Clause 4 of ISO 9001 requires an organization to evaluate itself and its context to define effects of various elements on the organization, i.e. how internal and external issues influence the company’s culture, organizational goals, products, process flow, markets and customers etc.
By defining the context of the organization, a company takes first step to detect risks and opportunities in the business context.
Though there’s no standard method prescribed for determining the context of the organization, some coherent steps and can make the process smooth and error free; here are these coherent steps:
Step 1- List internal and external issues that can affect the customer satisfaction and delivery of quality product and/or service:
Internal issues may include the approach to governance, contractual relationships with customers, complexity of processes, problems with organizational structure, culture, beliefs, values, or principles inside the organization.
The external issues may include the social responsibility, environmental issues, ethical concerns, political stability, legal framework, technological challenges and the economic environment.
All this information is surely in the heads of the CEO and the senior management, but it’s not documented properly. To start on this step, you need to organize brainstorming sessions and list down everything that appears in these sessions!
Step 2- List the interested parties, whose opinion about your company should be cared about:
The owners and the shareholders are the key people to give their opinion, but there are some more people whose opinion actually matters for the organization. They may include your customers/end users, suppliers and partners, regulator etc. as well as the society! Feedback from all these sources helps an organization to determine what can be improved and how.
Opinion of all such people adds value to the organization; and by identifying and meeting their needs you actually implement an efficient and effective quality management system.
You can conduct short yet effective surveys to gather opinions of interested parties.
Step 3- Identify the scope of the quality management system:
Other than the internal & external issues and interested parties, there must be a defined extent or boundary for which the organization is getting certified.
While determining the scope of the QMS you must consider all the requirements of relevant interested parties and explain that every ISO 9001 requirement is mandatory and may only be excluded if it cannot be applied.
Step 4- Get ready to put everything on paper:
The above three steps are all about brainstorming and gathering maximum information. Once the information is gathered, documentation is a must and the standard is very clear. However, the documentation procedure is extensive and may require tons of hard work if you are not using the right tool!
Step 5- Write context of organization using MyEasyISO:
MyEasyISO enables you to define and write context of organization in simplest possible way. You can document the context of organization using MyEasyISO’s step by step module.
Define internal and external issues, how they affect your organization and also list out the risks associated with each issue.
Define the stakeholder/interested parties names and give detail what you expect/ need from them, how it may impact your organization and also list out risks associated with stakeholder/interested parties.
Define the scope of QMS for which your organization getting certified and list out the clauses that are excluded and give justification for excluded clauses.
Here’s are some more detailed insights of the module:
Even if you’re not much familiar with the documentation procedure, you can do it perfectly using MyEasyISO as it comes with quick help about each feature.
Flowcharts, procedures and forms related to context can be captured in documented information module and a highly professional document can be downloaded with a single click!
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