ISO Compliance Essentials: Your Guide for Meeting Certified Standards

When it comes to managing a business, achieving compliance is often one of the trickiest challenges. It’s not just about ticking boxes; it’s about ensuring your organization meets recognized global standards and runs as smoothly as possible. 

That’s where ISO compliance comes in.

ISO has become the gold standard for companies seeking to demonstrate their compliance with regulations and rules to the highest levels. But what exactly is ISO, and how does ISO compliance work?

Today, ISO has become the go-to for establishing high compliance trust between your organization and the clients and prospects. It is among the world’s oldest NGOs, with its certification holding significant weight in various professions and fields. 

Source: Oneflow

Small businesses to large enterprises: who benefits from ISO compliance?

ISO compliance is open to all businesses, regardless of the industry. Be it SaaS companies, hospitals, or heavy goods manufacturers, ISO is accessible to all companies. 

Here are some common ones that seek ISO compliance:

Manufacturing companies

For manufacturing companies, the important standards to keep in mind are ISO 9001 (quality management), ISO 14001 (environmental management), and  ISO 45001 (occupational health and safety). 

ISO 9001 helps these companies improve product quality and optimize processes leading to satisfied customers. Implementing this not only ensures consistency but also continuous improvement in their operations.

ISO 14001 ensures these companies meet environmental standards, which is important for businesses looking to reduce their ecological footprint. ISO 45001, on the other hand, addresses workplace safety standards, helping manufacturers create a safer working environment for their employees.

Healthcare organizations

For healthcare organizations, ISO 13485 (medical devices quality management) and ISO 9001 are two standards to be met.

ISO 13485 is mainly used by medical device manufacturers to certify the safety and quality of their products. This is all the more crucial for an industry where product reliability can directly impact patient health.

Healthcare facilities also use ISO 9001 to guarantee service quality, ensuring every aspect of their operation meets high standards of excellence.

IT companies

The key standard for IT companies is ISO/IEC 27001 (information security management). It helps secure information and manage data, which is important in a sector where data breaches can cost companies millions of dollars.

ISO 9001 here plays the role of improving software development processes and services, which ultimately improves product quality and customer satisfaction.

Construction and engineering firms

Like manufacturers, construction and engineering firms use ISO 45001 (occupational health and safety). This helps them support safe working conditions on construction sites, lowering the risk of accidents. ISO 9001 boosts their project management and service quality, thus helping these firms complete projects efficiently and meet client expectations.

Food and beverage industry

Managing food safety across the entire supply chain, from production to consumption, is the most important priority in the food and beverages industry. ISO 22000 (food safety management) helps companies in this sector do just that by providing high standards of hygiene and safety, thereby preventing foodborne illnesses. ISO 9001 further amps up product quality and operational efficiency, helping businesses deliver safe, high-quality products to consumers.

Retail and wholesale businesses

For retail and wholesale companies, ISO 9001 is the main standard as it helps them optimize their operations and deliver smooth service. In addition, ISO 14001 promotes environmental responsibility throughout the supply chain, encouraging sustainable practices, such as e-signatures, in daily operations.

Financial services

Like IT companies, financial services use the ISO/IEC 27001 standard. It helps them protect sensitive financial data while maintaining transaction integrity. This, coupled with ISO 9001, improves service delivery, ultimately fostering trust and reliability in financial institutions.

Logistics and transportation industry

The logistics and transportation sector relies heavily on ISO 9001 to optimize its customer service and operational efficiency. This makes sure that goods are delivered on time, leading to happy customers.  

Other than that, ISO 28000 (supply chain security management) verifies the security of supply chains, helping companies prevent disruptions to their operations. 

Hospitality and tourism industry

ISO 9001 (quality management) is widely used by hotels and tourism businesses to improve guest satisfaction and service quality. To address the growing demand for sustainable tourism practices, businesses are now following ISO 14001 to show their commitment to environmental responsibility.

Education and training providers

For education and training providers, ISO 9001 implements high-quality teaching and administrative processes. This standard helps institutions maintain a consistent level of excellence in both their educational offerings and day-to-day operations.

How does having an ISO certification benefit you?

ISO certification comes with many benefits. Which ones are more valuable to your organization can depend upon your specific needs and the industry in which you operate. 

To help you narrow the list, let’s take a look at some of the important ones.

