How ISO 9001 Helps in Achieving Both Quality and Compliance

If you are a business owner who looks for a consistent position in the market, then ‘quality' is a pivotal concept for you. However, quality is more of a subjective concept in business. Different businesses offering different types of products or services have their own yardstick of quality. Generally, every business considers quality products or services to be those which are free from defects fulfilling the needs of their customers.

Despite that, the real challenge for many businesses in the matter of quality assurance is to comply with international or local regulations related to quality. Hence, achieving compliance with regulatory requirements as well as meeting customers’ requirements are together what businesses mean as quality assurance. While it is truly difficult for businesses to assure both, the right Quality Management System (QMS) such as the ISO 9001 quality management system helps businesses of any size or type to achieve compliance as well as the quality expectations of their customers. Here, in this article, we have explained how.

Keyways the ISO 9001 Quality Management System Assists Businesses to Achieve Quality & Compliance

Here is how the right QMS can help your business achieve quality assurance as well as conformity to regulatory requirements.

Knowing the quality objectives including customers’ expectations

To implement a strong and standardized QMS like ISO 9001, you need to first set clear objectives or goals of your quality management strategy. Having clear objectives will help you to improve your key businesses process and align some processes with the QMS approach.  Therefore, it is essential to make a list of your objectives which may include customer expectations, external requirements (i.e., suppliers’ requirements) and compliance-related requirements. These help in developing the QMS with realistic goals which give a direction to the quality managers in your organization.

Also, a QMS fosters transparency in the organization when the quality objectives are properly communicated to the employees at all levels. Therefore, there are minimal chances of them to make mistakes or waste time on useless tasks which level up their productivity.

Identifying the compliance requirements

Achieving quality assurance in your organization is meaningful when your processes, as well as products or services, meet compliance with general regulatory requirements. When you implement a standardized QMS like ISO 9001, compliance becomes an inherent part of your quality culture.  Maintaining compliance with the latest requirements also becomes an essential part of your long-term quality management strategy.

The ISO 9001 QMS helps you to achieve compliance. It helps you to identify the key measures or best practices required in your business to meet the essential regulations, local as well as global.

Makes employees responsible

When you have a strong QMS, the employees know their roles and responsibilities well regarding quality management. They understand how to deliver their roles for the best quality outputs. The QMS requires you to align the processes, document everything step by step, and instruct the employees. Thus, it makes them accountable for their tasks. They become highly motivated to work in the right way to ensure that every quality objective and compliance requirement is met.

Defining of KPIs

A uniform QMS works with not only a set of targeted objectives but also with a set of KPIs (Key Performance Indicators). When you have defined the KPIs related to quality in your business, you can determine the improvements required in your processes or corrective actions needed to achieve them. You also have to analyze the KPIs over time to ensure your dedicated QMS is working effectively. While setting the KPIs, you need to consider the quality expectations of both customers and suppliers, and then your compliance level. Therefore, when your KPIs escalate, it implies your efforts for meeting quality assurance and compliance are working well.

Finding out scopes for improvements

The right QMS promotes continual improvement in the business through periodic internal audits and reviews. You need to have a definite approach for evaluating your QMS against the given standard, ISO 9001’s requirements, periodically and implement necessary changes if needed. The regular evaluation of your QMS helps in identifying the areas where there are considerable scopes for improvements. Accordingly, you can take action to improve your QMS. Once your organization gets acquainted with such a process of continual improvement, it results in optimization of your processes leading to better quality and compliance maintenance. 

These are the main ways a concrete quality management approach can help your business to assure quality as well as compliance. One of the best approaches is the ISO 9001 Quality Management System (QMS) which makes it simple to fulfill your specific goals of quality and compliance. The standard helps you to fulfill them by adhering to best-practices with streamlined processes and employee cooperation.