Read this article carefully. It would assist you in understanding what the ISO 9001 certification actually is!!
If you would ask me what does it mean to implement the ISO 9001 Standards and to create a quality management system, I would say:
- Control over what is happening in your organization
- Clarity of information
- Control over working processes and the product realization
- Ambition for growth
Implementing the ISO standard and creating the appropriate quality management system will provide you with answers for questions that nobody in your organization is able to answer. Or does not want to… Before I start, I would like to add that this is an introduction for the implementation process – during this article I will refer you to more specific articles with more specific information that will answer your specific questions. You are also welcomed to send me Emails with questions regarding the implementation process. I cannot promise that all will be answered but I will sure try.
In this article I present you with some alternative solutions for achieving the certification for the ISO 9001 Standard and establishing a quality management system.
Note: The certificate is merely a reward received at the end of the implementation process; the process itself is what brings growth to the organization. In other words, do not do it only for the certification. If you chose to implement a quality management system according to the ISO 9001 requirements – strive to it effectively and to really contribute your organization. I highly recommend adopting the ISO standard. While it might not be shining and glamorous, it brings a lot of knowledge and, most importantly, it is one of the best know-how for your organization regarding processes – it is a control tool. We would present the basic elements of the implementing process and some alternative solutions for achieving the requirements and certification for the ISO 9001 Standard. The solutions are here to make the process easier and flowing.
Implementing the ISO standard is a strategic decision. It is a less measurable project when compared to something like developing a new product or installing new software, or implementing a new service or a new machine on the production line. The outputs of the project do not manifest themselves like a sales commission, an end of installation or delivered merchandise. Only after a period of time will the employees feel the difference and understand that the process provides order to the organization. It’s important to understand that it’s not an overnight process. It takes time and requires devotion.
How to manage a project of implementing quality management system
At this point, it’s likely that some questions such as “what is the ISO 9001 standard?” will arise.Simple said the ISO 9001 Standard is a management tool that organizes list the processes in the organization and guarantying that all organizational processes are:
- Defined
- Organized
- Documented
- Controlled
- Reported
- Measured
“So, what is the difference with what we are doing today”? As we mentioned before, implementing the ISO 9001 Standard and the establishment of a quality management system is a strategic decision usually made by top management – therefore we assume that top management lacks something – information regarding what is happening, planning of processes, processes arrangements or other useful and essential reports – processes and tools that would promote the organization – otherwise they would not invest so much time, money and human resources…
“What do you do with the ISO?” First, let’s understand the meaning of the implementation process. The following outlines the general points required in order for top management to commit to the process of implementing the ISO 9001 Standard and establishing an effective quality management system. The ISO 9001 Standard requires that the management will a documented statement in various forms and functionalities. The following are the specific requirements:
- Understanding the organization and its context – Understanding the context of an organization is now standard requirement. It is not a new concept but it is officially adopted by the ISO 9001:2015 Standard, and when developing a quality management system (QMS), it is required to identify, analyze, and understand the business environment in which the organization conducts its business and realizes its product. Any organization is a combination of different business entities (functions or systems – internal or external) that relate and interact with each other and exchange information and materials. The context of the organization is an outline of the interaction and integration of these business entities.
- Understanding the needs and expectations of interested parties – Understanding the needs and expectations of the interested parties is the first step in developing the QMS and the foundation for determining its scope, defining relevant quality objectives, and developing quality activities for achieving them. After understanding the context of the organization, it must be determined who the interested parties are and what their needs and expectations are. Interested parties are individuals and other business entities that may affect the organization’s ability to provide a product according to the specifications. Understanding their needs and expectations will create the organizational quality management conditions for the fulfillment of those needs and expectations over the long term and will enable the organization to achieve its objectives.
- Determining the scope of the quality management system – The scope of the QMS defines in which areas and boundaries the organization is active and describes the services, resources, processes, operations, and products the quality system applies to. In practice, it is a text that will be maintained as documented information and also appear on the certification. An accurate and correct definition of the scope is crucial because it determines which products and services are included under the QMS and that determines the processes and activities that need to be planned, controlled, and documented according to the ISO 9001 Standard requirements.
- Quality management system and its processes or Employing the Process Approach – The ISO 9001:2015 Standard employs the process approach in order to enable the organization to effectively plan its processes and their interactions (see clause 0.1 of the Standard—General). How effective? The effectiveness of an organization depends much on its ability to perform several interconnected activities simultaneously in order to achieve intended results—the expectations of the interested parties.
This webpage contains only a fragment of the chapter 4 Context of the organization from the book: ISO 9001: 2015 – A Complete Guide to Quality Management Systems published by:
Why choose the book ISO 9001: 2015?
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