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As Quality Resource Center continues to evolve, we are proud to announce an expanded focus on artificial intelligence solutions and digital transformation through our new online presence at QRC Central AI.

For nearly three decades, Quality Resource Center has supported organizations with ISO standards implementation, regulatory compliance, quality management systems, auditing, training, and operational excellence. Today, the business environment is changing faster than ever, and artificial intelligence is rapidly becoming a strategic advantage for companies seeking greater efficiency, consistency, and competitiveness.

Our new .ai focus represents more than just a website update. It reflects our commitment to helping clients integrate modern technologies into traditional management systems and compliance frameworks. From ISO 9001 and AS9100 to CMMC 2.0 and cybersecurity readiness, organizations are increasingly looking for ways to automate workflows, improve data analysis, streamline documentation, and enhance decision-making. Artificial intelligence can play a major role in achieving those objectives.

At Quality Resource Center, we believe AI should support people — not replace them. Our approach combines decades of real-world quality and compliance expertise with practical AI-enabled solutions that improve productivity while maintaining accountability and regulatory integrity. We are actively developing enhanced training systems, smarter document management approaches, automated compliance support tools, and AI-assisted business process solutions tailored to the needs of our clients.

The launch of our .ai platform also symbolizes our continued investment in innovation and forward-thinking client support. As industries evolve, Quality Resource Center intends to remain at the forefront of both compliance excellence and intelligent business transformation.

We invite our clients, partners, and colleagues to visit our new website and explore the next chapter of Quality Resource Center as we embrace the future of quality, compliance, and artificial intelligence.

ISO 9001:2015 Is Evolving—What to Expect from ISO 9001:2026

The long-anticipated revision of ISO 9001, the world’s most widely adopted quality management system (QMS) standard, is underway. Following nearly a decade of industry feedback, technological advancements, and shifting global expectations, ISO is preparing to release the updated ISO 9001:2026. Although still in the development and ballot stages, the upcoming revision is designed to keep the standard relevant, practical, and aligned with modern business realities.

While ISO 9001:2015 remains fully valid today, organizations should begin preparing for the changes expected in the 2026 edition. Unlike the transformational overhaul that occurred between the 2008 and 2015 versions, ISO 9001:2026 is anticipated to be a targeted, evolutionary update. Its primary purpose is to refine key concepts, address emerging risks, and improve clarity—rather than fundamentally restructure the standard.

One of the strongest drivers for revision is the rapid advancement of digital technologies. Since 2015, organizations have undergone significant digital transformation, from cloud-based operations to AI-driven analytics. ISO 9001:2026 is expected to place more emphasis on digitalized processes, the reliability and integrity of data, and the need for organizations to control and validate technology-enabled workflows. These additions aim to ensure that a modern QMS reflects today’s operational environment, in which data accuracy, cybersecurity awareness, and integrated software platforms play critical roles in consistent product and service quality.

Another anticipated enhancement involves risk-based thinking. ISO 9001:2015 moved the industry away from prescriptive requirements and toward proactive risk management. The 2026 revision is expected to strengthen this approach by providing clearer guidance on how organizations should identify, evaluate, and respond to risks and opportunities. This may include enhanced linkages between risk management, change management, and organizational strategy.

Additionally, ISO 9001:2026 will likely sharpen language around organizational context, leadership accountability, and competence development. Many of these topics were introduced in the 2015 edition but have proven challenging for organizations to interpret consistently. Expect the revision to include clarifications that make it easier for companies to demonstrate alignment between their mission, strategic direction, and quality objectives.

Environmental and social expectations—such as sustainability, resilience, and responsible sourcing—are also receiving global attention. While ISO 9001 will remain strictly a quality standard, early committee discussions indicate that ISO 9001:2026 may include subtle references to these themes, encouraging organizations to consider broader stakeholder expectations and the long-term impacts of their processes.

Importantly, the revision will maintain compatibility with the Annex SL high-level structure, ensuring alignment with related standards such as ISO 14001, ISO 45001, ISO/IEC 27001, and ISO 13485. This will continue to support integrated management systems and streamlined certification audits.

