ISO 45001 Adoption in U.S. Workplaces: Reducing Liability and Improving Employee Retention

In the past decade, the way we think about workplace safety has changed. Employees today, especially the younger generations, are choosing workplaces where their well-being is taken seriously. Safety is no longer about just avoiding accidents. It’s about creating an environment where people feel protected, heard, and valued.

More and more companies are turning to ISO 45001, the global standard for occupational health and safety, as a way to show that commitment. Not just for internal stakeholders but also for external stakeholders. The standard is not just a tool for compliance, it provides a  framework that helps strengthen safety practices, embedding them in day to day activities. When implemented well it aims to increase worker participation in the success of the system and therein also help and retain the workforce.

Why ISO 45001?

ISO 45001 encourages companies to be proactive, to identify hazards, assess risks, and put controls in place before anyone gets hurt. It aims to move organizations away from a reactive approach to safety. That is seeking to improve the system after responding after incidents happen, conducting investigations, filing reports, and hoping it won’t happen again.

There’s a legal benefit too. In the unfortunate event of an injury or OSHA investigation, organizations with ISO 45001 have documented proof that they’ve been diligent and systematic in protecting their people. That can reduce liability, minimize penalties, and demonstrate due diligence in court. But this should not be the sole goal for implementing ISO 45001.

Perhaps more importantly, ISO 45001 using a process based approach, helps build trust. This, of course, only when leadership commitment to their safety is clearly visible beyond a simple poster on the wall stating “safety first”. Employees want to know their safety isn’t just a box to check. When they see leadership investing in a formal safety management system, it sends a clear message: “You matter here.”

Workplace Liability Insights

According to OSHA, U.S. employers face millions of dollars in penalties every year for safety violations. Many of which are avoidable. Some of the most common citations include inadequate hazard communication, poor fall protection, and insufficient training.

Then there’s the cost of worker’s compensation claims, which continues to rise. The National Safety Council estimates that American employers spend over $1 billion per week on direct costs related to workplace injuries. That doesn’t include the hidden costs: lost productivity, new hire training, and legal fees.

Adopting ISO 45001 won’t eliminate all risk, but it dramatically lowers your exposure. You’re putting a system in place that helps you spot red flags before they turn into accidents, lawsuits or lost time injuries.

Employee-Centric Benefits

There’s another side to ISO 45001—and it’s one that doesn’t always get the attention it deserves: employee engagement and retention.

Workers want to feel safe. But beyond that, they want to feel like they belong in a culture that values their input. ISO 45001 calls for worker participation in identifying risks and improving safety systems. That inclusion fosters trust and loyalty.

When safety is seen as a shared responsibility—not just something the safety officer worries about—people speak up more. They report near misses. They suggest improvements. And they stay.

Especially with younger generations entering the workforce, this matters. They want to work for companies that walk the talk when it comes to health, safety, and well-being. If you can demonstrate that through your safety culture, you’re one step ahead in attracting and keeping top talent.

Case Examples

A mid-sized manufacturing company in the Midwest was experiencing frequent safety incidents. Their injury rate was above the industry average, morale was low, and OSHA had issued several citations over the years.

They decided to implement ISO 45001 as part of a broader effort to shift their safety culture. Over the next year, they trained leadership and managers, involved employees in hazard assessments, and rolled out new reporting tools. Further incidents were investigated to identify corrective actions and Saffety got the visibility it needed in front of leadership.

The results included,

  • Their incident rate dropped by 60%.
  • Employees began raising safety concerns early—before accidents happened.
  • Insurance premiums were renegotiated at a lower rate thanks to their improved risk profile.

In another example, a logistics firm operating across multiple warehouses struggled to standardize safety practices across sites. After implementing ISO 45001, they created a unified safety policy, held cross-site training, and rolled out consistent procedures. Within months, they saw measurable improvements in both safety performance and worker feedback.

These are just two examples of how ISO 45001 goes beyond paperwork. It changes behavior. It builds ownership. And it delivers results.

Implementation Guidance

Implementing ISO 45001 takes more than updating a few forms. It requires commitment from the top and collaboration across departments. Start by forming a cross-functional team. Safety isn’t just a safety officer/manager concern, it involves HR, operations, leadership, and frontline workers. Conduct a gap analysis to assess where you are and where you need to go.

Get your people involved early. Ask them what risks they see. Let them help identify hazards, controls and shape procedures. This builds buy-in and ensures the system reflects real conditions, not just what’s on paper.Seek ways to track the data and present it to the workers so they are in the know. Ask them for ideas to drive improvement across the system. At times the best ideas, hazard identification and suggestions come from the front line workers.

Remember, ISO 45001 is about more than passing an audit. It’s about building a resilient, people-first culture where safety isn’t an afterthought.

Conclusion:

Today’s workforce expects more. A safe workplace is a basic requirement, but a workplace where the employee’s safety is above all and where the worker feels valued is what sets leading organizations apart.

ISO 45001 gives you the framework to get there. It helps reduce liability, meet regulatory expectations, and most importantly, create a work environment where people feel protected, respected, and proud to be part of the team.

Whether you’re new to ISO standards or looking to upgrade your current system, now is the time to take action. Whether you are looking to learn more about ISO 45001, understand how to implement it for your organization or audit an existing system QMII’ ISO 45001 Lead Auditor Training is a great starting point.

Seeking additional support: contact info@qmii.com .

How ISO 9001 Helps U.S. Companies Reduce Operational Costs and Improve Customer Satisfaction

As U.S. companies face rising inflation, tighter margins, and increasing global competition, the pressure is on to deliver more value with fewer resources. Many organizations are looking beyond cost-cutting and exploring strategic frameworks that improve both efficiency and customer satisfaction.

