Most of the leading organizations have realized the fact that business success depends only on happy and satisfied customers. And, customer satisfaction can be achieved only with Quality. it has become insanely significant to encourage a culture of quality in the organization through streamlined processes.

What’s Quality?

Quality is referred to as any product or service being suitable for the purpose it is intended to serve while keeping it up to the customer’s expectations. Since quality may vary for different people based on the specification quality while the producers or manufacturers measure it with the degree of conformance and any support person may measure the quality in terms of reliability and sustainability.

Higher will be the conformance; higher will be the quality, reliability, and sustainability of the product.

With the increasing competition, ever-changing customer requirements, and evolving business landscapes, it has become important for businesses to have a robust quality management system in place to enable their quality teams managing end-to-end quality from anywhere around the globe.

What’s a Quality Management System and the Value It Offers?

A Quality Management System refers to the guidelines and procedures that should be implemented and improved for flawless quality management processes while driving a culture of continuous improvement.

As far as value contribution is concerned, a quality management system is a worthy investment to realize the true potential of your existing resources while keeping the operational risks and quality costs to a minimum.

A Quality Management System is important for any organization since it helps to attain business objectives while meeting:

• Customer Requirements
• Internal Requirements
• External Requirements

Benefits of Implementing a Quality Management System

Implementing an effective quality management solution can help any organization to leverage multiple benefits including error and waste reduction while building a culture of quality to encourage standardization and effective documentation throughout the organization. It further leads to customer satisfaction and achieving organizational goals.

Once you will have such managed processes and procedures, you can also maintain consistency and compliance to market your products and services even more confidently.

How to Implement a Quality Management System?

Implementing a quality management system is critical for an organization’s success, but it requires you to follow certain steps to avoid any operational issues.

For the successful QMS implementation, you need:

Commitment from the Management Team

First and foremost, your management team should be committed to implementing a quality management system since motivation drives from top to down. Senior management can set a perfect example for all other employees while helping them realize the benefits of quality management for the organization.

A Dedicated Team for QMS Implementation

You need to designate a dedicated team to understand and fulfil the needs of a QMS implementation process. This team will essentially bridge the gap between the senior management and ISO 9000 certification body. Moreover, the implementation team should represent every department.

To Create Awareness about ISO 9000

Organizing the awareness programs, surveys, and presentations will demonstrate your employees the advantages of implementing an ISO certified quality management solution in their day-to-day operations. Most importantly, it will encourage them to put maximum sincere efforts for successful QMS implementation.

Relevant Training Programs for Employees

Implementation of a quality management system cannot be successful unless your employees understand the process flow and procedures. It can be done only through effective training programs. Be sure to include all the quality management concepts in training including its impact if consistency is not maintained.

To Understand Your Organization’s Status

Your quality management system should be aligned with the standards and the guidelines defined in ISO 9000. Hence, you need to observe your organization’s status by comparing the existing quality processes with ISO requirements so that you can identify the improvement areas and can work on them.

To Document the Implementation Plan and QMS Process

Keeping your QMS implementation plans and processes documented is one of the key requirements to comply with ISO 9001. Make sure you document all the important processes, instructions, SOPs, etc. You can get a good electronic document management system to create and store all your controlled documents.

To Keep your Controlled Documents Managed

Not only documenting the processes and procedures will work, you have to manage them on a regular basis. You can use Qualityze Document Management Solution to manage all your controlled documents – be it storage, modification, version control, or deletion. No more chaotic paper-based files.

To Implement the Quality Management System

Once all the documentation part is covered, you must implement the quality management system. You can ensure effectiveness and efficiency with the use of a closed-loop quality management solution like Qualityze to manage all your quality requirements without any hassle.

To Perform Regular Internal Audits

Your job is not limited to the QMS implementation, you should establish a regulated internal audit process to ensure that all the processes, procedures, and guidelines are properly followed. Unlike traditional audit systems, the next-generation audit management solution serves the purpose quite productively.

To Review and Assess the Audit Findings

As we have already discussed the productive benefits of implementing next-generation audit management solution. Reviewing and assessing the audit findings is yet another advantage that you can leverage with an audit management solution by standardizing all the related processes across the organization.

To Get Certified and Registered

Once you have implemented a quality management system, it’s time to get registered and certified. Your implementation team can send a formal application to take the certification process forward. However, the validity of certification is only for three years. The certification bodies then will conduct regular audits for the renewal process.

To Foster Continual Improvement

Even when you gain the certification, you must try to improve the existing processes to leverage the benefits of the QMS implementation continuously. Also, continual improvement is a key aspect of quality management guidelines as specified by ISO. Continuity keeps sustainability.

If you follow the above-stated steps for QMS implementation, you will likely to attain your business goals with operational excellence. And, an Enterprise Quality Management Solution like Qualityze can make it easy for you to implement, manage, and maintain a quality management system.

