ISO 9001:2015 Standard | Quality Management System | PDF

What is ISO 9001:2015?

→ ISO 9001:2015 is an international quality management system (QMS) standard.

→ ISO stands for International Organization for Standardization.

→ In other words, we can say that this is the standard requirement for the quality management system.

→ This standard is published by the International Organization for Standardization.

→ It provides a framework and requirements for the Quality management system.

Table of Contents:

• What is ISO 9001:2015?
• What is a Quality Management System?
• Fundamentals of ISO 9001
• ISO 9001:2015 Clauses
• Seven Quality Management Principles
• Milestones of ISO 9001:2015
• Which Information Do We Get From ISO 9001?
• Key Updates of ISO 9001:2015
• Timeline of ISO 9001:2015 Standard Updation
• High-Level Structure Annex SL (HLS)
• General Terminology
• The Main Focus of ISO 9001:2015
• Process Approach
• Plan-Do-Check-Act Cycle
• Risk-Based Thinking
• Seven Steps For ISO 9001 Certification
• Benefits of ISO 9001:2015 Implementation
• Conclusion

What is a Quality Management System (QMS)?

→ A Quality Management System (QMS) is a standardized system that includes different documents processes, procedures, etc.

→ It also ensures that the products or services meet customer and regulatory requirements consistently.

→ QMS is a structured approach to manage and improve quality.

⏩Key components of a QMS are:

• Processes: Defined steps and activities to achieve specific outcomes
• Procedures: Detailed instructions on how to perform specific tasks
• Responsibilities: Clearly assigned roles and duties within the system
• Documentation: Records of activities and evidence of quality compliance

→ ISO 9001 is a QMS standard.

→ This standard is the most widely recognized QMS standard.

→ It provides a framework for organizations to implement and maintain a QMS.

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Fundamentals of ISO 9001:

→ 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 comprises the national standards bodies of more than 162 countries as of January 2018.

→ As per the latest update (2024) the International Organization for Standardization is a network of 172 national standards bodies.

→ This standard applies to any size of organization irrespective of its size, industry, or type.

→ Any business or organization can implement this standard to improve quality management systems and processes.

ISO 9001:2015 Clauses:

⏩The main classes of ISO 9001:2015 are:

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

Seven Quality Management Principles:

⏩ISO 9001:2015 is based on seven quality management principles that are:

1. Customer focus
2. Leadership
3. Engagement of people
4. Process approach
5. Improvement
6. Evidence-based decision making
7. Relationship management

Milestones of ISO 9001:

→ Initially this standard was introduced in 1987 and mainly focused on procedures.

→ The next revision was made in 1994 and focused on preventive actions.

→ Further revision was done in the year 2000 and 2008 both were based on process approach and PDCA.

→ For your better understanding refer to the below pictures.

Which Information Do We Get From ISO 9001?

→ 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.

Key Updates of ISO 9001:

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

Timeline of ISO 9001:2015 Standard Updation:

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

→ In September 2015, the latest version was published, 3 Years is a transition period.

→ So after September 2018, ISO9001:2008 is no longer be Valid.

High-Level Structure Annex SL (HLS):

→ Annex SL is a framework that provides a common high-level structure to different standards.

→ This structure has identical core text and common terms and definitions for ISO management system standards.

→ It was developed to ensure consistency and compatibility among the various management system standards.

→ High-level structure makes it easier for organizations to integrate multiple management systems.

→ In this standard, the clauses are rearranged and have the same structure as other 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.

→ So we can easily integrate various systems together.

→ This integration of various systems is called an Integrated Management System (IMS).

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.

⏩Refer to the below terminology for this standard:

• 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

The Main Focus of ISO 9001 Standard:

⏩This standard mainly focuses on:

1. Process Approach
2. Plan-Do-Check-Act Cycle
3. Risk-Based Thinking

01. 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

02. 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).

03. Risk-Based Thinking:

→ Risk-based thinking is a key component of ISO 9001:2015.

→ It encourages organizations to identify and address risks and opportunities.

→ Risks and opportunities can affect the conformity of products and services.

⏩Key Points in Risk Based Thinking are:

• Identification of Risks and Opportunities
• Risk Assessment
• Planning Actions to Address Risks and Opportunities
• Implementing Actions
• Monitoring and Review
• Documentation

Seven Steps For ISO 9001 Certification:

⏩Refer to the below-mentioned seven steps for ISO 9001 certification:

1. Executive and Management Overview/Planning
2. Gap Assessment and Planning
3. Documentation
4. Implementation and Training
5. Internal Assessment and Management Review
6. 3rd Party Registration Assessment
7. Sustain and Continual Improvement

Benefits of ISO 9001:2015 Implementation:

• Meet customer requirements.
• Improve product quality.
• 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 in the system and improve it.
• It helps to highlight deficiencies
• Provides continuous improvement approach
• Improved customer satisfaction
• Increased profitability and risk mitigation

Conclusion:

→ ISO 9001 is not just a standard or certification but it is more than that.

→ It is a strategic approach to quality management and it empowers organizations to achieve process and business excellence.

→ By implementing a robust Quality Management System (QMS), businesses can achieve various benefits such as enhanced customer satisfaction, and improved operational efficiency.

→ Also we can get more benefits like mitigating risks and driving continuous improvement.

→ ISO 9001 certification requires dedication and team effort.

→ This standard implementation serves as a solid foundation for sustainable growth, increased market competitiveness, and organizational success.

→ ISO 9001 is a powerful tool for organizations seeking to establish a culture of quality.

→ By fostering its principles and practices, businesses can unlock their full potential and achieve success.