This is where ISO 9001 certification comes in. Often misunderstood as just a “quality stamp,” ISO 9001 is, in reality, a powerful business tool. When implemented with intent, it streamlines operations, engages employees, improves supplier performance, and enhances customer trust. All this while reducing waste and inefficiency.

Let’s explore how ISO 9001 certification supports U.S. businesses in staying competitive without sacrificing quality.

ISO 9001 – A Framework for Efficiency:

At its core, ISO 9001:2015 is a blueprint for building a consistent and process-based system. This does not mean companies cannot adapt to changes. ISO 9001 addresses this aspect too. One immediate impact of implementing the standard is the standardizing of how work gets done. When procedures vary between teams or are reinvented with every new hire, mistakes, rework, and delays are inevitable.

ISO 9001 helps define clear standard operating procedures (SOPs) that reduce variability and eliminate guesswork. It encourages companies to document what works, train people consistently, and audit performance regularly to ensure it sticks.

This is not about bureaucracy. It’s about doing things right the first time. According to a 2021 ISO implementation survey, companies reported up to a 10–15% reduction in operational inefficiencies within the first year of certification. That includes fewer defective products, faster turnaround times, and lower overtime costs. For a client we supported in their implementation and certification journey the improvements started on day 2 of the project. The proposal management team, as they analyzed their process, identified ways they could improve their review process and get proposals out faster

In short, ISO 9001 gives organizations a system for spotting where things break down and fixing them at the root.

Cost Savings Through Risk-Based Thinking:

One of the standout features of ISO 9001:2015 is its emphasis on risk-based thinking. Rather than waiting for problems to occur, organizations are encouraged to anticipate them across all levels of operation.

Whether it’s a supplier failing to deliver on time, a recurring equipment issue, or a customer complaint pattern, ISO 9001 calls for identifying these risks early, evaluating their impact, and putting controls in place to prevent them from escalating.

This is especially valuable for U.S. companies juggling complex supply chains or operating in highly regulated sectors. Early detection saves money. It avoids expensive product recalls, production downtime, lost clients, and legal issues.

Let’s say your procurement team identifies a risk that a supplier may not meet a critical delivery window. A risk-based approach pushes you to mitigate it upfront—by finding a secondary vendor or renegotiating lead times, before it disrupts production.

These are not hypothetical benefits. Over time, structured risk reviews built into ISO 9001 management systems have helped businesses significantly reduce unplanned costs and “firefighting” cycles. It has also helped build continuity into the system.

Better Processes = Happier Customers:

Efficient internal processes aren’t just good for the bottom line—they also directly improve the customer experience.

When companies align their operations with ISO 9001, they strengthen key areas like:

  • On-time delivery
  • Product/service conformity
  • Customer complaint resolution
  • Feedback handling

ISO 9001 certification requires that companies monitor customer satisfaction and use that data to drive improvement. This means customers are not just passively surveyed, but actively factored into performance reviews and planning.

Moreover, the standard builds in a Plan-Do-Check-Act (PDCA) cycle ensuring that improvements aren’t one-time fixes, but part of a continuous improvement culture. Over time, this consistency earns loyalty and boosts customer retention.

In a market where reviews and referrals are king, delivering predictable, quality outcomes matters. And ISO 9001 gives companies the structure to deliver on that promise.

Cross-Departmental Alignment:

Another area where ISO 9001 certification adds value is in breaking down internal silos. Many companies lose efficiency not because people are unwilling to collaborate, but because they operate from disconnected systems, metrics, and assumptions.

ISO 9001 changes that. It encourages organizations to map out process interactions and assign clear responsibilities across departments. From sales to fulfillment, quality to HR, everyone understands how their work affects the organization’s objectives and outcomes.

Management reviews (required under Clause 9.3) bring different functions together to review performance data, risks, and opportunities. This regular cadence builds cross-functional awareness and supports informed, aligned decisions.

The result is fewer communication gaps, better handoffs, faster problem-solving and a stronger sense of shared purpose.

Conclusion:

In today’s uncertain economy, organizations that survive won’t be the ones that simply cut costs. They’ll be the ones that build smarter systems. Systems that reduce errors, anticipate risks, and create consistent value for customers.

ISO 9001 certification offers a proven framework to help U.S. companies do just that. From reducing operational waste to improving customer satisfaction and fostering internal alignment, the benefits go far beyond compliance.

For companies willing to go beyond the checkbox and truly embed the standard into their culture, ISO 9001 becomes a catalyst for operational excellence.

Want to explore ISO 9001 certification for your organization?
Visit www.qmii.com or contact us at info@qmii.com to learn how our training and implementation services can help you cut costs, drive quality, and build customer trust.

From Compliance to Competitive Advantage: How U.S. Defense Contractors Use AS9100 to Streamline Quality

For U.S. defense contractors, quality is not just a requirement, it is a mission-critical capability. In an industry where failures can compromise national security and endanger lives, quality systems must meet high standards. That is why AS9100, the aerospace and defense extension of ISO 9001, has become the gold standard.
AS9100 is more than just a quality management system (QMS) framework. It is a tool that enables defense contractor ISO compliance while building resilience, improving traceability, and driving operational excellence. From managing supply chains to reducing production risks, AS9100 offers a strategic pathway to win contracts and deliver with confidence.

Quality in Defense Contracting

Defense contractors must navigate a complex regulatory environment that includes not just ISO standards but also DFARS (Defense Federal Acquisition Regulation Supplement) and NIST SP 800-171, which addresses the protection of controlled unclassified information.

Defense contractors must navigate a complex regulatory environment that includes not just ISO standards but also DFARS (Defense Federal Acquisition Regulation Supplement) and NIST SP 800-171, which addresses the protection of controlled unclassified information.

In this context, AS9100 acts as a unifying structure. It integrates the foundational principles of ISO 9001 with defense-specific needs such as risk-based thinking, product safety, counterfeit part prevention, and first article inspection (FAI). For defense contractors seeking to align with federal requirements while enhancing process maturity, AS9100 delivers a comprehensive quality backbone.

