Difference between iso 9001 version 2008 and 2015

The difference between ISO 9001:2008 and ISO 9001:2015 lies primarily in the structure, focus, and approach of the two versions. ISO 9001:2008 followed a more traditional approach to quality management systems, emphasizing documentation and procedures. In contrast, ISO 9001:2015 adopts a more modern and holistic approach, focusing on risk-based thinking, context of the organization, leadership involvement, and stakeholder engagement. Additionally, ISO 9001:2015 introduces new concepts such as the process approach, documented information, and the emphasis on achieving desired outcomes. Understanding these differences is crucial for organizations transitioning from ISO 9001:2008 to ISO 9001:2015 to effectively implement and maintain their quality management systems in accordance with the latest standards and best practices. Let’s join GIAYCHUNGNHAN to explore the following article.

Nội dung bài viết

1. What is ISO 9001 standards?

ISO 9001 is part of the ISO 9000 standard – one of the most popular quality management system standards in the world today.

Up to now, the ISO 9001 standard has 4 versions and the current version is ISO 9001:2015. This standard is built on a high-level structure (HLS) that applies to all standards for management systems, applied the processes of creating and controlling products and services of enterprises to ensure that the needs are met and meet the expectations of customers and partners.

2. The standard structure

The first difference between ISO 9001:2008 and ISO 9001:2015 is that the standard structure has changed. ISO 2008 has 5 main parts from section 4 – 8, and ISO 2015 has 7 main parts from section 4 – 10, according to the table below:

ISO 9001:2008	ISO 9001:2015
1. Scope	1. Scope of application
2. Incitation criteria	2. Incitation criteria
3. Terms and definitions	3. Terms and definitions
4. Quality management system	4. Context of the organization
5. Leadership responsibility	5. Leadership
6. Resource management	6. Planning
7. Create product	7. Supports
8. Measure, analyze, improve	8. Make
	9. Evaluation of implementation results
	10. Improvement

For more information about Quality management principles of ISO 9001, You may be interested in the following article of GIAYCHUNGNHAN.

3. Terms, terms and principles of quality management

In addition to the structure, the improved version of ISO 9001:2015 also has changes in terms, terms and quality management system as follows:

ISO 9001:2008	ISO 9001:2015
Interested party => Customer	Interested parties => Not only customers
Process-based approach, encouragement	Approach according to a comprehensive process, based on risk management, change, knowledge
Products	Products and services
Objective	Objective and review other applicable requirements
Documents, records	Information is made in writing
Outsourced	External supply of products and services
8 principles of quality management	7 principles of quality management
Leader representative	Not required
Quality handbook	Not required
6 mandatory procedures	Not required
Preventive action	Not required
Excluded in article 7 [1.2]	Not excluded [4.3]

4. New points in ISO 9001:2015 standard

In addition to the above differences in the ISO 9001:2015 standard, there are many new points such as:

Organizational context

In the 2015 standard, the organizational context has new points such as: Organizational context/Business environment, Synthesis of internal/out-organizational factors/conditions that affect the organization’s access to products and services.

Leadership

Leaders are required to demonstrate leadership rather than just managing QMS.

Planning, QMS requirements

– Specific requirements when approaching the process.

– Recognize the required human resource capacity.

– Recognize and maintain core executive knowledge.

– Risk-based approach to control external suppliers.

5. What are the key differences between ISO 9001:2008 and ISO 9001:2015?

Answer:

Structure: ISO 9001:2015 uses the Annex SL structure, making it compatible with other ISO management standards, while ISO 9001:2008 does not.
Risk-based thinking: ISO 9001:2015 emphasizes risk-based thinking, whereas ISO 9001:2008 primarily focuses on preventive actions.
Documentation requirements: ISO 9001:2015 is less prescriptive about mandatory procedures and emphasizes documented information, unlike ISO 9001:2008, which requires specific documented procedures.
Leadership engagement: ISO 9001:2015 requires greater involvement of top management in the QMS.
Context of the organization: ISO 9001:2015 includes requirements to understand the organization’s context and interested parties, which were not present in ISO 9001:2008.

READ MORE INFORMATIONS ON: Difference between iso 9001 and iso 13485

6. Questions

What are the major structural differences between ISO 9001:2008 and ISO 9001:2015?

ISO 9001:2008 was based on an eight-clause structure, while ISO 9001:2015 follows the Annex SL high-level structure (10 clauses), which is aligned with other ISO management system standards. This structural change promotes easier integration with other management systems like ISO 14001 and ISO 45001.

What happened to the “preventive action” in ISO 9001:2015?

The specific clause for preventive action in ISO 9001:2008 was removed in the 2015 version. Instead, the risk-based thinking concept is embedded throughout the standard, addressing prevention more proactively.

How did the documentation requirements change from ISO 9001:2008 to ISO 9001:2015?

ISO 9001:2008 had explicit requirements for documented procedures and records, while ISO 9001:2015 offers more flexibility by requiring “documented information” without prescribing how to structure or format it. This allows organizations to maintain documentation in ways that suit their needs.

What are the implications of “context of the organization” in ISO 9001:2015?

The 2015 version introduces the concept of context of the organization (clause 4), which was not present in ISO 9001:2008. It requires companies to identify internal and external factors that affect their ability to achieve intended outcomes, along with stakeholder expectations.

We hope this article has provided you with valuable insights. If you have any questions or need further assistance, please don’t hesitate to contact GIAYCHUNGNHAN. We’re always happy to help!