Difference between ISO 9001 and ISO 9004

If you want to meet the requirements of your customers and consistently exceed their expectations, then you must implement a Quality Management System (QMS) that helps to foster a quality-first environment in your organisation. We all know that the benchmark for implementing an efficient QMS is ISO 9001, but if you have been researching the QMS, you must have come across ISO 9004 and would have heard how it can further improve the efficiency of your QMS. As expected, you may be confused between the two standards. In this article, we will clear your doubts and talk about the differences between ISO 9001 and ISO 9004.

What is the ISO 9001 document structure?

ISO 9001 is the most popular standard of the ISO 9000 series and lays out the recommendations for building a QMS. It integrates the seven quality management principles such as customer focus, evidence-based decision-making, process approach, employee engagement, leadership commitment, continual improvement and relationship management so that organisations can consistently deliver high-quality goods/services.

The ISO 9001 standard is divided into 10 clauses where the first three are introductory in nature, aimed to familiarise the reader with the terms and vocabulary that is utilised throughout the standard. Clause 4 talks about the context of the organisation, helping businesses identify all internal and external issues that might impact their QMS. Clause 5 talks about how leaders must showcase their commitment towards the QMS through adequate resources and effective communication. Clause 6 focuses on planning, urging organisations to create actionable steps to improve the efficiency of the QMS. Clause 7 talks about support, listing the people, infrastructure, knowledge, communication and documented information you need for the adequate functioning of the QMS. Clause 8 talks about the operation, teaching organisations to find out customer requirements, design specifications, external providers, and post-delivery support. Clause 9 talks about performance evaluation and how the efficiency, relevance and functionality of the QMS should be assessed through internal audits and management reviews. The last clause talks about continual improvement where organisations are urged to always find areas that can improve efficiency.

What is ISO 9004?

ISO 9004 is a document that accompanies ISO 9001 and provides further guidance to any organisation that wishes to improve its QMS. The goal of the document is to implement and update the processes created according to ISO 9001 requirements so that organisations can sustain their success and constantly improve their efficiency.

What is ISO 9004 document structure?

ISO 9004 document contains comparable clauses to ISO 9001, including:

• Clause 1, which defines the scope and provides guidance for making a QMS more successful.
• Clause 2 contains normative references that are fundamental definitions for the QMS.
• Clause 3 contains additional terms and definitions.
• Clause 4 provides recommendations for managing the system and success of an organisation.
• Clause 5 contains strategy and policy which brings in an assessment of the needs and expectations of other parties.
• Clause 6 focuses on resource management as an extension of the requirements in ISO 9001.
• Clause 7 focuses on process management and provides additional information regarding product realisation.
• Clause 8 focuses on monitoring, measurement, analysis and review, further building on the requirements of measurement and analysis in ISO 9001.

Clause 9 focuses on improvement, innovation and learning.

what are the differences between ISO 9001 and ISO 9004?

ISO 9001 focus primarily on meeting customer requirements, whereas ISO 9004 focuses on meeting the requirements of customers in addition to all other interested parties. The purpose of the ISO 9004 document is that it is meant to supplement the knowledge of ISO 9001. Therefore, ISO 9004 is commonly described as the key to sustained business success. ISO 9004 provides guidance for enhancing the overall quality of the QMS by improving its maturity in terms of strategy, leadership, resources and processes.

Ideally, the audit schedule should be divided to reflect each section of the ISO 9001 standard, and you can customise the schedule by determining which of the sections is of the greatest relevance to you. While the ISO 9001 standard does not require organisations to specifically adhere to an internal audit schedule, it is the easiest way to keep your audit program on track.

Also read: “how to maintain iso 9001 certification?”

Conclusion

ISO 9001 consulting will guide you in every step of the process. ISO 9001 consultants will come to your organisation to determine what are the areas where you are lacking and what are the areas where you are strong. Based on their gap analysis, they will recommend best practices that are utilised by the industry giants, so that your QMS is efficient and at par with the best of the industry.

The cost of the ISO 9001 certification is dependent on many factors such as the number of employees in the organisation, the number of outlets, the complexity of your processes and the products or services that you provide. ISO 9001 lays out the recommendations to build an effective QMS, whereas ISO 9004 provides supplementary information to further improve the efficiency of your QMS.