Compliance with AS9100 is often a precondition for working with major primes like Lockheed Martin, Raytheon, and Northrop Grumman on Department of Defense (DoD) contracts. It is not uncommon to see AS9100 cited as a contractual requirement for sub-suppliers, making it essential for competitiveness in the defense sector.

Benefits of AS9100 Beyond Certification:

For many organizations, the journey to AS9100 begins with customer pressure or procurement mandates. But the true value lies beyond the certificate. Once embedded into operations, AS9100 enables organizations to unlock long-term gains.

Supply Chain Standardization:
AS9100 introduces a consistent framework across the aerospace and defense supply chain, ensuring that from Tier 1 suppliers to sub-contractors, quality expectations are aligned. This common language reduces miscommunication, streamlines product quality, and enhances traceability across suppliers.
Advanced Risk Management and FAI:
The standard emphasizes proactive risk assessment, including production, delivery, and post-delivery risks. It integrates risk management as a core expectation, ensuring design and process conformity from the first build. Organizations using AS9100 report fewer reworks, more reliable timelines, and improved relationships with OEMs and defense agencies.
Additionally, AS9100 fosters configuration management and robust document control, both of which are essential in managing high-variation, low-volume defense projects where specifications can shift mid-cycle.

Case Study: AS9100 in Action:

One U.S.-based precision machining company, after achieving AS9100 certification, was able to compete for and win a multi-year contract with a Department of Defense (DoD) prime contractor to supply critical aerospace components. Prior to certification, the company had struggled with inconsistent documentation, reactive quality controls, and limited visibility into supplier performance.

By implementing AS9100, they:

  • Established a process-based QMS aligned with ISO 9001
  • Ensured their quality workflows reflect actuality
  • Integrated nonconformance tracking and corrective action leading to continual improvement
This allowed them to reduce internal rework by 30 percent, pass third-party audits with zero major findings, and build customer confidence during the bidding process. Their AS9100 certification became a competitive differentiator, not just a checkbox.

Integration Tips:

For organizations already certified to ISO 9001, transitioning to AS9100 is not a leap, it is a minor evolution. The standards share a common structure (Annex SL), making integration straightforward with the right planning.

Aligning with ISO 9001:

Start by mapping your existing ISO 9001 system to AS9100’s additional requirements. Focus on areas such as:

  • Product safety controls
  • Operational risk analysis
  • Counterfeit part mitigation
  • Configuration management
    It is important to involve leadership, suppliers, and production teams early in the transition to ensure clarity on the expanded expectations.

Leveraging QMS Tools:

Managing AS9100 requirements manually may be overwhelming based on the size of your organization. Many companies may opt to use digital QMS platforms to automate document control, track corrective actions, manage audits, and generate reports for compliance. These of course come at a cost.
A QMS dashboard ensures real-time visibility. Digitizing documentation allows for centralized records, and faster accessibility. It also reduces the time burden on quality teams, allowing them to focus on performance, not paperwork. However, simple tools like MS excel spreadsheets may be just what you need.

Challenges and Pitfalls

While AS9100 offers considerable benefits, it also comes with implementation challenges that organizations must be prepared for.

Resource-Intensive Documentation:

AS9100 demands thorough and consistent documentation. For smaller defense contractors, this can stretch resources. Establishing a document hierarchy, using templates, and assigning process owners helps reduce the burden while maintaining compliance. The records help demonstrate traceability.

Corrective Action Fatigue:

With AS9100’s emphasis on root cause analysis and preventive action, some teams experience corrective action fatigue. Avoid this by defining the problem well, training teams on effective root cause tools, and tracking action to manage action plans over time.
Continuous improvement should be meaningful, not mechanical.

Conclusion:

n today’s highly competitive and tightly regulated defense market, AS9100 does more than meet a requirement. It empowers defense contractors to build systems that support innovation, reliability, and readiness.

Those who treat AS9100 as a strategic asset — not just a certification — are better positioned to win contracts, build lasting partnerships, and support the nation’s defense with confidence.

Ready to strengthen your quality system and win more defense work? Enroll for an AS9100 Lead Auditor class to learn how to implement the standard’s requirements for your organization and how to audit it for effectiveness.

3 Top ISO Audit Mistakes U.S. Companies Make and How to Avoid Them

For U.S. companies pursuing or maintaining ISO 9001 certification, audit nonconformities are more than just procedural red flags. They can have real consequences ranging from delayed certification and lost contracts to damaged customer trust and lowered employee morale. Whether raised during internal or external audits, audit nonconformities in ISO 9001 are a reflection of risks that impact the system that the QMS should have proactively addressed. 

At QMII, we work with organizations across multiple industries who are often surprised when common, avoidable issues arise during audits. In this article, we highlight three of the most frequent mistakes companies make during ISO audits and show how you can avoid them through preparation, training, and a proactive quality culture.

Most Common Mistakes:

1. Lack of Operational Controls

One of the most common and costly audit findings in ISO 9001 is the absence of effective operational controls. Clause 8.1 requires organizations to plan, implement, and control the processes needed to meet requirements and deliver quality outputs. However, we often find that organizations either rely on informal practices or fail to define process parameters clearly.

This results in inconsistent product or service quality, rework, and missed customer expectations. Whether it’s unapproved work instructions on the shop floor or undefined acceptance criteria in a service delivery process, the lack of documented and implemented controls becomes a major nonconformance. Auditors expect to see evidence that processes are not only documented but followed, monitored, and improved over time.

2. Monitoring and Measuring Devices Not Maintained

Clause 7.1.5 of ISO 9001 requires organizations to ensure that monitoring and measuring resources are suitable for their purpose and maintained appropriately. Yet, calibration and verification records are frequently overlooked, especially in small or fast-paced environments.

