Context of the organization is one of the new concepts and differences between the ISO 9001:2008 and its younger brother the ISO 9001:2015. It pretty much changes the concept and application of chapter 4. The context of the organization as described in the ISO 9001:2015 requires you to detect and define various environmental, economic, technological and political conditions on the organization and how they reflect on the QMS; the company’s culture, objectives and goals, complexity of products, flow of processes of and information, size of the organization, markets, defines customers etc. It is also a mean to detect risks and opportunities regarding the business context.
The result is the new chapter 4 – context of the organization requires the organization to evaluate and position itself and its context. The output of this context evaluation will be determination of the scope of its quality management system.
Quality Management System and General Requirements – Context of the Organization
| 2008: 4. Quality Management System 4.1 General Requirements |
2015: 4 Context of the organization 4.1 Understanding the organization and its context |
With the ISO 9001:2008 it is necessary to evaluate whether the organization’s quality management system follows the general requirements. With the ISO 9001:2015 context of the organization – the organization shall analyze which issues (external as well as internal) that may affect its QMS or already have an effect. Chapter 4.1 – Understanding the organization and its context lists the aspects that may impact the quality management system.
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Understanding the needs and expectations of interested parties
| 2008: No equivalence | 2015: 4.2 Understanding the needs and expectations of interested parties |
Again, a change of concept and application of the chapter. The ISO 9001:2015 requires understanding who the different parties that are related to the QMS are and the implications that the quality management system might have on these parties. In order to be more detailed the ISO 9001:2015 Standard specifies which types of parties are expected. This requirement will assist the organization is determining the scope of the QMS better. I refer you to the next resource.
Understanding the needs and expectations of the interested parties is the first step in developing the QMS and the foundation for determining its scope, defining relevant quality objectives, and developing quality activities for achieving them. After understanding the context of the organization, it must be determined who the interested parties are and what their needs and expectations are. Interested parties are individuals and other business entities that may affect the organization’s ability to provide a product according to the specifications. Understanding their needs and expectations will create the organizational quality management conditions for the fulfillment of those needs and expectations over the long term and will enable the organization to achieve its objectives.
Interested parties differ from one another and thus have different needs and expectations. For example, investors want security for their investment and a good return, while customers expect to get a product that meets their needs in the most effective way. Identifying these expectations may be crucial for determining the scope of the QMS and setting the quality objectives.
Determining the scope of the Quality Management System
| 2008: No equivalence | 2015: 4.3 Determining the scope of the quality management system |
Here we have another point of interface of the two versions – the requirement to define the scope of the quality management system. But the concept of the ISO 9001:2015 is relative new demanding reference to the issues requested in paragraph 4.1 and the requirements referred to in 4.2. The concept of exclusion was also revised.
Exclusions – The requirements for proof that exclusion of chapters does not affect the ability of the organization to supply the goods or services according to defined requirements and customer satisfactory is not changed.
While the ISO 9001:2008 states that exclusions are to be made only of chapter 7 the ISO 9001:2015 lists chapters 7.1.4 (Monitoring and measuring devices) and chapter 8 (Operation).
Furthermore the ISO 9001:2015 requires the obtaining of full responsibility to outsourcing. It will be much difficult to exclude chapter 8.4. Control of external provision of goods and services (the equivalent to chapter 7.4 Purchasing). How will you manage it now? It is up to your quality management and its creativity.
Documentation Requirements vs. Documented Information
| 2008: 4 Documentation Requirements 4.2.1 General |
2015: 7.5 Documented Information 7.5.1 General |
The main application of this chapter is a basis for evaluation of your documentation against the standard’s requirements. The purposes of the documentations are as follows:
- Achievement of quality objectives
- Prevention of nonconformities
- Achievement of unity and equality between all the organizational units
Regarding the extend the of the scope there is no significant change and both standard requires the same:
- The size of the organization
- The level of complicity, functionality, and interrelations between its processes
- The qualifications and competence of the employees
There no Need for Quality Manual with ISO 9001:2015!
| 2008: 4.2.2 Quality Manual | 2015: No equivalence |
Another big Bang – No need for a Quality Manual! I will be honest – I am still digesting maintain the quality manual becauseI find it a very effective quality management tool… The quality manual is a document with a clear goal: to introduce and communicate the intentions, scope, and structure of a quality management system in an organization. How will the ISO 9001:2015 will go on without this declaration…
The new Control of Documents
| 2008: 4.2.3 Control of Documents | 2015: 7.5 Documented information 7.5.1 General 7.5.2 Creating and updating 7.5.3 Control of documented Information |
A definitive change of concept – the requirements for documented information refer to documents as well as records. The differentiation between the two applications (the requirements; the documents and the outputs; the records) is no more- the same quality requirements apply for both. The approach is different because it regards the whole production of document and records as a whole.
Documents control as well as records control as the ISO 9001 puts it (the 2008 as well as the 2015) will be accomplished through a list of activities that are required to be maintained when controlling documented information. The ISO 9001:2008 gathered them in two different paragraphs – 4.2.3 and 4.24. The ISO 9001:2015 on the other hand decided to separate the requirements for activities into three designated paragraphs (7.5.1 General, 7.5.2 Creating and updating, 7.5.3 Control of documented Information) – which are the natural process when maintaining documented information. The problematic of the ISO 9001:2008 was to derive the activities out of the requirements. With the ISO 9001:2015 it should be easier.
The ISO 9001:2015 refers to the format of the document and language and make the definition of documents more precise.
The definition of access was settled – the ISO 9001:2015 context of the organization refers to two types of access to documents – the right to read and use the content of the information on the document or record and the permission to read use and change or update it. This has a direct relation to the new approach. The ISO 9001:2008 “thought” that documents are printed and the hard copy is secured by the quality manager. But in our days when using paper becomes a dirty word the users might gain access to digital documents and update them.
Learn more about the new concept of the ISO 9001:2015 – Documented Information.
This webpage contains only a fragment of the chapter 4 Context of the organization from the book: ISO 9001: 2015 – A Complete Guide to Quality Management Systems published by:
Why choose the book ISO 9001: 2015?
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