ISO 9001:2015 | What is ISO 9001:2015 Quality Management System?

ISO 9001:2015 | What is ISO 9001:2015?

→ ISO 9001:2015 specifies requirements for a Quality Management System.
This standard helps an organization to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements.



1) What is ISO 9001:2015 (Quality Management System)?

ISO 9001 is the international standard that specifies requirements for a Quality Management System (QMS).
→ It is the most popular standard.
→ This standard was first published in 1987 by the International Organization for Standardization (ISO).
→ ISO composed of the national standards bodies of more than 162 countries as on Jan-2018.

2) Why we need ISO 9001: 2015 (Quality Management System)?

→ Meet Customer’s Requirements.
→ Improve Product Quality.
→ Increase Customer Satisfaction with your Products.
→ Develop a Professional Culture and Better Employee Morale.
→ Improve Efficiency, Reduce Waste, and Save Money.
→ Achieve International Quality Recognition.


3) ISO 9001:2015 (Quality Management System) Milestones:

→ The milestones of this standard are mentioned in the below picture.
ISO 9001:2015 (Quality Management System) Milestones



4) ISO 9001:2015 (Quality Management System) Timeline:

→ The timeline of this Quality Management System is mentioned in the below picture.
ISO 9001:2015 (Quality Management System) Timeline

→ In September 2015, the latest version is Published, 3 Year is a transition period.
→ So after September 2018, ISO9001:2008 is no longer be Valid.




5) Main Clauses of ISO 9001: 2015:


  1. Scope
  2. Normative reference
  3. Terms and definitions
  4. The context of the organization
  5. Leadership
  6. Planning
  7. Support
  8. Operation
  9. Performance evaluation
  10. Improvement

6) ISO 9001:2015 has a High-Level Structure (HLS)

→ In this standard, the clauses are rearranged and these are the same structure as other all standardized management systems, known as a ‘High-Level Structure’ (HLS).
 The main clauses of ISO9001, ISO 14001, ISO 22000, ISO 45001, etc. are all the same in High-Level Structure (HLS).
 So we can easily integrate various management systems together.
→ This integration of various management system is called an Integrated Management System (IMS).


7) Which information we get from ISO9001:2015 (Quality Management System):

→ Requirements of a quality management system.
 Product realization, including the steps from design to delivery.
 Planning and determining the process interactions.
 Management of resources, including human resources and an organization’s work environment.
 Responsibilities of management.
 Measurement, analysis, and improvement of the QMS (Quality Management System) through activities like internal audits and corrective and preventive action.




8) Some of the key updates in ISO9001:2015 (Quality Management System) include:

 The introduction of new terminology
 Increased leadership requirements
 Improved applicability for services
→ In the updated Standard New High-Level Structure (HLS) adopted.
 Restructuring some of the information
→ Also include a common guideline for the product, process, and services.
 An emphasis on risk-based thinking to enhance the application of the process approach

9) ISO 9001:2015 - General Terminology:

 General Terminology and Process Approach is an important part of  ISO 9001:2015 Quality Management System
 The adoption of a Quality Management System is a strategic decision for an Organization that can help to improve its overall performance.
 It also provides a Sound Basis for sustainable development initiatives.
         
     ⇒ This standard put into practice of
          → Process Approach
          → Plan-Do-Check-Act Cycle
          → Risk-Based Thinking 

     ⇒ erbal forms are used
          → “Shall” – Indicates a Requirement
          → “Should” – Indicates a Recommendation
          → “May” – Indicates a Permission
          → “Can” – Indicates a Possibility or Capability
          → “Note” is for Guidance in understanding or Clarifying the associated requirement 


10) Process Approach - General:

➝ The process approach is a management strategy
➝ When managers use a process approach, it means that they manage and control the processes that make up their organizations, the interactions between these processes and the inputs and outputs that tie these processes together


Process Approach - Genera

11) Process Approach - Plan-Do-Check-Act Cycle:

➝ PDCA (plan-do-check-act, sometimes seen as plan-do-check-adjust) is a repetitive four-stage model for continuous improvement in business process management.
➝ The PDCA model is also known as the Deming cycle, 
➝ Shewhart cycle is the plan–do–study–act (PDSA).


Process Approach - Plan-Do-Check-Act Cycle