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Quality Management Systems and ISO 9001:2015

This is part one of an article series dedicated to Quality Management and Management Systems Certification.

In everyday language, the terms company and organization are often used synonymously. In practice, however, this equation proves incorrect in many cases. Most often, the difference between a company and an organization is the existence or lack of quality management, respectively. In this article I am going to explore what it means for companies to establish and maintain a quality management system and how the ISO 9001 standard can help to achieve this.

What Is Quality Management?

Every one of us deals with quality every single day—and it is easy for us to judge if something is of good or poor quality. However, when it comes to describing what quality is, most of us seem to struggle. So, how can we manage something as difficult to define as quality in an entrepreneurial context? The answer, as you can easily guess, is the establishment and maintenance of a quality management system (QMS). A good starting point for designing a QMS is the ISO 9001 standard.

Before we look at QMS in general and the ISO 9001 standard in particular, I would like to clarify what quality management is; and best so by starting at a point where most of us have a very clear understanding: the evaluation of results.

If a company can deliver … quality all (or at least most of) the time, it is very likely that they have some sort of quality management in place.

At the end of the day, quality is when your customers perceive your products or services as high quality. This is the case when they receive what they have ordered, in the form in which they ordered it, at the agreed time, in the agreed quantity, and so on. If a company can deliver this quality all (or at least most of) the time and not just on coincidence, it is very likely that they have some sort of quality management in place. It takes a lot to achieve this:

  • defined objectives & strategies,
  • an organizational chart (organizational structure),
  • processes (operational structure),
  • defined responsibilities (role and job descriptions),
  • measurement of key performance indicators (KPI; achievement of objectives),
  • planned, continuous improvement.

In every organization, processes are discussed on a daily basis; most often those, which allegedly don’t work. Processes are essential for any organization to transform set objectives into measurable results. Yet, a clear documentation of these processes is often missing, which leads to very different views of a process. The resulting confusion and misunderstandings lead to frustration and, ultimately, a loss in quality.

The work processes in an organization cannot be limited by the boundaries of the organizational chart, but run accross the organization, across departments. This requires an orderly handover of tasks and good cooperation between all parties involved. This leads us to one of the favorite topics of any quality manager: interfaces.

The work processes in an organization cannot be limited by the boundaries of the organizational chart, but run accross the organization, across departments.

Why Companies Need a Quality Management System

Agreements are needed to translate the diverse requirements in an organization into the right activities in the right order. And with agreements, I certainly do not mean gentlemen agreements. They may be convenient and may even work under certain circumstances, but they are simply not suitable for managing complex organizations. Better tools and more reliable agreements are needed.

Of course, comparing a quality management system with a tool falls short. Rather, it represents a whole collection of tools that are very well coordinated. Let’s take a closer look at what distinguishes a QMS.

The big challenge is to define (1) objectives and (2) a strategy (bundle) that is suitable for paving the way to achieving these objectives. The exact path to achieving these objectives is then described in the defined and agreed processes. In order to put these processes to work, interfaces between departments or different areas of responsibility need to be established. Finally, all this needs to be documented and made accessible to all parties involved. Only then, you can assure that everyone has the same idea in mind when discussing work matters.

Setting objectives also involves the planning of results. These results will regularly be reviewed and benchmarked based on the defined KPIs and serve as the basis for continuous improvement and controlling.

With all this, we have described the essential parts of a management system. In order to transform it into a QMS, however, it also needs to be aligned to achieve the desired quality of products and services as perceived by the customer.

ISO 9001:2015—What’s in It for Me?

The ISO 9001 standard is a great starting point for establishing a QMS. It „sets out the criteria for a quality management system“ and provides „guidance and tools for companies and organizations who want to ensure that their products and services consistently meet customer’s requirements, and that quality is consistently improved“ (ISO 9000 family – Quality management, ISO).

Why should companies adopt the structure offered within the ISO 9001 standard? ISO 9001 was established around 30 years ago. The aim was to collect and standardize the views of as many experts as possible with regard to the requirements for a good organization. This has resulted in a globally valid standard, which has since been continuously developed and adapted to changing conditions in a five-year review cycle.

The latest revision of the standard, ISO 9001:2015, introduces a new high-level structure and is less prescriptive than its predecessor, ISO 9001:2008. It shifts its focus to the system’s performance, combines the process approach with risk-based thinking and employs the plan-do-check-act cycle throughout the organization, which makes it more flexible and adaptable than ever before. The video linked below can give a comprehensive overview of all the changes. (ISO 9001:2015 – Just published!, ISO)

In today’s globalized markets, a valid certification to ISO 9001 often … is a mandatory prerequisite for closing a deal.

Of course, you can use the structure and tools offered by the ISO 9001:2015 standard without aiming for a certification. However, a certification can be of great value to your organization since it demonstrates that your organization works professionally and according to internationally recognized standards. All this is checked during a third-party audit, conducted by external, unbiased experts. This way, your business partners and customers can be sure that you are a reliable partner. In today’s globalized markets, a valid certification to ISO 9001 often even is a mandatory prerequisite for closing a deal.


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From Preparation to Certification

Now that you know what a QMS is and what benefits the ISO 9001:2015 standard offers, I will outline what it takes to obtain a certification to ISO 9001 by answering the questions I get asked most often.

How can you obtain a certification to ISO 9001?
By commissioning an accredited certification body to conduct an audit according to ISO 9001, which you have to pass with a positive result.

What is an ISO 9001 QM audit?
An ISO 9001 QM audit is an examination by an external, person-certified expert: the auditor. It is checked whether the QMS of the organization meets the requirements of the ISO 9001 standard.

How long does an ISO 9001 audit take?
The duration of an audit depends on the size of the organization (number of employees) and will take at least one day.

What happens during an ISO 9001 audit?
After having checked all relevant documents, the auditor checks if all documented processes, procedures, and agreements are implemented and lived in practice (on site).

What is the result of an ISO 9001 audit?
Ideally, the auditor should file a positive audit report and propose the audited organization to be certified to ISO 9001.

What is the job of a certification officer?
The certification officer’s job is to check all audit documents filed by the auditor for compliance with the standard and also keep an eye on the execution of the entire audit order with regard to accreditation requirements. If everything is OK, the certification officer certifies the audited organization and a certificate is issued.


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