1. Improve efficiency and productivity: ISO standards require organizations to optimize their processes, reduce inefficiencies, and adopt best practices. This leads to higher productivity and smoother operations.
2. Enhance customer satisfaction: By adhering to ISO standards, companies ensure consistent product quality and service, which helps meet or exceed customer expectations. As a result, overall customer satisfaction and loyalty often improve.
3. Increase competitive advantage: ISO certification increases an organization’s credibility, giving it an edge in markets where quality assurance is key. It can help companies stand out from competitors who are not certified.
4. Ensure compliance with legal and regulatory requirements: Organizations align their operations with industry-specific legal and regulatory requirements to reduce the risk of non-compliance and associated penalties.
5. Open access to new markets: Many industries, especially international markets, require ISO certification as a prerequisite for doing business. It opens up opportunities for global trade and collaboration.
6. Improve risk management: ISO standards encourage organizations to identify, manage, and reduce risks in their processes. This leads to better decision-making and improved risk management.
7. Increase employee engagement: Involving employees in process improvement fosters a culture of quality, teamwork, and accountability. The result? Increased motivation and job satisfaction.
8. Reduce costs: By optimizing processes, reducing errors, and minimizing waste, ISO certification can lead to significant cost savings in production, operations, and supply chain management.
9. Enhance supplier relationships: ISO certification ensures suppliers and partners adhere to quality standards. It not only improves supply chain performance but also creates stronger relationships with stakeholders.
10. Support continuous improvement: ISO standards warrant organizations to remain innovative and efficient by promoting continuous improvement through regular audits, reviews, and performance assessments.
11. Increase credibility and trust: Being ISO-certified signals to customers, partners, and stakeholders that the organization is committed to maintaining high standards, which builds trust and credibility.
12. Better environmental and social responsibility: ISO certifications such as ISO 14001 and ISO 45001 help organizations manage their environmental and social responsibilities. They can enhance their reputation and contribute to sustainability goals.
13. Improve decision-making: With a data-driven approach to management, ISO standards can help organizations base decisions on accurate information and produce better outcomes.
14. Improve document control: ISO certification encourages better documentation practices, making processes easier to track, audit, and improve. This makes sure that important information is well-maintained and accessible.

What are the general requirements for certification? 

ISO sets out six different areas for assessing an organization's ISO compliance. Let’s examine all of them.

1. Quality management standards

Quality management is the backbone of an organization’s ability to consistently meet customer expectations while maintaining efficient internal processes.

• ISO 9001:2015 - quality management systems (QMS)
• Purpose: Sets out the criteria for a QMS.
• Applicable to: Can be used by any organization, regardless of size, sector, or industry.
• Key aspects: It focuses on a risk-based thinking approach, encouraging organizations to proactively identify and manage risks that could affect their performance. It adopts a customer-focused approach, ensuring that meeting customer needs and enhancing satisfaction are central to the system. Additionally, it requires active leadership involvement, promoting accountability and commitment from top management. The standard also advocates for continuous improvement, driving organizations to consistently seek opportunities for growth and efficiency.
• ISO 9000:2015 - QMS - fundamentals and vocabulary

• Purpose: Provides the basic concepts, principles, and vocabulary in quality management systems.
• Key aspects: It defines the terminology used in ISO 9001 and ensures a common understanding of the language and concepts related to quality management. Additionally, it explains the fundamental concepts and principles of quality management systems, offering organizations a solid foundation for implementing and maintaining an effective QMS.

• ISO 9004:2018 - quality management - quality of an organization

• Purpose: Guides organizations that want sustained success in a complex and demanding environment.
• Key aspects: It focuses on long-term performance and stakeholder satisfaction, helping organizations build strategies that go beyond short-term gains. It also includes guidance on continual improvement, encouraging organizations to evolve and adapt in order to thrive in changing environments and meet the needs of various stakeholders.
• ISO 19011:2018 - guidelines for auditing management systems

• Purpose: Provides guidance on auditing management systems, including principles and methods.
• Key aspects: It offers guidelines for internal and external audits of management systems. This applies to auditors and organizations implementing audits.
• ISO 10012:2003 - measurement management systems

• Purpose: Covers requirements for measurement processes and measuring equipment.
• Key aspects: It helps organizations manage their measuring processes and ensure they are fit for purpose.

