In today’s rapidly evolving industrial landscape, the emergence of Industry 4.0 has revolutionized manufacturing processes, paving the way for a new era of intelligent and interconnected production systems. At the heart of this transformation lies the integration of advanced technologies, data-driven decision-making, and automation to create what is known as smart manufacturing. As companies strive to stay competitive and meet ever-increasing customer demands, the focus on quality management has become paramount. To ensure superior product quality and streamline operations, manufacturers are now turning to automated quality management (AQM) systems, a key enabler in their journey towards Industry 4.0.

In addition to reading, you can watch this blog about Automated Quality Management too!

In this article, we explore the crucial role of automated quality management within the context of smart manufacturing. We will discuss the following points. Click on any point to jump to the section.

Discussion Points

I. Introduction
A. Definition and overview of Industry 4.0
B. Importance of automated quality management in smart manufacturing

II. The Key Elements of Industry 4.0
A. IoT and connectivity
B. Cyber-physical systems
C. Cloud computing and big data analytics
D. Artificial intelligence and machine learning

III. The Significance of Automated Quality Management in Smart Manufacturing
A. Real-time monitoring and control
B. CAPA for Quality Improvement
C. Data-driven decision-making and continuous improvement
D. Cost reduction and operational efficiency

IV. Implementing Automated Quality Management Systems in Smart Manufacturing
A. Connectivity and network infrastructure
B. Choosing the right software and tools
C. Training and upskilling the workforce

V. Challenges and Considerations in Implementing Automated Quality Management
A. Ensuring data security and privacy
B. Integration with existing systems and infrastructure
C. Overcoming resistance to change

VI. Case Studies and Success Stories
A. Real-world examples of companies implementing automated quality management in smart manufacturing
B. Demonstrating the benefits and outcomes achieved
C. Lessons learned and best practices

VII. Future Trends and Outlook
A. Emerging technologies in automated quality management
B. Integration of automated quality management with other Industry 4.0 technologies
C. Anticipated advancements and opportunities

VIII. Conclusion
A. Recap of the role of automated quality management in smart manufacturing
B. Benefits for manufacturers and the industry as a whole
C. Importance of embracing automation for quality control in the Industry 4.0 era

I. Introduction

A. Definition and Overview of Industry 4.0

The term “Industry 4.0” refers to the fourth industrial revolution, characterized by the integration of digital technologies into manufacturing processes to create smart and interconnected factories. It encompasses a wide range of advanced technologies and concepts that are reshaping the manufacturing landscape. Industry 4.0 leverages automation, data exchange, and real-time analytics to enable smarter and more efficient production systems.

B. Importance of Automated Quality Management in Smart Manufacturing

Furthermore, automated quality management plays a crucial role in successfully implementing Industry 4.0 principles in manufacturing. As production processes become increasingly complex and interconnected, the challenge of maintaining high-quality standards throughout the entire manufacturing lifecycle intensifies. AQM systems actively enable manufacturers to monitor and control quality parameters in real-time, guaranteeing that products meet stringent quality requirements. By leveraging advanced technologies such as IoT, data analytics, and artificial intelligence, AQM not only enhances quality control practices but also drives continuous improvement, ultimately contributing to the success of smart manufacturing initiatives.

II. The Key Elements of Industry 4.0

A. IoT and Connectivity

One of the key elements of Industry 4.0 is the Internet of Things (IoT) and connectivity. By actively enabling the interconnection of various devices, sensors, and systems within the manufacturing environment, IoT plays a vital role in facilitating seamless data exchange. This connectivity further enables real-time monitoring of production processes and quality parameters. IoT devices actively collect and transmit data, offering valuable insights into the performance, condition, and quality of machines and products. By integrating automated quality management with IoT, manufacturers can achieve enhanced visibility, control, and optimization of quality-related processes.

B. Cyber-Physical Systems

Cyber-physical systems (CPS) are an essential component of Industry 4.0. CPS combines physical machinery and equipment with digital technologies, allowing the physical and virtual worlds to interact seamlessly. In the context of automated quality management, CPS enables the integration of quality control systems with the production infrastructure. Real-time data from sensors, machines, and production lines are collected, analyzed, and used to make informed decisions and take immediate action to ensure product quality. By leveraging CPS, manufacturers can achieve tighter integration between quality management processes and the physical manufacturing environment.

C. Cloud Computing and Big Data Analytics

Industry 4.0 leverages cloud computing and big data analytics to handle the massive amounts of data generated within smart manufacturing environments. Cloud computing provides scalable storage and computing capabilities, enabling manufacturers to store and process large volumes of quality-related data. Additionally, big data analytics techniques are then applied to extract meaningful insights from this data, uncovering patterns, trends, and correlations related to product quality. By analyzing historical and real-time quality data, manufacturers can identify potential quality issues, optimize processes, and implement preventive measures to ensure consistent product quality.

D. Artificial Intelligence and Machine Learning

Artificial intelligence (AI) and machine learning (ML) technologies play a transformative role in Industry 4.0, including automated quality management. AI and ML algorithms can analyze vast amounts of quality data, identify patterns, and make predictions regarding product quality and process performance. These technologies enable manufacturers to move beyond reactive quality control towards predictive and prescriptive quality management. By continuously learning from quality data, AI-powered systems can provide valuable insights, optimize quality control processes, and even autonomously make decisions and adjustments to ensure optimal product quality.

III. The Significance of Automated Quality Management in Smart Manufacturing

A. Real-time Monitoring and Control

Automated quality management systems enable real-time monitoring and control of quality parameters throughout the manufacturing process. Traditional quality control methods often rely on periodic sampling and testing, which may result in delayed detection of quality issues. But with automated systems, sensors, and data collection devices continuously monitor critical quality variables, providing immediate feedback on process performance and product quality. Real-time monitoring allows for proactive interventions and prompt corrective actions, minimizing the risk of producing defective products or non-compliance with quality standards. By ensuring quality control in real-time, manufacturers can reduce waste, minimize rework, and improve overall production efficiency.

B. CAPA for Quality Improvement

Corrective and Preventive Action (CAPA) is a fundamental component of quality improvement strategies in manufacturing industries. CAPA is a systematic approach used to identify, investigate, and address the root causes of non-conformities or deviations from established quality standards. It aims to correct existing issues and prevent their recurrence, ensuring continuous improvement in product quality, process efficiency, and customer satisfaction. By implementing an effective CAPA system, organizations can proactively identify areas for improvement, mitigate risks, and foster a culture of continuous learning and innovation. CAPA serves as a powerful tool in driving quality improvement initiatives, enabling companies to stay ahead in today’s competitive business landscape.


C. Data-driven Decision-making and Continuous Improvement

Automated quality management systems generate vast amounts of data that can be leveraged for data-driven decision-making and continuous improvement. Through the application of advanced analytics techniques, such as statistical analysis and machine learning algorithms, manufacturers can gain valuable insights into the relationships between process parameters and product quality. By analyzing quality data, manufacturers can identify trends, root causes of defects, and areas for process optimization. These insights enable data-driven decision-making, allowing manufacturers to implement targeted improvements, optimize production processes, and enhance overall quality performance. The continuous improvement becomes a systematic and data-guided process, leading to enhanced product quality, customer satisfaction, and competitiveness.

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D. Cost Reduction and Operational Efficiency

Automated quality management systems contribute to cost reduction and operational efficiency in smart manufacturing. By minimizing quality defects and ensuring compliance with quality standards, manufacturers can reduce scrap, rework, and warranty costs associated with poor-quality products. Real-time monitoring and predictive analytics help optimize production processes, preventing quality issues and reducing the need for costly corrective actions. Additionally, automated systems also enable faster detection and resolution of quality deviations, minimizing production downtime and maximizing equipment utilization. Improved quality control and operational efficiency result in lower production costs, improved resource utilization, and increased overall profitability.

IV. Implementing Automated Quality Management Systems in Smart Manufacturing

A. Connectivity and Network Infrastructure

To support automated quality management systems, a robust and reliable network infrastructure is essential. High-speed connectivity allows for real-time data transmission and seamless integration of quality data with other manufacturing systems. This connectivity enables continuous monitoring, data analysis, and decision-making in real-time. Manufacturers need to invest in a secure and scalable network infrastructure that can handle the increasing volume of data generated by AQM systems.

