Myths Debunked: Understanding the ISO 9001 Implementation Process

ISO 9001 has become an increasingly popular quality management system (QMS) standard for companies around the world. However, there are many myths surrounding the implementation and certification process that can discourage organizations from pursuing it. In this article, we will debunk these myths and explain why the ISO 9001 based QMS is an important investment for any company.

Myth #1: Interested parties do not have adequate understanding of ISO 9001

It is often assumed that interested parties do not have the necessary appreciation of the ISO 9001 standard. This is a myth. While it may appear that implementing an ISO 9001 conforming system and getting certified is complex, there are many resources available to help companies understand and implement it successfully. In fact, many companies have achieved ISO 9001 certification without any prior knowledge of the standard.

Myth #2: It is expensive to establish quality management system (QMS).

Another common myth is that establishing a QMS is expensive. While there are costs associated with implementing a QMS, these costs are often offset by the benefits that a QMS can provide. For example, a QMS can help companies improve their processes, reduce waste, and increase customer satisfaction, which can ultimately lead to increased revenue and profitability.

Myth #3: It requires heavy emphasis on documentation.

There is a misconception that an ISO 9001 QMS requires a heavy emphasis on documentation. While documentation is an important component of the certification process, it is not the only component. The standard also requires companies to demonstrate that they have effective processes in place to ensure quality, which can be achieved through various means such as employee training, process improvement initiatives, and customer feedback mechanisms.

Myth #4: Period to achieve ISO certification is very lengthy and requires months of efforts.

Another myth surrounding the ISO 9001 implementation and certification process is that it takes a very long time to achieve certification. While it is true that the process can take several months, this timeframe can vary depending on the size and complexity of the organization. The time taken to achieve the end goal also depends on the commitment of personnel at all levels.

Myth #5: System is prone to failure when the company pursues certification

Finally, there is a myth that the ISO 9001 based QMS is prone to failure when a pursues certification. This is simply not true. In fact, certification provides an external validation of the effectiveness of the system.  Companies that approach ISO 9001 implementation and certification with a genuine commitment to quality are more likely to achieve success than those who view certification as a box to tick. The system must sustain achieved improvements beyond certification.

In conclusion, the ISO 9001 based QMS is an important investment for any company that is committed to improving their quality management systems. While there are many myths surrounding the implementation and certification process, these myths can be easily debunked. With the right resources and commitment, any company can successfully implement and achieve ISO 9001 QMS and its certification.

ISO 27001:2022-What Are The Key Changes?

ISO 27001:2022 is the latest update to the international standard for information security management systems (ISMS), replacing the previous version of ISO 27001:2013. The update brings about several changes, including updates to Annex A, which outlines the controls that organizations must implement to manage their information security risks.

Annex A has been revised to reflect the changing threat landscape and to provide organizations with a more comprehensive set of controls that can help them to manage their information security risks effectively. Here are some of the key changes to Annex A:

New Controls

The new version of Annex A includes several new controls that reflect emerging information security risks. These include controls related to cloud computing, mobile devices, and the Internet of Things (IoT). These new controls require organizations to implement additional measures to protect their information assets in these areas.

Consolidation of Controls

Annex A has also been revised to consolidate some of the existing controls. For example, the controls related to physical security have been consolidated into a single section. This makes it easier for organizations to understand and implement the controls and reduces the risk of duplication or confusion.

Changes to Control Objectives

The objectives of some of the controls have been revised to better reflect current best practices in information security management. For example, the control related to cryptography has been revised to include requirements for the use of strong encryption algorithms and key management practices.

Changes to ISO 27002:2022

The Guidance eon implementation of the ISO 27001:2022 Annex A controls has also been revised to provide more detailed guidance on how to implement the controls effectively. This includes guidance on risk assessments, vulnerability assessments, and incident management.

These changes to Annex A have significant implications for organizations that use the ISO 27001 standard. They will need to review their existing information security controls and processes to ensure that they comply with the updated requirements. This may involve implementing new controls or updating existing ones to address emerging risks and best practices.

In addition, organizations will need to ensure that they have the necessary resources and expertise to implement the new controls effectively. This may require additional training for staff or the engagement of external experts to provide support and guidance. For auditors certified by Exemplar Global they have until the end of the year to upgrade their knowledge and certificate.