Audit findings often arise when calibration certificates are expired, measurement tools are missing serial numbers, or maintenance logs are incomplete. In industries like manufacturing, logistics, and healthcare, this failure can compromise product conformity and safety. Auditors want to see traceability, calibration intervals, and documented procedures that ensure ongoing measurement accuracy.

3. Competence Requirements Not Met

Clause 7.2 focuses on ensuring personnel are competent based on education, training, and experience. Despite this, competence gaps remain a leading cause of audit findings. Many companies provide job descriptions or training certificates, but stop short of evaluating whether individuals are truly capable of performing assigned tasks.

Auditors will often ask, “How do you determine and verify competence?” If the answer is vague or unsupported by records such as training evaluations, skills matrices, or on-the-job assessments, it raises concerns about process reliability. Competence is more than initial qualifications; it includes ongoing development, particularly when roles change or new processes are introduced.

4. Poor Internal Audit Scheduling

Another frequent mistake is failing to schedule internal audits in a way that covers all processes over time or reflects risk-based thinking. Some companies audit only select departments or rush through audits just before the external assessment. This results in superficial findings and missed opportunities for improvement.

Clause 9.2 of ISO 9001 requires a planned, systematic approach to internal audits. When companies skip or delay these audits, they risk going into their certification or surveillance audits blind.

5. Incomplete Management Reviews

Clause 9.3 lays out clear expectations for management reviews, yet many organizations treat them as a checkbox task. Meetings may occur, but without comprehensive data, trend analysis, or meaningful input from leadership. Some fail to include critical elements like audit results, customer feedback, process performance, and risk updates.

Incomplete or unstructured management reviews often result in findings during external audits and signal to auditors that leadership is not fully engaged in the QMS.

Why These Mistakes Happen:

Over-Reliance on Tribal Knowledge and Unwritten Practices

Many organizations, especially those with long-tenured staff, rely heavily on informal knowledge and undocumented routines. While this may work day-to-day, it fails under the scrutiny of an ISO 9001 audit. Without clearly defined and implemented operational controls, variability creeps into processes, and staff may perform tasks differently based on personal habits rather than established standards. This gap becomes evident when auditors ask to see how a process is controlled and find that key steps are missing or inconsistently applied.

Neglecting Equipment Maintenance

Another common reason audit findings arise is the assumption that equipment “just works.” Without a system to ensure routine calibration, verification, and maintenance of monitoring and measuring devices, companies risk using tools that provide inaccurate data. This oversight is often unintentional, dates get missed, records aren’t updated, or the responsibility falls through the cracks during staffing changes. Unfortunately, even one uncalibrated device can undermine product quality and lead to nonconformities.

Failing to Define and Evaluate Criteria

Organizations often fail to define criteria and how the standard is interpreted and applied by them. For instance, what does a planned interval mean? Every month, quarter or annually. What does without undue delay mean? How do they define competence for each position?

As companies apply the standard they must clearly define the criteria to ensure effective control of the processes whether customer service, purchasing or design.  

How to Avoid Them?

Conduct More Frequent Internal Audits by Independent Auditors

One of the most effective ways to prevent audit findings is through regular and impartial internal audits. Rather than treating audits as an annual event, organizations should increase audit frequency—particularly for high-risk or high-impact processes. Utilizing independent auditors, whether from another department or trained third parties, brings fresh eyes and removes the risk of bias.

These audits shouldn’t just check boxes. They should probe whether operational controls are clearly defined, consistently followed, and achieving intended results. Findings from internal audits should feed directly into corrective actions and management review discussions, closing gaps before they escalate into external audit nonconformities.

Review Processes Regularly to Reflect Actual Practice

Many findings occur because documented procedures don’t match what’s happening on the ground. To prevent this, organizations should implement scheduled process reviews at intervals determined by the criticality and complexity of each process.

These reviews should involve both process owners and front-line users to assess:

  • Whether procedures are being followed
  • If undocumented workarounds have emerged
  • Whether existing controls are adequate for current risks

Making process validation a routine activity helps ensure controls remain effective and documentation stays aligned with reality.

Continually Reassess ISO Interpretation for Relevance and Applicability

As organizations grow, restructure, or introduce new products and services, their interpretation of ISO 9001 clauses must evolve. A clause that once had minimal relevance—such as those related to design, outsourcing, or organizational knowledge—may become critical as business operations shift.

To stay aligned, organizations should regularly revisit their clause interpretations and determine applicability in light of operational changes. This includes:

  • Periodic reviews of issues and risks
  • Evaluating if criteria and periodicity as defined are still valid
  • Adjusting documented information accordingly

This proactive reflection ensures the QMS remains both compliant and meaningful—not a static relic from initial certification.

Real Audit Failures (Without Naming)

One U.S.-based logistics company was cited for failing to update calibration records for critical equipment. The documentation was maintained by one employee who retired. No one else knew where the logs were kept, and the equipment continued operating without proper checks. A simple internal audit would have caught this.

Another example comes from a growing consulting company that wrote a 50-page quality manual filled with jargon and rarely-used procedures. Employees didn’t reference it, and as a result, process deviations went unnoticed. The external auditor flagged the disconnect between documented information and actual practice.

These failures weren’t due to lack of effort, but due to a lack of systems thinking and a reactive, rather than proactive, approach.

Conclusion:

ISO audit findings don’t have to be setbacks, they can be opportunities for meaningful improvement. By understanding the most common mistakes, investing in internal training, and using tools like clause guides and checklists, your organization can shift from fire-fighting to strategic quality management.

At QMII, we believe in building systems that work for you, not just for the audit. Our training and consulting services help U.S. companies build confidence, competence, and compliance into their QMS.

Don’t wait for the audit report to discover your gaps.
Visit our ISO 9001 training and internal audit programs, and turn audit readiness into a competitive advantage.

