Clause 4.4 – Quality Management System & Its Processes

Post author:Reval Vasu Hejmady
Post published:October 25, 2020
Post category:Quality Management System

What are the requirements of clause no.4.4??

This includes specific requirements necessary for the adoption of the processes approach when developing, implementing and improving a management system. This requires your organization to systematically define and manage processes and their interactions so as to achieve the intended results in accordance with both the policy and strategic direction.

Certification Auditors will expect to see a process model that explains the key processes of the business and how each relates and links to the others.

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1. Identify the inputs required and expected output from the process

Each process is getting the some input from upstream department and after carried out the regular process we got some output. In the QMS need to identify the particular inputs and what output we are expecting from the process. After completion of the process results should be evaluated so can identify the gaps and corrections can be applied.

2. Identify the sequence and interaction of the process

Each department is interacting with the department. It will go sequence wise, it cannot be missed otherwise expected results cannot be achieved. Proper sequence of the processes and where it is interacting with another department that all needs to identify and available while implementing the Quality Management System.

3. Identify the required resources for the processes and check the availability

Required resources to carry out the process including availability of the particular resource, both needs to identify and check during the results frequently.

4. Assign the roles and responsibilities for these processes

Assigning the role and responsibility of the process owner is essential task in the Quality Management System. Cristal clear roles and responsibilities should be identifies and explain to the owner to evaluate the results.

5. Address the Risk & Opportunities for these processes

Identify the risk of the processes and opportunities to reduce the potential risks, both parts are essential in these clause. The same should be link with the clause no.6.1 in the later process.

6. Evaluate these processes and implement the changes to ensure these processes achieve their intended results

Periodic evaluation of the each process as per defined Quality Objectives should be done. If some process failure to achieve their expected results, corrective action should be identify and implement to achieve the intended results.

7. Improve the processes and the Quality Management System

Improvement is the key of the Quality Management System. In the periodic evaluation it needs to verify whether the process is improving or not improving.

8. Maintain documented information to support the operation of its processes

Input and expected output of the each processes should be documented to explain the process, to verify the results and available for another departments to get the internal organizational knowledge.

9. Retain documented information to have confidence that the processes are being carried out as planned.

Documented procedures are essential part of the QMS to check the confidence that process is carrying out as defined and same results will be get after carry out the process.