Overall, the changes to Annex A in ISO 27001:2022 reflect the evolving nature of information security risks and best practices. Organizations that embrace these changes and take a proactive approach to managing their information security risks will be better positioned to protect their assets and maintain the trust of their stakeholders.

Risk Management is a Crucial Process for Any Organization

Risk management is a crucial process for any organization, regardless of its size or industry. It involves identifying, assessing, and mitigating risks that could impact the organization’s objectives. One widely used framework for risk management is ISO 31000:2018, which provides guidelines and principles for effective risk management.

ISO 31000:2018 is a global standard that outlines the principles, framework, and process for effective risk management. The standard defines risk as the effect of uncertainty on objectives, and emphasizes that risk management is an integral part of organizational processes and decision-making.

The standard provides a flexible framework for risk management, which can be customized to suit the unique needs of an organization. It outlines the following steps for effective risk management:

  1. Establishing the context: This involves identifying the internal and external factors that could impact the organization’s objectives, and understanding the organization’s risk appetite and tolerance.
  2. Risk identification: This involves identifying the risks that could impact the organization’s objectives, including both internal and external risks.
  3. Risk analysis: This involves assessing the likelihood and potential impact of each identified risk, and prioritizing them based on their severity.
  4. Risk evaluation: This involves determining the level of risk that is acceptable to the organization, and deciding whether any additional controls or measures are necessary to mitigate the risks.
  5. Risk treatment: This involves implementing the controls or measures necessary to mitigate the identified risks, and monitoring the effectiveness of those controls over time.
  6. Monitoring and review: This involves regularly monitoring the effectiveness of the risk management process, and reviewing and updating the risk management framework as necessary.

Adopting ISO 31000:2018 can bring a range of benefits to an organization. By implementing an effective risk management process, organizations can:

  • Protect their reputation and avoid damage to their brand
  • Enhance their decision-making processes by considering risks and opportunities
  • Reduce the likelihood of negative events and their impact on the organization
  • Improve stakeholder confidence and trust
  • Identify new opportunities for growth and innovation.

ISO 31000:2018 can be used as the basis for risk management required by other ISO management system requirement standards such as ISO 27001, ISO 9001 and others.

In summary, effective risk management is critical for the success of any organization. ISO 31000:2018 provides a framework for effective risk management, which can be tailored to suit the unique needs of an organization. By adopting this standard, organizations can enhance their decision-making processes, protect their reputation, and identify new opportunities for growth and innovation.

10 Steps to Bolster Maritime Cyber Security

QMII President and CEO, Dr. IJ Arora presented the topic “10 Steps to Bolster Maritime Cyber Security” at the Passenger Vessel Association at MariTrends. The presentation was well received and applauded by the packed room. The PVA Annual Convention was held at the Hyatt Regency Long Beach in Long Beach, California this year. The convention featured a variety of captivating sessions with various guest speakers that are leaders in the passenger vessel industry.

Click here for the full presentation.

How will ISO 22301 Benefit you?


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What is ISO 22301?

ISO 22301 is an international standard for Business Continuity Management Systems. This standard is designed to protect, prepare for, respond to, and recover from unexpected incidents when they arise. When your organization has a Business Continuity Management System, it is prepared to detect and prevent unforeseen threats.

ISO 22301 applies to all organizations no matter the size or industry. In 2012, when this standard was first developed, it was the world’s first international standard for implementing and maintaining effective business continuity plans, systems, and processes. It was revised in late 2019 to bring it up to date with current best practices and is based on the High-Level Structure (HLS).  Consequently, it aligns well with many other internationally recognized management system standards including ISO 9001 (quality management) and ISO 14001 (environmental management).

What are the benefits of being ISO 22301 certified?

There are many possible threats that organizations face including supply chain issues as we saw in the recent pandemic, or natural disasters such as earthquakes, floods, hurricanes, and tornadoes, and even cyber-attacks such as the recent news with the ransomware attacks on the oil and gas and food industries. These are major threats, but there are even other types of risks, such as the loss of skilled labor, power outages, and IT breakdowns that can cause disruption to a business.

How is a certification in ISO 22301 beneficial to an individual?

With a certificate in ISO 22301, you will be able to help your organization meet its business objectives and gain the necessary knowledge to manage a team in the implementation of this standard.

If your organization does not have a Business Continuity plan, then they may be at risk.  It is important to take these plans seriously or your business could suffer consequences. Some impacts of not having a plan include business failure, damaged reputation, loss of data and clients, and business interruption.