B. Choosing the Right Software and Tools

Selecting the appropriate software and tools is crucial for the successful implementation of automated quality management systems. Manufacturers should consider software solutions that offer features such as real-time data visualization, data analytics, and predictive modeling capabilities. The software should be compatible with existing manufacturing systems and able to integrate seamlessly with data from various sources. The software should provide open API so that the same can be integrated with any system as required.

C. Training and Upskilling the Workforce

Implementing automated quality management systems requires a skilled and knowledgeable workforce. Manufacturers need to invest in training and upskilling their employees to effectively operate and manage these advanced systems. Training programs should focus on understanding the principles of AQM, data analysis, and system operation. Employees should be familiar with the use of software tools, interpreting quality data, and implementing corrective actions based on real-time insights. Upskilling the workforce ensures that they can leverage the capabilities of AQM systems to drive continuous improvement, enhance product quality, and maximize operational efficiency.

V. Challenges and Considerations in Implementing Automated Quality Management

A. Ensuring Data Security and Privacy

Implementing automated quality management systems brings concerns about data security and privacy. With the collection and analysis of vast amounts of quality data, it becomes crucial to ensure that data is protected from unauthorized access, breaches, or misuse. But manufacturers must establish robust data security measures, including encryption, access controls, and secure data storage. Additionally, compliance with relevant data protection regulations, such as the General Data Protection Regulation (GDPR), is essential to safeguard customer and sensitive manufacturing data.

B. Integration with Existing Systems and Infrastructure

Integrating automated quality management systems with existing manufacturing systems and infrastructure can pose challenges. Compatibility issues, data interoperability, and connectivity between different systems need to be addressed. Hence manufacturers should evaluate their current systems and infrastructure to identify any gaps or limitations that may hinder the successful implementation of automated quality management. Seamless integration ensures the smooth flow of data, real-time insights, and effective coordination among different components of the manufacturing process.

C. Overcoming Resistance to Change

Implementing automated quality management systems often requires changes in processes, roles, and responsibilities, which can be met with resistance from employees. Therefore, some may be hesitant to adopt new technologies or fear that automation will replace their jobs. To overcome resistance, manufacturers need to foster a culture of openness, communication, and collaboration. Providing training and clear explanations of the benefits of AQM can help employees understand the positive impact it can have on their work and the overall organization.

VI. Case Studies and Success Stories

A. Real-world Examples of Companies Implementing Automated Quality Management in Smart Manufacturing

Examining real-world examples of companies that have successfully implemented automated quality management systems in smart manufacturing can provide valuable insights. Case studies can showcase different industries, such as automotive, electronics, or pharmaceuticals, and how they have leveraged automation to improve quality control. These examples can demonstrate the diverse applications of AQM and inspire other manufacturers to adopt similar approaches.

B. Demonstrating the Benefits and Outcomes Achieved

Case studies should highlight the benefits and outcomes achieved through the implementation of automated quality management systems. This can include improvements in product quality, reduced defect rates, increased operational efficiency, cost savings, and enhanced customer satisfaction. Quantifiable metrics and success indicators should be presented to showcase the tangible results obtained by implementing such a system.

C. Lessons Learned and Best Practices

Sharing lessons learned and best practices from successful implementations can guide other manufacturers in their journey toward automated quality management. Case studies should highlight the challenges faced, solutions implemented, and lessons learned throughout the process. This helps manufacturers understand the potential pitfalls, effective strategies, and key considerations for a successful implementation. By sharing best practices, the industry as a whole can benefit from the collective experiences of companies that have embraced AQM in smart manufacturing.

A. Emerging Technologies in Automated Quality Management

The field of automated quality management is constantly evolving, driven by advancements in technology. Emerging technologies such as blockchain, augmented reality (AR), and edge computing are expected to play a significant role in the future of quality management. Blockchain technology can enhance transparency and traceability in supply chains, ensuring the integrity of quality data. AR can provide real-time guidance and visualizations for quality inspections and maintenance activities. Edge computing enables faster data processing and analysis, facilitating real-time decision-making for quality control.

B. Integration of Automated Quality Management with Other Industry 4.0 Technologies

As Industry 4.0 progresses, the integration of automated quality management with other technologies will become increasingly important. Therefore, AQM systems will be seamlessly integrated with other Industry 4.0 technologies such as robotics, additive manufacturing (3D printing), and digital twin simulations. This integration will enable real-time quality control and feedback loops, where data from quality inspections and process monitoring can be fed back into the manufacturing process to make immediate adjustments and improvements. The synergy between these technologies will drive continuous improvement and ensure consistently high-quality products.

C. Anticipated Advancements and Opportunities

The future of automated quality management holds promising advancements and opportunities. Furthermore, advancements in artificial intelligence (AI) and machine learning will enable more sophisticated quality prediction models and anomaly detection algorithms. Therefore, predictive analytics will become more precise and accurate, providing manufacturers with actionable insights for quality improvement. Additionally, the use of robotics and autonomous systems for quality inspections and testing will become more prevalent, reducing human error and enhancing efficiency. Furthermore, the increasing adoption of cloud-based platforms and the Internet of Things (IoT) will enable seamless data sharing, collaboration, and benchmarking across manufacturing ecosystems.

VIII. Conclusion

A. Recap of the Role of Automated Quality Management in Smart Manufacturing

Automated quality management plays a vital role in smart manufacturing, enabling manufacturers to ensure consistent product quality, optimize processes, and meet customer expectations. By leveraging real-time monitoring, predictive analytics, and data-driven decision-making, these systems provide manufacturers with valuable insights into their production processes, enabling them to detect quality deviations early and take immediate corrective actions. The integration of AQM with other Industry 4.0 technologies creates a synergistic effect, facilitating continuous improvement and driving overall manufacturing excellence.

B. Benefits for Manufacturers and the Industry as a Whole

The implementation of automated quality management systems brings numerous benefits to manufacturers and the industry as a whole. Manufacturers can achieve higher levels of product quality, reducing defects and rework while enhancing customer satisfaction. Hence, the ability to make data-driven decisions and optimize production processes based on quality data leads to improved operational efficiency and cost savings. Additionally, these systems contribute to regulatory compliance, traceability, and supply chain transparency. These benefits collectively result in a competitive advantage for manufacturers, enabling them to thrive in the digital age of smart manufacturing.

C. Importance of Embracing Automation for Quality Control in the Industry 4.0 Era

Lastly, as the manufacturing industry continues to embrace Industry 4.0 principles, the importance of embracing automation for quality control becomes paramount. In an increasingly interconnected and data-driven manufacturing landscape, manual and traditional quality control methods become insufficient to meet the demands of speed, accuracy, and traceability. Automated quality management systems provide the necessary capabilities to leverage real-time data, advanced analytics, and predictive models to achieve superior quality control. Therefore, Embracing automation for quality control ensures that manufacturers can remain competitive, deliver high-quality products, and adapt to the evolving needs of the Industry 4.0 era.

The cannabis industry has become a topic of interest due to its potential for growth and profitability. Despite this, recent reports show that the industry is currently experiencing a declining trend. In this article, we will explore the root causes of this decline and discuss potential solutions.

The Slow Growth of the Cannabis Industry

Although several states have legalized the cannabis industry, it has struggled to break into the mainstream market. According to a report by Grand View Research, Inc., the global legal marijuana market size was valued at USD 6.3 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 25.4% from 2023 to 2030. One of the major barriers to entry for the cannabis industry is the banking restrictions and taxation issues it faces. Although some states have legalized marijuana, the federal government still considers it illegal. Hence banks are hesitant to work with them due to the risk of prosecution from federal authorities. This has made it difficult for businesses in the industry to secure financing.

Legal Marijuana Market Size

Image source: Grand View Research


The Legal Battle Between the Cannabis Industry and the Government

The legal battle between the cannabis industry and the government is ongoing. The government has attempted to shut down businesses in states where marijuana has been legalized. But they have been unsuccessful due to a lack of resources and support from other politicians.

A report by the National Cannabis Industry Association shows that the industry created over 321,000 full-time jobs in the US in 2020, despite being illegal under federal law. This highlights the potential for growth in the industry.

However, the lack of a cohesive federal policy for cannabis underscores the need for clearer regulations and guidelines. This could help ensure the long-term sustainability of the industry and its continued growth.

Legality of cannabis in USA

Image Source: Wikipedia


The Small Size of the Cannabis Industry

New Frontier Data’s report projects that the legal marijuana market in the US will reach USD 35.1 billion by 2025. This indicates that the cannabis industry is still relatively small when compared to other sectors.  On the other hand, Deloitte’s report suggests that the global pharmaceutical industry may reach USD 1.5 trillion by 2025, indicating a significant gap between the two industries.

