ISO 62304 Training Guide Introduction to ISO 62304 ISO 62304 is the international standard that defines the life cycle requirements for medical device software. It provides a structured approach to software development, maintenance, risk management, and problem resolution for medical software, whether standalone or embedded in a medical device. Who Needs to Understand ISO 62304? This standard is critical for: Complying with ISO 62304 ensures that your medical software is built with safety, traceability, and effectiveness in mind. It is often required to meet the regulatory requirements of major markets, including the U.S. FDA and EU MDR. Key Elements of ISO 62304 1. Software Safety Classification Software is classified based on its potential impact on patient health: Each class determines the level of documentation, testing, and validation required. 2. Software Development Life Cycle (SDLC) ISO 62304 outlines five key phases: 3. Risk Management Integration Risk management under ISO 14971 must be incorporated into every phase. Risk control measures should be verified and validated. 4. Configuration Management All software changes must be controlled. This includes versioning, status tracking, and configuration audits. 5. Problem Resolution Process All bugs, failures, and non-conformities must be tracked and resolved according to a documented procedure. Steps to Implement ISO 62304 in Your Organization Step 1: Perform a Gap Analysis Start by reviewing your current software processes against ISO 62304 requirements. Identify areas that need improvement. Step 2: Build a Compliance Team Form a cross-functional team involving developers, QA, regulatory affairs, and management. Step 3: Define and Document Procedures Create clear procedures for: Step 4: Train the Team Conduct detailed training sessions to ensure everyone understands ISO 62304 concepts and their role in compliance. Step 5: Implement Tools and Templates Use tools for: Templates can speed up documentation and improve consistency. Step 6: Conduct Internal Audits Regular internal audits ensure your processes align with ISO 62304 and are ready for external review. Benefits of Following an ISO 62304 Training Guide IEC 62304 Checklist IEC 62304 sets the framework for medical device software development, dividing its guidance into five key sections, specifically numbered from 5 through 9. ISO 62304 Awareness in Pakistan With growing digital health initiatives in Pakistan, adopting ISO 62304 standards is becoming crucial for startups and established med-tech companies. Following an ISO 62304 training guide helps organizations in Pakistan align with international best practices and expand their market reach. Conclusion This ISO 62304 training guide is a starting point for building high-quality, compliant medical software. By implementing the practices and tools described above, organizations can achieve safer products, smoother regulatory reviews, and better patient outcomes.
Understanding ISO 62304: A Short Guide to Medical Software Development Standards
In the rapidly advancing world of medical technology, software plays a critical role in ensuring the safety and performance of medical devices. ISO 62304 is the internationally recognized standard that governs the software life cycle processes for medical device software. Whether you’re a developer, QA engineer, or regulatory professional, understanding ISO 62304 is essential to building safe, reliable, and compliant software. đ What is ISO 62304? ISO 62304 outlines the framework for developing and maintaining medical device software, covering everything from initial concept and design to maintenance and problem resolution. It ensures that medical software is developed under a controlled and risk-managed environment, reducing potential harm to patients and users. đ Why ISO 62304 Training Guide Matters A structured ISO 62304 training guide helps organizations: đ Who Needs It? đ ISO 62304 in Pakistan In Pakistan, growing innovation in medical IT makes awareness of ISO 62304 increasingly important. By following an ISO 62304 training guide, local companies can align with global best practices, enhance product quality, and open new export opportunities.
