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Quality System Elements

Continual Improvement

This is a recurring activity to increase the ability to fulfill requirements, and ongoing improvement of the processes, products, and services through incremental breakthrough improvements.



Continual improvements allows organizations to remain competitive, meet the needs of the customer, and can also be equated with reducing process variation. 



Continuous Quality Improvement (CQI), is the philosophy and the actions for repeatedly improving the organization's capabilities and processes with a focus on customer satisfaction.

Corrective Action

This is action that is taken to eliminate the root causes and symptoms of an existing nonconformity to prevent recurrence. This includes remedial action, which is a temporary fix until the true cause can be identified. After the root cause is identified, there must be a verification and validation to ensure the problem does not occur again.



Corrective Action is a major component of the auditing process. Auditors must receive a corrective action plan whenever a non-conformance has been written. The department, or organization that was audited, must ensure the corrective action has been implemented before the follow-up visit by the auditor.

Human Resources

​Resources must be available in order for the system to work. The resources, or personnel, must be capable of fulfilling the requirements, be made aware of their role in the process and the importance of it, and be properly educated and trained.



It is important to establish a structured education/training program, and to maintain records of education, skills, experience, and training. When employees receive cross-training, this must be documented in the employee's file also.

Management Responsibility

Management must be committed to the development, implementation, maintenance, and improvement of the quality system. The quality policy and objectives must be established, a representative to manage the program must be identified, ensure a process of internal communication is in place, and everyone understands the information that is being presented. 



Management Reviews include reviewing various input items, such as, audit results, customer feedback, process performance, and improvement recommendations. The output of the reviews include making decisions regarding resources that may be needed, customer requirement improvements, and quality system process improvements.

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These reviews take place at least once per year. Some organizations have reviews on a quarterly basis, which helps identify improvement opportunities sooner in order to avoid major problems that can take place later on.

Measurement and Analysis

Monitoring and measurement involves ensuring the customer is satisfied by using data from surveys, complaints, or recommendations for improvement. An organization must listen to the voice of the customer, and make necessary adjustments in order to improve, or exceed customer expectations. ​

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All processes are monitored to determine if the system is effective and operating efficiently, nonconforming product, or services, are controlled and data is analyzed on a continual basis. The results of the analysis should be communicated with the organization, which is an important part of the internal communication process.

Product/Service Realization

Identifying and documenting procedures to fulfill customer requirements takes place during this process. Organizations should be mindful of requirements that are not provided by the customer, but are needed in order to produce the outcome requested by the customer. 

 

It is necessary to include any inspection and testing activities, verification, validation and monitoring throughout the realization cycle, and recording evidence of these activities.

Preventive Action

Organizations should determine the actions necessary to eliminate causes of nonconformances and prevent the problem from occurring again. A procedure is written defining requirements to determine potential problems and causes, implementation of the required actions to prevent nonconformances, records of the results based on the actions that were taken, and reviewing the effectiveness of the actions that were taken.

Quality System



The requirements for setting up a quality system include, establishing a quality policy and objectives, creating a quality manual, writing procedures to control the review, update, storage, and approval of documents, how records will be controlled, and any processes that have to be outsourced.

 

(Reference ISO 9001 Standard)

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