A new requirement for the ISO 9001 in 2015 was the introduction of the context of the organization. This clause stipulates organizations must review the external and internal issues dramatically impacting the planning and strategic objectives of the company’s QMS. This change affected clause 4 and caused confusion for some organizations.However, the requirement simply asks organizations to define the influence of different elements on the business, and how these elements impact the QMS and other important elements of the company. It is meant to identify risks and protection opportunities for the organization. Embark on these five steps to ensure your organization is compliant with the ISO 9001:2015 requirements.:
1. Look for Existing Compliances
There are some existing compliances amongst organizations because some newly established requirements match the ISO 9001:2008 Quality Manual. Companies who have already followed the ISO 9001:2008 have already defined their scope of quality and QMS according to the new standards through flowcharts or texts. Companies starting with the 2015 version from scratch will need to find the scope of QMS, then identify each process and their specific interactions. The documentation of this process is the output the auditor will need before inspection begins.
2. Identify Issues
Internal and external issues need to be identified and this might be considered to be a general statement. Be careful not to be overly expansive in identification of issues. Focus on the issues that directly affect customer satisfaction and the delivery of the quality in products or services. Specifically, the internal context focuses on the environment of the company. This includes management approach, contract fulfillment, and interaction with investors. Consider ideas related to the business’ values, culture, and environment. The external context issues are revealed through consideration of the company’s ethical, legal, political and economic environment. Some examples of external context include, but are not limited to:
- government laws
- technology changes
- outside events that affect the organization’s image
3. Identifying Separate Parties and Needs
Start this process by considering what parties, whether external and internal, have opinions that matter. This includes, but is not limited to:
- end users
- direct customers
Identify the needs of these essential groups to help provide additional value within the organization. Ask their opinions to discover ways to improve overall company production.
The most important part of the process is getting the changes on paper. In fact, the standard specifically instructs companies to document changes made to improve the context of the organization. Create a new document to replace the old Quality Manual to be presented before the audit, or simply add to the existing Quality Manual. Adding to the manual is only an option if a manual was created for the 2008 guidelines, however, it is the cheaper, more practical choice. Further, updating interested parties only means highlighting changes, not presenting a full document.
5. Review and Monitor Changes
This last part is one of the most significant parts of the overall change. Organizations may push this aside, but, with practice, it will become habit. Monitoring the external and internal issues and looking for chances for corrections will make any future changes easier on the organization. Two common acronyms for monitoring are SWOT (strengths, weaknesses, opportunities, threats) and PEST (political, economic, social, and technological). Use these acronyms for monitoring, and you’ll reach beyond the minimum standards toward improved overall processes. Do not make the context of the organization requirement one that is fulfilled for the audit then forgotten. The information gathered for the requirement is often useful, and should be taken seriously. In fact, some organizations will continue to update this requirement simply to gain the helpful information it provides. Further, the organization will be ready for upcoming changes to the ISO 9001.
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