ISO 90012015 Standard  Quality Management System

What is ISO 9001:2015?

→ ISO 9001:2015 specifies the Requirements of a Quality Management System (QMS)
→ This standard helps an organization to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements.
→ It is the most popular international standard that specifies requirements for a QMS.
→ This standard was first published in 1987 by the International Organization for Standardization.
→ ISO is composed of the national standards bodies of more than 162 countries as of Jan-2018.
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ISO 9001:2015 Clauses

  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

➥ Milestones:

→ The milestones of this standard are mentioned in the below picture.
Milestones of ISO 9001

Which information we get from ISO9001

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

ISO 9001-2015 Presentation

key updates:

→ The introduction of new terminology
→ Increased leadership requirements
→ An emphasis on Risk-Based Thinking.
→ Improved applicability for services
→ In the updated Standard New High-Level Structure (HLS) adopted.
→ Restructuring some of the information
→ It also includes a common guideline for the product, process, and services.
Quality Management Principles are reduced 7 from 8.


→ The timeline of this QMS System is mentioned in the below picture.
→ 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.

Timeline of ISO 9001

High-Level Structure Annex SL (HLS) ISO 9001:2015:

→ 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 ISO 9001, 14001, 22000, 45001, etc. are all the same in High-Level Structure (HLS).
→ So we can easily integrate various systems together.
→ This integration of various systems is called an Integrated Management System (IMS).

What are the benefits of ISO 9001 2015?

  • Meet Customer 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.
  • Establish and implement an efficient operation flow.
  • It helps to find out the problem from the system and improve it.
  • It helps to highlight deficiencies
  • Provides continuous improvement approach

ISO 9001:2015 Requirements

👉 Read Complete Clause wise requirement of ISO 9001_2015.

General Terminology

→ General Terminology and Process Approach is an important part of this standard
→ The adoption of this QMS standard 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.

The main focus of ISO9001:2015

→ Process Approach
Plan-Do-Check-Act Cycle
→ Risk-Based Thinking 

Verbal forms:

→ “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

Process Approach - General:

➝ This 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 General

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 PDCA

👉 See Also:


  1. Good Material for self study, thank you

  2. Very well structured.. Keep it up.. thanks for sharing

  3. Very gud information for basic learners.kindly add me in your WhatsApp group 9025993641

    1. Thank you for your feedback and you can join our what's app group by link provided at our Home page.

  4. Sir,
    Good morning
    Your WhatsApp & Telegram link not support.

    1. It is working. You can try to open that link with what's app and telegram app.
      Still you are facing any issue then you can connect us on

  5. Replies
    1. You can find the download link inside the article

  6. Good work Nikunj, very well done. Keep it up!!!

  7. It's very useful thanks

  8. Sir, your material is very useful
    can you please make pdf on FSMS 22000 : 2018

    1. Hi thanks for the suggestion we will definitely work on that.

  9. Your material is very good for all the learners. Thanks.

  10. Very well articulated. Is it possible to to have one such articulation on GMP or cGMP. Thanks for all the efforts.

  11. Sanjeev JahagirdarJune 17, 2023 at 6:48 PM

    How and which AI tool as Checklist we can use for ISO 9001-2015 Internal Audit

    1. You can connect us at


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