You are currently viewing ISO 9001:2015                               Clause 4 – Context of the Organization

ISO 9001:2015 Clause 4 – Context of the Organization

Context of the Organization

Quality management system (QMS) is a collection of business processes which focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization’s scope and strategic direction. It is expressed as the organizational goals and aspirations, policies, processes, documented information and resources needed to implement and maintain it. It is divided in to the 7 working clauses. In this article will start from the 1st working clause i.e. Context of the Organization.

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Context of the Organization means external & internal context which is impacting on the performance of the organization, objectives and entire management system. Main factors are Customer, supplier, investors, society, legal authorities, employees etc. Quality Management System is taking care of overall context of the organizations which is providing clarity before starting the planning to achieve the desired goal.

 

It is necessary to understand the context and their needs and expectations to identify potential risk if any. It will help us to improve the performance and can reach the decided goal or destination faster.
It is dividing in to the sub clauses to understand the requirements. Each sub clauses expressing the different requirements which needs to comply.  Organization who wants to improve their internal and external system or want to certify themselves for this standard, need to understand this clause and identify the proper context.
All clauses have been divided in to the sub clauses to understand the steps.

4.1 Understanding the Organization and its context

    • Identification of Internal and External Issues relevant to the Quality Management System.
    • Internal issues can be added related to required improvements, process or development which can be control by Organization
    • External Issues can be added related to political, legal, technological, competitive, cultural and social environment which cannot be control by Organization but can be reduce the intensity of that issue.
    • Positive and negative both types of issues shall be identified.
    E.g.  Positive Issue In Production Dept. – Use of more efficient tools to get the better effectiveness or Developing new machine skills and learning opportunity
    Purchase – Use of ERP software to check the current stock and order the material
    HR – More on job trainings to employees to increase the skills
    Negative Issue in Production Dept.- Unskilled workers or less awareness of digital technology to handle the machines
    Purchase – Less suppliers for special material or short lead time to arrange the material
    HR – Retention of the employee.
    These are the some examples of general issues in the Business Organizations.
    • You can use different types of methods to identify these issues. But it should be more clear and specific.
    • Needs to prepare action plan to resolve this issues. PDCA cycle shall be applied here to resolve those issues and check the compliance. 

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