Maritime Safety Management in the U.S.: Navigating ISM Code Compliance and USCG Expectations

The International Safety Management (ISM) Code is a cornerstone of maritime safety and operational excellence. Countries agree to implement the requirements of this code within their national legislature in order to make it enforceable. The USA has integrated the requirements into the U.S. Code and CFRs, the enforcement of which is overseen by the United States Coast Guard (USCG). For U.S.-flagged vessels and shipping companies, ISM compliance is not just a global expectation but a national requirement that intersects with both international maritime law and domestic enforcement.

Understanding how the ISM Code USA is interpreted, applied, and enforced can mean the difference between a smooth voyage and regulatory detention. More than just a compliance tool, ISM serves as a foundation for safer operations, reduced risk, and long-term business viability.

ISM Code Explained:

Adopted by the International Maritime Organization (IMO), the ISM Code mandates that companies establish a Safety Management System (SMS) that ensures safe practices in ship operations and a safe working environment. It also requires that risks are assessed, and that accidents, incidents, and non-conformities are reported and corrected.

Key Elements of the ISM Code:

  • A functional Safety Management System (SMS) tailored to vessel operations.
  • Appointment of a Designated Person Ashore (DPA) with direct access to top management, responsible for ensuring SMS effectiveness.
  • Internal audits and management reviews to continually improve the system.
  • Clear procedures for emergency preparedness, maintenance, and reporting of non-conformities.

While the ISM Code shares some similarities with ISO standards such as ISO 9001 (Quality) or ISO 45001 (Occupational Health and Safety), it is sector-specific and inherently maritime. The ISM Code was built on the framework of ISO 9002:1984. However, it directly targets the safety of life at sea, protection of the marine environment, and shipboard operational risk management.

USCG Expectations and Enforcement:

In the United States, the USCG is responsible for overseeing ISM compliance for U.S.-flagged vessels and companies. The ISM Code is enforced under 33 CFR Part 96, which outlines the U.S. implementation and compliance requirements for ISM. The USCG may delegate some of these responsibilities to recognized organizations (often classification societies) that meet their requirements. 

The USCG verifies ISM compliance through:

  • Document of Compliance (DOC) audits for companies.
  • Safety Management Certificate (SMC) audits for vessels.
  • Routine port state control (PSC) inspections for foreign flagged vessels.

Common ISM Deficiencies Found by USCG:

  • Incomplete or outdated safety management documentation.
  • Failure to follow emergency procedures during drills.
  • Maintenance not adequate completed per requirements.
  • Weak internal audit systems or audits performed superficially.
  • Lack of follow-through on corrective actions.
  • DPA not fulfilling the required oversight role or lacking training.

Deficiencies in these areas, based on severity of the finding not only risk detention of vessels but can also lead to suspension or revocation of certificates and significant financial penalties.

Challenges U.S. Operators Face:

Even experienced operators face hurdles in fully implementing and maintaining ISM Code compliance. Below we outline some of the common issues faced:

Documentation Burden

The SMS must reflect actual shipboard operations and be updated to reflect actuality. Generic manuals or excessive paperwork not aligned with reality can lead to non-conformities. Some companies fail to integrate procedures into daily operations, making compliance a passive effort. 

Crew Training and Engagement

ISM is only effective when the crew is trained, competent, and engaged. Many deficiencies arise when crew members are unaware of procedures or fail to apply them, particularly during drills or during critical procedures.

Internal Audits

Internal audits are often treated as a checklist activity rather than a genuine opportunity for improvement. Poor audit practices, inadequate auditor training, and failure to correct findings can erode the SMS’s credibility. QMII’s ISM auditor training prepares your auditors to be objective, impartial and focused on adding value to your system through audits.

Best Practices

Integration with ISO-Based Systems

Organizations that already maintain ISO 9001, ISO 14001, ISO 27001 or ISO 45001 systems can benefit from integration. Combining the strengths of each standard creates a more resilient and efficient management system that avoids duplication and strengthens performance.

A unified system allows for common procedures, shared risk assessments, and centralized documentation. When ISM becomes part of a larger strategic framework, it evolves from compliance to a tool for business improvement.

DPA Training and Risk Monitoring

The Designated Person Ashore (DPA) is a critical role under the ISM Code. This person must be trained not only in regulatory compliance but also in incident analysis, communication, and how to drive continual improvement.

DPAs should be equipped with tools for real-time risk monitoring, using information dashboards, near-miss tracking, and KPI-based decision-making. When the DPA functions as a proactive partner rather than a distant observer, safety outcomes improve measurably.

Case Study: ISM in Action:

A mid-sized U.S. shipping company operating a fleet of bulk carriers implemented a revamped SMS aligned with ISM and integrated key ISO 9001 principles. With support from QMII, they conducted thorough risk assessments, retrained their DPA, redesigned their hiring process and rolled out a dashboard of information.

By taking ownership of their SMS and viewing ISM not as a burden but as a framework for safety, the company saw operational improvements, and improved crew morale. Office personnel understood the value of the SMS

Conclusion:

ISM Code compliance in the USA is not just about meeting regulations—it is about building a safety culture, enhancing performance, and protecting lives and assets at sea. The USCG holds operators to high standards, and rightly so. However, when approached with intention and integration, ISM becomes a business enabler, not a checkbox.

Whether you are a small operator or a global fleet manager, understanding your responsibilities under the ISM Code is essential. More importantly, transforming those responsibilities into daily practices will set you apart in a competitive and safety-conscious industry.

Ready to evaluate your compliance posture?
Visit www.qmii.com or contact our maritime consultants for expert guidance tailored to your fleet.

How U.S. Companies Can Leverage ISO 9001 Certification to Win Government Contracts

Winning government contracts can be a game changer for U.S. companies, particularly small and mid-sized businesses seeking steady growth. Yet, competing in this space means meeting high standards for accountability, consistency, and performance. More now than ever with efficiencies being sought by DOGE. This is where ISO 9001 certification comes into play. 

