ISO 9001: 2015 Quality Management System: What is it and how does it work?

Quality management system ISO 9001: 2015, a very big name is not it? It may seem like something quite complicated to implement and maybe you may think it's not that important, but I assure you it makes all the difference!

In competitive moments in the market, such as the one we are living now, we must have everything organized to gain some competitive advantage, either by increasing productivity, calculating costs and selling prices correctly, positioning ourselves better in the marketplace, etc.

But what is Management System?

System is a set of "things" that, when put together, seek the same goal. Management is to completely manage some (or all) the area (s) of the company. So the management system is nothing more than a set of tools and work practices that serve to manage some sector.

Are there different types of management systems?

Yes, there are quality management systems, environmental, security, internal communication, people, sales, etc. And you have the Integrated Management System, which can cover several (or all) areas of the company.

As the system definition itself says, it is very common for you to see management systems that encompass more areas. For example, the Quality Management, which is the focus of our conversation today, brings requirements about customer communication, with suppliers, selection and training of teams, as well as the company's own finalist process (which is its operation - production of products or services) .

In addition, you can also classify Management Systems the way they were designed: your company can develop a management system internally can acquire a management system already structured by some company or you can merge modules of the management system acquired externally with private modules of your business, developed by your own team.

The guideline of the management system, in software or in documents on your intranet (or company network), is to have records and evidence, in order to bring historical data for future actions and even audits.

What is the need to have a Management System?

As I said above, a Management System (MS) is for you to organize your company information (sales, marketing, finance, quality, operation, logistics, inventory, etc.) in order to concentrate the data in a single location , bringing more information, which helps in better decision making. Of course, with more and better information, you can make better decisions and act right.

If you realize that your company suffers from repeated error problems, lack of basis for decision making (lowers the quality), lack of quality indicators, lack of standardization in the process (products leave with a lot of variation), lack of stock or raw material or even production efficiency because employees are lost too, these can be symptoms that you need to implement an MS or upgrade what you already have. It is at these points that a well implemented Management System helps!

What are the benefits of a Management System?

A Management System helps in all of the above, but of course it does not stop there!

In an operational setting, an MS helps you to better train your employees, standardize the execution of some process / product / service, improve the quality control level, aid in cleaning, organization (5S) and everything else. In a more managerial part, an MS helps you to make production mix decisions, customer service, sales history, demand projection, etc.

And to conclude, in a more strategic area, MS helps to make all decisions to keep the company alive: decisions related to Market share, Annual Planning, Strategic Planning and so on.

Then your company can choose one of the types of Management System said in the previous questions. You have total ability to know what works best for your company and implement. Remember to take into account the implementation time, cost of implementation, maintenance, and employee training.

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What are the difficulties of implementing a Management System?

The difficulties are related to the 3 factors above and a few more that we will describe here:

• Adaptation: Many employees may be apprehensive about their permanence at work after the implementation of MS, or many may not want to implement, since they think they are doing everything the best possible way
• Cost and Time: factors that management often takes into account before implementing and if everything is not well planned, deployment can be more expensive and time consuming than initially imagined.

To mitigate these risks and hardships, the main thing is for top management to fully buy the idea, support it, and provide all the support it needs to engage and motivate employees throughout the transition period. And more than implementing, one must continue with the maintenance and continuous improvement of the MS in the company.

How do I maintain an updated and efficient Management System in my company?

The two main points to keep an up-to-date, well-implemented and efficient MS in the company are: well-trained and responsible people with authority. During the implementation it is of the utmost importance to choose one or more responsibles for the Management System, which will have the role of disseminating the MS in the company, train new employees, follow up audits, etc. In addition, it is essential that all stakeholders are trained in their areas of competence within the MS.

Among the types of management systems, we see the Quality Management System (QMS), which covers part of the quality of the process / product / service focused on customer satisfaction. For this, the ISO (International Organization for Standardization) has the norm 9001, which brings requirements for quality management systems, which is nothing more than a listing with the types of management practices carried out by class companies (companies of great renown), compiled in order to bring the best of what is done by these companies. The ISO team has gathered all this information and created the standard in a generic way, adaptable to any type of company, at any size or any purpose.

ISO 9001 is not the only one that conduct quality management systems, but it is one of the most known and used worldwide and will be our focus on the rest of the article. As ISO is in Switzerland, each country has an accrediting body that translates those standards. In the case of Brazil, we have ABNT (Brazilian Association of Technical Standards).