Ultimate Guide to Implementing IMS in Power Plants (ISO 9001, 14001, 45001)
Introduction: Why Implement an Integrated Management System (IMS) in Power Plants? Power plants operate in high-risk environments with complex processes. To ensure operational excellence, safety, and environmental compliance, implementing IMS in power plants has become an industry best practice. An Integrated Management System (IMS) combines standards like ISO 9001 (Quality Management), ISO 14001 (Environmental Management), and ISO 45001 (Occupational Health & Safety) into a unified framework. This guide outlines a practical step-by-step approach for power plant operators and consultants looking to streamline operations, improve compliance, and drive sustainable growth. Step 1: Management Commitment and Strategic Planning IMS implementation begins at the top management level. Leadership must fully commit to: In the power sector, where risks are high and regulations are stringent, this commitment is essential to drive successful implementation and long-term improvement. Step 2: Conducting a Gap Analysis A gap analysis helps assess the current system against the requirements of ISO 9001, ISO 14001, and ISO 45001. The focus should be on: The findings will inform a detailed implementation roadmap for the IMS. âOur IMS implementation services are tailored specifically for power plants across Pakistan“ Step 3: Define IMS Scope and Context of the Organization Understanding the context of the power plant is crucial. This includes: Defining a clear scope helps ensure that the IMS is tailored to the plant’s specific risks and operational needs. Step 4: Risk Assessment and Opportunity Identification Each ISO standard emphasizes risk-based thinking. In power plants, this means: Opportunities for improvementâlike automation, energy efficiency, or waste reductionâshould also be identified and prioritized. Step 5: Integration of Processes, Documentation, and Controls Integrate the following key elements into one IMS framework: Using integrated controls reduces duplication and increases operational efficiency. Step 6: Training and Awareness Programs Staff at all levels must be trained on: A robust training plan builds a culture of accountability and safety, especially in hazardous environments like power plants. Step 7: Internal Audits and Management Review Regular internal audits are essential to evaluate system performance and identify non-conformities. Management reviews should: This cycle strengthens governance and ensures the IMS remains aligned with evolving needs. Step 8: Certification and Continuous Improvement Once the system is mature, engage with accredited certification bodies for audits. Achieving ISO certification provides: After certification, the focus should shift to continuous improvement. Conduct root cause analysis, implement preventive actions, and monitor trends in safety, emissions, and reliability. Implementing IMS in power plants is a strategic move that enhances compliance, sustainability, and safety in one unified framework. Benefits of Implementing IMS in Power Plants Final Thoughts Implementing IMS in power plants is more than a compliance exerciseâitâs a strategic initiative that improves operational efficiency, employee safety, and environmental performance. By integrating ISO 9001, ISO 14001, and ISO 45001 into a single system, power plants can meet global standards, drive continual improvement, and ensure long-term sustainability in a competitive energy sector. Organizations often realize significant efficiency and risk reduction by implementing IMS in power plants, streamlining management processes across departments.
The Benefits of Implementing IMS (ISO 9001, ISO 14001, and ISO 45001) in Power Plants
Benefits of Implementing IMS in Power Plants The benefits of implementing IMS in power plantsâspecifically by integrating ISO 9001, ISO 14001, and ISO 45001âare extensive and critical in today’s energy sector. An Integrated Management System (IMS) merges quality, environmental, and occupational health and safety standards into one streamlined framework. For power plants, where safety, sustainability, and operational efficiency are paramount, this unified approach delivers measurable value. 1. Enhanced Operational Efficiency Implementing ISO 9001 as part of an IMS ensures a consistent and process-driven approach to quality management. Power plants often involve complex workflows with high regulatory compliance. Standardizing these through IMS: 2. Improved Health and Safety Culture ISO 45001, the global standard for occupational health and safety (OH&S), is crucial for power plant operations where high-risk activities are routine. When integrated through IMS, this standard: A strong safety culture not only saves lives but also improves plant productivity and public reputation. 3. Environmental Compliance and Sustainability ISO 14001 focuses on environmental management. Power plants, particularly thermal and fossil-fuel-based units, significantly impact the environment. With ISO 14001 as part of the IMS: This is especially valuable in regions where environmental licensing and monitoring are strict. 4. Cost Reduction and Waste Minimization By integrating quality, safety, and environmental management, power plants can streamline operations and eliminate redundancies. IMS reduces: This ultimately leads to substantial cost savings and optimized resource allocation. 