ISO 9001 is the internationally recognized standard for quality management systems. It provides a framework for organizations to consistently provide products and services that meet customer and regulatory requirements. More than just a quality label, ISO 9001 serves as a strategic asset that signals credibility and process maturity.

Having helped several clients prepare for certification in pursuit of federal contracts, I have seen firsthand how ISO 9001 can enhance proposals and influence evaluations. In this article, we will explore how ISO 9001 fits into the U.S. government procurement landscape and how companies can leverage it to stand out.

Government Procurement Landscape:

U.S. federal contracts are governed by the Federal Acquisition Regulation (FAR), a comprehensive set of rules that standardize how government agencies procure goods and services. The FAR outlines stringent criteria for vendor selection, covering areas such as past performance, risk, cost efficiency, and operational controls.

Many solicitations, particularly those from the Department of Defense (DoD), the General Services Administration (GSA), and NASA, include quality system requirements or evaluation factors where having a documented and certified quality management system earns additional points.

ISO 9001 certification is not legally required for all federal contracts. However, it is frequently listed as a preferred or advantageous qualification in Requests for Proposals (RFPs), especially in sectors such as manufacturing, defense, logistics, engineering services, and IT support. ISO 9001 certification also provides an advantage to those seeking to win a seat on large value contract vehicles such as OASIS and Stars III.

ISO 9001 as a Trust Signal:

Government buyers are risk-averse by nature. They prefer vendors who can demonstrate control over their processes, consistency in outcomes, and a commitment to continual improvement. ISO 9001 certification acts as a powerful trust signal that a company meets these expectations.

Consider the case of a Virginia-based consulting firm I supported. Before certification, they struggled to pass technical evaluations for DoD contracts. After implementing ISO 9001 and passing their certification audit, they saw a notable improvement in proposal acceptance rates. Their documented processes aligned with the RFP evaluation criteria, giving them an edge in the pre-qualification stage.

In proposal evaluations, ISO 9001-certified companies often score higher in categories such as technical competence, quality control, and risk mitigation. In addition, agencies often view the presence of a third-party certification as a pre-vetting mechanism, reducing the due diligence burden on the contracting officer.

Beyond Compliance: Performance Benefits:

While the certification opens doors, the real value of ISO 9001 lies in its impact on operational efficiency and customer satisfaction. A certified quality management system helps reduce rework, minimize customer complaints, and control process-related risks. These improvements not only boost internal performance but also demonstrate reliability to government agencies.

For large value contracts federal agencies may conduct site visits or readiness assessments before awarding long-term contracts. In these situations, having ISO 9001 systems in place,  including document control, internal audit records, corrective action tracking, and risk-based thinking, makes a strong impression. I recall a scenario where a client preparing for a DoD contract shipyard audit used their system to walk through each of the evaluator’s questions. The structured response based on ISO 9001 processes led to a favorable outcome and a contract award.

In addition, ISO 9001 supports integration with other systems like ISO 14001 for environmental management or ISO 45001 for occupational health and safety. For contractors working with the DoD or agencies focused on ESG factors, this can be a strategic advantage.

Steps to Get Certified and Cost Insights:

Getting ISO 9001 certified involves several phases. First is the gap analysis, where your current system is compared against ISO 9001 requirements. Next is implementation, which includes developing or revising documentation, training employees, and conducting internal audits to name a few steps. Finally, you engage a certification body to conduct the external audit.

A typical implementation timeline ranges from 3 to 9 months, depending on company size, complexity, and resource availability. Smaller organizations with dedicated leadership can move more quickly, especially if they choose a practical, right-sized approach. QMII has helped a client with over 400 personnel achieve a stage 1 audit in their path to certification within 3.5 months.

In terms of cost, small micro businesses can expect to invest between $20,000 and $25,000, which includes consulting and training fees. Certification fees can be a total of $12,000 to $15,000 for a three year cycle. The investment may seem steep, but many clients recover it through increased contract opportunities, improved efficiency, and reduced nonconformity-related costs.

One tip I always give clients is to avoid overcomplicating their system. Use tools like spreadsheets for tracking existing procedures rather than creating unnecessary new documents. Appreciate your existing system and learn our methodology here. ISO 9001 is about value, not bureaucracy.

Conclusion:

ISO 9001 certification is more than a quality stamp; it is a tool to build credibility, demonstrate maturity, and gain a competitive edge in the government contracting space. For U.S. companies seeking federal contracts, ISO 9001 can improve pre-qualification scores, reduce risk perceptions, and help secure long-term, high-value business.

At QMII, we have over three decades of experience helping businesses implement ISO 9001 systems tailored for real-world performance. Whether you’re bidding on your first government contract or looking to improve your existing system, we can guide you through every step of the certification journey.Ready to assess your readiness for ISO 9001?
Download our free Action Planning Checklist and take the first step toward securing more government contracts with confidence.

Integrating Standards for Safe Nuclear Expansion

-by Dr. IJ Arora

As nuclear energy regains attention as a low-carbon solution, organizations developing these energy sources need to consider a systems approach to the safe launch and growth of facilities. Once considered a great alternative to gasoline and coal, the nuclear energy industry’s growth was negatively affected by incidents like those at Chernobyl and Three Mile Island.

In this short article, I will attempt to convey that customer focus (clause 5.1.2 of ISO 9001:2015) is best ensured by proactive, not reactive, measures. This can be achieved through appreciating hazards, converting them to risks, prioritizing them, and planning the management system to achieve desired objectives.