• ISO 10018:2020 - quality management - guidelines for people engagement

• Purpose: Focuses on engaging people within organizations to contribute effectively to the QMS.
• Key aspects: It provides strategies for improving employee participation in the QMS.

• ISO 14001:2015 (environmental management systems) and ISO 45001:2018 (occupational health and safety management systems): Though these are not directly part of the ISO 9000 family, they integrate well with ISO 9001 and focus on environmental and safety management, respectively.

2. Environmental management standards

As organizations strive to reduce environmental impact, ISO provides a framework for systematically managing environmental responsibilities.

• ISO 14001: environmental management systems (EMS)

• Purpose: Set criteria for an effective environmental management system. It provides a framework that an organization can follow to manage environmental responsibilities in a systematic way.
• Key aspect: It focuses on reduction of waste and pollution, sustainable use of resources, compliance with environmental laws and regulations, and continual improvement of environmental performance.
• Applicable to: All types of organizations, regardless of size or sector.

• ISO 14004: EMS - guidelines

• Purpose: Offers guidance on the establishment, implementation, maintenance, and improvement of an EMS based on ISO 14001.
• Key aspect: It provides more detailed advice for organizations on how to enhance their environmental management practices, such as through sustainability contract management.
• Applicable to: Organizations looking to develop or improve their environmental management systems.

• ISO 14006: EMS - guidelines for incorporating ecodesign

• Purpose: Helps integrate ecodesign into an EMS. Ecodesign involves minimizing environmental impacts throughout the product lifecycle, from design and production to end-of-life disposal.
• Key aspect: Sustainable product design and minimizing environmental impacts throughout the lifecycle of products.
• Applicable to: Organizations involved in product development and design.

• ISO 14064: greenhouse gas (GHG) emissions

• Purpose: Guides quantifying, monitoring, reporting, and verifying greenhouse gas emissions.
• Key aspect: It focuses on measuring and managing greenhouse gas emissions, managing carbon footprints, and verifying GHG emissions.
• Applicable to: Organizations looking to reduce their carbon footprint or those required to report on emissions as part of regulatory or voluntary commitments.

•  ISO 14046: water footprint

• Purpose: Provides guidelines for assessing the water footprint of products, processes, and organizations based on a lifecycle assessment.
• Key aspect: It focuses on water usage, its environmental impact, and the sustainable management of water resources.
• Applicable to: Organizations wanting to evaluate and minimize their water footprint.

• ISO 50001: energy management systems

• Purpose: Although focused on energy, ISO 50001 helps organizations reduce energy use, indirectly contributing to environmental management by reducing emissions and resource consumption.
• Key aspect: It revolves around energy performance improvements and sustainable energy use and efficiency.
• Applicable to: Organizations looking to improve energy management and reduce environmental impact through better energy use.

3. Health and safety management standards

Protecting the health and safety of employees and stakeholders is a top priority for any organization, regardless of its size or industry.

• ISO 45001:2018 - occupational health and safety management systems

• Purpose: ISO 45001 provides a framework for managing occupational health and safety (OH&S) risks. It helps organizations prevent work-related injuries and illnesses while promoting a safe and healthy workplace.
• Key aspect: It focuses on Identifying hazards and assessing risks, developing controls to minimize risks, and ensuring compliance with legal requirements and continual improvement of OH&S performance.

• ISO 14001:2015 - environmental management systems

• Purpose: While primarily focused on environmental management, ISO 14001 often intersects with health and safety concerns, particularly when managing hazardous materials or environments that affect worker safety.
• Key aspect: It focuses on establishing environmental objectives and management plans, ensuring legal compliance and reducing environmental risks, and fostering a culture of environmental and safety awareness.

•  ISO 9001:2015 - QMS

• Purpose: Though ISO 9001 primarily addresses quality management, it includes risk-based thinking that can impact health and safety when designing products or processes that involve human interaction.
• Key aspect: It focuses on identifying risks in processes that may affect health and safety and emphasizing continuous improvement in safety measures.

• ISO 31000:2018 - risk management guidelines

• Purpose: ISO 31000 focuses on risk management, providing a framework for identifying, analyzing, and managing risks, including those related to health and safety.
• Key aspect: It focuses on risk assessment and mitigation strategies, ensuring proactive management of risks to health and safety.

