Requirements of Quality Control Management System

There are 3 general requirements and five specific requirements and they are numbered as such.

i. Scope: This specifies requirements for a quality management system where an organization has to demonstrate its ability to consistently provide product that meet customer and applicable regulatory requirements, and aims to enhance customer satisfaction through the effective application of the system.

ii. Normative Reference: The reference in the standard to the latest versions of the documents ISO 9000:2001, Quality Management System, Fundamentals and Vocabulary.

iii. Terms and Definitions: Terms and definitions related to quality and quality management system are given.Quality is the degree to which a set of inherent characteristics fulfils requirements.Quality management system - is the management system that direct and control an organization with regard to quality.

iv. Documentation requirements: The requirement is identified for establishing, documenting, implementing, maintaining and continuously improving. The quality management system documentation shall at least include quality policy quality objectives quality manual documented procedure and the documents necessary to ensure the effective operation and control of its process.

Quality Policy- Top management shall ensure that there is a quality policy, which is appropriate to the organization and provide a framework for setting, reviewing and meeting requirements.

• The policy should reflect the following that it:-
•  Is appropriate to the purpose of the organization.
•  Include a commitment to comply with requirements and to continually improve the effectiveness.
•  Provides a framework for establishing and reviewing quality objectives.
• Is communicated and understood within the organization.
•  Is reviewed for continuing suitability.

 Example:-

Quality Policy

We are committed to fulfill the needs and expectations of our esteemed customers and delight them with quality of products as well as prompt and efficient services.We shall do this through complying with customers as well as statutory objectives  establishing and reviewing quality policy and quality objectives.

Quality manual – The organization will require a quality manual, which will include, scope of the quality system.

Control of records - As in the case of documents a documented producer is required to prepare, maintain and dispose of records.

v. Management Responsibility: Top management shall provide its commitment to the development and improvement of its quality management system.Communicate within the organization the importance of meeting customer and regulatory requirements, set policies and objectives and lead the organization by providing necessary resources and conduct the management reviews.

vi. Resource Management: Personal responsible for implementing quality management system shall be competent to carryout the assigned tasks. This can be achieved through education training, skills or experience.

 vii. Production Realization: Organizational processes must be planned and developed and these must be consistent with other requirements.

viii. Measurement Analysis and Improvement: The organization shall plan and implement the use of monitoring measurement analysis and improvement process to ensure conformity of the product and the quality management system.