Having served on a nuclear submarine and been on board when a nuclear accident took place, I know the pros and cons of this energy source. However, the world has changed since these tragic incidents and now there are advancements in not only nuclear technology but also in the management of nuclear facilities. ISO 19443:2018 a quality management system (QMS) standard built on the foundation of ISO 9001, but which is specific to the management of nuclear facilities. For those in the United States, ASME offers the NQA-1:2024 standard which is similarly dedicated to the nuclear industry.

Nuclear energy is perhaps an answer to the world’s power requirements. The demand for electricity is growing by the day with the extensive use of artificial intelligence and large data centers. A systems approach to management of this industry gives the world the best chance to appreciate risks systematically and plan for consequences proactively.

Grave negative effects to safety, security, health, and the environment are all likely consequences if a nuclear mishap takes place once again. Although the primary objective of a QMS is to get the desired output, it should not be at the cost of these potential harms.

The Three Mile Island facility is in the news once again for re-opening ahead of schedule. For those who do not remember, on March 28, 1979, a partial meltdown occurred at the Unit 2 reactor outside of Harrisburg, Pennsylvania. Environmental impacts included the release of radioactive gases into the atmosphere (albeit in limited amounts), long-term challenges in radioactive waste storage, and site contamination. Additionally, there were psychological and social effects that caused a loss of public trust in the nuclear energy industry.

As discussions emerge about reopening the Three Mile Island facility (now scheduled by 2027), evaluating its environmental effects through the lens of the ISO 14001:2015 environmental management system (EMS) is both prudent and proactive. Therefore, in the following section, I will outline the relevant applicable clauses from ISO 14001:2015.

Applicability of ISO 14001:2015 to a nuclear facility

Clauses 4.1 and 4.2, “Context of the Organization” and “Needs and Expectations of Interested Parties”

Nuclear facilities would benefit from considering:

  • Historical context (e.g., past accidents and public concern)
  • Stakeholders such as regulatory bodies, local communities, and environmental NGOs
  • Emerging media reports and public opposition or support as environmental risk indicators

Clause 6.1, “Actions to Address Risks and Opportunities related to Significant Environmental Aspects”

Considering a lifecycle approach, a reopened nuclear plant must assess:

  • Emissions of ionizing radiation
  • Spent fuel storage and long-term waste management
  • Thermal pollution from coolant discharge
  • Accident and emergency scenarios
  • And other significant environmental aspects requiring control measures and documentation

Clause 6.1.3, “Compliance Obligations”

This subclause involves alignment with:

  • Nuclear Regulatory Commission (NRC) rules
  • EPA guidelines on radiological impacts
  • International agreements on nuclear safety and waste

Clause 6.1.4, “Planning Action”

The plant must establish plans to:

  • Prevent recurrence of accidents like those of March 28, 1979
  • Contain and manage radioactive leaks
  • Mitigate environmental risks in both normal and abnormal operating conditions

Clause 8.2, “Emergency Preparedness and Response”

This subclause includes details critical for a nuclear facility and requires:

  • Detailed emergency response procedures for nuclear accidents
  • Training for first responders and public communication plans
  • Coordination with local and federal emergency management agencies

Clause 9.1.1, “Monitoring, Measurement, Analysis, and Evaluation”

To meet the requirements of this subclause, facilities must continuously monitor:

  • Radiation levels in air, water, and soil
  • Effectiveness of containment systems
  • Compliance with regulatory thresholds

Clause 10.1, “Nonconformity and Corrective Action”

This subclause would require that:

  • Any incident or near-miss must trigger a formal investigation
  • Includes lessons learned from:
    • The March 28, 1979 event itself
    • Any deviations during recommissioning or startup

A system approach to nuclear facility management

The opening (or, in this case, reopening) of a nuclear facility offers an opportunity to integrate modern management system practices with lessons learned from the past. ISO 19443:2018 and ISO 14001:2015 provide a structured framework to manage the needs of nuclear operations as well as public environmental concerns.

During my time consulting for numerous industries, I have found a strengths, weaknesses, opportunities, and threats (SWOT) analysis to be a very useful tool— especially the weaknesses and threats that help identify risks. A detailed SWOT analysis for the Three Mile Island facility might provide the following inputs as an example:

Technical and operational risks: aging infrastructure

  • Although it was not the site of the 1979 meltdown, Unit 1 is more than 50 years old.
  • Restarting involves complex retrofits, control system upgrades, and re-licensing—all of which require time and precision.
  • Rushing these checks might lead to overlooked fatigue, corrosion, or component failures.

Human factors

  • Post-incident, nuclear workforce training and institutional memory may be weak.
  • Skilled nuclear operators must be retrained or recruited, and hasty onboarding increases the chance of human error—a factor in many historical nuclear mishaps.

Environmental risks: radioactive emissions and waste

  • Restarting means handling spent fuel, coolant systems, and storage pools.
  • Hurrying these operations risks could lead to:
    • Leaks during fuel handling or containment failures
    • Inadequate radioactive waste protocols

Ecosystem disruption

  • Cooling systems may discharge thermal pollution into nearby rivers.
  • Emergency preparedness might not be fully revalidated for post-reopening conditions.

Better alternatives to a rushed restart

Although early reopening offers incentives like energy security, carbon reduction, and economic revival, these gains are precariously balanced against high-impact risks that could derail long-term viability. The strengths and opportunities may only be fully realized with a controlled, phased, and transparent approach, not through acceleration that bypasses environmental, technical, and social due diligence.

As such, organizations pursuing the development of nuclear energy plants must consider:

  • Phased reopening with public oversight
  • Third-party safety audits after at least two cycles of internal audits post implementation of the management system
  • Full-scale emergency drills and community outreach prior to operation
  • Independent environmental impact assessments (EIA)

Conclusion

The benefits of a fast reopening exist, however, the risks far outweigh short-term gains unless stringent safety, regulatory, and public engagement protocols are followed. Strategic value lies in measured and transparent activation/reactivation, not haste. ISO 14001:2015, ISO 19443:2018, and ASME NQA-1:2024 provide the framework for an integrated management system.