• ISO 22301:2019 - business continuity management systems

• Purpose: Ensures an organization can continue operating during and after disruptions, including health and safety emergencies such as natural disasters, pandemics, or workplace accidents.
• Key aspect: It focuses on planning for workplace safety during emergencies, ensuring resilience to health-related disruptions.

4. Energy management standards

Effective energy management not only helps reduce operational costs but also contributes to broader environmental sustainability goals.

Key elements of ISO 50001:

• Energy policy: Establish an energy policy that reflects their commitment to improving energy efficiency.
• Energy planning: Conduct an energy review to analyze energy usage, identify opportunities for improvement, and set baseline energy performance indicators. Establish objectives, targets, and action plans to enhance energy efficiency and reduce energy consumption.
• Implementation and operation: Ensure proper resources, competencies, and responsibilities are in place. Promote energy efficiency awareness across the organization and provide training where necessary.
• Performance monitoring: Regularly monitor and measure energy performance to ensure objectives and targets are met. Maintain records of energy consumption, efficiency, and improvement actions.
• Internal audits and review: Conduct internal audits to assess the effectiveness of the energy management system. Management reviews ensure continuous improvement by identifying areas for further development.
• Continual improvement: The standard promotes a continuous improvement process (plan-do-check-act cycle) for sustained energy performance enhancements.

5. Food safety standards

ISO has several standards related to food safety. However, the most widely recognized is ISO 22000, which is what we will focus on here:

• ISO 22000:2018: This standard specifies the regulations for a food safety management system. It includes requirements for the development and implementation of policies and procedures to ensure the safety of food products along the entire supply chain.
• ISO/TS 22002: This is a series of technical specifications that provide guidelines for specific sectors within the food supply chain, such as ISO/TS 22002-1:2019 (food manufacturing), ISO/TS 22002-2:2013 (feed manufacturing), ISO/TS 22002-3:2011 (packaging materials), and ISO/TS 22002-4:2013 (farming).
• ISO 22005:2007: This standard provides guidelines for the traceability of the food chain, which is critical for ensuring food safety.
• ISO 22196:2011: This standard is focused on measuring antimicrobial activity on surfaces, which can be relevant in maintaining hygiene and food safety.

6. IT security standards

Like with food safety standards, ISO has several standards related to IT security. The most widely recognized are:

• ISO/IEC 27001: Provides a framework for managing and protecting sensitive company information. It is the most well-known standard for information security management systems (ISMS).
• ISO/IEC 27002: Offers guidelines for organizational information security standards and information security management practices. It complements ISO/IEC 27001 by providing additional controls and best practices.
• ISO/IEC 27005: Focuses on risk management and provides guidelines for information security risk management. It supports the implementation of ISO/IEC 27001 by helping organizations identify, assess, and manage risks.
• ISO/IEC 27018: Addresses protecting personal data in the cloud. It provides directions for cloud service providers to protect personal data.
• ISO/IEC 27017: Offers guidelines for information security controls for cloud services, helping organizations manage the risks associated with cloud computing.
• ISO/IEC 27019: Provides criteria for information security management in process control systems, particularly relevant for industries like manufacturing and energy.

How can you ensure ISO compliance after you have been certified?

Once you've achieved ISO certification, the journey doesn't end there. Maintaining  ISO compliance after certification is just as crucial for improving your QMS. Ongoing compliance involves several key practices:

1. Regular internal audits: Regular internal audits will help you assess whether your processes are still in line with ISO standards. These audits help identify non-conformities and areas for improvement so that they can be promptly addressed before they snowball.
2. Management reviews: Holding management review meetings at regular intervals to evaluate the performance of your QMS is a great way to keep on top of things. This includes reviewing audit results, customer feedback, process performance, and any non-conformities. These reviews ensure your QMS continues to be effective and stays aligned with your organizational goals.
3. Employee training: Continuously train and educate your employees on ISO standards, procedures, and best practices. It can foster a culture of quality within the organization.
4. Document control: Maintain and update all documentation related to ISO standards, including policies, procedures, and records. Ensure that all documents are controlled, reviewed regularly, and updated as necessary to reflect changes in processes or standards.
5. Customer feedback: Actively collecting and analyzing customer feedback allows you to identify areas for improvement. Understanding your customers’ needs and addressing their concerns helps maintain the quality of your products or services.
6. Corrective and preventive actions: When non-conformities arise, corrective actions must be implemented to fix the problem. At the same time, preventive actions should be taken to avoid future issues. Document these actions and their effectiveness to help avoid the same mistakes going forward.
7. Continual improvement: Embracing the principle of continual improvement by regularly reviewing and optimizing processes can help your organization adapt to changes and stay compliant with ISO’s evolving standards.

