15 Ways to Enhance your Quality Management System

Posted by Luke Tayler on December 18th, 2018

No one can deny that ISO 9001 is one of the best and widely used standards for Quality assurance. The latest version of this ISO standard has marked remarkable differences from its earlier versions. This article has listed 15 most-effective ways that can help you boost your quality management system.

1. Leadership

Clause 5.1.1 of ISO 9001:2015 states, “Top management shall demonstrate leadership and commitment with respect to the quality management system by taking accountability for the effectiveness of the quality management system”.

In the earlier version, quality was considered only as a secondary task for the quality managers. However, a major change has been found in the current version. The quote mentioned above clearly reflects this change. Hence, your direction, drive, and path towards quality should be more effective, efficient, and strategic. Your leaders should hold authority over all of these aspects. It is expected that the leadership will help the organisation achieve quality excellence. Ultimately, it will lead you to the ISO 9001 certification.

2. Quality Objectives

As per clause 6.2.1, “The organisation shall establish quality objectives at relevant functions, levels, and processes needed for the quality management system”.

Once the leadership takes over the responsibility of maintaining the quality of your organisation, you should set out the quality objectives so that you can align the quality objectives with the business objectives of your organisation. You should realise that quality objectives are the requirements of the ISO 9001 standard. These objectives may differ from one business to another. You should always keep a balance between your business objectives and the quality objectives. This harmony is a key to your success.

3. Quality Policy

Clause 5.2.1 states, “Top management shall establish, implement, and maintain a quality policy that includes a commitment to continual improvement of the quality system.”

In the earlier versions, the quality policy statement was hung on the wall. The updated version, however, has made the leaders use the quality policy as a tool for implementing the right direction and the overall intentions. Hence, the quality policy has gained more significance in the latest version. You should work closely with your management and employees while drafting the quality policy for your business. You should also ask a reliable quality assurance consultant for drafting the quality policy for your organisation.

4. Quality Planning

Clause 6.2.2 states, “ When planning how to achieve its quality objectives, the organisation shall determine: a) what will be done; b) what resources will be required; c) who will be responsible; d) when it will be completed; d) when it will be completed; e) how the result will be evaluated.

Whenever you will make the quality planning, you need to consider each of these issues stated above. Remember that whenever your organisation will be audited by the independent auditors, they may want you to provide them with a convincing and logical quality planning.

5. Legal Compliance

According to clause 1 b), “This International Standard specifies requirements for a Quality Management System when an organisation aims to enhance the customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and requirements.”

If you want to gain ISO 9001 certification, you must take care of each of the regulations associated with the ISO 9001 Standard.

6. Safety Issues

Clause 8.3.5 states, “The organisation shall ensure that design and development and outputs specify the characteristics of the products and services that are essential for their intended purposes and their safe and proper provision”

Here, safety plays a critical role. You should achieve safety through quality design, quality process, and quality performance. The recent version of ISO 9001 attaches great importance to the safety issues.

7. Risk-Based Negative Thinking

There are two sides of a risk-based strategy- negative and positive. You should consider the issues stated in clause 4.1 and 4.2 to determine the risks and opportunities. These risks and opportunities should mitigate the anticipated risk factors.

8. Risk-Based Positive Thinking

Risk-based positive thinking refers to the clause 6.1.1 where the standard clearly mentions that a business should take into consideration the issues (4.1 and 4.2) that can ensure the further improvement of the organisation.

9. Correction & Corrective Action

According to ISO 9001:2015 requirements, you should come up with a proper plan for addressing the flaws or gaps existed within the system. At the same time, you should take some initiatives in advance to prevent the risks and loses.

10. Continual Improvement

It is perhaps the most discussed change in the latest version of ISO 9001. This latest version has attached immense importance to continual improvement. Only meeting the quality requirements is no more enough. It is equally important to improve the quality. In fact, your quality planning should clearly demonstrate an effective strategy for continual improvement.

11. Breakthrough Modifications

The standard has specified certain examples, which are expected from a certified quality management system. These examples include correction, corrective and preventive actions, continuous improvement etc.

12. Innovation

It is not enough to meet the present requirements of the customers. The companies should make innovative plans for meeting the future requirements of the customers and stakeholders.

13. Re-Organisation

An organisation should pay attention to the improvement of the suitability, availability, and effectiveness of the quality management system.

14. Customer Satisfaction

Customer satisfaction has always been the prime concern of the ISO 9001 standard. The current version is no exception. You must meet the customer requirements and achieve customer satisfaction.

15. Management Review

This is an additional requirement that was somehow subjugated in the earlier versions. The management should always remain active. It is mandatory for the management to review the Quality Management System regularly.

These are the fifteen points that you should consider to improve your Quality Management System and align it with ISO 9001:2015 requirements in the most effective ways.

Author Bio
Damon Anderson is an ISO expert and a passionate blogger. He has been working as a quality assurance consultant for more than a decade. He has expertise in ISO 13485 certification, ISO 17025 certification, and ISO 9001 certification.