5. Stronger Regulatory and Legal Compliance IMS supports a structured approach to meeting legal and regulatory requirements. With ISO 9001, ISO 14001, and ISO 45001 working in synergy: âPower plants across Pakistan are increasingly adopting IMS standards like ISO 9001, ISO 14001, and ISO 45001 to enhance operational efficiency, ensure environmental compliance, and improve workplace safety.â 6. Continuous Improvement Culture The PDCA (Plan-Do-Check-Act) cycle, a core component across all ISO standards, drives continuous improvement across operations. Power plants using IMS: Conclusion Final Thoughts: A Strategic Move Toward Excellence The integration of ISO 9001, ISO 14001, and ISO 45001 under an Integrated Management System (IMS) isnât just a regulatory checkbox â itâs a strategic investment in operational excellence. For power plants, this move results in optimized workflows, improved environmental stewardship, and an uncompromising approach to health and safety. Beyond compliance, IMS fosters a culture of continuous improvement. It empowers leadership and employees to take ownership of quality, safety, and sustainability â ensuring that these values are embedded across departments. This holistic framework not only reduces risks and improves incident response, but also enhances the plantâs reputation among stakeholders and the public. Moreover, the global energy sector is under increasing pressure to align with ESG (Environmental, Social, and Governance) goals. Adopting IMS standards positions power plants to meet future regulatory requirements and international benchmarks while reinforcing stakeholder trust. In conclusion, implementing ISO 9001, 14001, and 45001 through IMS at power plants is not just about ticking boxes â itâs about building smarter, safer, and more sustainable energy infrastructures that will stand the test of time. Benefits of Implementing IMS in Power Plants
How to Spot Phishing Emails in 2025 â Real Examples & Red Flags
How to spot phishing emails in 2025 Spotting a phishing email in 2025 is more important than ever. Despite growing security awareness, knowing how to spot phishing emails in 2025 can help you protect your personal information… Phishing remains one of the most dangerous and widespread cybersecurity threats in 2025. Despite increased awareness and advanced security systems, cybercriminals are constantly refining their tactics to deceive users. To successfully navigate online interactions, understanding how to spot phishing emails in 2025 is essential for everyone. Continually updating your knowledge on how to spot phishing emails in 2025 can make a significant difference in your online safety. Being aware of how to spot phishing emails in 2025 involves recognizing common signs and knowing what actions to take. As the year progresses, the tactics used by cybercriminals evolve; therefore, learning how to spot phishing emails in 2025 is crucial. According to the 2024 State of the Phish report by Proofpoint, 86% of organizations were targeted by phishing campaigns last year, and over 70% of them suffered a successful breach due to human error. Meanwhile, the UK governmentâs Cyber Security Breaches Survey 2025 reported that phishing now makes up 93% of all cybercrime incidents in the country. Take time to study how to spot phishing emails in 2025 to make informed decisions about the emails you receive. The first step in understanding how to spot phishing emails in 2025 is recognizing the characteristics of suspicious communications. By learning how to spot phishing emails in 2025, you can safeguard your online presence from potential threats. Why is phishing still so effective? Because it bypasses systems and targets peopleâoften exploiting urgency, fear, or curiosity to trick victims into clicking dangerous links, opening infected files, or sharing personal information. In this article, youâll learn how to spot modern phishing emails, recognize red flags, and avoid falling victimâwith updated tactics and real-world examples from 2025. â Quick Phishing Detection Checklist If you answer yes to any of the following questions, treat the email with caution: đ§ Sender & Domain đ Content & Style đ Links & Attachments đ Security Pressure If anything feels suspicious, pause and verify using an independent, trusted communication method. âIn Pakistan, phishing attacks continue to rise, making it essential for individuals and businesses alike to know how to spot phishing emails in 2025 to protect their sensitive information.â đ© 1. Suspicious or Generic Email Domains Legitimate organizations rarely use public email domains for business communication. If an email claiming to be from a major company arrives from an address like [email protected], itâs a red flag. Reputable companies use professional domains (e.g., @google.com, @chase.com). Scammers often count on people not checking the actual addressâespecially since 85% of people now open emails on mobile, where only the sender’s name may be shown. â Tip: Tap or hover over the sender name to reveal the real email address. đ© 2. Slightly Modified Domains As phishing attacks become more sophisticated, understanding how to spot phishing emails in 2025 is essential for everyone. Cybercriminals frequently register domains that closely mimic real ones, tricking users into clicking malicious links or sharing sensitive info. Learning how to spot phishing emails in 2025 can empower you to act quickly and effectively against potential threats. Keep in mind that knowing how to spot phishing emails in 2025 can help both