One of the newest parts of ISO 9001:2015 and related management standards are the concepts of context and interested parties. Identifying the “context of your organisation” and “interested parties” can be real stumbling blocks, particularly if you are thinking of transitioning from ISO 9001:2008 to ISO 9001: 2015.
The new clauses (4.1 and 4.2) mean that organisations may need to extend the way in which they look at how they operate within their business environment. Not just internal processes, their customers and their market, but also environmental impact, the social and cultural aspects of their company, their community, and their workforce and PEST. This new standard aims to ensure that businesses include all of these in their strategic planning and the scope of their QMS.
What the Standard actually says:
“4.1 Understanding the organization and its context
The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.
The organization shall monitor and review information about these external and internal issues.
NOTE 1: Issues can include positive and negative factors or conditions for consideration.
NOTE 2: Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social and economic environments, whether international, national, regional or local.
NOTE 3: Understanding the internal context can be facilitated by considering issues related to values, culture, knowledge and performance of the organization.”
“4.2 Understanding the needs and expectations of interested parties
Due to their effect or potential effect on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine:
a) the interested parties that are relevant to the quality management system;
b) the requirements of these interested parties that are relevant to the quality management system.
The organization shall monitor and review information about these interested parties and their relevant requirements. [Taken from ISO 9001:2015 (E)]”
Context
“Context” refers to the factors that are combined to affect the organisations continuing ability to provide products and services for its customers/clients. These must be identified looking at both the internal and external factors. All organisations in business operate inside a context, but this has not previously been acknowledged. Now the Standard requires that an organisation must examine itself fully, and not adopt a “one size fits all” approach.
Monitor and Review
How regularly “monitor and review” takes place will depend on leadership determining what, when and how. For many organisations review would be annually or even less, but for especially those in fast-changing environments, the review may be much more frequent. This is where establishing the correct context plays a critical part.
Interested Parties
“Interested parties” can be thought of as stakeholders, and they can include owners or shareholders, employees, suppliers and customers. In the wider context, governmental bodies, business associations, the communities where facilities or people are located, and debt holders.
However, dependent on the context of the organisation, these interested parties can be scrutinised and may not all of the above taken into account. An example of a relevant interested party would be one that can affect the process for ensuring conformity to your customers' requirements and any statutes or regulations that apply.
Needs and Expectations
That will depend on the interested party. A debtor can expect the company to be solvent, a supplier needs to be paid on time. However the range of needs and expectations can be much broader and change with the times eg PEST. A purchaser would not expect that your products were produced by slave labour or expect that they do not contain carcinogenic chemicals.
Summary
An organisation’s leaders must examine their context and interested parties, and then set up the strategic direction and the scope (boundaries) of the QMS. After that, using this context, they ensure that the quality policy and objectives are compatible with that context and the related strategic objectives.
Defining context and interested parties ensures the QMS is more effective and more efficient at delivering what the interested parties need and expect.
Please contact me now for any guidance you made need with identifying context and interested parties for your organisation if you are transitioning to ISO 9001: 2015. The deadline for the new Standard is approaching rapidly. We would also be delighted to help with audit of an established system or help in achieving ISO 9001or ISO 14001.
Steve Newston
Director, Isosure Limited
