If you want to show that your own company is committed to safety and healthcare management, you probably have done so until 2018 in the form of the OHSAS 18001 certificate. Since 2018, ISO 45001, the official successor, has been in place. Among other things, it explicitly requires management boards to take appropriate action and for external interest groups to be involved in the management...
Quality checks are important for every company. Of course, not only company executives are interested in the quality of their own services - customers, investors and creditors must also be able to rely on the company being led correctly and sustainably. So that you can show the world you’re your own quality management is performed at a high level, the International Organization for Standardization (ISO) has developed a standard and a corresponding certificate: ISO 9001.
What is ISO 9001 Certification intended for?
The goal of quality management is to constantly improve workflows and management. At the same time, communication within the company is as much a priority as customer satisfaction and workflow efficiency. Both the product being offered to the customer and the internal processes should continuously advance toward an optimum. In doing so, it is best for the company to introduce a quality management system (QMS). This helps with organizing quality management.
Whether this system is effective and also properly implemented is too difficult to assess externally. Also, such a comprehensive system can only be overseen with difficulty internally if one does not adhere to clear guidelines. ISO 9001 stipulates exactly this type of criteria. If a company obtains certification, they can advertise internationally that they have high quality-assurance mechanisms.
ISO 9001: The ISO 9001 standard international standards for quality management systems. In order to obtain a certificate, the system being utilized must demonstrably meet the requirements of customers and authorities.
ISO 9001 has already – along with other standards in the 9000 series – been in use since the 1980s. It was revised in 2000 and 2015. One assumes that over a million companies worldwide have ISO 9001 certification.
What is ISO 9001? The Standard’s Contents
In order to be able to receive an ISO 9001 certificate, the QMS being used must meet certain requirements. To this end, the standard contains seven sections (Chapters 4 to 10) with regulations.
The latest version of the ISO 9001 standard is in the same spirit as a High-Level Structure (HLS). Here it is a question of standardization within the context of management systems. All relevant ISO standards should use the same vocabulary so that the regulations are used to simplify work. The HCL follows the PDCA cyle approach.
How is your company set up and what does this mean in terms of requirements? This chapter of the ISO 9001 standard (to be precise, ISO 9001:2015) will ask you to evaluate your company. In doing so, you must take both internal and external factors into consideration. The size of your business plays as much of a role as establishing the market and customer base, and even company culture. QMS must deal with all of these factors. In the process, all potential trouble spots and hurdles that a QMS must overcome are revealed. All findings should be thoroughly documented.
This section addresses upper management’s obligation to have a well-functioning quality management system. This also includes management assuming accountability for the QMS. Should it turn out that the system is ineffective, then management assumes responsibility for this failure. Generally, leadership should set a good example by openly promoting the QMS. In doing so, they encourage all their other employees to adhere to the system.
Another important point – addressed in the standard as a subchapter – is customer orientation. Company management must make sure that customer demands are also met. To this end, the demands should be described in specific terms in order strictly work toward fulfilling the customer's wishes. It should always be the company’s objective to steadily increase customer satisfaction.
The so-called quality policy outlines management’s vision. Thus, the company’s objectives must always be compatible with quality management. This is why the definition of quality objectives is also among management’s responsibilities. Furthermore, one must assign clear roles and thus also rights and obligations.
Planning for QMS
The next section (chapter 6) deals with the actual planning of a QMS. Here, the requirements concerning this organizational step are defined. While doing this, risks and opportunities are an important factor. According to the standard, the planning should be carried out in such a way that the result minimizes risks and improves opportunities. To achieve this, both success factors must be defined and documented at the beginning. The second step then involves planning for how to address opportunities and risks.
This chapter also calls for quality objectives. It involves going into more detail so that the set objectives are specific and not abstract. This means that you should define objectives that are also measurable. Whether the self-defined objectives were thus achieved should be decided based on facts and not through interpretation.
In this section, it is mainly a question of managing resources. One of these resources is personnel. Company employees should receive support from management in the implementation of the quality management system. To this end, communication plays a very large role. All employees must be informed about objectives and the paths to achieving the desired quality standards.
For the purpose of this chapter, however, support also has to do with making other resources available. It is management’s responsibility to provide infrastructure, budget, measurement techniques and expertise in such a way that quality can be assured for the long-term.
The services and products offered by the company are the focus of this section. It is necessary for defining the requirements for services. How must the manufactured product or offered services be designed and/or be executed in order to achieve optimal quality? Requirements as well, such as the plan for how the company wants to realize these objectives should be thoroughly documented. Even with production steps that are carried out by third-party providers, responsibility and oversight remain within your operations.