 What will students learn about ISO 22301 from QMII?

During ISO 22301 five-day training at QMII, students will understand how to respond effectively based on the procedures that apply before, during, and after an event. It is important for an organization to implement a Business Continuity plan because it shows that you are prepared for the unexpected. This assures that your business will continue to operate without any major impacts or losses. Our training enables you to develop the necessary expertise to perform a Business Continuity Management System (BCMS) audit by applying widely recognized audit principles, procedures, and techniques.

 

Problem Solving : The QMII Way

What is problem solving?

What is problem solving? Problem solving is defined as the act of defining a problem, Identifying, prioritizing, and selecting alternatives for a solution and then implementing a solution. A problem – solving process is necessary for all business #management-systems. Why? Because #leadership wants to see continual improvement in their systems and identifying solutions that will effectively prevent recurrence of a problem will enable this. #Leadership needs to ensure their employees are provided with the appropriate training in problem solving techniques to develop and enhance this skill set. Identifying an effective solution can be accomplished by following the proper methodology.

At #QMII, our Problem-Solving workshop  teaches a team-based approach to eliminating root causes through effective corrective action using the eight-discipline problem solving (8D) methodology.

 

What is the Eight Discipline (8D) methodology?

The Eight Discipline Methodology (8D) is a problem-solving approach that we most used in various industries. Originally developed by the Ford company, The purpose of this methodology is to identify, correct, and eliminate recurring problems, making it useful in product and process improvement.  It consists of 8 steps: Create a team, Define the Problem, Contain the problem. Identify the Root Causes, Choose Corrective Actions, Implement and Validate Corrective Actions, Take Preventive Measures, and Thank the Team.

 

Define the problem

Although problems are initially a part of life, we as humans often make the mistake of trying to find a solution right away. We tend to forget that solutions are at the end and not the beginning of a structured process. Often too little time is spent on defining the problem statement well. Time is focused on fixing the issue and dealing with the consequences. Often then, organizations move on to fighting the next fire and a quick problem-solving effort is conducted to “justify” a pre-determined root cause. A well-defined problem is the beginning of a corrective action.

 

The QMII Way

QMII has over 35 years’ experience in systems approach and have successfully applied the 8D approach to problem solving. While there are many approaches to Problem Solving the 8D methodology encompasses the five whys and this is easy for all to understand and then implement. QMII connects the problem-solving approach to the system and in our workshop, we teach students where root cause analysis may lead to other tools as FMEA, Mistake Proofing, and Causal Analysis.  While the workshops help students identify the problem it also helps them understand and implement the remaining steps in the 8D methodology.

Our goal at QMII is educate students/clients on how to identify/appreciate the root causes of the problem to prevent further issues and to address the cause(s), which ultimately leads us to the outcome that should be a conforming product/service/output.  Good management systems ensure that processes remain the focus and result in conforming outputs.

THE BENEFITS OF ISO 9001


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Quality! Why is it so important? Quality can be defined as the standard of something as measured against requirement; the degree of excellence of achieving the requirement. Each day we read through hundreds and thousands of reviews just so we can buy a quality product or service. Even individuals searching for an ISO 9001 training are looking to identify a training provider that will provide quality training.

What is ISO 9001?

ISO 9001 is an international standard set by the International Organization for Standardization (ISO) that defines the framework for a quality management system.  Organizations that seek to deliver a quality product or service can use the framework to build a management system that would help attain this goal.

ISO 9001 Benefits

Even though many people have never heard of ISO or even ISO 9001, one might ask why do we need it?

Why not rely on this framework of reviews. However, those who relied on reviews will find that they are not a sure-shot formula to guarantee success in decision making. ISO 9001 also need not necessarily guarantee this. However, ISO 9001 is not meant for the customer, but for the organization implementing it. Although it is centered around the customer requirements, which primarily focuses on the customer, the benefit is to the organization implementing it.

There are many ways an ISO 9001 certificate can be beneficial.  When an individual obtains this certificate, the benefits are internally and externally. Customer satisfaction is the primary focus of the ISO 9001.  A quality system that Is implemented properly will result in customer satisfaction and a positive reputation for an organization.

ISO 9001 Training

ISO 9001 training provides an in-depth overview of the standard and how it is to be implemented.

