Are Provider Audits Mandated through ISO 9001?

by- Dr. IJ Arora

In relation to outsourced processes, the query (to paraphrase William Shakespeare) is, “To audit or to not audit?”

Take, as an example, the necessities from the principle process-based control machine usual, ISO 9001:2015. One would possibly imagine the machine way as equipped in clauses 4.4.1a thru 4.4.1h and conclude that tracking and regulate are had to recognize the dangers of the inputs and make sure persistent growth. The usual is supposed to be interpreted, and so not anything prescriptive is predicted. But, the query stays as to how organizations would possibly regulate the processes and ensure they’re assembly goals. Clause 5.2, “Coverage,” resulting in clause 6.2, “Goals,” supplies a touch that proof will have to be amassed of measurable goals being met. But, how can we get the inputs to attract a conclusion? The inputs are essential, and due to this fact there’s a want to decide the to be had accumulate and regulate knowledge.

In all probability the solution may also be discovered within the auditing serve as. By means of enforcing a strong provider analysis activity, together with audits as wanted, organizations can beef up the standard control machine and construct sturdy, dependable relationships with providers. Notice that requirements similar to ISO 9001:2015 don’t particularly mandate audits, but the intent of registration to a typical is to regulate the group’s processes. if now not auditing, then what different mechanisms can organizations use to regulate an outsourced activity and decrease dangers to their finish consumers?

Exerting regulate

Clause 8.4.2 of ISO 9001:2015 offers with the sort and extent of controls that a company should practice to externally equipped processes, merchandise, and products and services. The important thing sides on this dialogue come with making sure conformity, the kinds of controls wanted, and the level of those controls. Conformity has at its core the main to make sure that those exterior provisions don’t negatively have an effect on the group’s skill to constantly ship conforming services to its consumers. This implies the group should have mechanisms in position to make sure that the standard of the exterior inputs meet the group’s necessities and in the end fulfill buyer necessities.

Kinds of controls might be interpreted as acting a point of regulate, in all probability through auditing, even supposing auditing isn’t a selected requirement. The choice and analysis of the controls can be according to organising standards for deciding on and comparing exterior suppliers (e.g., a strong high quality control machine of their very own, previous efficiency, registration, and many others.) and/or undertaking thorough checks of doable providers (e.g., audits, questionnaires, web site visits, and many others.). As well as, you will need to installed position sturdy contractual agreements with exterior providers that come with transparent and measurable necessities, explicit key efficiency signs (KPIs), and acceptance standards for the needs of tracking and size. This may come with monitoring provider efficiency towards agreed-upon KPIs, examining knowledge to spot tendencies and spaces for growth, undertaking common efficiency critiques and comments classes, acting root purpose research and corrective and preventive movements when problems are known, and appreciating dangers through being proactive and the use of preventive measures.

The level of this regulate would rely at the criticality of the externally equipped activity, product, or provider to the group’s general high quality. For top-risk pieces, extra stringent controls (e.g., extra common audits or extra rigorous inspections) could be essential as, as an example, within the aerospace trade. In essence, clause 8.4.2 emphasizes the significance of proactive measures to make sure that exterior inputs don’t compromise the group’s skill to ship high quality services to its consumers.

Auditing supplies most of these inputs if the audit is appropriately deliberate and done. For instance, with approval, this stage of regulate might be completed through far flung cameras or the presence of the group’s inspectors on the provider’s amenities. The purpose is to care for the client focal point (clause 5.1.2) and include a risk-based way. The level of regulate will have to be proportionate to the related dangers. Power growth includes that the group will have to often evaluation and reinforce its processes for exterior controls.

Subsequently, even if clause 8.4 (particularly subclauses 8.4.1, 8.4.2, and eight.4.3) does now not explicitly mandate provider audits, it strongly implies their significance. Subsequently, a robust focal point on regulate should be interpreted. Clause 8.4 emphasizes the want to regulate externally equipped processes, merchandise, and products and services. Auditing is a a very powerful instrument for comparing a provider’s skill to fulfill high quality necessities and care for regulate over their processes.

Mitigating menace

To verify ok menace control, one should imagine if the provider’s efficiency at once impacts the group’s skill to ship high quality merchandise or products and services. Audits assist establish and mitigate doable dangers related to the use of exterior suppliers. Power growth is the most important consequence of auditing and offers precious comments on provider efficiency. This allows the group to spot spaces for growth of their processes and their practices round provider variety and provider control. Subsequently, even if now not strictly mandated, provider audits are extremely really useful for organizations in the hunt for to successfully put into effect ISO 9001 and make sure the standard in their services. The important thing issues can be:

  • Chance-based way. Auditing efforts will have to be desirous about providers that pose the easiest menace to the group’s high quality goals.
  • Number of analysis strategies. Audits are only one manner of provider analysis. Different strategies come with efficiency tracking, comments research, and web site visits.
  • Documentation. Care for transparent documentation of all provider analysis actions, together with audit findings, corrective movements, and growth plans.