individuals and organizations stay secure. For instance, in early 2025, scammers launched a phishing campaign using micros0ft-teams.net (with a zero instead of an “o”) to trick users into entering credentials on a fake Microsoft Teams portal. Just one unnoticed character can be enough to compromise your account. â Tip: Slow down and double-check the spelling of all URLsâeven a minor typo could be a trap. đ© 3. Grammar Mistakes and Awkward Language While phishing emails are increasingly polishedâsometimes even generated by AIâmany still contain awkward phrasing or minor grammar issues. If the language seems off, ask yourself: â Tip: A single typo isnât always a red flag, but combined with other clues, it can confirm suspicion. đ© 4. Dangerous Links or Attachments All phishing emails share one thing in common: a payload. Whether itâs a link to a fake website or a malicious attachment, the goal is to steal data or install malware. 𧷠Malicious Links In January 2025, fake emails impersonating Chase Bank used chase-secure-login.com, luring users into entering credentials on a spoofed site. â Tip: Always hover over links before clickingâcheck if the actual URL matches whatâs displayed. đïž Suspicious Attachments Phishing emails often disguise malware as invoices, tax files, or other official documents. A March 2025 IRS-themed scam used ZIP attachments that installed malware when opened. â Tip: Never open unexpected files. And never enable macros unless you’re 100% sure the source is trustworthy. đ© 5. Emotional Manipulation: Fear and Urgency Scammers exploit your emotions to rush decisions. The more pressure they create, the less time you have to think critically. Some recent examples include: These messages tap into your instinctsâfear of loss, desire to fix an issue, or pressure to respond to a boss. â Tip: Take a moment to breathe. Even if the message looks urgent, verify it through a second channel (such as logging in directly on the service’s official site or speaking to your manager). đ Final Advice: Stay Skeptical, Stay Safe Phishing attacks succeed by preying on trust and haste. The best defense is a calm, critical mindset and awareness of modern scam tactics. What you should always do: Cybercriminals are getting smarter, but so are we. Share this guide with your team or community and help build a culture of awareness. “How to spot phishing emails in 2025“ Make it a habit to remind yourself how to spot phishing emails in 2025 whenever you check your inbox. Adopting a proactive approach to email safety this year can greatly enhance your personal security. By regularly updating your strategies, youâll stay ahead of cybercriminals who evolve their phishing tactics every day. Together, we can create a
Regulatory Intelligence (RI)
In todayâs dynamic regulatory landscape, organizations face constant challenges in staying compliant with ever-changing laws, guidelines, and industry standards. The risks of non-compliance can lead to financial penalties, operational delays, and reputational damage. This is where Regulatory Intelligence (RI) comes into play â serving as a strategic enabler for proactive regulatory risk management and informed decision-making. In this blog, weâll explore: What is Regulatory Intelligence (RI)? Regulatory Intelligence (RI) is the process of systematically collecting, monitoring, analyzing, and interpreting regulatory information and trends from global, national, and industry-specific sources to assess their potential impact on business operations. It goes beyond passive compliance monitoring â providing actionable insights that help companies anticipate regulatory changes, adjust business strategies, and maintain a competitive edge. In simpler terms: RI transforms raw regulatory data into meaningful insights for timely, strategic decision-making. Regulatory Intelligence Important for Companies Modern businesses operate in highly regulated environments. Regulatory frameworks vary by country, industry, and product/service category â and they evolve rapidly in response to technological advancements, geopolitical issues, market disruptions, and public health considerations. Without a structured approach to RI, organizations risk: An effective RI system ensures companies: â Stay ahead of regulatory changesâ Align product development and market strategies with legal requirementsâ Make informed decisions on market entry, clinical trials, manufacturing, and labelingâ Proactively manage risk and protect brand reputation Which Companies Need to Implement Regulatory Intelligence? While RI is valuable for all businesses, it is essential for highly regulated sectors, such as: Any company that operates internationally or handles sensitive products, services, or customer data benefits significantly from a formal RI system. Benefits of Having a Regulatory Intelligence Framework Implementing a Regulatory Intelligence system offers several strategic and operational advantages: Early Warning System â Anticipate upcoming regulatory changes, allowing time to adjust processes, documentation, and product pipelines. Enhanced Compliance Management â Reduce the risk of regulatory breaches by staying informed and aligned with the latest requirements. Faster Product Approvals â Aligning submissions and processes to current regulatory expectations minimizes delays. Informed Decision-Making â Enable leadership to make evidence-based strategic choices regarding market expansion, partnerships, and product development. Competitive