The Need for an Overarching Federal Policy for Cannabis

The creation of an overarching federal policy for cannabis would be integral to the industry’s future success. Having a clear framework for the industry is crucial for promoting growth and innovation among all businesses and consumers. This would ensure that everyone is operating under the same rules and regulations. The Brookings Institution’s report highlights that a federal policy for cannabis would also help to address social justice issues related to drug policy. These include mass incarceration and racial disparities in drug arrests.

The Current State of the Cannabis Industry and the Economic Turmoil

The cannabis industry is currently experiencing a declining trend, with growth rates lower than expected. BDSA’s report indicates that the global cannabis market growth for 2021 is expected to be 25%, which is lower than the previous estimate of 38%. Several factors have contributed to this, including banking restrictions and taxation issues, legal disputes between the industry and the government, and the industry’s small size. However, with more states legalizing the use of marijuana, there is still hope for the industry’s growth potential. Companies like ATG Pharma are working to overcome these challenges and drive innovation in the cannabis industry.

Potential Solutions for Cannabis Industry Manufacturers

  1. Diversify Products: Manufacturers can diversify their product lines beyond just marijuana buds or edibles. They can consider developing products that use cannabis extracts such as oils, tinctures, and topicals. This can help expand the market and attract new consumers who may not be interested in traditional cannabis products.
  2. Improve Quality: One way to stand out in a crowded market is by producing high-quality products. Manufacturers can invest in better-growing practices, better packaging, and better testing procedures to ensure consistent quality. It is also important to have cannabis quality management software in place to make sure you are following all the right practices and do not deviate from government regulations.
  3. Process Optimization: Try to optimize your processes. There are a lot of systems that can reduce your workload and improve efficiency through automation. For e.g., companies like ATG Pharma can automate the filling, packaging, and labeling of finished products with RoboCAP.
  4. Educate the Public: There is still a lot of misinformation and stigma surrounding cannabis. Manufacturers can help combat this by educating the public about the benefits of cannabis and how to use it safely and responsibly. This can be done through advertising campaigns, educational materials, and community outreach programs.
  5. Advocate for Change: Manufacturers can advocate for changes to federal law to remove banking restrictions and taxation issues that are currently hindering the industry’s growth. They can also support efforts to promote social justice and equity in drug policy.
  6. Focus on Research and Development: The cannabis industry is still in its early stages, and there is a lot of potential for innovation. Manufacturers can invest in R&D to develop new products, new delivery methods, and new strains that appeal to a wider audience.


The cannabis industry can be a significant contributor to the global economy and society. Despite facing challenges like banking restrictions, legal battles, and small market size, it has created numerous jobs and shown promising results in medical research. As we move forward, it is essential to focus on the industry’s potential and promote responsible use, investment in research, and smart regulations to ensure its promise as a driver of economic growth, medical innovation, and social progress. With more states legalizing the use of marijuana, there is still tremendous growth potential for the industry.

Moving forward, we should focus on the potential of the cannabis industry and its positive impact on individuals and society. To achieve this, we need to promote responsible use, invest in research, and implement smart regulations. These measures will help ensure that the cannabis industry fulfills its promise as a driver of economic growth, medical innovation, and social progress.

Software as a medical device (SaMD) refers to software designed for medical purposes. These can include mobile apps, clinical decision support systems, and medical image analysis software, among others. To ensure the safety and efficacy of Software as a medical device (SaMD), government agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) require that SaMD undergoes a clinical evaluation.

We have written a detailed blog on SaMD that discusses the eligibility, origin, classification, expected growth, and many other aspects of Software as a Medical Device.

But in this blog, we will discuss a very specific topic of SaMD. Here we will analyze all aspects of Software as a medical device (SaMD) clinical evaluation.

In addition to reading, you can watch this blog about Software as a medical device clinical evaluation too!

FDA released a guidance document on this subject back in 2017, please check it here.

Clinical evaluation is the process of assessing the clinical performance and safety of SaMD. Basically, it involves identifying the intended use of the software, determining the clinical benefits and risks associated with the software, and conducting clinical studies to evaluate the performance of the software in a clinical setting.

The Importance of Software as a medical device (SaMD) clinical evaluation

Clinical evaluation is crucial for ensuring that SaMD is safe and effective. By evaluating the clinical performance and potential risks of SaMD, clinical evaluation helps to protect patients. Additionally, it ensures that the patients receive the best possible care.

Clinical evaluation is also important for gaining regulatory approval. SaMD must obtain regulatory approval from agencies like the FDA and EMA before healthcare providers buy it. The regulatory approval process includes clinical evaluation, which is a crucial component of demonstrating the safety and efficacy of the software.

Three important components of SaMD clinical evaluation

Basically, the Clinical Evaluation of SaMD has mainly three key components. They are,

3 components of SaMD clinical evaluation

Valid clinical association

Does your SaMD output have a valid clinical association with the targeted clinical condition of your SaMD?

Analytical Validation

Can your SaMD process input data accurately, reliably, and precisely to generate output data?

Clinical Validation

Can your intended purpose for the target population in the context of clinical care be achieved through the use of your SaMD’s accurate, reliable, and precise output data?


Steps Involved in Software as a medical device (SaMD) clinical evaluation

Furthermore, there are several steps in SaMD clinical evaluation:


Steps Involved in Software as a medical device (SaMD) clinical evaluation

Identify the intended use of the SaMD

The first step in SaMD clinical evaluation is to identify the intended use of the software. This involves defining the medical condition that the software is intended to diagnose, treat, or prevent, as well as the patient population for which the software is intended.

Identify the clinical benefits of the SaMD

The next step is to identify the clinical benefits of the SaMD. This involves determining how the software will improve clinical outcomes. Some examples would be, improving patient outcomes, reducing the risk of adverse events, or increasing efficiency in the clinical setting.

Identify the risks associated with the SaMD

The third step is to identify the risks associated with the SaMD. This involves assessing the potential risks associated with the use of the software. Some examples would be, misdiagnosis, inaccurate data analysis, or incorrect treatment recommendations.

Define the clinical evaluation plan

After identifying the intended use, clinical benefits, and risks associated with the SaMD, the next step is to define the clinical evaluation plan. The plan outlines the methodology for evaluating the clinical performance of the software and identifying any potential risks.

Conduct clinical studies

The next step is to conduct clinical studies to evaluate the clinical performance of the SaMD. The type and size of the study will depend on the intended use of the software, the clinical benefits and risks, and the regulatory requirements.

Analyze the results

The final step is to analyze the results of the clinical studies. Comparing the clinical performance of the software to the intended use, clinical benefits, and risks outlined in the clinical evaluation plan is essential. After conducting the comparison, the analysis results are then utilized to determine if the software is safe and effective for use in clinical settings. The analysis results are also used to assess whether the software meets the regulatory requirements for marketing and sale.


SaMD is an important and growing area of medical technology, with the potential to revolutionize healthcare delivery. However, we must subject SaMD to rigorous clinical evaluation to ensure that it is safe and effective. Clinical evaluation is a crucial component of the regulatory approval process for SaMD. It involves identifying the intended use, clinical benefits, and risks of the software. Clinical studies are conducted to evaluate the performance of the software. The objective of clinical evaluation is to ensure that SaMD is safe and effective. The evaluation process helps to protect patients and improve the quality of healthcare delivery.

“If it’s not documented, it didn’t happen” – Urban legend.

If it's not documented, it didn't happen meme - meme


Documentation is crucial when it comes to running a business. It’s the lifeblood of a quality management system (QMS). If you lack an efficient document management strategy, you won’t be able to achieve several crucial QMS capabilities. These include maintaining up-to-date and accessible records, enforcing consistent procedures throughout the organization, and verifying the implementation of corrective actions when required.


In addition to reading, you can watch this blog too!


The importance of document management

So, why is document management so important? First and foremost, if it isn’t documented, it didn’t happen! Documentation is an important element of guaranteeing quality in your organization and the QMS.  If you do not document your procedures, it becomes difficult to find holes in the system or identify opportunities for improvement. What you can’t measure, you can’t improve!

Document management is also essential for maintaining the quality of your business operations. It’s not just about keeping papers; it’s about making sure those documents are easily and quickly accessible when you need them. This is where the correct software comes in, keeping track of all your papers in one place and making them more accessible than before.