When taking into consideration the outsourcing of a activity, the group should assess and decide the factors through which providers are decided on. Via systematic analysis, a company can put into effect a rigorous provider variety activity that comes with:

  • Detailed questionnaires to collect knowledge at the provider’s high quality control machine, processes, and features
  • Reference exams made through contacting earlier consumers to evaluate the provider’s efficiency and reliability
  • On-site visits to watch the provider’s operations and assess their amenities, apparatus, and body of workers
  • A risk-based way matrix to prioritize providers according to the possible impact at the group’s high quality goals

In making plans bids, growing contractual agreements, or different processes involving outsourcing, the next will have to be regarded as:

  • Transparent specs. Outline transparent and measurable necessities for the outsourced services or products.
  • Efficiency metrics. Determine KPIs to trace provider efficiency, similar to on-time supply, defect charges, and buyer delight.
  • Contractual consequences. Come with clauses for non-compliance with contractual tasks, similar to past due deliveries or subpar high quality.

The procedures for tracking and measuring outsourced processes should be nicely idea out and will have to be carried out when tendering a freelance. Consider, including necessities due to this fact is continuously tricky. Imagine the next:

  • Common efficiency evaluation. Behavior common efficiency critiques with providers to trace their efficiency towards agreed-upon KPIs.
  • Knowledge research. Analyze knowledge on provider efficiency, similar to defect charges, supply instances, and buyer proceedings to spot tendencies and spaces for growth.
  • Comments mechanisms. Determine a machine for gathering and examining comments from interior and exterior consumers relating to provider efficiency.

Whether or not a company prefers to audit or use different way of controlling the outsourced activity, a well-thought-out collaboration and verbal exchange plan will have to be made, taking into consideration:

  • Open verbal exchange channels. Care for open and common verbal exchange channels with providers to deal with issues, percentage knowledge, and collaborate on growth tasks.
  • Joint drawback fixing. Paintings collaboratively with providers to spot and unravel problems associated with high quality, supply, or different efficiency issues.

Power growth is integral to any excellent control machine. As a abstract I’d recommend the next:

  • Common critiques and updates. Often evaluation and replace your provider control processes to verify they continue to be efficient and aligned with converting industry wishes.
  • Provider construction. Enforce methods to assist providers reinforce their high quality control programs and function.

By means of enforcing a mixture of those mechanisms, organizations can successfully regulate outsourced processes, decrease dangers, and make sure that they obtain fine quality services from their providers.

Clause 9.2.1 of ISO 9001 does certainly recommend that auditing outsourced processes is excellent follow. This clause states that organizations will have to habits interior audits to guage the effectiveness of the standard control machine. The scope of interior audits generally comprises all related processes and actions inside the group. How this pertains to outsourced processes is the place the requirement turns into open to interpretation. Despite the fact that it does now not explicitly state “provider audits,” the clause means that comparing the effectiveness of processes which might be outsourced is a part of assessing the total effectiveness of the QMS. If the outsourced processes considerably have an effect on the group’s skill to fulfill buyer necessities, then the ones processes will have to be integrated within the scope of interior audits.

Dr. IJ Arora’s article was published in the Exemplar Global Publication “The Auditor”. Click here to read the featured article.

The Baltimore Bridge Collapse—Another Case of a Failed Management System

By – Dr. IJ Arora

Can good management systems make organizations immune to disasters? The Baltimore bridge (or, more precisely, the Francis Scott Key Bridge) collapsed in 2023 because the container vessel MV Dali collided with it. This was a tragedy, perhaps caused by the failure of several management systems, the ship, the port, the state, and whoever else was involved.

The National Transportation Safety Board (NTSB) investigation is ongoing, and will no doubt look at the part played by MV Dali, its crew, and its operator. However, my thought is that MV Dali or other ships plying the waters should have, by simple statistical probability, been considered as risks by the authorities. Between the water channel, the high number of ships sailing in and out regularly, and the bridge itself, there was likely to be an collision someday. Perhaps it was not a matter of if, but when! Therefore, should the bridge have been better designed and made safer based on these known and appreciated risks? After all, not all accidents can be completely avoided, but each tragedy has lessons learned as responsive action. The lessons become the data that drives risk identification and trends, thus making the system proactive. I am sure the NTSB is considering all this. In the meantime, without going into the ongoing investigation, there would seem to be some basics which are common indications of systemic failures. Be it the Titan submersible, or the Boeing management system,  as a subject-matter experts in  process-based management systems, I see a common cause: the failure of the system to  deliver conforming products and services.

In this short article, I want to discuss this bridge collapse in the context of the management system, considering ISO 9001:2015 generically and the requirements of ISO 55001:2024—“Asset management—Vocabulary, overview and principles” specifically. ISO 55001 was first published in 2014. It was developed as a standalone standard for asset management, building upon the principles of ISO 9001 and other relevant standards.

Could simply designing a good system based on the standard have enabled the organization to better assess the associated risks? Perhaps they were assessed, and a bridge allision was considered an extremely low-probability occurrence. If that were the case, the discussion would be on prioritization of risks.

