What are the 4 main differences between ISO 9001:2008 and ISO 9001:2015? 

ISO 9001:2015 HAS TEN CLAUSES INSTEAD OF EIGHT

The following table shows the relationship of the ISO 9001:2008 clauses to those in the new ISO 9001:2015.

ISO 9001:2008

ISO 9001:2015

0. Introduction

0. Introduction

1. Scope

1. Scope

2. Normative reference

2. Normative reference

3. Terms and definitions

3. Terms and definitions

4. Quality management system

4. Context of the organization

5. Management responsibility

5. Leadership

6. Planning

6. Resource management

7. Support

7. Product realization

8. Operation

8. Measurement, analysis and improvement

9. Performance evaluation

10. Improvement

The first three clauses in ISO 9001:2015 are largely the same as those in ISO 9001:2008, but there are considerable differences between ISO 9001:2008 and ISO 9001:2015 from the fourth clause onwards. The last seven clauses are now arranged according to the PDCA cycle (Plan, Do, Check, Act). The following figure shows this.

 

The PDCA cycle is a four-step management method used to achieve and maintain control and continual improvement for process and products.

 

Plan- Establish the objectives and processes necessary to deliver results in accordance with the target or goal.

Do- Implement the plan, execute the process, make the product.

Check- Study the actual results and compare against the expected results.

Act- If the CHECK shows that the PLAN implemented in DO is an improvement, then that becomes the new standard. If not, then adjustments are made to insure consistent improvement.

 

By diligently using the PDCA cycle, we can insure that complacency never occurs, and that Cubbison is consistently raising and maintaining our standards.

 

Clauses 4, 5, 6 and 7 of ISO 9001:2015 come under PLAN, clause 8 comes under DO, clause 9 comes under CHECK and clause 10 is covered by ACT.

With this new arrangement, the new ISO 9001:2015 strives to give additional momentum to the continuous and systematic improvement of processes within organizations and businesses, such as the Cubbison Company.

 

ISO 9001:2015 PUTS MORE FOCUS ON INPUT AND OUTPUT

There is more emphasis in ISO 9001:2015 on measuring and properly assessing the input and output of processes. According to ISO 9001:2015, We closely monitor which articles, information and specifications are involved in the production process. We also clearly check whether good articles come out of the production process.

 

RISK-BASED THINKING IS AT THE CORE OF ISO 9001:2015

Risk-based thinking has a very important place in ISO 9001:2015. We use risk analysis in order to decide for ourselves which challenges we see in the management of our business processes.

Formal risk analysis, familiar to many organizations via FMEA or HACCP techniques, is now standard for everyone. To emphasize their dominance, the concept of ’risk’ occurs forty-eight times in ISO 9001:2015, compared with only three times in ISO 9001:2008.

The addition of risk-based thinking has made the ‘preventive measures’ of ISO 9001:2008 redundant. These preventive measures no longer appear in ISO 9001:2015. The transition from ‘Preemptive measures’ to ‘Risk-based Thinking’ is a smart one, as it acts to analyze situations, and solve potential problems long before they begin to develop.

 

LEADERSHIP AND COMMITMENT IN ISO 9001:2015

ISO 9001:2015 also places more emphasis on leadership and management commitment. It requires greater involvement by top managers and business leaders in controlling the quality management system.

This way, ISO 9001:2015 is intended to encourage integration and harmonization with business processes and business strategies. This helps emphasize top management responsibility to ensure the effectiveness of the quality management system.

Because ISO 9001:2015 pays more attention to risk management, interested parties and the context of the organization, the quality management system also fits in better with the needs of the top management.

The quality management system is now more than ever a means for being strategically successful by addressing the needs of interested parties and by managing opportunities and threats.

The ‘management representative’ of ISO 9001:2008 was a member of the management committee who had the responsibility and authority for steering the quality management system along the right lines. ISO 9001:2015 does not mention this aspect any more. The idea behind the change is that quality is a matter for everyone and for all levels within the organization.

 We, at the Cubbison Company, are proud to be recognized as one of the few companies to achieve this level of certification to date. To us, our ISO 9001:2015 registration is verification of our ingenuity, leadership, progressiveness, and our attention to detail, efficiency, quality, safety and care for our customers in the printed electronics and product identification industries.

See our ISO 9001:2015 Certification announcement here!