Transition periods typically range from 2–3 years after publication. Organizations certified to ISO 9001:2015 will have ample time to update their systems once ISO 9001:2026 is officially released.

In summary, ISO 9001:2026 is poised to modernize—not reinvent—the global benchmark for quality management. Organizations that embrace digital maturity, strengthen risk management practices, and align quality with strategy will be well positioned for a smooth transition.

Quality Resource Center Partners With California Manufacturing Technology Consultants

Silicon Valley based Quality Resource Center (QRC) announced today a partnership with the Torrance, California based California Manufacturing Technology Consultants (CMTC), to provide an array of ISO 9001 and other similar Standards based consulting.

“We are extremely proud of our partnership with California Manufacturing Technology Consultants” stated Dan Terry, President and CEO of Quality Resource Center. “This is a truly synergistic relationship that leverages our more than a quarter century of operation with the vast resources of CMTC. Our product portfolio including ISO 9001, AS9100, ISO 13485, ISO 45001, ISO14001, IATF 16949, and more is an ideal fit for their client base.”

“Working with QRC is indeed a partnership of great synergy. We look forward sharing their industry best experience in so many areas with our highly valued clients” stated Marty Jones, Director of Delivery Resources at California Manufacturing Technology Consulting. “As Dan mentioned, this is a truly synergistic relationship that offers much more than the sum of our separate parts to our valued clients.”

CMTC’s Made in CA Program is dedicated to highlighting the contributions of California’s manufacturers and raising awareness of the products made in the Golden State.

Founded in 1992, California Manufacturing Technology Consultants www.cmtc.com, is headquartered at 690 Knox Street, Suite 200, Torrance, CA 90502.

Founded in 1992, Quality Resource Center (www.qrccentral.ai) is the industry’s oldest and most prestigious ISO based consultancy. With offices in both California and New York City, QRC is headquartered at 111 North Market Street, Suite 300, San Jose, California, 95113.

Quality Resource Center Opens New York City Office

San Jose, California based Quality Resource Center is proud to announce the opening of their New York City office.

The Quality Resource Center’s new offices are located at 315 Madison Avenue, 3rd and 4th Floors, New York, New York 10017.

“We are extremely pleased to reach this important milestone. New York city is the epicenter of the entire business world. Demand for our services in this area has increased dramatically over the years, and this action will allow us to better serve the entire east coast of the United States, including New York, Boston, Philadelphia, the Carolinas, Atlanta, Florida, and more. I am pleased to have placed the entire operation under the steady hand of Dennis Marinsik, our Senior Vice President of Major Accounts. Dennis has been with QRC since the beginning, and we know that under his guidance we will continue to perform at a superior level” remarked Dan Terry, President and CEO of The Quality Resource Center.

“We have gained a reputation over the years as the industry leader in ISO 9001 based quality management systems, and a trusted partner for our clients. Our mission is simple: we exist solely for the benefit of the client; we offer superior service, superior value, and we solve our client’s problems. We are committed to their success. When our clients succeed, we succeed. We have retained so many of our original clients over the years. I take that as a point of personal pride for myself, as well as our entire QRC team. Under Dan’s leadership, I expect QRC to continue to thrive” said Dennis Marinsik.

Founded in 1994, The Quality Resource Center is the oldest and most prestigious ISO 9001 based quality management systems consultant firm, with over 500 successful client registrations in more than a quarter century of operation. In addition to ISO 9001, The Quality Resource Center proudly serves the ISO 14001 Environmental Management, AS9100 Aerospace, ISO 13485 Medical Device, ISO 27001 Data Security, and IATF 16949 Automotive industry segments.

The Company’s Headquarters remain at 111 N. Market Street, Suite 300, San Jose, California. Telephone 1-800-244-5409. www.QRCCentral.com. ©Copyright 2020, all rights reserved.

What is Quality 4.0 and What You Need to Know About It.

Quality 4.0 aligns quality management with Industry 4.0. It represents a “failure is not an option” priority for organizations and their quality leaders. To assist quality leaders and their teams in keeping pace with Digital Transformation and lead the Quality 4.0 charge, this article highlights the key elements and philosophies needed to embrace and execute this important new concept.