As of the time of this writing (September 2024), the investigation into the Baltimore bridge collapse is still ongoing, and the lawsuits are starting to fly. Although the exact cause of the collapse remains under investigation, we can consider several factors that might have contributed to the incident. MV Dali experienced a series of electrical blackouts before the allision. The implementation of the vessel’s safety management system (SMS, based on the ISM Code) could be a factor. The stability, age, and condition of the bridge are, I am sure, being investigated as a potential contributing factor. Then, there is always human element. There may have been errors on the part of the ship’s crew or the bridge’s operators. Was the SMS designed to support them in such a scenario? What factors may have caused operators at all levels to perhaps not follow requirements and mitigate the risks? The NTSB’s investigation will highlight a detailed analysis of the ship’s navigation systems, the bridge’s structural integrity, and the actions of the individuals involved in this tragedy. Their final report will provide a comprehensive understanding of the incident and may include recommendations to prevent similar occurrences in the future.

However, even at this stage we can agree that bridges in general are national assets. They are valuable infrastructure that provides essential services to communities. Although it is not publicly known whether the state of Maryland specifically implemented ISO 55001 for its bridges, the principles and practices outlined in this standard could have been beneficial in managing the risks associated with the Baltimore bridge. Through the implementation of this standard (and/or ISO 9001), the authorities could have performed:

  • Risk assessments. ISO 55001 requires organizations to conduct regular risk assessments to identify potential threats and vulnerabilities. A thorough assessment of the bridge’s condition, age, and traffic load could have helped identify potential risks and inform maintenance and repair decisions, as could have changes in procedures, protection of navigation channels, and so on.
  • Lifecycle management. The standard emphasizes the importance of managing assets throughout their entire lifecycle, from planning and acquisition to maintenance and disposal. By following ISO 55001, the state could have developed a comprehensive plan for the bridge’s maintenance, upgrades, and eventual replacement.
  • Performance measurements. ISO 55001 requires organizations to establish measurable objectives or key performance indicators (KPIs) to measure the effectiveness of their asset-management activities. This could have helped the state monitor the bridge’s condition and identify any signs of deterioration.
  • Continual improvement. The standard promotes a culture of continual improvement, encouraging organizations to learn from past experiences and make necessary adjustments to their asset-management practices.

It is impossible to say definitively whether ISO 55001 would have prevented the Baltimore bridge collapse. However, the principles and practices outlined in the standard could have helped to reduce the risk inherent in such incidents. By adopting a systematic and proactive approach to asset management, organizations can improve the reliability and safety of their infrastructure. A systematic study must go beyond what the MV Dali contributed to the Baltimore bridge collapse; it is also important to consider the broader context and the potential contributions of other factors:

  • Bridge design and maintenance. The age and condition of the bridge are likely to be factors in the investigation. Older infrastructure may be more susceptible to damage or failure, especially if it has not been adequately maintained or upgraded.
  • Vessel traffic. The frequency and intensity of vessel traffic in the area can also influence the risk of allisions. The bridge is in a busy shipping channel; therefore, the likelihood of incidents was higher.
  • Safety measures. The presence or absence of safety measures such as buoys, warning systems, or restricted areas can also affect the risk of allisions. This needs to be studied and are factors the authorities would know.
  • Human elements and factors. Errors on the part of both the ship’s crew and bridge operators can contribute to accidents. Factors such as fatigue, inexperience, or inadequate training may play a role. What led to these issues? Error proofing, mistake proofing, and failure mode and effects analysis (FMEA) are tools that could be part of the effective management system.

Let us therefore consider ISO 55001 and the relevant clauses of the standard which could apply to the collapse of the Baltimore bridge.

Clause 4—Context of the organization

  • Clause 4.1—Understanding the external context, such as the age of the bridge, traffic volume, and environmental factors, is crucial for risk assessment.
  • Clause 4.2—Identifying the needs and expectations of relevant interested parties, including the public, commuters, and regulatory bodies, is essential for effective asset management.

Clause 6—Planning

  • Clause 6.2.1—The bridge’s asset management plan should have included clear objectives for its maintenance, repair, and replacement.
  • Clause 6.2.2—Specific objectives related to safety, reliability, and cost-effectiveness should have been established.
  • Clause 6.2.3—Detailed planning for maintenance, inspections, and upgrades would have been necessary to ensure the bridge’s structural integrity.

Clause 7—Support

  • Clause 7.1—Adequate resources, including funding, personnel, and expertise, should have been allocated for bridge maintenance and inspection.
  • Clause 7.2—Ensuring that personnel involved in bridge management have the necessary competence and training is essential.
  • Clause 7.3—Raising awareness among all relevant stakeholders about the importance of bridge maintenance and safety is crucial.

Clause 8—Operation and maintenance

  • Clause 8.1—Regular inspections and monitoring of the bridge’s condition would have helped identify potential problems early on.
  • Clause 8.2—A well-defined maintenance schedule, including preventive and corrective maintenance, would have been necessary to address issues before they escalated.

Clause 9—Performance evaluation

  • Clause 9.1—Establishing KPIs to measure the bridge’s performance, such as safety records, traffic flow, and maintenance costs, would have provided valuable insights.
  • Clause 9.2—Regular monitoring and evaluation of these KPIs would have helped identify areas for improvement.