ISO 9001 has come to signify a global base minimum for a quality management system. Inherent in the certification that customers see is a commitment from the organization to continually improve, to identify and segregate non-conforming outputs and to design controls to ensure the process can deliver per requirements. An organization purchasing from another halfway around the world has some level of confidence now in their assessment and purchase. ISO 9001 training will demonstrate that ISO themselves say don’t just rely on certification. Determine the type and extent of control on the outsourced provider based on their impact to your processes.

ISO 9001 training can be tailored for all levels of the organization. For management who want to understand their role in the system as also why they should invest in it. The workforce wants to understand how it benefits them and why they should adapt to the changes as they take place. Auditors need to understand the interpretation so they can assess if the system is being well run. So, while an organization may not need ISO 9001 certification, they can surely benefit from ISO 9001 and ISO 9001 training.

Here at QMII, we provide ISO 9001 lead auditor training in a unique format that allows all levels of the organization to attend the same class and leave when their relevant section is complete. Please Join us in one of our classes to learn more about ISO 9001 and how it can better your future.

 

ISO 14001 Management System Certification – Cost versus Value


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The most popular type of management systems used today often depends on the type of organization, and how they run their operations.  ISO 9001:2015 Quality Management Systems is the most popular for companies selling products to the military, along with AS9000:2016 Rev D for aviation, space, and defense organizations.  Food processors lean toward ISO 14001:2015 Environmental Management Systems (EMS) and ISO 45001:2018 Occupational Health and Safety (OH&S).  The size of the organization can have a significant bearing on whether they get certified or claim to conform.  It cost less to state you conform than to conduct the number of audits needed to become, and stay, certified.

Agricultural oriented small and medium enterprises (SMEs) will often opt for EMS.  Vineyards, vegetable farms, and livestock farms like ISO 14001.  Therefore, it depends a lot on the percentage of SMEs that are in those businesses.  In many cases, the percentage of organizations conforming to ISO 14001 depends on the amount of local or government pressure to conform.  In Europe and China, ISO 14001 is much higher than in the USA, in part due to government and environmentalist pressure.

Agricultural businesses and those that are getting pressure from socially responsible groups are the types of organizations that become ISO 14001 certified.  Meat packaging companies like Smithfield Ham in Virginia (now owned by a Chinese company), is ISO 14001 certified.  Only four major Ports in the USA are ISO 14001 certified (Port of Virginia is one) but many countries require the certification.  Partly due to all of the food coming into the Ports, but also due to the amount of pollution generated by boats, trains, and trucks that service the Ports. Ports are also now looking at ISO 50001 Energy Management Systems in conjunction with ISO 14001 certification.

One of the key drivers is the desire to meet ISO 14001 Standard requirements in the markets that they want to operate in or sell to.  It is difficult to open facilities in most of Europe, the Middle East, and China without having an ISO 14001 certification.  Environmental impact, energy efficiency, pollution reduction, and sustainability are considered by government permitting organizations.  This is more important for large organizations, but many SMEs also want to sell internationally.

Like other ISO Standards, it takes about a year of internal audits to be ready to claim conformity or get certified to ISO 14001.  SMEs, due to their smaller size, could take less time.  Medium-size businesses, with multiple locations, may elect to just have their headquarters certified, and state conformity for branches and suppliers.  An organization may elect to get its headquarters operation certified and use second-party audits to confirm that its other facilities and suppliers conform to the Standard.

The major cost of becoming certified involves training and multiple audits to get ready for certification.  Once ready, a third-party audit is required.  Most SMEs could be ready within a year.  The actual cost would vary depending on the number of employees trained, and the number of audits conducted before certification.

With good training and responsible staff, most SMEs can become certified.  All processes need to be in line with the goal of using environmental best practices.  In some cases, the cost of changing current processes can become a barrier.  Organizations can consider out-sourcing some processes in order to become more environmentally friendly.  Internal and second party audits can help an organization determine what, if any, processes need to be modified or out-sourced.

There are many reasons why organizations decide to become certified, but over time, reasons have changed for both small and large organizations.  With the new high-level-structure (HLS), EMS is now more similar to other standards.  Organizations that use to be ISO 18001 are now considering ISO 45001, which has OSHA embedded in it.  SMEs, like larger organizations, appreciate the value of being certified to popular standards and promote their conformity in their promotional material.  Many companies that are certified to ISO 9001 have to get the certification to sell to government agencies.  Many of the companies that get ISO 14001 certification, feel their end-users appreciate the company for having it.