  1. According to a survey conducted by IDC, poor document management can cost companies up to 30% of their revenue annually.
  2. In a study by the Association for Information and Image Management (AIIM), 25% of respondents reported that poor document management practices led to a loss of business.
  3. A report by the Aberdeen Group found that companies with poor document management practices experience a 25% longer time to market and a 20% longer sales cycle compared to those with best-in-class document management practices.
  4. PricewaterhouseCoopers (PwC) estimated in a report that 21.3% of all productivity loss in the workplace is due to poor documentation practices.

Document management as part of the QMS framework

Document management is an important component of the QMS framework for guaranteeing quality, compliance, traceability, and efficiency. A well-organized document management software helps you to record information about your operations and guarantees that this expertise is not lost when employees leave or change jobs. ISO 9001:2015 mentions the documentation requirement again and again in multiple clauses. To know in detail, do check this PDF published by ISO.

Document management is critical in ensuring the quality of your business processes

Documentation plays a vital role in ensuring the proper execution of personnel training, retention, and development activities. It also helps teams to document and share best practices between departments and businesses, leading to greater efficiency and effectiveness.

During audits, it’s crucial to remember that if it’s not documented, it didn’t happen. Auditors require appropriate documentation relating to audit trails, actions taken, approval matrix, and specific process training. Such documentation will validate the effectiveness of your QMS, ensure regulatory compliance, and identify areas for improvement.

Managing all these requirements can be challenging with a paper-based QMS, which is why a cloud-based QMS is of high significance.

The auditors would want to see the audit trails.


A documented approval matrix is crucial.


A snapshot as well as deep diving capability in the training module are essential.




Finally, we cannot overemphasize the significance of document management. It is a critical component of any QMS, since it ensures the quality and integrity of your business processes at all times. So, if you haven’t taken document management seriously, now is the moment. By utilizing the right tools and methodology, you have the ability to streamline your documentation process and improve compliance. This can help ensure that your organization runs smoothly and efficiently.

However, if your documentation is lacking, auditors may begin to question the effectiveness of your QMS. This could lead to compliance issues and negative repercussions for your business.

In today’s complicated and highly regulated business environment, companies need a solid regulatory strategy. The regulatory strategy is a blueprint for how a firm will adhere to the rules and laws that control its business. Developing a regulatory strategy involves recognizing possible risks and creating countermeasures to those risks. The regulatory strategy also involves maintaining regulatory compliance and fostering a compliance culture inside the firm.

This article will cover all that you need to know about regulatory strategy.

In addition to reading, you can watch this blog about regulatory strategy too!

Prerequisites for developing a regulatory strategy

The following are some requirements for creating a regulatory strategy:

  1. Recognizing the regulatory environment: It’s critical to comprehend the regulations that are relevant to your product or service. Part of this involves understanding the regulatory structure, rules, and requirements that you must adhere to in order to receive regulatory clearance.
  2. Product or service knowledge: To create a successful regulatory strategy, you require a detailed grasp of the product or service. Knowing the product’s intended application, target market, and potential dangers and advantages is part of this.
  3. Regulatory knowledge: Regulatory knowledge is essential for managing the challenging regulatory environment.  It’s crucial to have a team with the required regulatory experience, including legal counsel and regulatory affairs professionals.
  4. Identification of potential regulatory obstacles: In order to create a plan to get around them, it is crucial to identify potential regulatory obstacles as early in the process as possible. Understanding possible difficulties with product development, clinical testing, and regulatory filings falls under this category.
  5. Communication plan:  To guarantee that you inform all stakeholders about the regulatory policy and its development, you need an efficient communication strategy. Communication with regulatory bodies, investors, and other significant stakeholders is part of this.
  6. Budget and resources: Developing a regulatory plan calls for an acceptable budget. It also requires resource allocation to ensure that all required procedures are done to get regulatory clearance.


Steps for developing a regulatory strategy

Below, we discuss all the steps for developing a regulatory strategy.

Identify Relevant Regulations

Finding the rules that relate to your organization is the first step in creating a regulatory plan. Federal, state, and local rules and regulations may be included in this.

For instance, if you work in the healthcare sector, you might have to abide by HIPAAFDA, and OSHA rules. If you work in the financial services sector, you might have to abide by SEC, FINRA, and CFTC rules.

Assess Regulatory Risk

After identifying the pertinent regulations, assessing regulatory risk comes next. The danger of not complying with the relevant regulations is known as regulatory risk. Therefore, it is crucial to recognize possible risks and assess their possibility and potential effects on the company. To do this, it entails looking into present practices, rules, and procedures to find areas of non-compliance and evaluating how it might affect the company’s operations. Moreover, prioritizing risks according to how they could affect the company’s operations is essential.

Develop a Compliance Program

The next stage is to create a compliance program after you have determined the pertinent legislation and evaluated regulatory risk. A compliance program is a collection of guidelines, processes, and checks. The purpose of the compliance program is to make sure a business complies with all relevant rules and laws. To guarantee efficacy, you should routinely evaluate the compliance program. You should also revise the compliance program to reflect the unique risks that you have identified.

Establish a Culture of Compliance

Establishing a compliance culture inside the firm is crucial, too.  This entails fostering a culture in which compliance is everyone’s responsibility and is treated as a top priority. This entails regularly educating and training staff on regulatory obligations. It also involves ensuring that they appreciate the value of compliance. Additionally, it involves putting in place a procedure for reporting possible compliance problems.

Role of quality management software for developing a regulatory strategy

Using quality management software (QMS) effectively may help a business create a regulatory plan. Firstly, QMS systems may aid in ensuring that a business’s goods and services are of a high calibre and satisfy consumers’ wants, as well as the regulatory requirements of the sector. In addition, companies may manage the procedure for submitting regulatory filings and supporting paperwork to regulatory agencies with the use of QMS. This might entail monitoring the progress of submissions, making sure that all required supporting materials are included, and ensuring that submissions are done on time.

Furthermore, QMS can assist businesses in tracking their long-term regulatory compliance. By monitoring key performance indicators (KPIs) pertaining to quality and legal compliance, businesses can pinpoint areas that need improvement. You can use this data to create a comprehensive regulatory plan that addresses areas of non-compliance and identifies opportunities for improvement.

Ultimately, the function of quality management software in creating a regulatory plan is to assist in making sure that a company’s goods and services are of high quality and satisfy client expectations while also meeting regulatory criteria. By prioritizing regulatory compliance and utilizing QMS effectively, businesses can maintain a competitive edge in the market while avoiding costly legal repercussions.


In conclusion, all corporate operations must have a regulatory plan. It entails locating pertinent rules, evaluating regulatory risk, creating a compliance program, and fostering a compliance culture inside the company. A thoughtful regulatory plan may reduce regulatory risk, safeguard the business’s brand, and guarantee long success. Companies may create a strong regulatory strategy that will aid them in navigating the complicated and dynamic regulatory landscape by using the strategies indicated in this article.

The significance of cannabis quality control and assurance cannot be over-emphasized, especially for large-scale cannabis firms. Failure to comply with quality assurance testing can have serious repercussions. These repercussions include product recalls or seizures due to contamination or inappropriate pesticide application. Such incidents not only endanger customers, but may also result in significant financial losses for business owners. Furthermore, they can jeopardize their reputation and consumer trust.

In addition to reading, you can watch this blog about Cannabis Quality Control too!

Why cannabis quality control is important

As the demand for high-potency THC grows, cannabis farmers are depending on testing laboratories more than ever. Given the possibility of pesticide reporting mistakes, it is critical to assure accurate findings. Additionally, profit-driven lab methods emphasize income over consumer health. Therefore, it is also critical to educate customers to ensure their awareness and understanding.

Testing laboratories must set a level of quality while serving their consumers, regardless of the less-than-ethical, yet enticing options.

  1. In a study researchers tested 20 different cannabis samples from dispensaries in California and found that 90% of the samples contained pesticides, fungicides, or other contaminants.
  2. In another study researchers found that over 80% of CBD products tested contained either more or less CBD than advertised, with some products containing no CBD at all.

Cannabis Quality Control Testing

In cannabis quality control testing, you carry out a series of tests and inspections at different stages of the production process.

Some of the most common tests include:

  1. Microbial testing: This involves testing for the presence of bacteria, fungi, and other microorganisms that can cause infections.
  2. Pesticide testing: This involves testing for the presence of pesticides and other chemicals that may have been used during the cultivation process.
  3. Heavy metal testing: This involves testing for the presence of heavy metals such as lead and arsenic, which can be harmful to human health.
  4. Potency testing: This involves testing the levels of cannabinoids such as THC and CBD in the product to ensure that it is consistent with the label claims.
  5. Residual solvent testing: This involves testing for the presence of solvents such as butane that may have been used during the extraction process.

