Clause number 4 of ISO 9001 2015 has got 4 sub clauses.
Implementation guideline for each subclause is as below.
4.1 – Understanding organization and its context.
This clause demonstrates that every organization is different in size and type. It is different in terms of employee strength, employee competence, infrastructure, customer requirements. supplier performance, regulatory requirements and so on. As these factors are changing, internal and external issues arising due to these factors are also different in different organization. This clause requires that at the begining of implementation of ISO 9001 2015 quality management system, internal and external issues as per context of organization shall be assessed. Such issues will be input to the Risk management process.
4.2 – Understanding needs and expectations of interested parties.
This clause requires that organization shall determine interested parties affecting to quality management system. Once these interested parties are identified, their requirements pertaining to quality management system shall be determined. These requirement will be input to the Risk management process.
4.3 – Determining scope of the Quality management system. Understanding organization and its context.
This clause requires that depending upon issues identified in clause 4.1, interested parties requirement identified in 4.2 and based on nature of products and services organization is providing, organization shall define scope of quality management system. Scope must indicate products and services of organization. It also shall be ensured that none of clause of ISO 9001 2015 standard should get excluded till proper justification is available and organization does not escape from its responsibility for complying with product and services requirements and enhancement of customer satisfaction.
4.4 – Quality management system and its processes.
This clause requires that organization shall identify processes for quality management system. Once processes are identified- required input, expected output, responsibility and authority, performance indicators, risk and opportunities, resources, monitoring and measurement of processes, implementation of corrective actions and bringing improvement shall be done for each process.
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