Clause 10—Improvement

  • Clause 10.2—The bridge’s management should have implemented a system for monitoring and measurement, including data collection and analysis.
  • Clause 10.3—Predictive maintenance techniques could have been used to identify potential failures before they occurred.

My objective in writing this article is help demonstrate that by applying the principles of a standard, be it generic ISO 9001 or a more specific standard (as in this case, the asset-management system standard ISO 55001) the organization (in this case the state of Maryland) could have strengthened its asset-management practices and potentially mitigated the risks associated with the Baltimore bridge collapse.

The above article was recently published in the Exemplar Global publication – ‘The Auditor’.

Excellence in Auditing Presented by Dr. IJ Arora for Exemplar Global

“How Auditing Helps Prevent Tragedy,” presented by Dr. IJ Arora with Wendy Edwards (Project Director of Exemplar Global) at the Exemplar Global’s Excellence in Auditing Expo!

Click the link here to understand the critical role auditing plays in averting potential disasters. Whether you’re in risk management, quality assurance, or simply interested in safety and security, this discussion offers valuable perspectives and actionable takeaways.

Link to the Presentation

Can Boeing Deliver a Long-Term Solution to their 737 MAX Problems?

Dr. IJ Arora

Boeing is in the spotlight again with its 737 MAX planes, which have already had a deeply troubled history. Customer focus (which is clause 5.1.2 of ISO 9001 and AS9100) seems to have been lost somewhere.

I have read several recent articles on these incidents as well as Peter Robison’s book Flying Blind: The 737 MAX Tragedy and the Fall of Boeing, all of which point to a worsening situation for Boeing. The public perception of this great American company, which has always been committed to top-class engineering and trusted products, is changing from one of respect to one of caution. Travelers are wondering, “Should I fly in a 737 MAX?”

Boeing and the aerospace industry in general have high standards for quality and product safety. In this article, I postulate whether a company’s quality management system can guarantee that nothing goes wrong for customers. Can it ensure perfection? If not, what are the alternatives—and why have one at all?

What happened and who is responsible?

For those not familiar with the 737 MAX incident in January, shortly after an Alaska Airlines flight departed from Portland, Oregon, a cabin door panel blew off. As investigations are still ongoing the causes have not yet been fully determined. Boeing also had a software issue on the 737 MAX, resulting in the crash of a Lion Air flight in 2018 and an Ethiopian Airways flight in 2019.

Here in the United States, the Federal Aviation Administration (FAA) plays a critical role in providing regulations to ensure flight safety, and also provides oversight of aircraft manufacturers, airports, and maintenance providers. In the case of the Alaska Airlines flight, it seems that the FAA failed to uphold its trusted role. The FAA’s numerous checks and balances, most of which are intended to focus on customer safety, were like aligning holes in slices of Swiss cheese. It will be interesting to see what changes this incident brings about at the FAA. Then again, can regulatory oversight guarantee safety of flight?

The AS9100 standard, which is specific to the aerospace industry, isn’t the brainchild of a single entity, but rather a collaborative effort driven by two key players:

  1. The International Aerospace Quality Group (IAQG). This international organization brings together representatives from aviation, space, and defense companies across the Americas, Asia/Pacific, and Europe. They actively participate in developing, maintaining, and updating the AS9100 standard.
  2. Standardization organizations. These bodies, such as the Society of Automotive Engineers (SAE) in the Americas and the European Association of Aerospace Industries (now the AeroSpace and Defence Industries Association of Europe), officially publish and distribute the standard.

It is important to note that AS9100 builds upon the foundation of the more general ISO 9001 quality management system standard. While ISO 9001 lays the basic framework, the IAQG adds industry-specific requirements crucial for ensuring safety and quality in the aerospace domain.

In addition to the manufacturer and the FAA, the owner/lessor of the aircraft also plays a role in ensuring the plane is properly maintained. This includes selecting a competent maintenance provider, hiring competent engineers, and having robust processes in place. With so many different stakeholders, can blame be attributed to just one when accidents happen? Furthermore, should blame be the name of the game? Perhaps not! It is important to note that the system is implemented to support each user and that all stakeholders in the value chain play their part as well.

Audits, inspections, and management systems: Are these the solution?

Behind every tragedy, casualty, and mishap is a chain of related events. The immediate suspect when these types of critical failures occur are poor inspection protocols, perhaps even the dreaded “human error.” However, this may be the low-hanging fruit and a deeper dive may identify other causal factors, such as asking if the quality audit failed.

What is the difference between an audit and an inspection? Can they replace each other or are inspections alone enough? The simple answer is no! Both are needed due to fundamental differences in approach. Audits look at the processes to ensure the management system produces conforming products and services. An efficient management system must include the following, to name a few:

  • It must be well-defined, starting with the “as-is” state of the system.
  • Risks must be identified (clause 6.1) based on the context of the organization (clauses 4.1 and 4.2).
  • A clear definition of the product must be identified.
  • Effective audits and periodic review must be undertaken by management.
  • Outsourced processes must be controlled.