At its core, Quality 4.0 is the digitalization of quality, management systems and compliance. It does not focus exclusively on the technology itself, but rather on the improvements in culture, collaboration, competency and leadership that are produced by those technologies.

What is Quality 4.0?

Quality is the essential aspect of all businesses that cuts across all industries. It basically includes, but is not limited to, quality engineering, quality management systems, quality control and quality assurance. Quality 4.0 integrates all these elements utilizing new technologies that can be integrated into management systems, certifications, and more.

A good example of this is Blockchain, offers valuable methods for process traceability, from equipment maintenance and calibration certificate to even process data analysis control. A blockchain is a growing list of records called blocks that are linked cryptographically. Each individual block contains a cryptographic hash of the previous block, a timestamp, and transaction data. By definition, a blockchain is resistant to modification of the data.

“Big Data” and “The Internet of Things” (IoT) data are already used for real-time process monitoring and measurement. Augmented reality, the art of blending the physical-digital environment and helping navigate through it easier is another great example. Greater connectivity, new modes of production, and intelligent processing with computing capabilities allows visualization of data faster and better than ever.

The Intersection of Quality and Technology

Industry 4.0 and its technologies provide new ways for people, machines and data to interact, transforming powerful technologies into accessible commodities, resulting in a disruptive synergy of culture, leadership, collaboration and compliance, resulting in forward thinking quality teams standing ready to resolve many long-standing challenges that have prevented innovation and improvement.

The Foundational Pillars of Quality 4.0

Data – By definition, Quality is data driven, and data driven decision making is the key. Organizations must seek ways to combine data from various systems to ensure accuracy and transparency in their decision making.

Analytics –Traditional quality metrics typically describe what has happened, why it happened and what might happen next, but they fail to determine what actions to take. This type of analysis can be achieved by utilizing Big Data, Machine Learning (ML) and Artificial Intelligence. Successful organizations will develop an analytics strategy after or concurrently with a data strategy or the value of the analysis will be of little value.

Connectivity – The integration of various business information technologies (IT) (e.g., EQMS, ERP, PLM, etc.) with operational technology (OT) (e.g., technology used in laboratories, manufacturing and service) is a longstanding challenge. The key here will be enabling data, processes and people to work together in symbiotic fashion.

Collaboration – The adoption of Enterprise Quality Management Software (EQMS) facilitates execution of collaborative processes with the help of email, automated workflows, portals and even paper documents. The advent of social listening and blockchain have transformed collaboration in recent years, and future success will utilize the disruptive powers of connectivity, data and analytics.

App Development – The creation of created “mashup” apps that combine content from multiple sources into a single interface, represent an emerging tool for operations and management, thus realizing the full potential of interactive apps available today, including wearables, augmented reality and virtual reality.

Scalability – Many companies cite disjointed data sources and systems as significant roadblocks to achieving quality objectives. Cloud computing can be a valuable tool to achieving scalability, along with data lake technologies (A data lake is a system or repository of data stored in its natural/raw format,[1] usually object blobs or files. A data lake is usually a single store of all enterprise data including raw copies of source system data and transformed data used for tasks such as reporting, visualization, advanced analytics and machine learning). Start by assessing the current scalability – or the ability to support data volume, users, devices and analytics on a global scale – of your in-house systems.

Management Systems – As of the writing of this paper, less than a quarter of companies have adopted an EQMS. The resulting core process fragmentation makes it difficult for companies to deploy effective quality technology. Harmonizing and automating processes and systems enables quality staff to shift their focus to innovation and improvement.

Compliance – A large percentage of companies report that ensuring compliance was a key strategic objective for quality management, closely followed by reducing the total cost of quality. Quality 4.0 provides multiple opportunities to automate compliance. Highly configurable, automated and connected EQMS solutions, and tools to automate validation are now available.

Culture – Few organizations and their cross-functional teams clearly understand how quality contributes to strategic success. The improved connectivity and collaboration offered by Quality 4.0 makes a culture of quality attainable.

Leadership – Barely ten percent of companies report that quality is a priority for top management. To confront this, quality teams must align their objectives and clearly link them to the organization’s strategic objectives. Quality leaders must advocate and lead quality across the organization, especially at the executive level.