Quality management system  for cannabis quality control

Quality management systems are an essential component of any cannabis company’s operations, embedding quality assurance as an instinctive organizational norm. Companies must regulate cannabis products, like other consumables such as food and water, to protect customer safety.

Cannabis businesses with quality management processes can immediately detect potential problems. They can then take remedial action to avoid costly mistakes or product recalls. This is important for maintaining the quality of their products and protecting their reputation.

Quality management systems are critical for getting an advantage over competitors in a business as competitive as cannabis. Especially with the possibility of federal regulation looming in the not-so-distant future. Investing in quality control is not simply another expenditure.  Implementing this eventually enhances corporate profitability. It also serves as a critical investment for the company. Such an investment can provide benefits even in a federally regulated environment.

Creating cannabis quality control methods

Creating quality control methods for cannabis goods is crucial. It ensures that the company’s quality control process is as automated, efficient, and consistent as feasible. You should consider the following points before designing the method.

  • While developing QA SOPs, it is critical to consider state requirements, current corporate SOPs, and working with well-established and trustworthy laboratories.
  • It is also critical to use resources to automate and improve QA operations, from document management to tracking shipments and recording problems.

Implementing cannabis quality control measures requires a systematic approach. The following steps can help guide the process:

  1. Establish quality control standards – The first step is to establish quality control standards that are consistent with local regulations.
  2. Conduct risk assessments – Conducting risk assessments can help identify potential hazards and risks associated with the production process.
  3. Develop standard operating procedures – Develop standard operating procedures (SOPs) that outline the steps involved in the production process and the quality control measures you need to implement.
  4. Train employees – Training employees on the SOPs and quality control measures are essential to ensure that they follow them consistently.
  5. Conduct regular audits – Conduct regular audits to ensure that you follow the quality control measures and to identify areas for improvement.

Implementing the cannabis quality control process

Firms that use ERP and quality management software to handle compliance and business operations may integrate cannabis quality control into the whole compliance process. It is vital to manage a seamless operation by utilizing a cannabis quality management software system. This system may assist in automating procedures, recording problems, monitoring, and tracking data. Taking stock of the compliance process is the first stage in preparing the organization for QC success. This step involves enhancing compliance practices, optimizing QC procedures, and aligning them to operate as an extension of the existing compliance process.

When integrating the QC process with compliance standards, it is critical to learn from different sectors. It is also essential to determine how to integrate GMP ideas on a scale that is appropriate for the organization.  Elevating the compliance process with QC norms is critical, and it requires us to thoroughly document methods and develop accurate formulae that we can readily copy. Including employees, continuing education in the annual compliance plan is also a high focus. This plan provides an opportunity for staff to review best practices in food safety, product handling, and other areas.

Using quality management software that is GMP validated is also a good idea. Isolocity is a third-party GMP-validated quality management software that specializes in the cannabis industry.

Contact us today to learn more!


Blog Inspiration:


What is a Software as Medical Device (SaMD)?

According to 21 CFR 862 or 866, a SaMD is a software that has received FDA approval as a medical device or as a CLIA-waived device. A SaMD might contain digital tools like electronic health record systems that assist AME workflow procedures like reading patient reports or gaining access to electronic medical records, or mobile applications that allow data sharing.


SaMD – eligibility for software

SaMD includes software that satisfies all three requirements;

  1. It includes particular elements called for by regulatory bodies for safety and efficiency.
  2. In accordance with the necessary rules and regulations, it must undergo testing and certification by an approved agency.
  3. The producer must offer proof that they adhere to these rules.

In addition to reading, you can watch this blog about SaMD too!

The origin of SaMD

HIMSS (Healthcare Information and Management Systems Society) created the term SaMD in 2009. SaMD is a software component of a medical device or system, but it does not meet the criteria of an electronic health record (EHR). SaMD does not collect patient data or provide users access to their own medical information through the app itself. For example, SaMD could be an app that allows users to track their blood pressure over time.

Classifications of Software as a medical device

The IMDRF classified SaMD into three types based on the software’s complexity and potential risk to patients.

  • Type I SaMD is a low-risk software application that has a low probability of harming patients and performs simple functions like fitness tracking apps and apps for managing minor symptoms.
  • Type II SaMD is a moderate-risk software application that is more complex than Type I and has a higher probability of causing harm to the patient if it malfunctions, examples include clinical decision support software, and medical image analysis software.
  • Type III SaMD is a high-risk software application that is the most complex and has the highest probability of causing harm to the patient if it malfunctions, examples include software that controls medical devices and software used for the diagnosis or treatment of serious medical conditions.

SaMD Classifications

It’s important to note that regulatory agencies may have different classification systems for SaMD, but the IMDRF classification is widely recognized.

Expected growth of SaMD

In the upcoming years, the rise of SaMD would continue to pick up speed. From 2021 to 2028, it may expand at a compound annual growth rate (CAGR) of 25.6%. The expanding acceptance of mobile health (mHealth) solutions, the prevalence of chronic illnesses, and the demand for affordable healthcare solutions are some of the drivers that are fueling this rise.

The COVID-19 pandemic contributed to the rise of SaMD. The healthcare sector turned to telemedicine and distant care to lower the risk of infection transmission. The ability to remotely monitor patient health and deliver prompt treatments makes SaMD technologies well-suited for remote care.

Technological improvements, rising patient demand for individualized, patient-centered care, and the need for affordable, effective healthcare solutions will all contribute to the expansion of SaMD. Regulatory difficulties and worries over data privacy are two obstacles, though.

How can I get a software license from the US Food and Drug Administration (FDA)?

The good news for US-based developers is that obtaining a software license from the FDA is not too difficult. What you must do is as follows:

  • Become a maker of electronic medical devices (EMDM). You can do this by submitting a registration form online or by submitting Form FDA 2532a via the Medical Device Reports System of your state (MDR). You should register as soon as possible if your product is already on the market and patients or healthcare professionals are using your product so that no one unintentionally uses it without the FDA’s official permission
  • If your product does not already have an ID number assigned by the FDA, request one.

What documents do I need to apply for a software license from the FDA?

Depending on the kind of medical device you will use with your software, you will require different documentation to apply for a software license with the FDA. For instance, if it’s an implanted device, you’ll need to include details on its design, operation, and safety and efficacy information. You simply need to submit information on the device’s design and function if it’s not an implanted device and doesn’t need pre-market clearance or notice.

Who can apply for a software license from the FDA?

It depends on your circumstances. Small businesses without venture money or other support will very certainly have to submit their licensing applications. If this is not the case and you have access to grants or investments, some businesses can speed up the procedure by doing all of the paperwork and research for you.

Be sure the agency is reliable if you decide to use them rather than doing it yourself. Several frauds out there take advantage of folks who lack knowledge or free time.

How long does it take to get a medical device license?

The FDA issues medical device licenses, which are necessary to commercialize your product in the US. The following factors affect how long it takes to obtain a medical device license:

  1. The kind of device you’re building. For e.g. a Class II medical device is easier to acquire an IDE than a Class III
  2. The advanced clinical study design suggested
  3. Regardless of whether you have previous expertise managing clinical studies utilizing comparable devices or technology

What if my software is considered as SaMD but doesn’t have a software license from the FDA?

If your software is classified as SaMD, but you don’t have a software license from the FDA, you must stop selling it right once to avoid legal repercussions. Before enforcement begins, there could be a grace period. But this can only be ascertained by communicating with the FDA directly.

As SaMDs are considered medical devices, the FDA must authorize their use in customary clinical procedures. You must submit a premarket approval (PMA) application to obtain permission for your SaMD. Your application must contain details about how you created the device and why it is secure and efficient. These data will be examined by the FDA before a decision is made about the approval of your product.


We hope you found this article helpful and informative. Keep an eye on this blog post as we will keep adding more information related to SaMD. For any inquiries, feel free to contact us.

In this blog, we will discuss the importance of leadership in quality management. Additionally, we will also touch upon the types of leadership.

Leadership is essential in quality management because it provides direction, motivation, and guidance to the organization’s quality improvement efforts. Quality management involves ensuring that products or services meet or exceed customer expectations while maximizing efficiency, productivity, and profitability. Effective leadership is critical to achieving these goals and driving continuous improvement.