Inspections play an important role by identifying defects prior to release, thus protecting not only the client/customer/user/warfighter, etc., but also the reputation of the organization itself. With that said, inspections don’t contribute to continual improvement because they focus on fixes as opposed to long-term solutions. In effect, they do not really add value since the organization has already incurred the cost of producing the defective part or product. The creators of the Toyota Production System (i.e., lean) came up with the Andon process to catch a defect as early in the process as possible so as to fix it before the problem went too far down the line.

Management systems are not just a collection of documents. To function properly, they require commitment at all levels of the organization, including top management providing the needed resources. It takes time to build a culture of quality in which shortcuts are avoided and there is no fear of speaking up. Customer focus must not be compromised. For example, release of conforming product should go through the process specifically called out by clause 8.6; any interference by top management to truncate this process would imply the loss of customer focus. Is this a possibility? Perhaps, but the investigation must reveal the truth. In this case of the Alaska Air incident both the Boeing customers and Boeing as a company have suffered. It is my hope that investigators will identify all failed parts of the system from each responsible party. These may include not only failed inspections, but also suboptimal processes. This could end up taking us back to an inadequate quality management system.

Quality management systems: Can they deliver?

Given the above, can a properly designed and well-audited management system (supported by good inspection techniques to help ensure conforming product) guarantee that nothing goes wrong with an organization’s output? My opinion is that no one can guarantee this completely. However, risk can certainly be greatly reduced when everything is implemented well. This includes the training of personnel, which correlates strongly to competence; unfortunately, this is often the first budget to get cut when resources are scarce.

When high-visibility incidents like these occur, it may be forgotten that airplanes remain the statistically safest mode of travel on earth. This is primarily due to robust quality management systems, well-adopted regulatory frameworks, and regular oversight. Humans play an important role in the success of the management system, from the commitment at the top to the buy-in by the workforce (clause 5 to clauses 7.1.3, 7.1.4, and 10.3). Taken together, this helps create an environment where quality can flourish within the organization.

Boeing may be doing a lot correctly, and yet the results could be unacceptable depending on the performance of outsourced processes (clauses 8.41/8.4.2/8.4.3). After all, the fuselages for the 737 MAX are made by Spirit AeroSystems Holdings Inc. Spirit AeroSystems is located in Wichita, Kansas; once these fuselages are manufactured, they are shipped by rail to Boeing’s facility in Renton, Washington. Therefore, not only is a major component of the 737 MAX outsourced, but the shipping and preservation of product (clause 8.5.4) also could contribute to the product’s nonconformity. Overall, Boeing remains responsible for the entire supply chain (clause 4.3), with their obligation to “ensure conformity of its products and services and the enhancement of customer satisfaction.”

Even with a solid quality management system in place, this or similar failures can occur. There is no way to assure the public of 100-percent performing (i.e., perfect) output. The fear in the minds of air travelers is valid and will remain so until an exhaustive root cause analysis of this issue is performed and those root causes are resolved. The current events beg the question: Did Boeing improve their management system after the Ethiopian Airlines 737 MAX crash? If they had bent to the oars and gone deep into their review to uncover and permanently fix the holes in their management system, this event may never have occurred. Surface corrections, or what some organizations call “fix -it” solutions, only remove the symptoms. The root causes must be addressed and resolved (clause 10.2.1). There are no shortcuts to quality.

In conclusion

It has taken years for air travelers to feel safe and unconcerned about air safety. I travel a lot internationally, and often pick an airline based on their service and comfort, but now I (as well as the broader public, I would imagine) need to consider which aircraft will transport us. It is a new fear about product safety that has its genesis in Boeing not operating its management system efficiently and losing customer focus. The worst is the erosion of public confidence in federal oversight and its intent to keep the customer safe.

I have spent my life studying similar complex problems and leading teams in helping organizations find long-term sustainable solutions. This requires bold and dynamic leadership (clauses 5.3 and 5.1) for leaders to plan and implement change. Appreciating and accepting risks (i.e., keeping the customer in focus) and moving forward is integral to true leadership. Ethics is still not a clause of ISO 9001 and AS9100, but ethical leadership is about doing the correct thing for all stakeholders.

In seminars at which I present, I often ask senior managers: “If you have a choice between following the procedure and/or doing the correct thing, what would you do as a leader?” The answer—I hope—is to do the correct thing at all times. But then, hope is not a plan. Air safety cannot be based on hope and faith. Boeing needs the leadership to redesign their system if they are to bring the public trust back for this great American company.

Hyperlink to the thing characteristic in Exemplar International e-newsletter – “The Auditor”

10 Steps to Safeguard Maritime Property from Cybersecurity Threats

IJ Arora, Ph.D

Cybersecurity threats have become a pressing concern in the modern era due to our lives becoming increasingly dependent on computerization. However, with the convenience of technology comes vulnerability to malicious attacks. The maritime industry, with a growing reliance on technology, faces significant cybersecurity threats. Dr. Jekyll and Mr. Hyde (i.e., good and bad) exist and have always existed. Protecting against cyberattacks is crucial to ensuring the industry’s stability and security.