By integrating these practices into your organization's structure, you can ensure that it remains ISO compliant and continues to deliver quality to your clients.

Common challenges in achieving ISO compliance and how to overcome them 

ISO compliance can be hard to achieve. In particular, ISO 9001, for quality management, and ISO 2700, for information security, can be difficult. Nevertheless, here are three common challenges and ways to overcome them:

Understanding complex ISO standards

ISO standards are often detailed and complex, requiring a deep understanding of both the technical requirements and the specific application to your organization. Many businesses struggle with interpreting these requirements and aligning them with their processes.

Solution: Invest in proper training for key personnel or hire external ISO consultants to interpret and implement the standards. These experts can break down the requirements and tailor them to your specific operational needs.

Employee resistance to change

Implementing ISO standards usually requires significant changes to processes, which can lead to resistance from employees. This resistance can manifest in low engagement or failure to adopt new practices.

Solution: Involve employees early in the certification process. Regular communication, training sessions, and workshops can help them understand the benefits of ISO certification. Offering incentives for compliance and demonstrating how it improves efficiency can also increase buy-in.

Resource constraints

Achieving ISO certification is resource-intensive, requiring time, financial investment, and dedicated personnel. Smaller organizations often find it hard to allocate these resources without disrupting daily operations.

Solution: Create a phased implementation plan. Instead of overhauling all processes at once, focus on gradual improvements and assign a dedicated team or project manager to oversee the certification process. Additionally, budgeting for external support, such as ISO consultants or auditors, can simplify efforts and reduce long-term costs.

Advice from an expert on ISO certification

Axel Ideström, having led Oneflow through the certification process, knows the ins and outs of ISO certification. He helped bring all parts of the company up to ISO’s exacting standards. 

Here are some insights we gained about the challenges, insights, and lessons learned during that journey.

Q: What were your biggest challenges during the ISO implementation process, and how did you overcome them?

From a personal point of view, my lack of experience was the initial and main challenge. The entire chapter was new to me. I had never led a certification process before, although I realized my experience as a bid manager would come in handy. The key for me was diving into research -- reading a lot about the ISO framework and learning from previous organizations who had learned from this experience.

Q: Looking back, are there any steps you wish you had taken earlier in the process to make the implementation smoother?

I think I could have communication status updates to groups outside of the project groups more often.

Q: How did you handle the documentation and record-keeping requirements of ISO? Any tips for maintaining accuracy and consistency?

Simply by storing it in a task management tool. Naming pages made it easy to understand what each contained. My main advice is to assign clear ownership of tasks. Divided ownership usually equals no one taking responsibility.

A concrete tip I recommend using is what we call "activity trackers." Simple, yet effective. We created a table listing tasks, responsible persons, deadlines, status updates, and a comment section. This way it's simple to go through all the different tasks and revise them according to the daily work.

Q: What advice would you give to companies just starting their ISO journey, especially regarding resource allocation and timeline management?

Start by talking to organizations that have already gone through the cerification process. To limit your mistakes, try to learn as much as possible. 

Another piece of advice is to bring ISO consultants on board. We had weekly meetings to discuss the status of current tasks and plan ahead. Their experience made the process smoother than it would have been without them.

Lastly, and most importantly, involve key stakeholders as early as possible. It's crucial everyone is on the same page from the beginning. For the main internal stakeholders, this project will be time-consuming and require them to delegate other less important tasks.

Q: Can you discuss any specific areas where your company saw measurable improvement as a result of achieving ISO certification?

Some of the main advantages of going through this process have been structuring our internal process, policies, and other relevant documentation. Clear ownership, risk documentation, and relevant links between different departments and processes are some of the many improvements we have achieved during the last twelve months of the certification project.

ISO beyond the checklist

ISO compliance is more than just meeting standards — it’s a strategic investment in your organization’s future. As standards evolve, so too must your organization. By putting ISO standards into your company’s culture and operations, you’ll not only meet today’s challenges but also future-proof your business against emerging risks and opportunities. 

Take the lead, stay compliant, and ensure long-term success for your ISO-compliant business.

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Edited by Monishka Agrawal and Shanti S Nair