But before we discuss the importance of leadership in quality management, let’s just talk about the types of leadership.

In addition to reading, you can watch this blog about leadership in quality management too!

Types of leadership in quality management

We have come across this fabulous study and we are inspired by this. As per the study, there are mainly eight types of leadership.

Importance of leadership in quality management - Types of leadership


  1. Reformer: This leader is adaptable to change and creates and designs the changes that the organization requires.
  2. Negotiator: This leader upholds the organization’s external legitimacy and obtains resources; he or she is politically adept, persuasive, and possesses influence and authority.
  3. Builder: This leader is task-oriented and work-focused; exhibits a high degree of enthusiasm, drive, and energy; and motivates followers to embrace responsibility, achieve goals, and remain productive.
  4. Director: This leader has clear expectations for procedures such as planning and goal making, as well as an emphasis on decisions to address issues; chooses alternatives; establishes objectives; defines roles and responsibilities; develops rules and policies; assesses performance; and provides instructions.
  5. Organizer: This leader maintains the structure and the system running; preserves company continuity, reducing disruptions; performs bureaucratic responsibilities; reads and assesses reports; explains budget; creates and organizes plans and proposals.
  6. Monitor: This leader is concerned about knowing the organization’s intentions and if individuals are following the rules and the organization is reaching its goals; is detail-oriented and good at rational analysis and dealing with routine information; addresses problems rationally.
  7. Supporter:  This leader encourages group efforts; fosters cohesion and teamwork; manages interpersonal conflicts; mediates disputes using conflict resolution techniques; and seeks to resolve problems with the team.
  8. Mentor: This leader fosters people’s growth through an empathetic mentoring process; listens actively; supports reasonable claims; expresses gratitude; compliments individuals and provides credit to people for their achievements.


Importance of leadership in quality management

Now let’s discuss the importance of leadership in quality management.

Sets the tone for the organization:

Quality management leaders set the tone for the organization’s culture of quality. Leaders who prioritize quality create a culture of excellence. Additionally, they encourage employees to take ownership of their work and strive for continuous improvement.

Aligns the organization’s goals with customer needs:

Quality management leaders ensure that they align the organization’s goals with customer needs and expectations. Leaders who focus on customers understand what their customers want. Such leaders work to ensure that the organization delivers products and services that meet those needs.

Encourages continuous improvement:

Quality management leaders encourage and promote a culture of continuous improvement. By constantly seeking ways to improve processes, products, and services, leaders ensure that the organization remains competitive and relevant.

Builds trust:

Quality management leaders build trust with their employees and customers by consistently delivering high-quality products and services. This trust is critical to maintaining long-term relationships and loyalty.

Drives innovation:

Quality management leaders promote innovation and creativity by encouraging employees to take risks and try new things. Leaders who are willing to take calculated risks can drive innovation and keep the organization ahead of the competition.

In summary, effective leadership is essential in quality management because it sets the tone for the organization’s culture of quality, aligns the organization’s goals with customer needs, encourages continuous improvement, builds trust, and drives innovation.


Is the leader for quality management expected to be an expert in the field?

The leader of a quality management team must have solid expertise, not absolute knowledge. They should understand quality management principles and collaborate with specialized team members. The leader oversees activities, ensures adherence to standards, and develops improvement strategies. Quality management is multifaceted, so expecting expertise in every aspect is unrealistic. Instead, leaders foster collaboration and leverage team skills. Continuous learning and staying updated are crucial to guide the team effectively. The leader promotes a culture of learning and development to address quality challenges.

In this article, we will discuss and answer the top 20 frequently asked questions about QMS. If you are starting your journey as a quality professional looking forward to grasping all aspects of quality management, you should start with this blog. Here are the 20 questions that we will discuss today. To go to any answer quickly, just click on the question here.

    1. What is QMS?
    2. What are the 7 QMS principles?
    3. What is QMS software?
    4. What does QMS software do?
    5. What are the benefits of QMS in an organization?
    6. What is QMS certificate?
    7. How to get QMS certification?
    8. What is QMS audit?
    9. How to audit the process-based QMS?
    10. How to create a QMS / How to implement a QMS /How to set up a QMS system?
    11. What are the different types of QMS?
    12. What does a QMS consist of?
    13. What does QMS measure?
    14. What is a QMS manual?
    15. What is ISO QMS?
    16. What is QMS training?
    17. What is the difference between ISO and QMS?
    18. What is the difference between TQM and QMS?
    19. What is the structure of quality management system QMS?
    20. Why should your QMS be regularly monitored and evaluated?

1. What is QMS?

QMS (Quality Management System) is a set of procedures, processes, and activities that assist a firm in meeting customer requirements, government regulations, and internal standards. It offers businesses a systematic approach to quality management.

A good QMS assists firms in improving their processes so that they can offer products and services faster and cheaper than their competitors – all while maintaining high levels of customer satisfaction and quality!

2. What are the 7 QMS principles?

  1. Customer focus: All operations and decisions in an organization revolve around the customer.
  2. Employee engagement: Engaged employees are more productive, which can lead to improved revenues for your company.
  3. Leadership: Leaders must instill a culture of continual improvement by remaining open-minded and willing to make changes as needed.
  4. Process approach: Many industries utilize process approaches to increase performance by focusing on specific tasks or activities inside an organization.
  5. Improvement: Assessing performance against key performance indicators (KPIs), setting improvement targets, and monitoring progress, with the information used to promote improvement.
  6. Evidence: An important component of the QMS is evidence-based decision-making. It contributes to increased quality, efficiency, and safety.
  7. Relationship management: Conflicts between employees or supervisors can also harm relationships, affecting productivity and morale in your firm. A good QMS will aid in the prevention of these issues by establishing clear expectations for conflict management.

3. What is QMS software?

QMS software is a piece of software used to automate the quality management system. It can also be used to help in quality management system design, deployment, and management.

QMS software aids in the improvement of product or service quality by offering a centralized platform for controlling all components of your quality system, such as:

4. What does QMS software do?

Following are some of the most common features of QMS software:

  • Document Management: A centralized repository for storing, organizing, and maintaining quality-related documents such as policies, procedures, work instructions, and records. Documents can be kept up to date, managed, and available to authorized individuals using QMS software.
  • Process Management: A system that manages and controls quality-related activities such as nonconformance management, corrective and preventive actions, and internal audits. These operations can be automated using QMS software, which also provides a centralized mechanism for tracking and managing them.
  • Change Management: A system for managing QMS changes such as policy, procedure, or process workflow adjustments. Change management software can automate operations and serve as a central repository for tracking and managing changes.
  • Training Management: A system for managing employee QMS-related training and competencies. Quality management software can provide a centralized system for managing employee training and competency, as well as automating the process of allocating and tracking training requirements.
  • Risk Management: A system for managing and mitigating QMS risks. QMS software can help you identify, assess, and manage risks, as well as track risk-related KPIs.
  • Reporting and Analytics: QMS software can provide reporting and analytics capabilities for measuring and evaluating quality-related data like as nonconformities, corrective and preventive measures, and customer complaints. These technologies can help firms make data-driven decisions by providing insights into areas for improvement.

5. What are the benefits of QMS in an organization?

  • A quality management system can assist firms in staying ahead of the competition by enhancing product quality, efficiency, cost-effectiveness, and customer happiness.
  • A QMS enables an organization to meet customer requirements, comply with legislative or regulatory obligations, and improve business performance.
  • It also contributes to the development of a culture of continuous improvement by facilitating transparency and feedback on process performance. This enables firms to identify holes in their systems and take corrective action before production is halted or items are recalled due to product problems.
  • Another advantage of having a QMS is that it assists businesses in identifying cost-cutting opportunities by reducing waste through efficient material handling, improving utilization rates through better scheduling and batch sizing strategies, and improving employee performance by utilizing Lean concepts such as ‘one piece flow’.

6. What is QMS certificate?

A QMS certificate is proof that you met the requirements of your selected quality management system. The ISO 9001:2015 standard demands you to keep records of your operations and how they contribute to the achievement of your business goals.

Depending on who issues it, the certificate will appear different. But it will contain some basic information about your firm and its products/services, as well as contact information for additional inquiries or questions about their products/services. It may also incorporate trademarks or insignia pertaining to other standards against which they have been certified (for example if they have achieved BS EN ISO 14001 Environmental Management System certification).

There are two ways to obtain an ISO 9001:2015 certificate: through an accredited certification body or directly from a company such as SGS, which performs independent third-party audits.