Understanding cybersecurity in the maritime industry

Cybersecurity in the maritime sector involves safeguarding systems, information, and assets from unauthorized access, disruptions, or manipulations. The industry’s growing reliance on technology, including networks controlling essential functions like navigation and communication, makes it an attractive target for cybercriminals. To maintain business continuity, it is crucial that companies assess their current cybersecurity posture and act to proactively improve it. The maritime industry supports trade and the economy at large, so a cyberattack can have broader consequences beyond just affecting a single vessel or company. For this reason, the intent of the attackers might be broader than simply affecting a specific entity for ransom.

Current challenges in maritime cybersecurity

Before delving into the 10 essential steps to fortify against cyberthreats, it’s crucial to acknowledge the prevalent challenges faced by the maritime industry, which include:

  • Business continuity disruption due to breaches
  • Lack of comprehensive response plans
  • Growing reliance on automation
  • Insufficient awareness
  • Vulnerabilities in cloud computing
  • Rise in phishing and social engineering attacks
  • Internal threats and attacks

Controlling both information technology and operational technology systems is critical to fortifying cybersecurity. Various systems within the small passenger-vessel sector are susceptible to cyberthreats, including bridge systems, access control systems, passenger servicing and management systems, and communication systems.

The 10 steps

When addressing cybersecurity, organizations must consider protecting information itself as well as the asset on which that information is stored. Control of both information technology (IT) and operational technology (OT) systems is critical to fortifying cybersecurity. Additionally, management must consider the confidentiality, integrity, and availability of information and how these three aspects may potentially be compromised.

Step 1: Leadership commitment

Leaders must drive the need for cybersecurity and ensure that it is baked in (not buttoned on) to processes. They need to engage the workforce to contribute to the system. To do this, they can:

  • Appoint a cybersecurity manager to ensure accountability and garner buy-in.
  • Make cybersecurity integral to business processes and consider risks vs. rewards.

Step 2: Use a system framework

Employ the plan, do, check, act (PDCA) cycle as the foundation for a robust cybersecurity approach. This is also the approach prescribed by the Passenger Vessel Association (PVA) safety management system (SMS) framework.

  • Develop and regularly update cybersecurity policies aligning with organizational needs and threat landscape changes.
  • Identify clear roles and responsibilities for all concerned with cybersecurity aspects of the SMS.

Step 3: Contextualize risk

  • Consider the broader context of operations, trade patterns, technology, and legislative factors.
  • Identify stakeholders, online networks, assets, critical components, and business-sensitive information.

Step 4: Risk assessment (3D framework)

Leaving hazards in uncertain states is a drawback for proper risk assessment. It is the responsibility of leadership to convert uncertainty into clearly defined risks within the context of the organization and then prioritize those risks.

  • Organizations must assess hazards in terms of probability, severity, and the likelihood of detection.
  • Risks should be prioritized with consideration given toward confidentiality, integrity, and the availability of information.

Step 5: Build controls into processes

Controls can be split into various categories, including administrative, physical, human, and technological. In some cases one control may suffice, but for the most part a combination of controls must be applied. Identified controls should be implemented based on the feasibility rule, meaning that although they may look good in a vacuum, ease of implementation must be considered. Information security should be a part of everything the organization does—not an add-on. This includes:

  • Implementing technical security controls like firewalls and intrusion-detection systems.
  • Adopting a layered security approach (i.e., “defense in depth”) to effectively mitigate against various threats. This entails creating multiple barriers to prevent access to information—physical, passwords, firewalls, VPNs etc.

Step 6: Maintain basic measures

Basic safety measures are easy to implement and, for the most part, they are cost-effective. This can include cybersecurity awareness training for personnel, physical security, and password security. Below are a few more, although this is not an exhaustive list:

  • Keep hardware and software updated.
  • Enable automated antivirus and anti-malware updates.
  • Limit administrator privileges and control removable media.
  • Avoid public network connections without a VPN.
  • Regularly backup and test information-restoration capabilities.

Step 7: Employee awareness

It is important to make employees aware of the need for good cybersecurity protocols. Employees are often the weakest link in the security chain. Statistics show that almost 36 percent of data breaches are caused by employee negligence. Immediate actions organization can take include:

  • Educate employees on cybersecurity best practices to minimize human error.
  • Train personnel to identify phishing attacks and report incidents promptly.

Step 8: Emergency preparedness

No organization is immune to cyberattacks. It is important to have a plan in place for responding to attacks quickly and effectively. The plan should include steps for mitigating the damage, containing the attack, and investigating the incident. You can use ISO 22301: 2019, “Business continuity,” to develop this plan.

  • Your plan should include comprehensive processes for responding to cyberattacks swiftly and efficiently, including reporting mechanisms.
  • Test and improve your business continuity plan regularly.

Step 9: Assess effectiveness

The check stage of the PDCA cycle is vital to instill confidence in the effectiveness of the organization’s cybersecurity measures.

