Question

Planning the product design and development process falls within which major activity in the ISO 9001 quality system?

Select one:

a. measurement, analysis, and improvement

b. product realization

c. resource management

d. management responsibility

Answer 1

Answer: Option b: product realization

Explanation:
Product realization is the term used in ISO 9001:2008. It is used for designing, planning, and realization of the product provided to the customers with measurable quality. It defines clear certifiable standards and processes to bring a product into the market. It formulates a clear idea of what a product will be and is defined in drawings, statements of works, functional product specs, and their equivalents. Based on this idea the management can determine objectively if the product was realized and the process for product realization is efficient and functioning effectively. The product realization mechanism should be available to understand the customer's requirements and to ensure the desired product is realized.
To conclude it provides a basic framework for parties to communicate their expectations and to ensure the needs are met irrespective of the cultural and geographical location of the parties. This helps to provide a reliable quality product based on customers' expectations.
Management responsibility refers to senior management involvement in establishing quality policy and creating strategic objectives. They must be involved in assigning resources to ensure the system is integrated into business processes.
measurement, analysis, and improvement in Iso 9001. The QMS requires the use of factual data to make decisions. Measurement and monitoring are collecting evidence. It will evaluate the effectiveness and performance of the quality management system. This evidence is used to improve processes and imp[rove systems within the organization.
Resource management first identifies the adequacy of the resources and if they are being optimally utilized.