7. How to get QMS certification?

To obtain the certificate, the organization must undergo a rigorous audit.

It evaluates the organization’s quality management system and determines whether or not the organization meets standards and regulations. Independent third-party auditors who are accredited by the International Standards Organization (ISO) or any other international accreditation body recognized by them perform audits.

After audit completion, the auditor sends the report to the certifying organization, which checks whether or not everything is satisfactory.

The certification body evaluates if the auditors are qualified professionals who can be trusted to do their duties. When they do an audit, it also checks to see if they are independent and objective. The auditor must be licensed by a government agency and accredited by professional organizations such as the International Organization for Standardization (ISO), the Accreditation Board for Engineering and Technology (ABET), and others.

When the certifying body is satisfied, it issues QMS certification and transmits it to the organization.

The firm can now use the QMS certification as proof of ISO 9001:2015 compliance.

8. What is QMS audit?

Quality Management System auditing is the process of determining if a certain organization’s quality management system complies with ISO 9001 criteria. Internal or external auditors can perform this function.

Internal audits are performed by a company employee who will evaluate if there are any gaps between what has been planned and what has been implemented on the ground level, which could result in the improvement of processes or improvements needed to meet customer requirements as well as expectations set by all stakeholders involved with the project execution phase, such as employees working on projects, suppliers providing services/products, and so on.

External audits are conducted by third-party consultants hired specifically for this purpose; they will assess the overall functioning of various departments within organizations using checklists provided by respective regulatory bodies, such as the ISO 17021:2011 standard, from which the majority of checks originate (but not limited).

9. How to audit the process-based QMS?

Auditing is an essential component of quality management systems. Audits assist you in ensuring that your company has satisfied all regulatory criteria, such as ISO 9001 or AS9100 certifications.

To conduct an effective audit, keep the following points in mind:

  • A review of the documentation compiled during the design process for the quality management system. This comprises a review of any documents relating to your QMS (for example, policies and procedures), as well as any supporting paperwork like training materials, results from internal audits, and third-party external audits.
  • An evaluation of your quality system’s actual performance in regard to regulatory requirements or industry standards (if applicable).

10. How to create a QMS / How to implement a QMS /How to set up a QMS system?

Explain the vision and mission of the organization.

The first stage in developing a quality management system is to define the vision, mission, and goals of the firm. This will assist you in developing a plan that is in line with the company’s objectives.

List the strategic goals of the organization.

The first stage in developing a quality management system is to identify the organization’s strategic goals. Strategic objectives are goals and objectives that will assist you in achieving your organization’s vision, purpose, and values. These are often multi-year objectives with precise success measures that may be measured at regular times throughout the year.

Determine the items, services, and customers.

  • Goods and services: Explain the goods and services offered.
  • Customers: Determine who your customer base is and what their demands are by answering questions such as: Who do we serve? What do they expect of us? How might our products or services better address those needs?

List the departments that produce goods or provide services.

The first stage in developing a quality management system is to identify all of the departments that produce goods or provide services. After that, describe their relationship. For example, the customer service department is in charge of dealing with consumer concerns. Finally, describe how each process works from beginning to end and what information is transmitted across departments along the route.

This is your operations map; list all of the procedures used to generate or provide products and services.

Your operations map outlines the steps your company takes to manufacture or distribute goods and services. It should include all of the processes required to generate your product, from beginning to end, including any outsourced steps.

List all of your quality systems.

Include all of your quality systems (policies, procedures) that are employed in these processes, as well as any forms that personnel or departments must complete in order to keep the firm running smoothly (i.e., checklists, forms). This is your quality management system layout.

Demonstrate how the various quality management tools work together to achieve control throughout the process chain – this is your control map.

It’s time to develop your control map when you’ve chosen the tools that are most appropriate for your firm and have a strong knowledge of how they work together.

If you want to know more about the scope of a QMS, we suggest this blog – Scope of quality management system (with PDF template)


11. What are the different types of QMS?

There are various forms of QMS that can be adopted depending on the industry, size, and aims of the business. Some of the most common forms of QMS are as follows:

  • ISO 9001 QMS: This is a standard for implementing a QMS that focuses on achieving customer needs and improving continuously. It is the most extensively used QMS standard in the world.
  • Lean QMS: This method focuses on identifying and removing waste within processes in order to increase efficiency and save costs. It evolved from the Toyota Production System and is widely employed in the manufacturing and service industries.
  • Six Sigma QMS: This methodology uses statistical analysis to detect and eliminate flaws in processes, resulting in higher-quality goods and services. It’s frequently utilized in the manufacturing, healthcare, and finance industries.
  • Agile QMS: This methodology entails frequent feedback and collaboration among team members in order to swiftly react to changing customer demands and expectations. It is widely utilized in the software development and information technology industries.
  • Integrated QMS: This method combines different management systems, such as quality, environment, and health and safety, into a single system to reduce duplication of work and increase efficiency.

12. What does a QMS consist of?

A QMS typically consists of the following components:

  • Quality Policy: A declaration outlining an organization’s commitment to quality as well as its intentions about the quality of its products, services, and procedures.
  • Quality Objectives: Clear, measurable goals that an organization establishes in order to implement its quality policy.
  • Quality Manual: A document that outlines the organization’s quality management system, processes, and quality objectives.
  • Document Control: A method for managing documents like as policies, procedures, work instructions, and records to ensure they are current, correct, and controlled.
  • Training and Competence: Procedures that train personnel and make sure they are competent, and aware of their roles and responsibilities in accomplishing the quality objectives of the organization.
  • Nonconforming Product/Service Control: Procedures for identifying, controlling, and correcting items or services that do not satisfy quality standards.
  • CAPA: Corrective and preventive actions are procedures for identifying, investigating, and correcting the underlying causes of issues and preventing their recurrence.
  • Audits: Audits and reviews are procedures for assessing the efficacy of the QMS and identifying areas for improvement.
  • Continuous improvement: Methods for finding and implementing improvements to the QMS, products, and services.
  • Customer Feedback: Procedures for gathering and acting on customer input in order to increase customer satisfaction.

13. What does QMS measure?

A Quality Management System measures many areas of a company’s quality-related activities to ensure that they are meeting customer expectations and accomplishing their quality goals. A QMS typically includes the following critical measurements:

  • Customer Satisfaction: The degree to which customers are satisfied with the organization’s products or services, as measured by surveys, feedback, and other customer communication channels.
  • Quality Objectives: Specific, measurable goals for accomplishing the organization’s quality policy, such as reducing defects, boosting efficiency, or enhancing customer happiness.
  • Process Performance: The effectiveness and efficiency of an organization’s processes in reaching quality goals, as assessed by measures like cycle time, error rates, and throughput.
  • Product/Service Conformity: The extent to which products or services meet client requirements and specifications, as determined by inspections, testing, and other quality control operations.
  • Nonconformities and Corrective Actions: The quantity and severity of discovered nonconformities, as well as the effectiveness of corrective and preventive activities taken to resolve them.
  • Audit and review findings: The findings and recommendations for improvement from internal and external audits and reviews of the QMS and related procedures.
  • Training and Competence: The effectiveness of training programs and employees’ competency in carrying out their QMS-related duties and obligations.
  • Continual Improvement: The efficacy of the organization’s attempts to enhance its QMS and related processes, as assessed by indicators such as the number of improvement projects, their impact on quality targets, and the effectiveness of the improvement process.

14. What is a QMS manual?

A manual for the Quality Management System is a document that describes the QMS. It’s a reference document. It covers all of your company’s rules and procedures for putting its quality management system into action.

It also serves as system documentation, such as how you’ll implement control measures and monitor them over time, and instructs those who utilize it on how to carry out those operations efficiently.

15. What is ISO QMS?

ISO 9001:2015 is a standard for quality management systems. It is an international standard that sets the standards for a written and implemented system that consistently provides products and services that meet the expectations of consumers, including after-sales support needs while being cost-effective and sustainable.

ISO 9001:2015 offers four major advantages:

  • Increased customer satisfaction as a result of better product or service delivery
  • Improved employee motivation and commitment to meeting high-performance criteria
  • Decreased waste due to less rework or corrective action required on low-quality work (this can be measured using statistics)
  • Decreased costs incurred as a result of process improvements

16. What is QMS training?

QMS training is critical for ensuring that employees understand the value of quality as well as their roles and responsibilities.