In conclusion, I would say a good strategy to implement and to safely accelerate nuclear energy deployment must include the adoption of a management system. ISO 14001:2015 ensures environmental responsibility and community accountability; ISO 19443:2018 drives quality, culture, and nuclear-supplier discipline; and ASME NQA-1:2024 enforces technical rigor and traceable QA processes. Together, these standards offer a comprehensive, risk-based, and stakeholder-aligned approach.

Rushing implementation without such integration would leave critical blind spots. An integrated implementation roadmap including these standards could guide the strategic and operational implementation in support of safe, controlled nuclear energy expansion.

The article was recently published in “The Auditor” An Exemplar Global Publication.

Types of Challenging Auditees – and How to Engage Them Effectively

– by Julius DeSilva

In every audit, auditors will encounter a diverse range of personalities—some cooperative, others a bit more complex. Understanding and managing these interactions is a core skill, particularly when auditees inadvertently—or intentionally—create barriers to transparency. Here are the most common types of challenging auditees, and expanded strategies on how to engage them effectively.

1. The One Word Wonder

Characteristics:

  • Offers short, clipped answers.
  • Rarely expands on details unless specifically asked.
  • May be uncomfortable, anxious, or disengaged.

Enhanced Strategies:

  • Build rapport early: Start with informal, low-stakes conversation before diving into audit questions. A simple “How long have you been with the company?” can ease tension.
  • Use layered questioning: Follow up “Yes/No” questions with: “Can you walk me through how that works?” or “What happens next?”
  • Prompt with context: “When I reviewed the procedure, it mentioned X—how is that handled in your area?”
  • Be patient and unhurried: Silence is a tool. After a question, wait calmly. Many reserved auditees will fill the silence with additional information if not interrupted.

2. The Egoist

Characteristics:

  • Seeks to dominate the conversation.
  • May condescend or subtly undermine the auditor’s authority.
  • Talks more about theory than actual practice.

Enhanced Strategies:

  • Acknowledge their expertise: Use phrases like “You clearly have deep experience in this process” to soften defensiveness.
  • Redirect focus to conformity: “That’s a great point. Let’s tie it back to what the standard requires and how your team demonstrates that.”
  • Anchor with facts: Use documentation and objective evidence as neutral ground—“Let’s take a look at the latest calibration log to verify that.”
  • Avoid debates: Don’t match ego with ego. Instead, maintain a calm, confident presence grounded in your role and purpose.

3. The Perfectionist

Characteristics:

  • Presents carefully curated documents.
  • May try to steer you away from real-time observations.
  • Views any finding as a personal failure.

Enhanced Strategies:

  • Normalize findings: “It’s common for systems to evolve, and audits are a way to support that continuous improvement.”
  • Use the PDCA approach: Frame observations as part of the cycle—”This finding shows an opportunity to adjust and refine the process.”
  • Request real-time demonstrations: Ask to observe actual practices in the workplace—not just documentation—to validate implementation.
  • Showcase positive practices: Where applicable, cite strengths during the audit to balance critique and support their desire for excellence.

4. The Over-Talker

Characteristics:

  • Provides excessive detail, often going off-topic.
  • Turns simple answers into storytelling sessions.
  • May genuinely enjoy the audit—or be trying to obscure weak spots.

Enhanced Strategies:

  • Set time expectations upfront: “We’ve got 30 minutes scheduled to cover this section, so let’s focus on the core areas first.”
  • Use summary statements: “So, to confirm, your process begins with A, goes through B, and ends at C—is that correct?”
  • Politely interrupt: “Sorry to cut in—I just want to make sure we stay on track. Can you show me the documentation for that step?”
  • Assign structure: Give the auditee a format to follow. “Can you explain this in three steps—input, action, output?”

5. The Ghost

Characteristics:

  • Avoids being present.
  • Pushes responsibility to others.
  • Responds only under pressure.

Enhanced Strategies:

  • Secure buy-in from leadership: During opening meetings, confirm auditee availability and responsibilities with senior management.
  • Use formal scheduling tools: Calendar invites, email confirmations, and audit plans in writing create accountability.
  • Document delays diplomatically: If access is denied or delayed, note this in the audit record professionally.
  • Adapt and improvise: Shift to records review or interview other personnel if the primary auditee is unavailable. Highlight systemic access issues in findings if applicable.

6. The Nervous Novice

Characteristics:

  • Easily flustered.
  • May fear saying the “wrong thing.”
  • Often new to audits or in a junior role.

Enhanced Strategies:

  • Create a low-pressure environment: Explain that the audit is not a test of their personal performance.
  • Break questions down: Instead of asking “How does your process ensure compliance with Clause 8.5.1?”, ask “What’s the first step you take when starting this task?”
  • Avoid audit jargon: Use plain language, e.g., “How do you make sure things are done the right way every time?”
  • Reassure through transparency: Let them know what you’ll be asking and why. “Next, I’d like to look at how you manage incoming materials—is that okay?”

Final Thoughts: Mastering the Human Element of Auditing

At its core, auditing is not just about finding nonconformities—it’s about understanding how people interact with systems. Every auditee, no matter how challenging, offers insight into how the organization truly functions. As auditors, our role is not to judge personalities but to uncover evidence that reflects the effectiveness of processes. This requires patience, emotional intelligence, and a steady commitment to impartiality.

By adapting our approach to the individual while remaining anchored in the audit objectives, we build credibility and foster cooperation—even in the most resistant environments. Ultimately, the success of an audit is measured not only in findings, but in the quality of the dialogue, the clarity of the evidence, and the positive influence it has on continual improvement. A skilled auditor doesn’t just complete a checklist—they leave behind a stronger, more self-aware organization.

The article was recently published in “The Auditor” An Exemplar Global publication.