What is the difference between ISO 9001:2008 and 2015?
→ ISO 9001 is an international standard for Quality Management Systems (QMS).
→ The standard is periodically reviewed and updated by ISO committee members.
→ So we can ensure it remains relevant to the current business environment.
→ The main difference is the New High-Level Structure
→ 9001:2015 has 10 clauses while 9001:2008 standard has 8 clauses.
→ 9001:2015 has a new high-level structure, as mentioned in the picture below.
Table of Contents:
- What is the difference between ISO 9001:2008 and 2015?
- 10 Key Differences Between ISO 9001-2008 and 2015
- Major Differences In ISO 9001 Terminology
- Quality Management Principles
- Key Focus of ISO 9001:2015
- Conclusion
10 Key Differences Between ISO 9001-2008 and 2015:
→ Now we will learn about the 10 major differences between old and new standards.
⏩10 key differences between ISO 9001:2008 and 2015 are:
- Structure and Format (Annex SL)
- Risk-Based Thinking
- Terminology Changes
- Context of the Organization
- Leadership and Commitment
- Documented Information
- Focus on Outcomes
- Improvement
- Stakeholder Focus
- Simplification and Flexibility
⏩01. Structure and Format (Annex SL)
→ ISO 9001:2008 follows the older structure with eight clauses.
→ ISO 9001:2015 adopts the Annex SL structure.
→ This Annex SL is a common framework for all new and revised ISO management system standards.
→ This structure consists of 10 clauses, making it easier to integrate with other management system standards such as ISO 14001, 45001, 50001, 22000, etc.
⏩02. Risk-Based Thinking
→ In the older version risk management was implied but not explicitly required.
→ Preventive actions were addressed more traditionally.
→ While the new version emphasizes risk-based thinking throughout the entire QMS.
→ Organizations are required to identify and address risks and opportunities in a structured manner.
→ This shift means preventive action is integrated into the planning and process approach.
⏩03. Terminology Changes
→ ISO 9001:2008 uses terms like "documents," "records," and "product."
→ ISO 9001:2015 updates terminology, where "documents and records" are combined into "documented information,".
→ Similarly "product" is replaced with "products and services".
⏩04. Context of the Organization
→ The older version focuses on the internal processes of the organization.
→ The newer version introduces a requirement to understand the context of the organization, including internal and external factors, and the needs and expectations of interested parties.
→ The interested parties are customers, suppliers, regulators, etc.
→ This helps to align the QMS with the organization’s strategic direction.
⏩05. Leadership and Commitment
→ In ISO 9001:2008, the responsibility for the QMS could be delegated to a management representative.
→ So we can say earlier it was a position or person who is a management representative.
→ ISO 9001:2015 requires top management to take a more active role in the QMS.
→ There is no longer a requirement for a "management representative".
→ Now management can assign the same responsibilities to any person.
⏩06. Documented Information
→ The older version requires specific documented procedures and records.
→ The newer version is focused on the effectiveness of processes rather than the documentation.
→ The term "documented information" replaces "documents" and "records".
→ The requirements are also more flexible, allowing organizations to determine the necessary level of documentation based on their needs.
⏩07. Focus on Outcomes
→ ISO 9001:2008 emphasizes compliance with specified procedures and controls.
→ While ISO 9001:2015 focuses more on achieving desired outcomes and results.
→ The standard encourages organizations to define quality objectives and monitor their achievement.
⏩08. Improvement
→ ISO 9001:2008 contains requirements for corrective actions and preventive actions.
→ ISO 9001:2015 focuses on continual improvement, with an emphasis on proactive improvement rather than just corrective actions.
⏩09. Stakeholder Focus
→ The older version was primarily focused on customers.
→ While the newer version is primarily focused on including other stakeholders.
→ The stakeholders include employees, suppliers, regulators, customers, etc.
⏩10. Simplification and Flexibility
→ ISO 9001:2008 was more prescriptive, with detailed requirements for procedures.
→ ISO 9001:2015 is less prescriptive, offering more flexibility to organizations in how they choose to implement the standard and meet the requirements.
Major Differences In ISO 9001 Terminology:
→ The major difference between the old standard and the new one is mentioned in the below picture.
→ The word Products" is replaced by "Product & Service" in the new standard.
→ So the latest standard is common for most organizations.
→ Previously, the word "Exclusions" was used; now, it is replaced by the word "Not Used."
→ In the old standard "Management Representative" was the post in the organization.
→ But now in the new standard Management Representative post is removed and Similar responsibilities and authorities are assigned to any person in the organization.
→ Before we told as Documentation, Quality Manual, Procedure, Records, etc. but now as per the new standard, all things are known as Documented Information.
→ In the old standard it was mentioned as a work environment but now in the latest standard, it is replaced by an environment for the operation of processes.
→ As per the old standard, we used to say monitoring & measuring equipment but now it is monitoring and measuring resources.
→ Previously we used the "Purchased Product" word but now it is replaced by "Externally provided Products".
→ In the old standard, the supplier word was used but in ISO 9001-2015, instead of supplier "External Provider" word is replaced.
Quality Management Principles:
→ Quality Management Principles are reduced from 8 to 7 nos:
⏩The 7 Quality Management Principles are:
- Customer Focus
- Leadership
- Engagement of People
- Process Approach
- Improvement
- Evidence-based decision making
- Relationship Management
Key Focus of ISO 9001:2015
→ Now we will learn about the key focus of the new standard.
→ Latest Standard emphasis on the below Key focus area that can improve our QMS.
⏩Key focus of ISO 9001-2015 are:
- Customer feedback
- Customer complaint
- Product and service failure
- Employees and other interested parties' feedback
- Innovation
- Risk-Based Thinking
- Determined opportunity
- Internal or external audit results
- Management review results
- Identified nonconformity
- Identified opportunities for improvement
- Puts greater emphasis on leadership engagement
- It helps to address risks and opportunities in a systematic manner
- It uses simplified language
→ The new standard has a common structure and terms, which are particularly helpful to organizations for using multiple management systems at a time.
→ New High-Level Structure allows an organization to have an integrated management system.
→ 9001:2015 is more user-friendly for service and knowledge-based.
Conclusion:
→ ISO 9001, the latest standard offers a more modern, flexible, and integrated approach to quality management.
→ The changes encourage organizations to take a more strategic approach to quality management.
→ Also, the latest standard focuses on risks, opportunities, and overall business performance.
→ ISO 9001 is a valuable tool for organizations.
→ This standard strives for excellence in quality management.
→ Also it offers a structured approach to improving operations, ensuring compliance, and achieving long-term success.
really good content
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