Advantage â Stay ahead of competitors who react to changes instead of proactively planning for them. Operational Efficiency â Standardize regulatory processes and improve cross-functional communication. Reputation Management â Minimize negative publicity and strengthen relationships with regulators, partners, and customers. How to Develop and Implement a Regulatory Intelligence System Building an RI system involves careful planning, resource allocation, and stakeholder engagement. Hereâs a practical roadmap: 1-Define RI Objectives and Scope 2- Identify Reliable Information Sources Curate a list of credible, authoritative sources such as: 3- Implement RI Tools and Technologies Adopt specialized software platforms and tools to automate information gathering, monitoring, and reporting: 4- Build a Cross-Functional RI Team Assemble a team comprising regulatory affairs specialists, legal advisors, quality assurance, product development, and market access professionals. Define roles: 5- Establish a Governance Framework Create standardized processes for: 6- Develop RI Reporting and Communication Channels Set up regular reports, dashboards, and alerts for internal stakeholders â regulatory teams, product managers, legal counsel, and executive leadership. Recommended formats: 7- Train and Educate Employees Organize RI workshops, regulatory updates, and scenario-based training sessions to build awareness and competence across the organization. 8- Review and Optimize Regularly Best Practices for Effective RI Implementation Prioritize markets and regulations with the highest impact potential. Leverage technology for automation, data analytics, and visualization. Integrate RI into enterprise risk management frameworks. Maintain transparent communication with regulatory authorities. Benchmark RI activities against industry standards. Ensure leadership buy-in and allocate dedicated budgets. Regulatory Intelligence is no longer a ânice to haveâ â itâs a strategic necessity in todayâs fast-evolving regulatory and business environment. Companies that invest in structured RI programs gain significant operational, compliance, and competitive advantages. By following a clear framework for developing and implementing RI, organizations can proactively manage risks, accelerate market readiness, and confidently navigate global regulatory landscapes. Future-ready companies donât just comply with regulations â they lead through intelligence.
 OUR POWER OUR PLANET
Today, weâre reminded that our planet is not just our homeâitâs our shared responsibility. Our Responsibilities Each of us has the power to drive sustainable change. Small actionsâlike reducing waste, supporting green initiatives, or innovating with sustainability in mindâcan collectively make a big impact. đ± What can we all do?. Objectives of Earth Day are universalâand they call on each of us to: In countries like Pakistan, Earth Day holds even deeper significance. From rising air pollution levels and water scarcity to deforestation and climate-induced floods, the environmental challenges we face are both urgent and real. Itâs a crucial time to raise awareness, support local climate action, and push for long-term, sustainable policies that protect our natural resources and vulnerable communities. Caring for the Earth isnât just good ethics, itâs good business. Letâs continue to lead with purpose and protect what mattersâfor ourselves, for future generations, and for the planet we all share. đđ
Cyber Threats During the Holidays: How to Stay Safe From Seasonal Scams and Data Breaches
As the year draws to a close, letâs look at: 3 major data breaches from 2024 COMBs (compilations of many breaches) aside â like the MOAB (mother of all breaches) in January 2024, which leaked more than 26 billion records â letâs look at three major breaches from 2024: 1. National Public data breach In August 2024, NPD (National Public Data) confirmed a breach that compromised sensitive information, including Social Security numbers, affecting nearly all Americans. The breach was linked to unauthorised access attempts in December 2023 and potential data leaks in April and summer 2024. Personal data of up to 2.9 billion individuals was reportedly posted on the dark web for $3.5 million (about ÂŁ2.8 million). 2. Ticketmaster data breach In May 2024, Ticketmaster, a subsidiary of Live Nation, experienced a significant data breach, apparently affecting 560 million users. The threat actor ShinyHunters claimed responsibility, offering 1.3 TB of customer data, including personal data and credit card details, for sale on the dark web. 3. Internet Archive data breach In October 2024, the Internet Archive, including its Wayback Machine, suffered a cyber attack that exposed data of potentially 31 million users. The breach involved a malicious JavaScript pop-up that directed users to check compromised email addresses and passwords. Exposed data included email addresses, usernames and bcrypt password hashes. 