Risk Based Thinking ISO 9001-2015

 Risk-Based Thinking - ISO 9001:2015

➤ "Risk-based thinking ensures these risks are identified, considered and controlled throughout the design and use of the quality management system."


1) What is Risk?

→ An ISO 9001:2015 defines Risk as “The Effect Of Uncertainty On an Expected Result."
Risk Based Thinking ISO 9001-2015

2) What is Risk Based Thinking?

 It is something we all do automatically and often sub-consciously.
→ Risk-based thinking makes preventive action part of the routine.

3) Risks Associated In a System:

→ According to Risk Based Thinking in ISO 9001:2015, the Risk associated with 
    a system is affected to below criteria:

     1. External Provider
     2. Input
     3. Process
     4. Output
     5. Customer



→ Also, the Risk associated with a system is affected to 6M like:
     1. Man
     2. Machine
     3. Material
     4. Method
     5. Mother Nature (Environment)
     6. Measurement (Measures)

Risk Based Thinking ISO 9001-2015

4) Strengths and Weakness – Internal Factor of Risk Based Thinking:

→ According to Risk Based Thinking, the strength associated with a system is like:
     1. Infrastructure
     2. Machines
     3. Resources
     4. Good Will
     5. Fewer Competitors



→ Similarly, according to Risk Based Thinking, the weakness associated with a system is:
     1. Delay
     2. Defects
     3. Scrap
     4. Complaints
     5. Repetitive Issues

Risk Based Thinking ISO 9001-2015


5) External Factors for Risk based Thinking:

Risk Based Thinking ISO 9001-2015


→ According to Risk Based Thinking, the External Factors associated with a system is
     explained below:
     1. Political Factor
     2. Economical Factor
     3. Social Factor
     4. Technological Factor
     5. Environmental Factor
     6. Legal Factor

     1. Political factors in Risk Based Thinking:

     → “Political factors are basically how the government gets involved in the economy.”
     → Political factors are… 
     → Tax policy, 
     → Labor law,
     → Environmental law,
     → Tariffs etc....



     2. Economic factors in Risk Based Thinking: 

     → Economic factors, those economically affect the organization like:
     → Economic growth, 
     → Interest rates, 
     → Exchange rates and 
     → The inflation rate etc.…

     3. Social factors in Risk Based Thinking:

     → Social factors are socially related to the organization like:
     → The cultural aspects,
     → Customs, festivals,
     → Lifestyle and
     → Locality etc.….



     4. Technological factors in Risk Based Thinking:

     → Technological factors are technological aspects like …
     → New process adaption,
     → R&D activity, automation,
     → Technology  incentives and
     → The rate of technological change etc.…

     5. Environmental factors in Risk Based Thinking:

     → Environmental factors are include ecological and environmental aspects such as…
     → Weather,
     → Climate and
     → Climate change
     → Natural Resources etc.…

     6. Legal factors in Risk Based Thinking:

     → Legal factors include the statutory and regulatory compliances  associated with 
          the system.



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