Competency – Quality 4.0 facilitates an improved baseline competency of workers, as well as better scaling of specialized knowledge. Other technologies including certain social media, Machine Learning, Artificial Intelligence, mashup apps, wearables and VR can yield improvements in training and knowledge sharing.

What Should you do?

  1. Evaluate where you stand on each of the 11 elements of Quality 4.0
  2. Recognize and embrace the potential uses of analytics, apps, data, connectivity and other technologies to influence performance across the enterprise
  3. Establish a Digital Transformation strategy. Align your quality objectives with it.

Current State –

A recent American Society of Quality survey of companies around the world found that only 16% of companies have started any Quality 4.0 initiatives. 63% of companies reported that they have not even started any planning on the topic.

Furthermore, Europe is ahead of the Quality 4.0 race. Nearly a quarter of companies have already started planning on the subject. In the US this number drops to just 6%.

Companies that initiated Quality 4.0 initiatives have stated that they intend to apply the concept for quality data centralization, data security and continuous monitoring anywhere, anytime.

While the initiative is still very new, quality professional must be increasingly aware of it and endeavor to understand the need to create a plan to define their strategies in their companies.

Quality 4.0 will transform all aspects about implementation and quality controls.

QRC SALESFORCE

Silicon Valley based Quality Resource Center is pleased to offer Q-Force™, our Salesforce Customer-Relationship Management (CRM) Consulting services.

 

CRM manages a company’s interaction with current and potential customers using complied data analysis from a range of different communication channels, including a company’s website, telephone, email, live chat, marketing materials, social media and more.

 

Utilizing the CRM approach allows businesses to learn more about their target audiences and how to best cater to their needs, thus improving business relationships with customers by specifically focusing on customer retention and ultimately driving sales growth.

 

Offerings include but are limited to–

  • Design, Development and Administration
  • Business and Systems Use Case Analysis
  • Project Scoping
  • Manage and prioritize daily case inquiries
  • Upgrade cycles
  • Development of reports and dashboards
  • Documentation and Presentations
  • Quality assurance and testing processes
  • Manage and prioritize daily case inquiries
  • Visualforce/Apex development
  • Salesforce.com Web Services APIs – Force.com SOAP and REST-based Web Service APIs, etc.

Quality Resource Center offers over a quarter century of elite client services, with over 1,000 satisfied customers supporting a multitude of diverse businesses and markets. Please contact Quality Resource Center today to arrange a live, complementary 20 minute consultation.

 

ISO 9001 – A Great Idea!

The benefits of ISO 9001 should not be underestimated. Organizations of all sizes benefit greatly by leveraging this standard, realizing cost and efficiency savings, and resulting improvements in the bottom line. Here are six good reasons to embrace the ISO 9001 –

  1. Optimization of Process Integration – Viewing the overall processes and how they interact using the process approach of ISO 9001 enables the Organization to more readily identify improvements in efficiency, resulting in cost savings. Optimizing process flows can also drive efficiencies, reduce errors, reduce rework, and eliminating waste that can occur when processes are not maintained with consideration of inefficiencies.
  2. Employee Engagement – involving employees in improving the processes they work with results in happier and more engaged employees, enabling greater productivity. Engaged employees are especially more productive when they understand the process and how they contribute to the result. No one is more valuable than the people working on the process in identifying areas that need improvement and helping design and implement real improvements.
  3. A Culture of Continual Improvement – Continual improvement is a cornerstone management principle of ISO 9001. Embracing the commitment to improve your processes and organizational outputs will identify inefficiencies by design and deployment use of systematic methodologies.  This is especially evident when problems occur and effective in reducing the impacts of problems by eliminating their root causes. Embedding this in your organization’s DNA results in tangible, continual year over year improvements greatly benefiting the Organization.
  4. Enhancing the Image of the Organization – ISO 9001 is the gold standard of internationally recognized quality management systems and has become the de facto method for creating world class quality management systems. It is often a requirement when an organization is considering a supplier. This is particularly the case when competing for public sector jobs in many countries. Holding ISO 9001 certification is a powerful marketing tool.
  5. Customer Satisfaction – A foundational principle of the ISO 9001 is measuring and improving customer satisfaction.  Improving customer satisfaction results in retaining customers. This means more repeat business, better customer testimonials, and more customer referrals. And more revenue!
  6. Fact based Decision Making – Another key principle of ISO 9001 is the evidence-based decision making. Decisions based on evidence, rather than “gut feeling” focuses on applying resources to the areas that will improve efficiencies and increase cost savings with less trial and error. Monitoring the processes you are improving allows you to see how much improvement has occurred – based on the data.

