ISO 9001:2015 QMS Awareness - Quality Management System And Its Processes

ISO 9001:2015 QMS Awareness - Quality management system and its processes

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Quality management system (QMS) is a systematic approach to managing quality throughout an organization. It involves identifying customer needs, designing and delivering products (and services) that meet those (customers’) needs, and continually improving processes to enhance customer satisfaction. Clause 4.4 of ISO 9001:2015 QMS standard mentions requirements on the establishment, implementation, maintenance, and continual improvement of the QMS processes. According to the requirements of clause 4.4 of the standard, the organization needs to:

 

-        Establish, implement, maintain and continually improve the organization’s quality management system, including the processes needed and their interactions.

-        Determine processes needed for the quality management system and application of determined processes throughout the organization.

-        Determine inputs required and output expected from determined processes.

-        Determine sequence and interaction of determined processes.

-        Determine criteria and methods as well as monitoring, measurement and related performance indicators for effective operation and control of determined processes.

-        Determine resources needed for the determined processes.

-        Ensure availability of determined resources needed.

-        Assign responsibilities and authorities for determined processes to people in the organization.

-        Apply determined criteria and methods and also monitoring, measurement and related performance indicators needed for the effective operation and control of determined processes.

-        Address risks and opportunities as determined as per clause 6.1 of ISO 9001:2015 QMS standard.

-        Evaluate determined processes to ensure achieving intended results.

-        Implement any changes needed to ensure achieving intended results.

-        Continually improve determined processes.

-        Continually improve the quality management system of the organization.

-        Maintain documented information (procedures) that support the operation of organization’s processes.

-        Retain documented information (records) that provide confidence that the processes being carried out as planned.

 

To meet requirements as mentioned in clause 4.4 of the standard, organizations must also look to the requirements mentioned in clause 5 to clause 10.

 

Examples of documented information (procedures) that are required to maintain may be:

 

-        Process maps

-        Flow charts

-        Procedures

-        Work instructions

-        Manual

-        Quality policy

-        Quality objectives and targets

 

Examples of documented information (records) required to retain may be:

 

-        Records of process performance and effectiveness

-        Internal and external audit reports

-        Management review records

-        Fitness of monitoring and measuring resources

-        Basis used for calibration / verification when no measurable standard exists

-        Competence evidence of persons

-        Corrective action reports

 

The above examples are indicative, there may be more.

 

In conclusion, ISO 9001:2015 QMS standard provides a framework for establishing, implementing, maintaining, and continually improving a quality management system and clause 4.4 of the standard requires organizations to establish, implement, maintain and continually improve quality management system processes.  

 

Think of the following Questions

 

(i)             What are the requirements for quality management system and its processes in clause 4.4 of ISO 9001:2015 QMS standard?

(ii)            Why an organization needs to maintain certain documented information?

(iii)           Why an organization needs to retain certain documented information?

 

 

Best wishes,

Keshav Ram Singhal

 

Please have your comments / reaction.

 

To train your employees with ISO 9001:2015 QMS Awareness, please supply them “TRAIING HANDBOOK ON ISO 9001:2015 QMS AWARENESS” (ASIN: B093YFFY7Z), which is available worldwide at Amazon. Please search this Training Handbook in Amazon Website of your country.

 

 You may also supply your employees following eBooks - (i) A Concise Guide on Creating and Updating Documented Information (eBook)  (ii) Applying Risk-based Thinking in an Organization Implementing ISO 9001:2015 QMS (eBook)  

 

Thanks.