To be sustainable, an organization needs to consider many factors.  These factors typically fall into one of the three pillars of Sustainability – Social, environmental and economic categories.  All organizations want to be socially responsible and do minimal damage to the environment, but they have to address the economics of operation.  The key is to strike a balance and establish a management system with processes that can be defended in the light of internal and external audits.

– by Peter Burke

Aspects and Impacts: Let’s start here

Every organization needs to consider the aspects of their organization, and the impacts they have on the planet.  Understanding the impacts is critical to the sustainability of the organization, and in the long run, the planet.

Most organizations only consider the impacts of their processes in relation to waste created and materials used.  While these are important, an organization should consider all aspects of their operation and processes before they start a business.  This includes the facilities, people, materials and other elements of their operations.  Once operational, they need to continually evaluate all process to look for improvement.

Many aspects are considered by organizations in order to borrow money to launch a product or service.  This is a good place to start.  Clearly understanding the impacts the organization will have on the local environment and community is a good step toward launching a sustainable business.  Lenders, both private and public, will be more generous lending if they know the organization is considering all three pillars of sustainability; social, environmental and economic.

Generally speaking, recycling an existing structure to a new operational use has less impact than building a new facility.  Applying building technics recommended under Leadership in Environmental and Energy Design (LEED) and Energy Star, will also reduce environmental impacts, and improve the operational economics.  If new structures are required, considering the site location, building facing direction and proximity to water, public transportation, and workers, will also help the organization conform to LEED and other building Standards.  Local communities will be much more accepting of an organization operating in their community if the proper design considerations are considered before construction is begun.

Once operational, every group in an organization needs to evaluate their processes on a regular basis to determine what improvements can be made to the aspects of the organization, and the impacts of there processes.  Management is accountable for the operation of the organization, but every department needs to be responsible for their processes.  This is not just the manufacturing or production departments, but also sales, marketing, receiving, packaging, shipping and customer services.  Organizations are also responsible for the performance of their products and/or services, and often the potential recycling of products. 

The International Organization for Standardization (ISO) has established Standards that can be used by an organization to help improve their management system processes and reduce risks.  ISO 14001:2015 Environmental Management Systems and ISO 9001:2015 Quality Management Systems can be used separately, or together, to provide guidance in improving an organization’s operations.  Lenders and communities appreciate the value of a well-run organization that understands the aspects of their operations and addresses the impacts.

Environmental Best Practices in Vineyards

The number of vineyards in the United States, and abroad, have grown substantially over the last 20 years.  New technology and controlled stainless steel fermentation processes have improved the product of even relatively small vineyards.  Many of the best vineyards are also focusing on their environmental impacts to ensure sustainability.  They are finding that taking a hard look at some of their processes can reduce negative environmental impacts, and in fact, reduce operating costs. 

Implementing an ISO 14001:2015 based Environmental Management Systems can help a vineyard archive sustainability and reduce operating costs.  It can also get the organization recognized as a responsible business neighbor in the community with happy and proud employees.  It starts with the owner’s decision to implement an environmental management system, then getting all employees aware, and on onboard to help improve operational processes.  

Environmental Management Systems (EMS) address recycling, and water conservation. These are important elements that are common to all vineyards.  One company that was spending over $50,000 a year on recycling, not only reduced their recycling cost, they actually saved over $7,000 a year after introducing a new recycling program as a part of their EMS. The program included 95% of its solid waste, packaging, and recycling.  New approaches to water use and heat exchange were able to reduce water use by over 35%.  Water used in the winemaking process is now processed on site and used in the vineyards, instead of being flushed down the drain. 

An EMS gets organizations to address the environmental aspects of their business and the impact they have taken into consideration the business environment they operate in, the needs of the stakeholders and risks associated with their business. Let us consider the aspect of energy use and the impact it has on the business including the organization’s carbon footprint. Taking the example further installing solar panels on buildings reduces energy operating costs and produces no carbon emissions.   One company was able to use solar for 75% of its energy use. 

QMII, with its 32 plus years of experience, can help a vineyard educate its employees so they are aware of the requirements of the internationally recognized and accepted standard for Environmental Management Systems – ISO 14001. Our course will outline the next steps the vineyard can take to begin implementing an EMS within their business.  We offer introductory environmental management system courses that will help a vineyard conform and/or become certified to the Standard.