3 threats organisations face during the holiday season 1. Ransomware attacks During the holiday period, cyber criminals know that many organisations have fewer staff available, and potentially more lax security. This can lead to increased ransomware incidents, as illustrated by last yearâs holiday season. Todayâs ransomware doesnât just encrypt data â it often exfiltrates data, too. Threat actors exploit a range of vulnerabilities for this, including: 2. DoS (denial-of-service) attacks Retailers and e-commerce platforms are particularly vulnerable to DoS attacks during peak shopping times, aiming to disrupt services and cause financial losses. A DoS attack involves a cyber attacker flooding your servers with requests such that they canât cope. That can result in your website, emails and other services going down, depending on the server targeted. Platforms may also be targeted by a DDoS (distributed denial-of-service) attack. This is a variant of a DoS attack, with the key difference that DDoS attacks involve multiple machines attacking the target. (With a DoS attack, just one computer is attacking the server.) Attackers may also launch a DoS attack to distract you from a different attack â ransomware, for example. 3. Phishing and social engineering Phishing and social engineering attacks invariably rise during the holidays, targeting both consumers and employees. Common holiday scams include: With more staff out of office, threat actors may also impersonate an employee, asking a âcolleagueâ to take action on their behalf. Such emails often contain a sense of urgency, or try to manipulate you in another way. Donât forget: social engineering is all about exploiting your psychology. As our penetration tester Hilmi Tin explained in this interview, attackers take advantage of the fact weâre curious, or make clever use of fear tactics. He also recommends simply taking ten seconds to look out for warning signs â particularly if the message is unexpected and making you feel like you need to do something. How to protect your sensitive data To protect your sensitive data â including personal data â make sure youâre clear on: Tools like data inventories, data flow maps and ROPAs (records of processing activities) will help with this. Ideally, these also highlight the technical and/or organisational measures in place to process and secure that data, as required by the GDPR (General Data Protection Regulation). Other tools like DPIAs (data protection impact assessments) also provide valuable information, making it easier to understand your data, so you can better manage your risks. Up-to-date policies and procedures will also improve your cyber security and privacy stance, and ensure youâre ready to deal with any threats.
A hospital, a chain of clinics, or a pharmaceutical company â each is a perfect storm for cybercrime
The healthcare industry is facing a cybersecurity crisis like no other. In 2023, cybercriminals targeted healthcare with over 200 breaches, compromising 89 million patient records. By the first half of 2024, this wave of attacks surged by 9.3%, affecting 45.5 million more records. Ransomware, often devastating, hit hardest, demanding $1.5 million on average per attack and plunging hospitals into chaos as critical systems were locked and lives put at risk. Whatâs at stake isnât just money or data â itâs trust, safety, and patient care. A breach doesnât just steal information; it can halt surgeries, delay diagnoses, and shatter the integrity of an entire organization. The reality? Healthcare organizations are not prepared. And they canât afford to stay that way. The Human Side of Healthcareâs Cyber Crisis Healthcare workers are extraordinary. They juggle life-saving decisions, long shifts, and constant multitasking while navigating the pressures of a high-stakes environment. But hereâs the hard truth: 46% of healthcare employees still fall victim to phishing attacks, even after training. Why? Because traditional training wasnât built for the realities of their world. Generic programs that ignore their unique roles, pressures, and time constraints are doomed to fail. When training feels irrelevant, disconnected, or burdensome, itâs no surprise employees view it as just another task to tick off during an already overloaded day. Itâs not that healthcare employees donât care â theyâre being set up to fail by an outdated system that doesnât meet them where they are. From Awareness to Readiness: The AEC Approach At AEC , we believe that true security isnât about checking boxes, itâs about building readiness. Itâs about empowering every employee, from administrators to nurses, to become an active part of the defense against cyber threats. So how do we do it? By rethinking everything about how cybersecurity training is delivered:
The illustrated guide to implementing and maintaining a medical device quality management system
Implementing a medical device quality management system, or QMS, is a regulatory requirement for medical device manufacturers. In the medical device industry, there is a strong focus on the regulatory requirements and creating conforming procedures. But a QMS should also make the organisation efficient and result in products that have high quality. As such, implementing and maintaining a QMS requires skills beyond regulatory requirements. The art of implementing and maintaining a medical device QMS is rarely described and few training courses are available. This illustrated guide was written by Peter Sebelius, who has implemented numerous quality management systems throughout his career and is a member of the Joint Working Group which authored the latest version of ISO 13485. This guide will: What is a medical device Quality Management System (QMS)? A Quality Management System, or QMS, is a comprehensive framework, or set of documented procedures, that guides people in an organisation to consistently deliver products that meet customer andâŻregulatory requirements. According to the ISO 9000:2015 standard, aâŻQuality