Recently, ISO launched the new version of the QMS standard: ISO 9001: 2015 and it brings many new features in order to make the management system of our companies more and more solid. By itself, ISO 9001 already addresses aspects such as: leadership, strategy, customer communication, customer satisfaction, new products, operation, suppliers, quality control, process improvement, etc., which causes many companies to use the MSQ in an IMS (integrated management system) with other ISO standards, such as 14001 (environmental), or with other production management systems (ERPs, MRPs, etc.).

A Quality Management System based on ISO 9001: 2015 works on the basis of PDCA (Plan - Do - Check - Act), which basically consists of planning the strategy of your company, connected to the operation and quality, having a formed team and defined processes execute the action plans and implement the necessary improvements so that the company works correctly evaluate the process through audits and meetings, and products / services through verifications and validations and finally act in a way to give continuity in the things executed correctly with good result or to improve actions that can have better performance in its management.

What are the principles of the ISO 9001: 2015 Quality Management System?

• Customer Focus: Organizations depend on their customers and therefore must meet their current and future needs, their requirements and strive to exceed their expectations.
• Leadership: Leaders establish unity of purpose and the direction of the organization. They must create and maintain an internal environment in which people can be fully involved in achieving the goals of the organization.
• Engagement of People: It is essential for the organization that all people are competent, capable and engaged in delivering value (achieving company goals and objectives related to their work).
• Process Approach: Consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes that function as a coherent system.
• Improvement: A continuous improvement of the overall performance of the organization should be a permanent goal of the organization.
• Evidence-based Decision Making: Decisions based on data analysis and evaluation are more likely to produce the desired results. And those based on facts generate more precision and agility, besides causing less rework.
• Relationship Management: Creating and maintaining enduring relationships with stakeholders brings a number of advantages such as: Brand strengthening Supply contracts Increase in turnover.

How is ISO 9001: 2015 QMS divided?

As already mentioned above, the ISO 9001: 2015 Quality Management System uses the PDCA method and is divided into 10 items, the first three being more introductory:

• Scope: which says what is the scope (the purpose) of the standard for a company. This item also says that the standard is generic and applicable to any company:
• references to name what are the references and current versions used in the standard
• Terms and Definitions: This item says that the concepts used in the document, refer to the standard.

The 7 other items are where the norm begins to apply so that the organizations begin to, in fact, implement the QMS. With this, the PDCA is used, as we see in the image below:

• Organization Context: It talks about the context of the company, its stakeholders, risks and opportunities of the business and the internal and external knowledge of the organization.
• Leadership: Shows the need for leadership commitment to the QMS, its implementation and dissemination throughout the company, with a focus on the client and each person with his correct duties.
• Planning: This item discusses all of the QMS planning, as well as changes and objectives to achieve planning.
• Support: It about of all the need for financial support, people, infrastructure, documentation, etc., necessary for the operation of the company.
• Operation: Item that conduct all of the operation of the company's finalistic process, as well as the development of new products / services / processes, control of suppliers, customer service, delivery, after sales, etc.
• Performance Evaluation: An item that contains all aspects of evaluating the QMS regarding its performance, with audits, customer satisfaction and QMS review.
• Improvement: Item aimed at the continuous improvement of the QMS, which also shows how to act in case of detected nonconformities.

What are the new features of the ISO 9001: 2015 Quality Management System?

The new version of ISO 9001 (ISO 9001: 2015) brings considerable newness in leadership, where the leadership in each area will now have an important role in the work, motivating the team and disseminating the QMS in their area. In addition, the process approach and the identification of internal / external risks is present in all the items of the standard, in order to make the QMS more comprehensive in all areas of the company.

Another point is the importance given to the knowledge of the organization (internal) and how the company seeks new sources of updating (external knowledge), besides the documentary part, which is more open for the company to use what is appropriate. Finally, the structure of the standard, using the 10 items comes from the idea of ??ISO to use this same model for other standards in order to improve integration among other management systems.

How do I start implementing QMS in my company?

In order to start implementing a QMS in your company, you need knowledge of your business (know your customers, stakeholders, market influences, external and internal analysis of your company, other competitors, etc. Basically a business plan and strategic planning, so you know who you are and where you want to go).

Based on this, it is worth studying the company process (mapping processes, dividing areas, etc.), because with this internal structuring it is possible to start implementing the ISO items, since only then you will be able to implement management practices that will relate to ISO items and create important documentation to keep your process logged and available for improvement.

Finally, for a QMS to run properly in the company, it needs a lot of people involvement and commitment to use the system, as well as making updates to improve.

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