How to deal with the context of the organization - ISO 9001:2015

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How to deal with the context of the organization - ISO 9001:2015, point 4?

If the organization has developed a quality manual according to the ISO 9001:2008 standard, then there should be no big problem in dealing with the context of the organization.

Why?

In the quality manual, there is a section on getting to know the organization, which usually contains the following:

• basic information about the organization,
• information about products and services,
• vision and mission of the organization.

These parts of the quality manual can serve as a basis for point 4.1 - Understanding the organization and its context.

Furthermore, it is possible to address external and internal contexts by supplementing this point with the outputs of the STEP analysis (social, technological, economic and political aspects) or SWOT analysis (strengths, weaknesses, opportunities and threats to the organization).
 

What matters is the way in which the data and facts the analysis is compiled. Mainly in terms of data credibility and breadth of facts.

In Section 4.2, Understanding Stakeholder Expectation Needs, it is necessary to clarify what the organization's stakeholders are.

Stakeholders are usually:

• Organizers (vision, financial returns, goals, environmental requirements, health and safety requirements, innovations, personnel requirements and others)
• Workers - employees of the organization (usually based on a collective agreement or incentive rules in the areas of cities, education, qualifications and others)
• Customers (deadlines, quality, reliability, performance, innovation)
• Suppliers (clearly and timely purchase requirements at reasonable prices)
• State (government) in the form of legislative or normative requirements (legislative requirements in the form of laws that apply to the organization, or a list of technical or other standards).

If we define the requirements of stakeholders, then we must not forget that the cycle of continuous improvement of PDCA applies in this case as well.

In practice, this means that with the requirements we have defined and planned, we should do the following:
 

• describe how to measure, monitor their implementation - application in practice
• analyse their effectiveness and efficiency
• design and implement measures for improvement.

Standard clause 4.3: Determination of the subject of the quality management system:

At this point, the requirements of the standard are focused on the subject of the quality management system. Therefore, we recommend aiming mainly at those activities - products from the Commercial Register - that the organization actually performs and are the main subject of the organization's income.

These activities - products need to be considered from several angles. For example, in terms of meeting stakeholder requirements.
 

At this point, it is also necessary to assess which requirements of the standard apply to the implementation of the activities in question. If some requirements of the standard do not apply, a justification must be provided.

Point 4.4 of the quality management system and its processes:

When meeting the requirements of this point of the standard, we recommend defining all the processes that the organization applies in the implementation of products and activities, or meeting the requirements in a clear table of processes.

We recommend a description of the processes in the form of a so-called process card, in which the requirements of points under a) to f) of the standard are determined.

The interrelationships between processes can also be described visually in the process map.

We hope that these few tips will help you, at least in part, in applying the requirements of point 4 of ISO 9001:2015.