It is the fourth clause of ISO 9001:2015 standard. Context means circumstances or condition of the company. So, in this clause details idea of the company should be clarified including what kind of product or services it provides, what are the necessary processes what are the external and internal issues, who are the interested parties what is the scope of the quality management system etc should be mentioned clearly before proceed to certification to ISO 9001:2015.
There are four sub clauses of this principal clause number 4. They are: 4.1 Understanding the organization and its context , 4.2 Understanding the needs and expectations of interested parties, 4.3 Determining the scope of the quality management system, 4.4 Quality management system and its processes
4.1: Understanding the organization and its context : The organization shall determine, regularly monitor & review the external and internal issues. External issues are legal, technological, competitive, market, cultural, social and economic environments, whether international, national etc. Internal issues are organizational values, culture, knowledge, and performance.
4.2: Understanding the needs and expectations of interested parties: Two things are mentioned in this sub clause. That are: determine the interested parties and assess the requirements of those parties which are relevant to its QMS. It can vary company to company. However the common interested parties are: customers, owners, employees, providers, bankers, regulators, unions, partners, community, news media, competitors, law enforcement, emergency responders etc.
4.3: Determining the scope of the quality management system: It is one of the required and mandatory requirements for company and it shall be maintained as documented information. Scope determining time the following things should be considered: a) external and internal issues (see 4.1); b) requirements of relevant interested parties (see 4.2); c) products and services of organization. The organization shall apply all the requirements of this QMS standard 9001:2015. However, provide logical justification if any clause is not applicable in scope of quality management system.
4.4: Quality management system and its processes: Determining the processes and showing their interactions among the processes is mandatory for effective implementation of the qms in the organization. In the processes following things should be included: a) determine the inputs required and the outputs expected from these processes; b) determine the sequence and interaction of these processes; c) determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes; d) determine the resources needed for these processes and ensure their availability; e) assign the responsibilities and authorities for these processes; f) address the risks and opportunities as determined in accordance with the requirements of 6.1; g) evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results; h) improve the processes and the quality management system. Documented information and retain documented information for the processes is also necessary. During the audit these documented information and retain documented information will be reviewed by the auditor.