  • Conduct regular cybersecurity assessments, including third-party evaluations for objectivity.
  • Evaluate assets, vulnerabilities, IT/OT risks, physical access, and breach potentials.

Step 10: Continual improvement

  • Embrace continual improvement through the PDCA cycle to maintain vigilance.
  • Invest in training personnel on cybersecurity standards like ISO 27001.

Conclusion

Taking cybersecurity seriously and implementing these 10 steps can significantly mitigate the risk of cyberattacks. Begin the process by conducting a gap assessment using a qualified person to assess where your system currently stands and what actions need to be taken.

Your action plan should identify risks, gaps, and the controls needed. These controls can easily be integrated into the existing safety management system. Investing in cybersecurity today will better prepare your organization to manage future risks. Leadership involvement is crucial, and these steps serve as a solid foundation to effectively fortify cybersecurity measures.

About the author

Inderjit (IJ) Arora, Ph.D., is the President and CEO of QMII. He serves as a team leader for consulting, advising, auditing, and training regarding management systems. He has conducted many courses for the United States Coast Guard and is a popular speaker at several universities and forums on management systems. Arora is a Master Mariner who holds a Ph.D., a master’s degree, an MBA, and has a 33-year record of achievement in the military, mercantile marine, and civilian industry.

Above article is featured in the following:-

Foghorn Magazine

Exemplar Global Publication “The Auditor”

Looking Ahead at ISO 9001

ISO 9001 has proactively kept up with various industry expectations, over the years, to allow

application by a broad spectrum of industry including the defense forces. The 2015 revision was

a thoughtfully planned giant step. It defined risk (ISO 9001 Clause 6.1) in the context of the

organization (ISO 9001 Clause 4.1 & 4.2) and removed exclusions provision from certification by

redefining what an organization does not do or outsources in the scope (ISO 9001 Clause 4.3). It

also removed preventive action, a reactive concept, and introduced proactive risk appreciation

(Clause 6.1 of ISO 9001 & Clause 8.1 in industry specific standards as AS9100).

This took preventive action from the delayed “Act” stage of the PDCA (Plan-Do-Check-Act) stage

to the more logical sensible “Plan” stage. After all, “look before you leap”, as the historical

fundamental, could not be left as a preventive action decision. It had to be at the look – plan

stage! Risk also needed not just mitigation, but also acted as an input, to be used to bring in

innovation in terms of OFI (opportunity for improvement).

These were all positive steps in keeping with technical advancements and computerization and

AI (artificial intelligence) tools. The HLS (high level structure), later updated to HS (harmonized

structure), recognized the need to enable ease of implementation of integrated management

systems. This in turn leading to efficiency, ROI (return on investment) and where applicable

environmental protection, security of the global supply chain, business continuity, cyber

security and health and safety.

The differentiating of knowledge (ISO 9001 Clause 7.6) from competence (ISO 9001 Clause 7.2)

was also a clever needed change. Organizations needed to define their corporate knowledge

aspects and differentiate it from the individual knowledge of personnel. Knowledge and

competence needed merging and a healthy marriage but needed recognition that they were

different. Removal of the reference to Quality Manager (QM) and Quality Manual from the

standard, took away the narrowness of thinking in quality, and brought the clarity to leadership

to remain accountable and to differentiate authority delegation from retaining the

accountability.

I am a member of the TAG-176 group, and yet have not really contributed much to the next

expected changes to ISO 9001. I am sure the TC-176 is working on this. Nevertheless, it is time

to debate and consider updating the standard.

Since the 2015 version was a major fundamental change, I doubt there would be a significant

departure from this 2015 version in the next major update. Unlikely that the next version may

have revolutionary updates. The emphasis, I think would be to clarify and strengthen the

present thoughts in the 2015 version. I would consider the following:

1. Two Standard Concept: I have over the years thought about the two prongs:

manufacturing and service, approach. Both the service and the manufacturing industry

have been using the standard. Some may consider the need for a separate

manufacturing and a service standard as the next step. However, over the years I have

feared too much bureaucracy which the two standards approach brings. I think the two

standard approaches may actually cause more issues than to resolve them. Might I

opine that Clauses under 8.3 for D&D can, if needed, be strengthened, clarified or more

useful notes as applicable to service version incorporated to assist implementers,

consultants and auditors?

2. Risk be better defined and OFI be clarified, to avoid auditors using it as a tool to sneak in

recommendations. OFI is the outcome of considering risk as an input for innovation. It is

not a recommendation.

3. The knowledge clause needs meat to strengthen it, and to better make it inclusive to

systematizing the requirements for organizations to systematize lessons learnt.

4. An annex added to bring clarity and ease to designing and implementing a combined

management system for an organization.

5. Clause 4.3 Scope, in defining scope requires consideration of the context of the

organization, which is based on Clauses 4.1 and 4.2. However, while the scope has to be

available as documented, 4.1 and 4.2 do not require documentation. I would suggest

both clauses 4.1 & 4.2 to have context as a documented requirement.

In conclusion, I think, updating the standard ground up is not a wise idea at this stage. Perhaps

slight tweaking to include some minor changes would give stability in implementation of an

already robust standard.

