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14 September 2022
The ISO 9001:2015 standard is a set of requirements that determines the framework for an organization's quality management system. Since these requirements should apply to any organization of any size and in any industry worldwide, they are written in a rather generic way. The downside is that it's rather hard to understand what exactly the standard prescribes. This article will shed some light.
The ISO 9001:2015 requirements stipulate the processes of a quality management system, but what does this mean? A quality management system is vastly more than quality control. While quality control is generally well understood, a quality management system refers to the management of the entire company and its processes. As such, the ISO 9001 standard affects virtually the entire company.
The ISO 9001:2015 standard is organized into 10 clauses. Clauses 1-3 are introductory and explanatory sections. Clauses 4-10 contain the actual ISO 9001:2015 requirements.
The three introductory clauses don't contain any ISO 9001:2015 requirements but rather provide important background information to facilitate easier understanding. Clause 1 (Scope) explains that the standard specifies the requirements for a quality management system so that products and/or services consistently meet requirements and enhance customer satisfaction. Clauses 2 and 3 merely provide references to ISO 9000:2015 which contains fundamental information and vocabulary.
In clause 4, ISO 9001:2015 sets the requirements for the foundation of the ISO 9001 quality management system. The "context of the organization" is the business environment in which the company operates.
Clause 5 of ISO 9001:2015 is all about the responsibilities of top management within the ISO 9001 system. It includes requirements for active involvement as well as for responsibilities that can be delegated.
Clause 6 focuses on planning. The requirements address risk management, the definition of organizational targets, and change management.
Clause 7 of ISO 9001:2015 is all about support functions. It includes requirements for various resources, competence and training, communication and documentation.
In clause 8, the ISO 9001:2015 standard sets the requirements for the processes needed to achieve the product or service. This is how your product or service is designed, produced, tested, handled, shipped, etc.
Clause 9 is all about measuring and evaluating. Most of the requirements in this clause address various ways of generating data, but there is also a section on analysis and one on management reviews where decisions are made based on the derived information.
In clause 10, the standard requires companies to determine and identify opportunities for improvement. The corrective action process is one of the key sections in the standard designed to achieve improvement.
Clauses 4 through 10 have been set up to follow the PDCA cycle, which stands for "Plan, Do, Check, Act". The cycle is a continuous quality improvement model that is used in a variety of contexts, including Six Sigma implementations. The main point of the PDCA cycle is to help facilitate change in an organized, systematic manner and fundamentally support the ISO 9001 goal of improving quality management.
Plan: Planning requires the establishment of objectives, determination of resources, and risk management. Important input factors are the context of the organization, customer requirements, and needs of other relevant interested parties.
Do: During this phase you need to implement what was planned. This includes the heart of your business: the production and/or provision of services.
Check: The next part in the PDCA Cycle is to monitor and/or measure key processes and their output against targets and analyze the results.
Act: After evaluating the results of your monitoring and measuring, the standard requires taking action to improve performance as necessary.
ISO 9001:2015 requirements also follow ISO's High Level Structure, which ensures consistency across ISO management system standards. In addition to the structure, punctuation, choice of words, and basic terminology are also consistent. All this makes it easier to integrate ISO 9001 with other management standards. The High Level Structure is defined in ISO's Annex SL.
ISO 9001 requirements affect each position in a different way. To make full use of ISO so that the organization runs more efficiently, customers are more satisfied, and profits are maximized, proper training is indispensable. All too often, executives and department managers are neglected when it comes to ISO 9001 training – despite the fact that it's these positions that could generate the highest rewards for the company if they were trained to fully utilize ISO 9001.
No matter if you just want to find out more about ISO 9001:2015 requirements or if you want to ensure that all key positions get the best training, we have an effective online course for you.
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