A Guide to Quality Objectives
Driving continuous improvement in your organization wouldn’t be possible unless you have set some quality objectives. Even ISO 9001:2000 requires an organization to identify and document its quality objectives before heading to process-level improvem...
Transforming Automotive Industry with Quality Standards
Whether you call them complicated or the basic guidelines, quality standards are critical for every industry to ensure that they are meeting the minimum requirements. However, these requirements may not always fulfill customer expectations that are g...
Here’s a List of Must-Follow Regulations for Nutraceuticals
The quality and compliance standards are continuously getting stringent for every industry including nutraceuticals. They are not as regulated as the drugs are. They rather fall under different food categories. However, you may find different legal d...
7 Common Challenges in Manufacturing Industries
The continuous evolution of technology has led to many innovations and revolutions for the manufacturing industry including the most talked-about one i.e. Industry 4.0. The era of digitization has brought so many exciting changes for the manufacturin...
Quality Management System vs. Total Quality Management
The increased emphasis on “Quality” has made it mandatory for organizations to have a structured, streamlined, and standardized quality management system that can help them manage all the quality processes while mitigating operational risks. However,...
Why You Need a Document Change Control Software for QMS?
Any organization to comply with statuary requirements requires a regulated process for document change control especially the ones that belong to the pharmaceutical and medical device industry. These industries need a strategic approach to manage the...
A Quick Overview of ISO 19011:2018 Audit Management Guidelines
Audit Management Systems are vital for organizations to maintain a culture of continuous improvement while achieving business objectives. There has been a recent upgrade made to the ISO 19011:2018 Guidelines for Audit Management Systems to help organ...
What are the External Factors that affect Quality Management?
From regulatory requirements to global market shifts, several external factors impact quality management. In this blog, we uncover the key challenges businesses face and how they can develop proactive strategies to maintain high-quality standards. Re...
5 Essential Components of Quality Improvement in HealthCare
Quality Improvement is one of the challenging and complex aspects for the healthcare industry that focusses on improving the patient experience since they need to align the industry changes with the different levels and processes of their organizatio...
What is Document Control? How an EDMS helps you with it?
Before winning the confidence of your customers, it is very important to win the confidence of your employees that the information they are referring to is accurate, appropriate, and adheres to regulatory standards. If they will not be sure about the...
8 Disciplines of Problem Solving for Improved Product Quality
For manufacturers, it is quite common to encounter quality issues in products and services repeatedly. This may result in numerous problems. Some of them can be directly reported by customers while some may be identified by an internal audit team. In...
Implement a Successful CAPA System in 4 Steps
Having a well-structured and organized corrective action and preventive action system is vital for any organization to support its improvement activities while meeting compliance and quality requirements. But, it’s no less than a challenge to establi...
Supplier Quality Management Strategies
The manufacturing industry has witnessed a massive change due to continuously evolving regulatory requirements and complex operational structures. They need to develop quality supply chains throughout the business to attain the goal of customer satis...
Two Faces of Manufacturing Quality Problems
Delivering quality is the most important business objective for any manufacturing firm. If you have a great product but fail to maintain quality and face quality problems consistently, you are likely to lose success to your competitors’ hand. Any bus...
Know How Auditing Suppliers Help to Grow Your Business
Maintaining supplier relationships has become more critical than ever. Though an organization depends on suppliers for the production, it doesn’t mean that all the flaws in the supplier processes should be ignored. There should be stringent processes...
Using Quality Metrics to Improve QMS Strategy and Processes
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 q...
Effective Communication's Role in Change Management Process
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 busin...
Nonconformance VS Noncompliance: A Brief Guide
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 betwe...
Learn how employee training impacts workplace productivity
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 employeesfor better Workplace Productivity. As they say, the...
Product-Centric Quality Approach for Improved CAPA Processes
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 ...
9 Significant Reasons You Need eQMS instead of QMS
In the era of digitization, every industry is experiencing transformations more than they ever expected including the highly regulated industries including manufacturing, healthcare and lifesciences. It cannot be denied that such industries need to a...
What is Closed Loop Quality Management System?
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...
What is Data Quality Management? Why is it important?
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, av...
Five Common CAPA Mistakes Companies Need to Avoid
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 a...
Address Quality & Manufacturing Challenges in Life Sciences
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 so...
9 Tips for an Effective Supplier Strategy for Combo Products
With the evolution of the combination products developed by medical device manufacturers and pharmaceutical companies in partnership, the need for a robust quality management system is accelerated. In an effort to improve health and safety for the pa...
Change Management: Mastering the Art of Subtle Transitions
The ever-growing and evolving business world, an organization needs to cope with the technological advancements and changes to be successful. More you will be your adaptability; higher will be the chances of success. Hence, managing change has become...
Electronic Signatures: Modern Quality Document Verification
As organizations are going paperless with the adoption of electronic document management systems and record-keeping, the next natural evolution for them is electronic signatures. The norm of digital signatures has offered companies a secure way to ve...
What are the Challenges in Managing Medical Device Records
The medical device industry has witnessed tremendous growth in the past 10-20 years – in terms of revenues as well as the technical complexities of the product. There have been technological evolutions too in the medical device industry, but healthca...
7 Reasons: It’s Time for Cloud-Driven QMS
Organizations need effective EQMS to manage their quality management processes efficiently while mitigating compliance and operative risks. A quality management solution ensures you have streamlined processes to maintain a balanced structure and achi...
