ISO 9001 Explained: A Beginner's Guide to Quality Management

What is the ISO 9001 in QMS ? What are the Principles and Requirements of ISO 9001:2015?

ISO 9001:2015 is one of the most recognized standard that defines the Quality Management System requirements.The revised ISO 9001 standard is based on the high-level structure and integrates with other management systems such as IATF 16949, ISO 14001, and ISO 45001 standards. 

What is ISO?

ISO stands for International Organization for Standardization. The dictionary meaning of the ‘ISO’ word is ‘Similar’.

It is ISO & not IOS – why?

‘Iso’ is a word derived from the Greek word ‘Isos’ meaning ‘equal’. Remember ‘isometric’ ‘Equal’ relates to ‘standard’. Translation of the organization’s name in different languages may result in different acronyms, hence a common name “ISO”

What is ISO 9001?

ISO 9001 means a standard that defines the QMS (Quality Management System) requirements, aims to produce quality products and services, and ultimately to meets customer needs and expectations.

ISO 9001 Quality Management Systems – Requirements.Revised ISO 9001 standard specifies requirements for a QMS when an organization:

• Needs to demonstrate its ability to consistently deliver goods and services that meet customer and all applicable legal requirements.
• Aims to increase customer satisfaction by implementing the system effectively, including processes for system improvement and ensuring to meet all applicable legal compliance and customer requirements.

All the requirements of ISO 9001:2015 quality management standard are generic and can be applied to any company or organization, regardless of its size, type, or products and services it provides.

ISO 9001:2015 Approach

The revised ISO 9001:2015 standard is based on the following three approaches:

• Process approach
• PDCA Approach
• Risk-based thinking

The old ISO 9001:2008 standard was based on the Process approach and PDCA approach only.

The Risk-based thinking is the new approach that is added in revised ISO 9001:2015 standard to address the risk opportunities that could cause its processes and quality management system to deviate from the planned results.

Risk basically is the effect of uncertainty on expected/desired results.

Importance of ISO 9001 in QMS. Enhances Customer Satisfaction: The primary objective of ISO 9001 is to enhance customer satisfaction by meeting their requirements and expectations. The standard emphasizes the importance of understanding customer needs and providing products and services that meet those needs.

Improves Operational Efficiency:

ISO 9001 requires organizations to establish and maintain processes that are effective and efficient. By following a structured approach to managing processes, organizations can improve their operational efficiency and reduce waste.

Difference in clauses – ISO 9001:2008 and ISO 9001:2015

There is no change in the first three clauses of the revised ISO 9001:2015 standard and are the same as those in ISO 9001:2008, but there is a considerable difference from the fourth clause onward.

Clause	As per ISO 9001:2008 old version	Clause	As per ISO 9001:2015 new version	Remarks
Cl. 0	Introduction	Cl. 0	Introduction
Cl. 1	Scope	Cl. 1	Scope	Same
Cl. 2	Normative References	Cl. 2	Normative References	Same
Cl. 3	Terms and Definitions	Cl. 3	Terms and Definitions	Same
Cl. 4	Quality Management System	Cl. 4	Context of the organization	Change
Cl. 5	Management Responsibility	Cl. 5 Cl. 6	Leadership Planning	Change
Cl. 6	Resource Management	Cl. 7	Support	Change
Cl. 7	Product realization	Cl. 8	Operation	Change
Cl. 8	Measurement, analysis, and improvement	Cl. 9 Cl. 10	Performance evaluation Improvement	Change

 Quality Management System ISO 9001 | Fast reality

The fast facts about the  Quality Management System ISO 9001:2015 are:

• ISO 9001:2015 replaced  ISO 9001:2008 standard.
• The revised ISO 9001 was published in September 2015.
• The revised standard consists of 10 clauses. Earlier there were 8 clauses in ISO 9001:2008.
• The changes were managed by the ISO committee ISO/TC 176.
• ISO 9001:2015 is more compatible with other management systems, such as ISO 14001, and ISO 45001, making it more effective and efficient to integrate management systems.
• IATF 16949 standard will be used in conjunction with ISO 9001:2015. i.e. Organizations looking for IATF certification will have to follow the ISO 9001:2015 standard separately.

ISO 9001 Principles | Quality Management System Principles. 7 Quality Management. Principles as per the latest standard are:

• Customer focus
• Leadership
• Engagement of People
• Process Approach
• Improvement
• Evidence-Based Decision Making
• Relationship Management

 QMS Principles – ISO 9001:2015 Vs ISO 9001:2008. The major changes incorporated in ISO 9001 quality management principles are:

• Involvement of people changed to Engagement of people.
• Factual approach to decision-making changed to Evidence-Based decision-making.
• System approach to management changed to Improvement.
• Continual Improvement and Mutually Beneficial Supplier Relationship changed to Relationship Management.
• The new standard is based on the seven quality management principles whereas the old standard was based on the eight quality management system principles.

Seven Quality Management Principles (As per ISO 9001:2015 new version)

1. Customer focus
2. Leadership
3. Engagement of People
4. Process Approach
5. Improvement
6. Evidence-Based Decision Making
7. Relationship Management

Eight Quality Management Principles (As per ISO 9001:2008 old version)

1. Customer focus
2. Leadership
3. Involvement of People
4. Process Approach
5. System Approach to Management
6. Factual Approach to Decision Making
7. Continual Improvement
8. Mutually Beneficial Supplier Relationship

ISO 9001 Clauses. 9001 ISO 2015 clauses are:

• Clause 1:Scope
• Clause 2:Normative References
• Clause 3: Terms and Definitions
• Clause 4: Context of the organization
• Clause 5: Leadership
• Clause 6: Planning
• Clause 7: Support
• Clause 8: Operation
• Clause 9: Performance evaluation
• Clause 10: Improvement

The mandatory seven clauses of ISO 9001 are: clauses 4 to clause 10.  All these clauses are arranged according to PDCA cycle.

When to Implement ISO 9001? When a company wants to improve its QMS with the intention of enhancing its goods or services, and eventually customer satisfaction. The ISO 9001 standard is most commonly used when:

• Customers specify this need in their contracts.
• Countries need certification in order to trade with them.
• Businesses aim to increase the quality of their goods and the level of customer satisfaction.
• Organizations want to meet all legal and statutory compliance.

• Facilitates Continuous Improvement: ISO 9001 requires organizations to continuously monitor and improve their processes. This helps organizations identify areas for improvement and implement changes that can result in better quality products and services, improved customer satisfaction, and increased efficiency.

• Enhances Competitiveness: ISO 9001 is recognized globally as a standard for quality management. Organizations that implement ISO 9001 can demonstrate their commitment to quality, which can help enhance their reputation, build customer confidence, and improve their competitiveness in the marketplace.

• In summary, ISO 9001 is important in QMS because it provides a framework for organizations to consistently meet customer requirements, improve efficiency, reduce waste, and continuously improve their processes.