 

ISO 9001 Is Foundational

ISO 9001 is a solid foundation for implementing many other Annex SL based management standards, such as ISO 14001 for environmental management and ISO 27000 for IT service management, which follow much of the same structure and organization

The international nature of ISO 9001 has already been identified and is, in fact, such a basic and influential standard that it has been used as the basis when industry groups want to add specific industry requirements, thus creating their own industry standard. Among these are IATF 16949 (Automotive), AS9100 (Aerospace), and ISO 13485 (Medical Devices).

 

What Is a Quality Management System (QMS)? — ISO 9001 & Other Quality Management Systems

Quality management systems (QMS) are formalized systems documenting the processes, procedures, and responsibilities needed to achieve quality policies and objectives. An effective QMS coordinates and directs an organization’s activities in meeting both customer and regulatory requirements, continually improving effectiveness and efficiency.  

ISO 9001:2015 is the international standard specifying requirements for quality management systems. It is the most widely accepted approach to quality management systems.

Although the term QMS is sometimes used to describe the ISO 9001 standard or the group of documents detailing the QMS, in practice it literally refers to the entirety of the system. Documentations only serve to describe the system.

Quality management systems serve many purposes, including:

  1. Reducing waste
  2. Lowering costs
  3. Engaging staff
  4. Improving processes
  5. Setting organization-wide direction
  6. Facilitating and identifying training opportunities

 

Standardization

Quality became increasingly important during World War II. To expedite production processes without sacrificing safety, the United States military began to use quality techniques of sampling for inspection, aided by the publication of military-specification standards and training courses.

In the post-war economy, the importance of quality only increased. Japanese Industry embraced a quality revolution, reversing their reputation for poor quality exports by embracing philosophies of American leaders like W. Edwards Deming and/or Joseph M. Juran, effectively shifting focus from inspection to improving all organization processes. By the 1970s the U.S. industrial sectors such as steel, electronics and automobiles had been decimated by Japan’s high-quality competition. Years later the Japanese would fall victim to the Koreans, a result of the same approach.

 

Benefits of quality management systems

Effective design and deployment of a quality management system will impact affects every aspect of an organization.

The major benefits include:

  1. Meeting and or exceeding Customer Requirements
  2. Meeting the organization’s requirements.  

Additional benefits include the ability to produce consistent results, preventing mistakes, reducing costs, and continually improving the organization’s offerings.

 

ISO 9001:2015 and other quality management standards

While other standards related to quality management systems include industry specific super sets of the ISO 9000 family (including ISO 9000 and ISO 9004, ISO 14000 environmental management systems, ISO 13485 quality management systems for medical devices, ISO 19011 auditing management systems, and IATF 16949 for automotive-related products, and AS9100D for aerospace management systems), ISO 9001:2015 is by far the most implemented quality management system standard in the world.

 

Elements and requirements of a quality management system

  1. Quality policy and quality objectives
  2. Internal processes and their interactions
  3. Quality manual
  4. Procedures, instructions, and records
  5. Data management
  6. Customer satisfaction from product quality
  7. Improvement opportunities
  8. Quality analysis

Each element serves a purpose toward the overall goals of meeting the customers’ and organization’s requirements.

 

Establishing and Deploying a QMS

The Plan-Do-Check-Act (PDCA) allows for continuous improvement to both the product and the QMS. The basic steps to implementing a quality management system are as follows:

  1. Design
  2. Create
  3. Deploy
  4. Control
  5. Measure
  6. Analyze
  7. Improve

 

Design and Construction

The design and construction activities serve to develop the structure of a QMS, its processes, and plans for deployment. Top management must oversee this portion to ensure that their vision, the needs of the organization, and the needs of its customers are a driving force behind the systems development.