Qualityze is built upon the world’s most secure and reliable platform, Salesforce.com, which enables your quality teams to manage end-to-end quality from anywhere around the globe. It also comprises features like Alerts, Notifications, Electronic Signature, Audit Trails, Reports, and Dashboards.

The Bottom Line

Implementing a quality management system is critical for every business to meet the quality expectations of its customers while meeting compliance and conformance. With an eQMS like Qualityze, you can establish a streamlined process and procedures to manage all your quality requirements as well as risks effectively and efficiently.

If you want to make the process of change implementation smooth, put fewer efforts, and assist your employees, you must establish a streamlined process that makes the change management easy without facing any resistance.

As we all know that the business environments are changing very rapidly, and effective change management process has become the necessity. There should be effective communication in the organization because it is critical for making a change successful. But nowadays, it has become quite difficult to analyze the right communication approach based on organizational culture.
Continue Reading >>

Do you often feel confused with the usage of terms Nonconformance and Noncompliance? If yes, you are not alone.

Since both the terms are used interchangeably, the confusion is the common outcome. In this post, we will understand the differences between the two, which may initially seem trivial to you. But once you will get to know how these processes work for attaining the goal of product quality, there won’t be a room for confusions anymore.
Continue Reading >>

Modern organizations that want to get maximum returns from the investments need to focus on creating a human capital difference through effective training and development programs for their employees. As they say, the workforce is the most valuable asset for any organization. You should unleash the real potential of this asset to become a great organization from a good one.

The organizations who have already invested in advanced training solutions tend to achieve both short- and long-term business objectives since their employee engagement rate has significantly increased. Even the employees nowadays understand the need for continuous skill improvement and learning to be competent. This is the reason training has become the buzz word in nearly every industry.
Continue Reading >>

Designing a product that serves its intended purpose is critical for medical device manufacturers, as it could have a great impact on a person’s health- for that matter even life. You can still manage your tasks if your internet modem is not working as it should be, but can you manage to breathe if your inhaler is insufficient to provide you the medication when you are already struggling to breathe. The worst scenario here could be a risk to your life, which is not acceptable at all.

Credit goes to the technology advancements, the medical industry has better and improved solutions to sustain lives and offer quality care like never before. When a nonconformance is identified in a medical device, it needs urgent attention. You need to investigate its root cause, resolve the issue as soon as possible, and most importantly, prevent its recurrence in the near future. You must have an effective CAPA process or CAPA management software to ensure timely correction or prevention of the product issues that may have frightening consequences.
Continue Reading >>

In the era of digitization, every industry is experiencing transformations more than they ever expected including the highly regulated industries including healthcare and lifecsiences. It cannot be denied that such industries need to adopt the next-generation quality management systems to assist the critical quality processes and procedures since customers are aware and concerned for quality products more than ever. Attaining quality is not important with respect to customer expectations, but also to comply with the compliance and regulatory requirements.

Continue Reading >>

In the quality domain, it’s a common belief that sooner a nonconformance gets identified and resolved, lesser will be its impact. The advent of technology and cloud-based solution for quality management have made this belief even more actionable. The quality professionals can now have deeper insights and can make informed decisions with the use of closed-loop quality management system.

Especially when the next-generation solutions are making their way at such a faster pace – from designing, manufacturing, distribution, and marketing – industry leaders prefer to bring together the prominent data resources and systems that can form a closed-loop quality process between the key processes and the teams.

With such closed-loop processes, you can facilitate improvements in the existing quality management system for driving continuous improvement while reducing the overall quality issues and costs. Let’s first understand the term quality management system and closed-loop quality management in detail before moving to the discussion on its significance.
Continue Reading >>

With the increasing popularity of analytics and big data, business owners are becoming aware of the significant role that data management plays for an organization. Credit goes to factors like forecasting customer expectations, product management, availability, improved customer services, and competitor’s analysis, data quality management is a critical function for any organization.

One important condition applicable here is that the data should be complete, accurate, and consistent to help businesses make informed decisions. It won’t be wrong to say that modern businesses cannot afford to ignore data quality management.
Continue Reading >>

CAPA is often the most discussed topic among all the aspects of the closed-loop quality management system due to the critical role it plays.  Still, companies face difficulty in implementing it right and feel frightened by the thoughts of regulatory audits. Such difficulties often come as a surprise in the highly advanced technological era when companies have access to cutting-edge CAPA management software.

In fact, the CAPA process is becoming one of the challenging aspects for the organizations as the time passes by and the regulatory standards getting stringent. This results in immense pressure on the companies to follow best practices, which further leads to certain mistakes that they don’t even realize.
Continue Reading >>

Lifesciences industry is undergoing a huge digital transformation wherein they are adopting newer and smarter technologies for attaining operational excellence. The best thing about the digital transformation is the evolution of quality management solution for the Lifesciences industry that serves the intended purpose of improving product and process quality quite effectively.

However, there are still many Lifesciences companies struggling with quality management and manufacturing challenges. Let’s have a deeper understanding of the challenges before discussing their resolution.
Continue Reading >>