How Would You Implement a Quality Management System Complying with ISO 9001?
All companies say they care about quality. Fewer can prove it. Ask yourself a blunt question: if a customer, an auditor, or a new hire asked how your organization guarantees consistent results, could anyone point to a system, or would they point to the few people who “just know how things are done”? That gap is exactly what a quality management system is built to close.
If a company wants to obtain ISO 9001 certification, it has to implement a quality management system that conforms to the standard. That is not a one-weekend project, and it is not a marketing badge you buy. What follows are the practical steps to create and implement a quality management system that complies with ISO 9001, and the mindset that keeps the effort from collapsing under its own weight.
What Is a Quality Management System?
A quality management system, or QMS, is the documented set of processes, responsibilities, and records an organization uses to consistently meet customer and regulatory requirements. It is how you turn “we try to do good work” into “here is exactly how we do good work, and here is the evidence.” The internationally recognized model for a QMS is the ISO 9001 quality management standard, which is built on principles like customer focus, leadership, process approach, and continual improvement.
ISO 9001 does not tell you how to run your business. It tells you to define your processes, follow them, measure them, and improve them. In plain terms, ISO 9001 is about “say what you do and do what you say.” The system exists so that quality does not depend on heroics or on whoever happened to be in the room.
Creating a Quality Management System
Developing and using the QMS, as well as the audit that follows, are going to take real time and effort. If you’re doing it purely for marketing’s sake, and you think you can knock out a QMS and pass a certification audit in a matter of months, you’re in for a rough ride. You’ll never get a solid quality management system under you, and you’ll never make the deadlines, because they were unrealistic from the start.
First, It Is About Customer Focus
If you build ISO 9001:2015 quality procedures for a QMS because you genuinely want to give your customers the best of everything, and customers are the reason for everything you do, then you’ll take the time you need to get it right. You won’t set unrealistic goals and deadlines, and you won’t drive yourself crazy trying to figure out why you never meet the customer’s expectations. Customer focus is not a slogan on the wall; it is the organizing principle of the whole system.
Voice of the Customer
You have to collect the voice of the customer, capture the requirements from the customer, and then communicate those requirements to design and development. Design and development, in turn, communicate what they believe the customer wants back to the customer for confirmation through verification and validation. Then design and development communicate specifications to purchasing, manufacturing engineering, and quality and testing, to make sure the product is made as designed.
Miss any link in that chain and the customer’s real requirement quietly gets lost in translation. The QMS exists to keep that chain intact and documented, so the thing you deliver is the thing the customer actually asked for.
Next, Communicate with Stakeholders
Keep in mind that a core problem with ISO 9000 implementation is communication. An effective quality implementation is really about communicating effectively with the stakeholders of your organization. You need to identify, meet, or exceed the requirements of customers, suppliers, employees, and management. Internal departments like quality, sales, marketing, design, manufacturing, accounting, and management all have to communicate using the same language.
ISO 9001 is about “say what you do and do what you say.”
Quality communicates to management through internal audits, management reviews, and quality objectives, showing that the system is capable of consistently reproducing the product or process. The company then communicates its consistency to its stakeholders through its quality policy, its ISO certification, and visible management commitment.
When we talk about effective communication, we mean a real two-way exchange of information. Both the sender and the receiver have to be actively engaged and providing feedback for it to work. Implement an effective quality management communication system and the savings will be significant, because waste is produced when one or more groups or departments stop talking to each other. Total up the cost of all of your nonconformities, defects, and deviations from plan, and you have the cost of poor communication.
Management Commitment
Management communicates its quality commitment by allocating budget for continuous improvement through corrective action and preventive action, training, and infrastructure. According to the American Society for Quality, the cost of poor quality can run to a substantial share of revenue, which is precisely the waste a well-run QMS is designed to recover.
The top manager responsible for the ISO QMS needs a fairly high level of authority in the organization. They have to be able to make decisions, apply resources, and implement changes related to the QMS without having to ask permission or feel they are overstepping. The QMS touches many different parts of an organization, and someone in a low position of authority simply will not be able to implement and manage it effectively.
That person also needs to be in a secure enough position to tell the truth to higher management, whether that is a General Manager or a President in a larger multi-plant organization. Someone lower in the organization is often not comfortable being candid with senior leaders, for reasons that range from fear to simply feeling out of place. An ISO QMS that has no open channel to higher management about its functionality and effectiveness will never truly benefit the organization.
7 Easy Steps to a Quality Management System
- Develop a quality management system (QMS).
- Implement the QMS and collect data.
- Review the data you collected and use it to drive improvement.
- After several cycles of the quality management system, you should have an indication of whether it is working. When you are sure it is…
- Apply for a certification audit. Your country’s national ISO member body can point you to certifying bodies, registrars, and other resources.
- A few weeks after the audit, the certification auditor will tell you whether you passed, or where you were weak and need improvement. If you passed, celebrate it: your quality management system is now ISO certified. And…
- If you did not pass, make the necessary changes, at the bare minimum, and reapply for a certification audit.
Create a Quality Management System and Keep the Big Picture
Alright, so they are not really easy steps, but the concept itself is not complicated. Each of the steps above breaks down into successively smaller pieces, the activities, people, and tasks that make it real. If you start with the big picture and keep the big picture handy, you’ll do fine. Refer to it continually as you build. That is where a lot of companies go wrong: they focus on just one part of the whole story as if that one part were the whole story. Build the system for the customer, communicate across every department, and commit the authority and budget to sustain it, and ISO 9001 certification stops being a hurdle and becomes a byproduct of running the business well.
Frequently Asked Questions
What Is a Quality Management System in ISO 9001?
A quality management system is the documented set of processes, responsibilities, and records used to consistently meet customer and regulatory requirements. ISO 9001 is the international standard that defines what an effective QMS must include, built around customer focus, leadership, a process approach, and continual improvement.
How Long Does It Take to Implement a QMS?
A realistic implementation runs several months to more than a year, depending on the size and complexity of the organization. You need enough cycles of collecting data and driving improvement to prove the system works before you apply for a certification audit. Trying to rush it purely to earn the badge is the fastest way to fail the audit.
Why Is Communication So Important in ISO 9001?
A core problem with ISO 9000 implementation is communication. Customers, suppliers, employees, and every internal department must communicate using the same language so requirements are not lost between design, development, purchasing, manufacturing, and quality. Most nonconformities, defects, and deviations trace back to poor communication between groups.
What Role Does Top Management Play in a QMS?
Top management shows commitment by allocating budget for continuous improvement, corrective and preventive action, training, and infrastructure. The manager who owns the QMS needs enough authority to make decisions and apply resources, and enough security to tell higher management the truth about how the system is performing.
What Are the Basic Steps to Get ISO 9001 Certified?
Develop the QMS, implement it and collect data, review the data to drive improvement, run several cycles to confirm it works, then apply for a certification audit through a registrar. If you pass, your system is ISO certified. If you do not, correct the weaknesses the auditor identified and reapply.