 

Deployment

Deployment is best achieved in a systematic manner, stratifying each process into subprocesses, and educating staff on documentation, tools, and metrics.

 

Control and Measurement

Control and measurement are accomplished through routine, systematic audits of the quality management system.

 

Review and Improve

  1. Review and improvement deal with how the results of an audit are handled.
  2. Determine the effectiveness and efficiency of each process toward its objectives
  3. Communicate these findings to the employees,
  4. Develop new best practices and processes based on the data collected during the audit.

The design and deployment of an effective QMS is a major organizational commitment and should not be taken lightly. Organization’s great increase the effectiveness and efficiency of their QMS by retaining industry experts like the Quality Resource Center www.TheQualityResourceCenter.com. With over a quarter century of service, the Quality Resource Center remains the gold standard in ISO based quality management consulting. The Quality Resource Center – Experience the Difference.

AS9100D – Risk Management vs Risk-Based Thinking: Just What is the Difference?

AS9100D – Risk Management vs Risk-Based Thinking: Just What is the Difference?

Risk-Based Thinking requires organizations to consider the risks they face during strategic planning, planning for product and service conformity, management review, and when taking corrective action. The idea is that the organization works to identify risks, decides if action is required, and if applicable, takes action. That said, It is important to note that it is not necessary to track the risk as the project progresses to judge the effectiveness of the action, and whether additional action is necessary.

Risk Management, on the other hand, is a process for identifying risks, determining actions to mitigate those risks, tracking those actions, and then re-assessing any remaining risk after actions are deployed. It involves not just thinking about risk at certain stages during the realization of products and services, but also having a process to track these risks until they are addressed, mitigated, or eliminated.

What is required for operational risk management, and what isn’t?

To start with what is not required – there is a note specifying that while clause 6.1 “Actions to address risks and opportunities” addresses the risks and opportunities for the QMS, clause 8.1.1 “Operational Risk Management” is limited to risks that are associated with operational processes needed by the organization to provide its’ products and services. Therefore, while your organization may identify a QMS risk that your organization might soon have a rival company to compete with, this is not a risk that needs to be tracked according to the risk management requirements, as it is not an operational risk.

There are at least five requirements that an organization needs to consider during the planning, implementation, and control of the operational risk management process. They are:

  1. Assign Responsibilities – Who owns the process? Who constitutes the Team? Which departments need to be included? If actions are likely to be assigned to a certain department or function, it is best to have them involved in the whole management process.
  2. Determine Risk Assessment Criteria – What criteria will be used for risk assessment? How will you quantify which risks to accept and what you will mitigate? A note in this clause states that within the aviation, space, and defense industry, risk is generally expressed in terms of the likelihood of the occurrence and the severity of the consequences (a good example of this might be Failure Mode Effects Analysis or FMEA).
  3. Identify, Assess, and Communicate Risks – Any risk of product failure due to must be communicated to those who design and realize the product. Without effective communication, risk identification is ineffective.
  4. Identify, Implement, and Manage Mitigation Actions – There are a multitude of ways to address risk, ranging from risk reduction all the way to complete elimination of the risk – or, in other words, try to prevent the risk from happening. If a risk exceeds your acceptable criteria, take actions to address the risk and track those actions.
  5. Re-evaluate the Risk that remains when mitigation is complete, and continue to work to reduce it – Risk management is an iterative process, where the risk can always be reduced.

Has anything really changed from AS9100 Rev C?

The requirements have remained greatly unchanged since the past revision. Risk management process requirements were already included in AS9100 Rev C as risk management, and the five requirements have remained basically as they were. The real change here is the clarification that these requirements only applied to operational risk, hence the name change in the clause. The other change from Rev C is the addition of the two notes to clarify how these requirements are separate from risk-based thinking and to make it clear that risk in aerospace is a combination of likelihood and severity. For organizations that are already compliant with AS9100 Rev C, the current risk management process should most likely remain unchanged.