management system is defined as: Quality management systema system to direct and control an organisation in terms of quality. Having a QMS that meets the requirements of applicable norms and standards is required for medical device manufacturers and is a regulatory requirement. Thus, manufacturers cannot legally place their medical devices on the market without it. Some people may frown upon implementing a QMS, thinking it is burdensome and creates significant overhead for the organisation. However, a QMS is not much different from a playbook or onboarding documentation organisations in non-regulated industries would implement to achieve organisational efficiency. The documented procedures of the QMS should act as comprehensive guides, ensuring seamless onboarding of new hires, streamlined workflows, and adherence to quality standards. And when properly implemented, it is an investment that should pay itself back with improved organisational efficiency and reduced failure costs, both internal as well as external. Not to mention improved customer and employee satisfaction.⯠The bitterness of poor quality remains long after the sweetness of low price is forgotten.Benjamin Franklin Why start-ups must implement a quality management system For a medical device manufacturer, implementing a QMS based on the ISO 13485 standard will cover a lot of what is required, but it is not sufficient in itself. The norms and standards that the medical device quality management system must meet depend on the type of medical device and which market the device is to be placed on:⯠There may be other norms that have to be implemented in the QMS, for example:⯠There are also voluntary standards that may be considered, for example:⯠All the norms and standards above can be integrated into one quality management system.⯠The structure of a medical device QMS Even though there are some variations in terms of the requirements, most QMS will include the following elements:⯠What is an ISO 13485 quality manual? The quality manual is the top of the QMS and the starting point for anyone who is attempting to access the QMS to understand, use or audit it.⯠Think of the quality manual as the document you would give someone who wants to understand how you work with quality. And as it is the starting point, it also makes perfect sense, and is required to include the documented procedures in the quality manual or reference the SOPs that contain them.⯠Below is an example outline of an ISO 13485 + MDR quality manual:âŻÂ 1. Purpose2. Scope ⯠âŻ3. Contents 4. Introduction 1. Regulatory framework and purpose of the QMS 4.2. Scope of the QMS 4.3. Exclusions and non-applicability 5. Quality management system 5.1. Quality policy 5.2. General ⯠⯠5.3. Main processes 5.4. Supporting processes 5.5. Quality management system structure 5.6. Technical documentation 5.7. Control of documents and records 6. Management responsibility 6.1. Management commitment 6.2. Quality policy and objectives 6.3. Responsibility, authority, and communication 6.4. Management review 7. Resource management 7.1. Human resources 7.2. Infrastructure 7.3. Maintenance 7.4. Work environment and contamination control 7.5. Design and development 7.6. Manufacturing of products 8. Feedback, measurement, analysis, and improvement 8.1. Feedback 8.2. Complaints and reportable events 8.3. Internal and external audits 8.4. Unannounced audits 8.5. Corrective actions and preventive actions 8.6. Improvement 9. Change history 10. Annual quality plan What is an ISO 13485 standard operating procedure or SOP? The standard operating procedures (SOP) are written instructions that describe how a process should be carried out. SOPs may differ in their level of detail; a product lifecycle SOP may describe the process of the initiation of a product development project all the way to removing the product from market. Such a document would naturally be written on a fairly high level. Other SOPs may be very granular and detailed, for example defining exactly how to process a customer complaint.⯠The ISO 13485 will require an organisation to have about 31 documented procedures. The ISO 9000 standard defines procedure as: Procedurespecified way to carry out an activity or processNote 1 to entry: Procedures can be documented or not. Does this mean that the organisation must have 31 SOPs? The answer is no.⯠The SOPs are paper or electronic documents containing the documented procedures. This means that one document, SOP or even the quality manual, could contain one, two, half or just about any number of documented procedures.⯠Forms and templates for ISO 13485 An absolute majority of medical device manufacturers will have both forms and templates in their QMS but they areâŻnot explicitly required. In fact, neither forms nor templates are mentioned in ISO 13485. But it is strongly recommended to implement forms and templates in your QMS to assist creating records and data collection. Records Records are at the lowest level of the QMS. It could be argued that they are not part of the medical device quality management system, but rather the output of operating the quality management system. Records would be the documents that are created and show the results of something, for example, the meeting minutes from a design review meeting. This would be a record that shows that the design review took place and the relevant information relating to that design review. Records are often created using either forms or templates.⯠Paper-based QMS