Communication with your customer base in accordance with ISO 9001 is also part of a product or service. This comprises the disclosure of information regarding the offering or even the provision of help resources such as a support line. You must set clear guidelines within your company with respect to how these tasks are to be handled.
This section deals with monitoring the quality management system: Which methods are utilized in order to check the effectiveness of the QMS? An audit’s findings are to be documented and archived as accurately as possible. In terms of quality management, however, they must also measure customer satisfaction, so methods must be defined for this as well. However, you are not only auditing internally, but externally as well. The standard explicitly mentions that this also includes management. In a management assessment, management’s performance should be examined critically with regard to quality management.
How the measurement methods should specifically look is not defined by the standard. Every company can decide based on their own situation. What is important is that specific data can be collected. Furthermore, you should perform all data collection and analyses at regular intervals.
The concluding chapter of the ISO 9001 standard deals with the continuous improvement of your quality management system. In doing so, you determine with which resources quality will be further increased in the future. This involves determining problems during your first step. Where are there starting points for improvement? In a second step you plan measures for improvement. Improvement should occur continuously according to ISO 9001 – thus, when it comes to quality, stasis should not prevail.
Advantages of implementing ISO 9001
ISO 9001 involves dealing with an international standard, not some form of law. The corresponding certificate is an optional means of promoting your company, not a requirement. Every company is at liberty to approach quality management differently. However, there are good reasons for why companies should still adhere to the guidelines.
On the one hand, certification clearly stands out. ISO 9001 means a lot – across all industries as well. An ISO certificate has a high value in most parts of the world. In this way you build trust in your company on the international stage. Both customers and business partners can be sure that a business with this certificate uses a system for ensuring quality over the long-term.
On the other hand, with ISO 9001 you have a good guidebook. Instead of trying to determine regulations, and as a result perhaps fail to do so, with the standard you have a sophisticated work available. Many experts have worked together on the ISO standard and have kept it current through revisioning. Therefore, anyone who works according to the standard reference will sooner or later notice improvements, such as increased customer satisfaction – provided that one is disciplined in their adherence to the provisions.
How do you get ISO 9001 Certification?
When you receive ISO 9001 certification, it means an independent authority has determined that the quality management system being utilized meets the international standard. There are many certifiers for this: it partly involves private companies; however, many associations perform audits as well.
Before you choose a certifier, it is necessary to install a quality management system or adapt an existing one to the ISO standard. This also involves preparingthe necessary documents. Then you usually perform an internal audit. This means that you simulate the audit and, in this way examine your company for weak spots. To this end it can be helpful to call in an external consultant who can ensure an objective perspective. They can also provide tips for solving problems.
Only then does the actual audit takes place, and indeed in two phases. First of all, the auditors review your documentation. If this is complete and correct, the second phase follows. Should the auditor notice smaller flaws, you can eliminate these for them at the beginning of the second phase. With larger abuses, however, the audit is terminated. There should be no more than three months between the first and second step.
In the second phase, the actual activities are audited. For this, the auditor visits the business premises and speaks with employees. In the second step the documentation is reviewed again – but this time it’s more detailed. The certification authority then generates an audit report where all items which are in agreement with the standard are listed, as well as those that deviate from it. This document is the basis for the closing meeting, in which the auditor presents to you their findings. If your QMS is not yet compliant with the standard, you have 90 days to make adjustments. Then a follow-up audit occurs.
If you pass this audit, the certification authority issues you a certificate. This is valid for three years. During this time, annual surveillance visits occur. For this, an auditor arrives at your business and performs an audit on a sample basis. This means that the audit is far from comprehensive as that which is needed to obtain ISO 9001 certification. Recertification occurs after three years.
It is hard to say how high the costs are for certification, as this depends on various factors. In general, larger companies have more of a financial burden than smaller ones. Here providers follow the regulations for the International Accreditation Forum (IAF), which provides a price scale arranged according to the number of employees. Also, the industry in which you are active is crucial in determining the price, as your employees’ workflows affect the auditor’s amount of work. In addition, a follow-up audit generally costs extra.
However, these are only the costs that directly result from ISO 9001 certification, that is to say, via the price set by the certifier. Furthermore, you must think about the internal financial burden that will result from installing a QMS. Developing the system, training employees and adapting to ISO 9001 guidelines are time-intensive activities, and for this reason have costs associated with them.
Anyone who would like to learn more about building a QMS in accordance with ISO 9001 can find further details in our article on the subject of continuous improvement process.