ISO 9001 Context of an Organization

The notes to sub-clause 4.1 provide guidance. An organization, for example, could develop a list of areas in which issues could exist and perform periodic evaluations of any existing or emerging problems that might affect meeting requirements.

Examples of internal issues that could be considered include Internal audit results and self-assessment results, Analysis of quality cost data, Analysis of technology trend information. Competitive analysis, Results of customer reviews, audits, complaints and feedback, Actual versus intended internal values and culture, Organizational performance, Best practices of the organization and comparisons with industry benchmarks, Employee satisfaction data analysis.

One process that is underused but powerful in identifying internal issues is a self-assessment. It should be considered for serious attention. Self-assessments can be complex, using criteria such as those of the Malcolm Baldrige National Quality Award, the European Foundation for Quality Management, or the ASQ guidelines for performing a QMS self-assessment.

The assessment also can be simplified by using the seven quality management principles as a guide.
It is up to each organization to determine how detailed the analysis should be and what follow-up action, monitoring, and review are needed.

External issues can be found through several techniques such as analysis of Economic environment and trends, International trade conditions, Competitive products and services, Opportunities and conditions related to outsourcing, Technology trends, Raw material availability and prices, Potential changes in statutes and regulations, Benchmarking best-in-class performers in and outside the current marketplace.

Also, consider the potential interactions with other processes of your QMS. For example, sub-clause 4.1 may have direct or indirect interactions with your processes dealing with interested parties, risks, and opportunities, or with clauses 8, 9, and 10. These new requirements related to the organization and its context should provide the organization an opportunity to expand the breadth and depth of its QMS, integrate the QMS with the strategic and tactical management of the organization, and align objectives throughout the organization.