the device reliability, the assuredness of which is shared by the developer and contract manufacturer (CM). Likewise, the board development process is a collaboration, yet in this case, maximizing efficiency without sacrificing quality is the objective.

Today, the ability to adopt and maintain effective customer-focused PCBA development and production is not only desirable but demanded. In fact, the prevailing standard for product development, ISO 9000, and subsequent revisions, mandate that customer concerns be considered throughout a product’s lifecycle. Let’s take a look at why an ISO 9000 quality management system is so important and the essential aspects that it should include.

Why an ISO 9000 Quality Management System is So Important

When building PCBAs, some combination of IPC standards typically guides the design, manufacturing, and testing stages of development. Although adhering to these standards is required, many OEMs and end-use suppliers make purchasing decisions based upon whether you implement and adhere to the principles of an ISO 9000 quality management system.

The family of ISO 9000 contains a set of globally accepted standards that define quality management concepts and principles and provide a framework for creating a quality management system (QMS) that strives to continually improve the quality of products and services for customers. The set includes the following:

ISO 9000 Quality Management System Standards

 

• ISO 9000:2015 Quality management systems — Fundamentals and vocabulary

This document provides the underlying concepts and principles on which the other ISO 9000 standards are based.

• ISO 9001:2015 Quality management systems — Requirements

This standard establishes generic requirements that can be used to demonstrate an entity’s commitment to consistently furnishing products and services that meet its customer’s regulatory requirements and seeks to improve its customers’ satisfaction by instituting a system to continually improve quality and maintain statutory compliance(s).

• ISO/TS 9002:2016 Quality management systems — Guidelines for the application of ISO 9001:2015

In this standard, an organization can find suggested actions and steps to implement the requirements for a QMS set forth ISO 9001:2015. The purpose here is to provide a general framework and no specific industry, product, or service type is targeted.

• ISO 9004:2018 Quality management — Quality of an organization — Guidance to achieve sustained success

To assess whether the adopted QMS is sustainable, an organization can look to this standard, which includes an assessment tool that can be utilized by any size or type of entity.

For more specific guidance on particular aspects of a generic ISO 900 compliant QMS, please refer to the list of supporting technologies standards provided by ISO. Now, we can see what is needed to best apply these standards to PCBA development.

The Essentials for a Customer-centric ISO 9000 QMS

Although implementing an ISO 9000 quality management system is not a regulatory standard throughout the PCBA industry, its compliance is required for OEMs and electronics suppliers to critical industries; such as medical devices, aerospace, and automotive systems. This mandate may be instituted directly by requiring ISO 9001 certification and/or by incorporation of the standard into other regulations. ISO 13485 and similarly AS9100D are examples of mandatory QMS attributes for the medical devices and aerospace industry, respectively.

At the center of all ISO 9000 quality management system standards and others based upon them is the customer. These standards dictate the necessity of a customer-centric approach that extends from the start of development through the end of a product’s lifecycle. Moreover, to satisfy this standard requires the inclusion of all vendors and suppliers that contribute to the process and to a great extent, your CM who actually builds your boards. This can be accomplished by ensuring your CM embodies the attributes listed below.

ISO 9000 Quality Management System Essentials 

 

• An ISO 9001 certified CM

It is essential that your CM is as committed to a customer-centric QMS as you are and this is best illustrated by their being ISO 9001 certified.

• A secure component supply chain

Quality for electronics begins with the components used; therefore, it is imperative to source from qualified vendors and de-risk your component procurement process to minimize susceptibility to counterfeits, delays, and low-quality components.

• Open and transparent system communication

An effective QMS must include real-time access to needed data for all system entities, while simultaneously limiting access to unauthorized users or systems. This is best accomplished by a digital thread manufacturing process.

• Agile manufacturing

Open or universal data access enables the optimization of an agile manufacturing process or the ability to transmit change requirements quickly such that system equipment modifications can be incorporated as fast as possible.

• Data traceability

The ability to retrace data paths throughout development is critical as this provides the basis upon which QMS improvement is based.

• Effective risk management

For a QMS to be most customer-centric, it must be adaptive and capable of making necessary modifications to improve quality, which is the goal of risk management.