What is ISO 9001, and how does it work?
The simplest answer- is ISO 9001 is a one-stop solution for all your quality-related problems. How? By giving you a step-by-step set of recommendations that you can follow to build your own customised, efficient and self-improving Quality Management System (QMS). This article will discuss what ISO 9001 is, why it is crucial for you as a business owner and how it works.
What is ISO 9001?
The ISO 9001 standard is an internationally acclaimed standard that is applauded for its flexibility and adaptability. It is published by International Organization for Standardization (ISO) and has undergone many revisions, with the latest update occurring in 2015. This is why the standard is commonly referred to as ISO 9001:2015. To be updated and released, there had to be an agreement by the majority of the member countries in ISO so that the standard becomes internationally recognised and accepted by most countries across the globe. The standard has 10 clauses, and organisations can create their own quality management system.
What is a QMS? And why is it important?
The ISO 9001:2015 standard defines a QMS as a framework that provides requirements to be implemented by a company that wishes to create procedures, processes and policies necessary to develop products or services that consistently meet regulatory and customer needs, with the ultimate goal being to enhance customer satisfaction. Quality management systems are the underlying foundation of all eminent quality assurance methods or activities. A QMS is often referred to as a collection of records, documented procedures, processes and policies which define the internal set of rules in an organisation, helping them tailor their product/service specifications as per customer requirements.
Why is ISO 9001 important?
As stated above, the standard is internationally acclaimed and recognised for creating, implementing and maintaining a QMS. This standard is so important and popular because organisations of any size or industry can utilise it. Certification to the standard provides reassurance to your target audience that you have established an efficient QMS based on the seven quality management principles of ISO 9001. The efficiency of this standard is so potent that it is used as a foundation to create industry-specific standards such as ISO 13485 for medical devices, AS 9100 for the aerospace industry or IATF 16949 for the automotive industry. Another ode to its efficiency is that despite the global recession of 2017, and the pandemic, organisations implementing ISO 9001 remained stable.
What is ISO 9001:2008?
Before the revision of the ISO 9001 standard, ISO 9001:2008 was utilised. This predecessor has undergone minor additions in 2015, such as greater emphasis on managerial accountability, document control and continual improvement.
What are ISO 9001:2015 requirements?
The structure of the ISO 9001:2015 standard is divided into 10 clauses, whether the first three are introductory in nature and the next seven contain the requirements for the QMS. To be certified, companies must adhere to these requirements. The seven clauses include the following:
- Clause 4: Context of the organisation- This clause urges organisations to understand their business to implement a QMS. This begins by identifying internal/external issues, the expectations of all interested parties, defining the scope of the QMS and identifying how the processes interact with each other.
- Clause 5: Leadership- This clause covers the need for the top management to become instrumental in the QMS implementation. The standard urges top management to demonstrate a commitment to their quality objectives and the QMS by ensuring that a customer focus is prioritised across the organisation, the quality policy reflects the unique needs of the organisation, and adequate roles and responsibilities are assigned to ensure the efficient functioning of the QMS.
- Clause 6: Planning- This clause urges top management to appropriately plan for the ongoing functioning of the QMS by determining all risks and opportunities related to the quality objectives so that mitigation and improvement steps can be taken to accomplish quality objectives.
- Clause 7: Support- This section includes the requirements around awareness, competence, communication and controlling documents so that the efficiency of the QMS can be upheld with a solid foundation of adequate resources.
- Clause 8: Operation- This section deals with all elements of planning and creation of products or services by outlining requirements on product reviews, design, control, external providers and product outputs.
- Clause 9: Performance evaluation- This section includes the recommendations to monitor whether your QMS is functioning as planned by having requirements for assessing customer satisfaction, ongoing management reviews and ISO internal audit.
- Clause 10: Improvement- This section contains requirements that are needed to improve the efficiency of your QMS over time.
ISO certification consultants
Understanding each clause’s applicability and relevance can become an unbearable task. Thankfully, ISO certification consultants exist to simplify this process. These consultants help you implement your QMS but also help you achieve certification by assisting you in internal audit, troubleshooting, modifying and improving its efficiency.
ISO 9001 is important because its flexible nature can be adapted to the unique situation of any organisation, allowing them to measure their customer requirements and creates products that are a perfect fit for those requirements.
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