A Complete Guide to ISO 9001: Quality Management Systems

More than a million organizations worldwide have improved their businesses with the help of ISO 9001. But how has it helped them? What exactly is a quality management system? And how to get ISO 9001 certification?

We’ll tackle these and many more questions to help you understand the standard better. You’ll learn the following:

• What is ISO 9001?
• What Topics come under ISO 9001?
• What are the Uses of ISO 9001 Certification?
• How to get ISO 9001 Certification?
• What Does the Cost of ISO 9001 Certification Depend on?

What is ISO 9001?

Defined as the international standard that clearly states the requirements for a quality management system (QMS), ISO 9001 is used by organizations to establish credibility. It demonstrates that their products and services meet customer and regulatory requirements.

One of the most prevalent standards in the ISO 9000 series, it’s the only standard in this series in which organizations can get certified. First issued in 1987 by the International Organization for Standardization (ISO), the current version of ISO 9001 was released in September 2015.

For your information, ISO is an international agency comprising national standards from over 160 countries.

Quality Management Systems

These are a collection of business processes focused on regularly meeting customers’ requirements and enhancing customer satisfaction. They are aligned with the purpose and strategic direction of an organization.

What Topics come under ISO 9001?

The first thing to understand is that ISO 9001 has been developed on the plan-do-check-act methodology (a four-step model used for bringing change), also known as the PDSA cycle. It gives a process-based approach to the different procedures and responsibilities associated with effective quality management in an organization.

Here are some specific sections of this standard that include information on different topics, such as:

• Guidelines (including documented information, planning, and ascertaining process communications) needed for a quality management system (QMS)
• The various responsibilities associated with management
• Management of various resources, such as human resources and the work environment of an organization
• The different steps involved in product realization, from design to delivery, among others
• Activities, such as internal audits and corrective and preventive action that are required for tracking the metrics, analyzing them, and improving the QMS

As we mentioned earlier, the current version of ISO 9001 was revised in 2015 to ensure that it remains consistent in adapting to the changing work environments in which organizations operate. Here are some of the primary updates that were made in ISO 9001:2015:

• New terminology was introduced
• Some existing parts were restructured
• Risk-based thinking was highlighted to improve the application of the process approach
• The number of requirements for leadership went up
• Enhanced applicability for services

What are the Uses of ISO 9001 Certification?

An ISO 9001 certification has multiple benefits and focuses on not just improving the customer experience. This process will also enhance your employees’ productivity and, ultimately, your organization. As the standard lays down the guidelines for an efficient quality management system, these are its advantages:

• Organizes a QMS
• Consistently enhances different processes
• Results in more satisfied customers, better management, and happier employees
• Saves money

These are just a few benefits. The bottom line is that since it provides a concrete structure to how you can approach different processes, it helps streamline them, ensuring quality, and, therefore, assists your organization in generating more money.

How to get ISO 9001 Certification?

The process of obtaining ISO 9001 certification is different for an individual and an organization. Let’s take a look at both:

ISO 9001 Certification Process for an Individual

If you’re an independent contractor and need to get ISO 9001 certification, you’ll need proper ISO 9001 training. After that, you’ll need to pass the necessary certification exams. Once you successfully clear them, you get certified.

ISO 9001 Certification Process for an Organization

The process can be divided into two parts:

Stage One: Documentation Review

To ensure that the documents you submit meet all the ISO 9001, auditors from a certification body of your choice will review them.

Stage Two: Main Audit

In this stage, the auditors will be checking to see if your actual activities are aligned with both ISO 9001 and the documentation you have provided. This is done by reviewing those documents, records, and company practices.

What Does the Cost of ISO 9001 Certification Depend on?

The ISO 9001 certification costs vary depending on the company. Not every company wants the same things, such as some may wish to include the design and development process, while others might like something else.

The final amount will be based on the efforts behind implementing the necessary processes to meet the requirements. Similarly, the cost of onboarding certification auditors will vary depending on how complex the chosen processes are and the number of employees involved.

Here are the main categories that will be considered when deciding the cost:

• ISO 9001 education and training
• External help
• Certification costs
• Amount charged for the employee’s time
• Money needed to sustain your QMS

Out of these, you’ll most probably be spending the most on certification costs. To minimize these, you can reach out to different certification bodies and compare the rates. Further, you can also take their help to identify gaps in your documentation and work on rectifying them before the final audit.

Many seem to think that since it’s not a legal requirement, why even bother? But when you think about its benefits, coupled with the fact that it has the potential to turn your business around, you should consider getting the ISO 9001 certification.

And if you want more information, just reach out to us! We’re right here.

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