ISO 9001:2015 – Exclusions

Exclusions to what an organization does were integral to the ISO 9001 standard prior to the 2015 version update. After all an organization cannot do all the work. Clause 7.1.1 lays the foundation on this thought by accepting that an organization must determine and provide resources. In doing so it determines the constraints and capabilities of the existing resources and what needs to be obtained from external providers. As such in previous standards, the organization, when seeking certification, requested exclusion on those processes that it did not perform.

The drawback of this was a major flaw. Over the period of time, some of these organizations, sheltered under the exclusion provision even lost the ability to pick the correct outsourced party! For example, if the organization builds highways, but outsources bridges and tunnels, then it must have the ability to be able to pick the correct vendor/ contractor who will not let the customer down. The revised 2015 version of the standard therefore in the wisdom of TC-176, removed this exclusion provision. It does not imply now the organization cannot outsource what it does not do. All that it means that the organization can review the applicability of the requirements based on its size, complexity and decide on the activities it needs to outsource.

With the exclusion provision removed, the organization would need to do due diligence in appreciating the range of its activities and the risks and opportunities it encounters as also the effect if any of the outsourced vendors not performing to accepted requirements. The organization then remains accountable for the outcome of the outsourced processes and products and services externally obtained. To ensure their consistency and levels of acceptance, it would need to take measures as required by clauses 8.4.1, 8.4.2, and 8.4.3 of the ISO 9001 in enforcing monitoring and measuring to protect its customer and clients.

This assurance that an organization can not and will not outsource those activities which by its decision will not result in failure to achieve conformity of products and services. Clause 4.3 of ISO9001 in determining the scope of the quality management system clearly requires that conformity to the ISO 9001 can only be claimed if the requirements determined as not being applicable do not have an adverse impact on the promises made by the organization. The products it provides, based on externally obtained subproducts or services must not affect customer satisfaction.

In terms of auditing, it is incumbent upon auditors that they carefully seek conformity to this requirement when auditing. Internal audits to ISO 9001 must provide the objective inputs to top management to make better decisions and appreciate the risks of outsourcing to nonperforming and or underperforming outside organizations, remembering they remain accountable and answerable for the final product or service. Ensuring the organization’s accountability for the conforming products and services whether outsourced or not is the responsibility of the organization.

QMII’s ISO 9001 EG (Exemplar Global) certified lead auditor training designed carefully to meet the objectives as envisaged in the standard.

ISO 14001 – Environmental Management System Auditing

With the HLS (high-level structure) common to all standards ensuring the ten-clause structure an organization can ensure the best results to its management system by having an integrated management system. A divided approach to managing an organization based on several standards can often result in environmental and quality policy being in conflict. If occupational health and safety (ISO 45001) are also to be integrated, it enables the management to consider the risks in the combined context of the organization. When these are separated the combined risks can be mixed. Further, if security is to be also part of the management system (ISO 28000 – still not in the HLS format), integrating the system would ensure a functional management system.

Environmental management system based on ISO 14001, has integral it the consideration of aspects, their impacts, recognition of significant impacts, and prioritization of the same. Experience shows that implementing ISO 14001 is easier and simpler and more readily accepted by the employees when the organization already has a functioning Quality Management System (QMS) based on ISO 9001 in place.

A well-implemented EMS, EMS ensures cost savings by recycling, reduction in consumption, and cost savings in waste. This gives tremendous advantages over competitors for projecting the organization as a responsible company but when tendering for business. Managing risks is more comprehensive, as the leadership is able to see combined risks to the organization in quality, safety, occupational health, and security. The demonstration of commitment to improving the environment in a socially responsible manner is more systematically implemented by interpreting the ISO 14001.

Auditing the integrated management system, if that be the choice (recommended), or just the EMS based on ISO 14001 requires the auditors to first interpret the standard based on company policy, the organization’s goals based on consideration including expectations of the interested parties and the external and internal issues aligned to statutory requirements. Auditors, particularly internal auditors must ensure the interpretations of ISO 14001 are aligned per guidelines for the industry. ISO 14001 certification can improve an organization’s reputation and result in improved relationships to the mutual benefit of stakeholders and the organization.

Auditors must not forget that internal auditing is not to judge the legal compliance of the processes. Legal compliance is a requirement and is best judged by compliance auditors. Internal auditors audit to see that the organization has the processes to ensure compliance. Internal auditors look at the plans of the organization to ensure processes monitor environmental aspects and mitigate as required, systematically address them.

QMII (www.qmii.com) has for 30 plus years integrated management systems and training lead auditors for various standards including ISO 14001. With our vast consulting experience in ISO 14001, we reinvest our field experience into the content development of our courses. The real-world experiences back our instructors and training material in ensuring auditors understand ISO 14001.

A good internal audit process, for any standard, particularly the ISO 14001, should start with a good plan. Good QMII training ensures, auditors prioritize audits, and allocation of time-based on risks, previous results, the importance of the process. The audit cycle is often one year (can vary), and so depending on the environmental importance of the process and past performance-critical environmental aspects can be audited.