What is ISO 9001? A Detailed Explanation

Quality is a fundamental to any good product or service. But how can an organisation cater do these standards and regulations? By adhering to Quality Management Protocols. ISO 9001 provided by the International Organisation for Standardisation (ISO) provides the perfect framework for you to provide the best quality of services. But do you know What is ISO 9001?Globally, ISO 9001 is identified as one of the most widely used QMS standards equipped to address the various aspects of quality. It has more than 1.1 million certified organisations in about 170 countries, according to ISO Survey 2022. Thus, you see, it is crucial to learn about this standard, in order to comply with quality management protocols.

So, wait no more and read this blog on What is ISO 9001. Inthis blog you will learn everything about this standard, its benefits, requirements and much more!

Table of Contents

1) Understanding ISO 9001

2) Why is ISO 9001 important?

3) Who should use the ISO 9001 standard?

4) What is a Quality Management System?

5) What are the ISO 9001 requirements?

6) How is ISO 9001 implemented?

7) Conclusion

Understanding ISO 9001 

You might be wondering What is ISO 9001? ISO 9001:2015 is a globally recognised standard for developing, implementing, and upholding a QMS for businesses. It can be used by any company regardless of its size and sector.

Because it is an internationally accepted standard, many organisations demand this certification from their suppliers, creating a system to guarantee customer satisfaction and progress. When you are certified by ISO 9001, the clients will feel secure for having a QMS in place based on the seven ISO 9001 Quality Management principles.
 

Why is ISO 9001 important?

With more than a million certificates given to organisations, ISO 9001 is the most recognised Quality Management standard in the world which is acceptable in 189 countries. It is because this standard has importance, due to the following reasons:

a) Customer confidence: The standard among organisations ensures good quality assurance systems in operation, thereby leading to the increase of customer confidence and satisfaction.

b) Effective complaint resolution: ISO 9001 stipulates the rules for getting through customer concerns in a timely and satisfying manner, hence getting the problems solved as soon as they appear.

c) Process improvement: The standard allows the assessment and eradication of wastes, improvement of processes and provision of data that is of high standard for informed decision making and consequently better outcomes.

d) Ongoing optimization: The ISO 9001 enforced audits and reviews assists organisations to understand their Quality Management system and be able to consistently improve, maintain competitiveness, and realise sustainable success.

Who should use the ISO 9001 standard?

The ISO 9001 may be implemented by any organisation that aims to advance its Quality Management system, meet the criteria of the customers and the applicable statutory and regulatory requirements as well as increase customer satisfaction. 

It is appropriate for all types of organizations, irrespective of their size and it also applies to all the sectors including manufacturing, services, healthcare, education, government, and non-governmental organizations. On top of that, ISO 9001 can be used by certification bodies or other external entities for evaluation of how an organization complies with this International Standard.

What is a Quality Management System?

The Quality Management System also known as the QMS is a system, made up of policies, processes, documented procedures and records. This document package specifies the set of internal criteria as to how your company manufactures and delivers your product or service to your customers.

Your QMS should be tailored to the specific needs of your company and the product or service you provide. The ISO 9001 standard provides a set of guidelines to help ensure you do not miss out on any crucial parts of a QMS that could hinder your success.

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What are the ISO 9001 requirements?

It is important to understand What is ISO 9001 requirements. The ISO 9001:2015 Standard's structure comprises ten sections, with the first three serving as introductory, while the remaining seven outline the QMS requirements. The following explains the content of the seven primary clauses:

1) Clause 4: Context of the organisation - This section outlines the prerequisites for understanding your organisation to establish a QMS. It includes mandates for identifying internal and external factors, recognising stakeholders and their expectations, delineating the QMS's scope, and pinpointing your processes and their interactions.

2) Clause 5: Leadership - The leadership requirements emphasise the pivotal role of top management in QMS implementation. Top management is tasked with demonstrating commitment to the QMS by fostering customer focus articulating and disseminating the quality policy.

3) Clause 6: Planning - Top management must also strategies for the sustained operation of the QMS. This entails assessing risks and opportunities within the organisation's QMS and establishing quality objectives for enhancement, along with plans for achieving these objectives.

4) Clause 7: Support - The support section addresses the management for all resources critical to the QMS. This encompasses the need to govern various resources, including human resources, infrastructure, the work environment, monitoring and measurement tools, and organisational knowledge. It incorporates requirements related to competence, awareness, communication, and control of documented information.

5) Clause 8: Operation - The operational requirements encompass all phases of product or service planning and creation. This section covers planning, reviews of product requirements, design, supervision of external suppliers, product or service development and release, and management of nonconforming process outputs.

6) Clause 9: Performance evaluation - This section outlines the prerequisites for ensuring the effective functioning of your QMS. It entails monitoring and measuring your processes, evaluating customer satisfaction, conducting internal audits, including ISO 9001 audits

7) Clause 10: Improvement - The final section encompasses the prerequisites for enhancing your QMS over time. This includes evaluating process nonconformities and taking corrective actions. These sections adhere to the Plan-Do-Check-Act cycle, which leverages these elements to facilitate change within the organisation's processes, driving and sustaining improvements.

How is ISO 9001 implementated?

Understanding the need to implement the quality standard will help you achieve effective results in your business. Hence, the first step before implementing ISO 9001 in your organisation should be identifying the purpose of getting accredited. This step will help you involve all the members of the organisation and provide an improved awareness that you are committed to maintaining quality.  

Next, you need to confirm the requirements with a copy of ISO Standards as a basis for specific legislation. Then, you must formally define the quality policy and objectives in a document per the ISO 9001 Standards. This standardisation helps you measure and monitor the progress of your improvements.  

Once you have completed all your paperwork and put your processes in place, you must first complete the installation of ISO 9001 before the firm gets certified. To guarantee a successful certification your organisation must also take the following actions:     

Internal audit 

It examines your QMS procedures. The objective is to ensure that records are in place to certify that the procedures are followed and identify issues and flaws that could go unnoticed.

Management review 

A formal assessment of the management system procedures by your management needs to be determined to analyse the pertinent facts, make suitable decisions, and allocate resources.    

Corrective actions 

After the internal audit and management review, you must address the underlying causes of any issues found and record your process for doing so ensuring compliance with the ISO 9001 audit checklist. The certification procedure for businesses is divided into two phases:    

a) Stage One (documentation analysis): The auditors from your preferred certification organisation will verify that your paperwork complies with ISO 9001 criteria during Stage One.  

b) Stage Two (major audit): Here, the certification body auditors will examine paperwork, records, and business practices to see if your actions comply with ISO 9001 and your documentation. 

Conclusion 

We hope this blog helped you understand What is ISO 9001 and how you can implement it in your organisation. Additionally, this blog also presented and discussed its seven principles and benefits. Deploying a QMS is a necessity as it’ll streamline processes, cut excess costs, and enhance the quality of your products and services. 

Do you wish to improve the quality of products and services of your organisation? Then, consider attending ISO 9001 Training right away!