  • QMS Overview: An overview of the QMS, including its purpose and components. This training teaches participants about the organization’s quality policy, quality objectives, and processes.
  • Document Control: Instruction on document control processes such as document creation, review, approval, and distribution. This training teaches employees the value of document control in keeping policies, processes, and other documents up to date, correct, and managed.
  • Process Control: Instruction on how to control and manage quality-related processes such as nonconformance management, corrective and preventative actions, and internal audits. This course teaches participants how to identify, report, and correct nonconformities, as well as how to conduct internal audits to verify that procedures are effective and efficient.
  • Quality Tools and Techniques Training: Instruction on the many tools and techniques used to manage quality-related activities, such as statistical process control, root cause analysis, and failure modes and effects analysis. This workshop teaches participants how to utilize these tools to identify and address quality issues.
  • Risk Management: Training on risk management principles and methods, including how to identify, assess, and mitigate risks connected to the QMS. This program teaches participants how to manage risks in order to meet quality objectives.
  • Training on the principles and techniques of continuous improvement, including how to identify and apply changes to the QMS, products, and services. This training teaches staff the need to constantly upgrade the QMS in order to meet client expectations and meet quality targets.

17. What is the difference between ISO and QMS?

  • ISO is a global standard-setting organization that creates and publishes standards for a variety of industries and sectors. On the other hand, QMS is a framework that firms use to manage and improve their quality-related operations.
  • ISO 9001 is a specific ISO standard that gives guidance for implementing a QMS. But QMS is a broader concept that incorporates multiple quality management methods, tools, and techniques.
  • ISO 9001 is concerned with customer satisfaction, continuous improvement, and effective process management. But QMS is concerned with quality-related activities such as document control, corrective and preventive actions, and internal auditing.
  • ISO 9001 is a certification standard that organizations can get by showing conformity with the standard’s standards. But QMS is a management system that organizations can deploy regardless of whether they seek certification to enhance their quality-related activities.

In summary, ISO is a standards development body that creates standards such as ISO 9001, which gives recommendations for implementing a QMS. In contrast, a quality management system is a framework to manage and improve quality-related operations, which may include applying ISO 9001.

18. What is the difference between TQM and QMS?

Organizations utilize Total Quality Management and Quality Management System to improve the quality of their products, services, and processes. There are, however, some significant differences between the two:

  • TQM is a management philosophy that emphasizes continual product, service, and process improvement. On the other hand, QMS is a framework for managing and regulating quality-related processes.
  • Total quality management stresses all employees’ participation in the quality improvement process. But a quality management system focuses on certain quality-related procedures such as document control, corrective and preventive actions, and internal audits.
  • TQM focuses on customer happiness and addressing customer requirements. On the other hand, QMS focuses on meeting quality objectives and adhering to quality standards.
  • Total quality management covers tools and techniques for quality improvement such as statistical process control and root cause analysis. On the other hand, a quality management system contains processes for managing and controlling quality-related activities.
  • TQM is more adaptable to varied company cultures and structures. But QMS is frequently more standardized and focused on quality standard compliance.
  • Total quality management is a larger management concept that emphasizes continuous improvement and the participation of all employees in the quality improvement process. On the other hand, a quality management system is a more particular framework for managing and regulating quality-related procedures.

19. What is the structure of quality management system QMS?

A QMS structure typically includes the following components:

  • Quality Policy: Quality policy is a high-level statement of an organization’s commitment to quality and customer satisfaction.
  • Quality Objectives: Clear, measurable, realistic, relevant, and time-bound targets established by an organization to meet its quality policy.
  • Quality Manual: A document that outlines the quality management system of a company, including its rules, procedures, and processes.
  • Organizational Structure and Responsibilities: A clear explanation of all personnel involved in the QMS’s roles, responsibilities, and authority.
  • Document Control: A system for developing, evaluating, approving, disseminating, and controlling all QMS-related documents.
  • Processes: A collection of interconnected actions that convert inputs into outputs in order to supply goods or services to clients.
  • Risk management:  It is the process of detecting, assessing, and controlling risks to the QMS.
  • Training and Competency: A program that ensures that personnel have the information, skills, and abilities needed to complete their given jobs.
  • Monitoring and measurement: A system for monitoring and measuring the performance of the QMS and the processes it comprises on a regular basis.
  • Continuous improvement: A continuous improvement culture entails creating improvement goals, recognizing possibilities for improvement, executing changes, and monitoring the success of those improvements.

20. Why should your QMS be regularly monitored and evaluated?

  • Ensuring Compliance: Frequent monitoring and evaluation can assist in ensuring that the QMS complies with applicable legislation, standards, and client expectations. Organizations may stay in compliance and avoid costly penalties and other negative repercussions by reviewing and updating their QMS on a regular basis.
  • Finding Opportunities for Improvement: Frequent monitoring and assessment can assist in identifying aspects of the QMS that are not performing optimally and may require improvement. Organizations may improve their operations, increase efficiency, and improve customer happiness by recognizing and addressing these areas.
  • Tracking Performance: Monitoring and evaluation can assist in tracking the performance of the QMS and its separate components over time. Organizations may detect trends and patterns, quantify the success of their improvement efforts, and make data-driven decisions by tracking performance.
  • Enabling Continuous Improvement: A major part of QMS is continuous improvement. Frequent monitoring and evaluation can offer organizations with useful input that they can utilize to continuously improve their QMS and its processes.
  • Improving Customer Satisfaction: A QMS’s ultimate purpose is to assure customer satisfaction. Frequent monitoring and assessment can assist in identifying areas where the QMS falls short of customer expectations and implementing remedial actions to increase customer satisfaction.


You should have a better idea of what a quality management system is and how it works now that you’ve read this article.

These are some crucial considerations to keep in mind:

QMS is not a department; it is a method of managing quality throughout your organization.
QMS is about more than simply products or services. It’s about improving all elements of your business, from customer service to accounting processes.
The goal of implementing a successful QMS isn’t just to meet legal requirements. It also allows employees to focus on doing their jobs well rather than worrying about whether they’re producing bad workmanship or false reports!


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ISO 17025 vs ISO 9001 – both standards are for quality management systems, but they have different purposes. The purpose of this article is to explain the difference between these two standards. This article will also explain how you can use them together for greater efficiency.

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What is ISO 9001?

The International Organization for Standardization, or ISO, defines a quality management system (QMS) as a documented process of planning, implementing, and monitoring activities designed to achieve consistent results that meet customer requirements and expectations.

ISO 9001 is a standard developed by the International Organization for Standardization, or ISO. It’s one of the most popular standards in use today. Many organizations around the world use this standard. The organization published the first edition of this standard in 1987.

ISO 9001 outlines the requirements for a quality management system (QMS). It is recognized globally as the best practice standard for QMS.

What is ISO 17025?

ISO 17025 is a technical standard for the competence of testing and calibration laboratories.  The standard specifies that all organizations involved in test and calibration activities should implement a quality system that meets its requirements. The standard applies to all types of laboratories whether they are commercial or governmental; commercial, industrial, or academic; large or small in size.

The aim of ISO 17025 is to ensure that:

  • Qualified personnel makes accurate measurements using proper procedures on qualified equipment in order to produce data that other parties who need it for their own purposes (e.g., product development) can rely upon.
  • An organization’s customers know what they can expect from its services before placing an order (i.e., confidence in competence).

ISO 17025 vs ISO 9001 – the two standards can complement each other to create a comprehensive program for quality management.

ISO 9001 is a standard for quality management systems. It provides guidelines for setting up and maintaining an effective system to manage your organization’s processes. It also includes requirements for periodic reviews of the effectiveness of the system within your organization, as well as how you will monitor its ongoing performance against those requirements (for example, by using audits). Because of its focus on process improvement, ISO 9001 does not specify how you should meet customer needs. It rather helps ensure that all aspects related to meeting customer needs are managed effectively. That helps organizations deliver products or services in line with those needs at all times – without exception!

In contrast, ISO 17025 is specifically for testing and calibration laboratories. Its scope doesn’t extend beyond these types of organizations (although some would argue whether this is actually true). It provides guidance on establishing what constitutes good practice when conducting tests or calibrations in order to test methods used in various industries such as automotive manufacturing; aerospace engineering; electronics manufacturing; food processing plants–you name it!


ISO 17025 vs ISO 9001 – two of the most common quality management standards. They both help organizations manage their processes and products, but they do so in different ways. ISO 9001 ensures customer satisfaction by requiring businesses to follow all steps in the production process. However, ISO 9001 does not mandate the testing of all parts of a product by an independent third party before the sale, which is why some people prefer ISO 17025.