07 Feb ISO 9001 Requirements for Clause 4 Explained
Regardless of industry, if your organisation uses a quality management system, meeting ISO 9001 requirements ensures compliance with the international standard for QMS. The standard is used by businesses to gain ISO certification. It shows that they can consistently deliver goods and services that adhere to legal as well as customer standards. Clause 4 addresses the first step in meeting QMS requirements.
What is ISO 9001 Clause 4?
The first step in meeting ISO 9001 requirements is to connect the company’s goals and intentions with the QMS. This is the “context of the organisation” process addressed in ISO 9001 Clause 4. In this case, the context covers the many elements making up an organisation. It also addresses the effects on the quality management system. Clause 4 reflects the company’s size, its markets, and how they define the consumer. It also helps identify risks and opportunities and their effect on the QMS.
Using ISO 9001 Clause 4 and its subclauses serves multiple purposes. It determines external and internal issues and observes and reviews them. Internal issues include organisational structure, the strength of the workforce, and the culture of the workplace. External issues include changes in technology and the economy as well as the actions of competitors.
ISO 9001 Clause 4 also identifies, monitors, and reviews all interested parties which include customers and competitors but also contractors, subcontractors, government, and regulatory bodies. It sets forth the scope of the QMS and the processes for inputs, outputs, responsibilities, risks, and rewards.
Outline of Clause 4 ISO Requirements
Regardless of industry, ISO 9001 requirements remain the same. Clause 4 includes the four subclauses outlined here.
Clause 4.1: The Organization and Its Context
To meet ISO 9001 requirements, a company must determine the purpose of its business, its nature, as well as its strengths, weaknesses, dangers, and opportunities. When creating and executing a quality management system, organisations must consider both internal and external factors. It is noted that these impacts can also include how regulations, technological advancements, and even traditional consumer, economic, and competitive considerations affect the organisation’s objective.
Clause 4.2: The Needs and Expectations of Interested Parties
This criteria takes into account the needs and wants of everyone in the company who might have an impact on its mission, and who, in turn, might have an impact on its quality management system. Listing any hazards related to stakeholders or other interested parties is a part of the process. ISO 9001 requirements Clause 4.2 also requests that those applying for ISO 9001:2015 certification have a continuous mechanism in place for identifying these interested parties and their specifications.
Clause 4.3: The Scope of the Quality Management System
In order to execute and become certified under your organisation’s QMS, you must first define its scope. Given that ISO 9001 is a general standard, not all of its standards apply. In this case, you must justify why they do not. The standard mandates that the QMS’s potential scope expands to take into account how to meet the demands of those pertinent groups mentioned above.
Clause 4.4: QMS and Its Processes
ISO 9001 requirements include an understanding and control of the order of each phase in the QMS processes and how one element affects another. This includes the measures used to gauge their effectiveness. It also addresses the criteria used to indicate success and how to analyse the process to ensure continuous optimisation to better achieve its goals.
ISO Requirements for Business
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- Resources and a network of support to help businesses succeed
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