Hi, Friends some times we heard few casual comments about system standards like " ISO ne kuch fayda nahi hua? (ISO certification doesn't gave any benefit). Most of the time people consider it as a hurdle in their day to day work. If you follow it without understanding the intent then definitely its a burden or load on your head/ hurdle in your work. Standards guide us to work in a structured way & every step in a structured methodology is always having micro benefit which adds value to our process of meeting goal or objective. In practice we deviate structured way & go for short cuts to meet aggressive time line. This leads us to deviate from right path of structured methodology defined in standards.
Following are the key potential benefits of implementing quality management system (QMS) based on international standard.
- the ability to consistently provide products & services that meet customer & legal requirements.
- facilitating opportunities to enhance customer satisfaction
- addressing risks & opportunities associated with its context and objectives
- the ability to demonstrate conformity to specified QMS requirements
This international standard employs the process approach, which incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking.
a) What is Process Approach?
This approach enables the organisation to control the interrelationships and interdependencies among the processes of the system so that overall performance of the organisation can be enhanced.
Process approach involves
- systematic definition and management of processes & their interactions
- to achieve intended results in accordance with Quality Policy & strategic direction of the organisation
- using PDCA cycle with focus on risk based thinking aimed at taking advantage of opportunities and preventing undesirable results.
Application of process approach enables
- understanding and consistency in meeting requirements
- the consideration of processes in terms of added value
- the achievement of effective performance
- improvement of processes based on evaluation of a data and information
Schematic representation of the elements of the process
a) What is Risk based thinking?
Risk based thinking is nothing but to determine the risk and opportunities that need to be addressed to
- give assurance that the QMS can achieve its intended results
- enhance desirable effects
- prevent or reduce undesired effects
- achieve improvement
and plan actions to address these risk and opportunities.
This international standard doesn't have separate clause on preventive action. The concept of preventive action is expressed through the use of risk-based thinking in formulating QMS requirements. Standard doesn't insist any formal methods for risk management or documented risk management process. However, organisations can show evidence of risk based thinking by various methods such as SWOT analysis, DFMEA, PFMEA, Risk register etc. suitable to organisation.
If we need benefits of this international standard then we should follow principle of Adequacy, Adherence and Effectiveness of QMS through PDCA cycle till we meet quality objectives of our organisation. There is no other way..............
