ISO 9001
Services according to ISO 9001
Our team of experts have over 25 years of experience and can help you implement the applicable Quality Management System (QMS) according to ISO 9001.
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ISO 9001
ISO 9001 is one of the most internationally recognized standards for Quality Management Systems (QMS). ISO 9001 provides a framework and set of principles that ensure a common-sense approach to the management of your organisation to consistently satisfy customers and other stakeholders. ISO 9001 certification aims to continuously improve processes and aims to provide products and services that live up to the demands and wishes of customers and other stakeholders. The following steps are required in the framework:
- As a manufacturer or distributor, you must eventualise how you are positioned on the market in terms of your value propositions and stakeholders. Opportunities and threats that may influence your organisation must be mapped and, when needed, measures must be taken (risk based approach).
- The wishes and demands of stakeholders must be identified. Then, your organisation will analyse to what extent these needs are met and what measures can be taken to improve this.
- Management must show leadership within the quality management system. In addition, quality objectives must be drawn up for the organisation and processes, and the policy must be established and implemented.
- Herein a risk analysis will be created, for the QMS and processes of your organisation, which will take into account your context and stakeholders requirements.
- The organisation must define requirements for the infrastructure and working environment with regards to the delivery of the products and services. This includes requirements around the building, cleanroom, and storage where the products or services are processed.
- The procedures necessary to achieve the organisational objectives and to meet the requirements of the context, stakeholders and risk management must be established. Primary processes, such as marketing, sales, delivery, service (maintenance) and supporting processes, such as purchasing, complaints, audits, risk management, corrective measures, competencies, infrastructure and working environment for your products and services, are taken into account. The ‘plan, do, check, act – cycle’ applies here.
- If you are involved in the life cycle of a medical device, the applicable procedures from the role within the MDR can also be described in the quality management system. This can be integrated into the topics above. Where necessary, additional processes are established within the primary and supporting processes and vigilance, recall, identification and traceability.
Ensure and maintain your Quality!
Difference between ISO 9001 and ISO 13485
ISO 13485 is the standard that is set specifically for chain partners of medical devices, and states that a company must guarantee the quality, safety and effectiveness of their medical devices. This starts with the manufacturers, where the medical device is designed, developed and produced, and can also be applied to distributors, importers and suppliers in the chain. This applies to all medical devices from class I, IIA, IIB, III and requires more documentation for the procedures and registrations within the QMS. ISO 13485 certification can only be obtained when you are involved in the life cycle of a Medical Device.
ISO 9001 standard defines general quality requirements, and every company can achieve its certification, whereas ISO 13485 explicitly addresses the requirements for medical devices. ISO 9001 is more focused on how the company is organised to keep the satisfaction of customers and stakeholders, and continuous improvement central. It is also an option for manufacturers of products that belong to Class I for which ISO 13485 is too complex, too heavy or not mandatory. The MDR related processes for Medical Devices can be implemented herein. This way, you meet the requirements of the MDR and you immediately have a demonstrable quality management system in accordance with an internationally recognised standard for quality management systems. ISO 9001 gives more freedom in the interpretation and design of the described processes. ISO 9001 mostly focuses on the following:
- Customer focus
- Leadership
- Involvement, knowledge and competence of people
- Process approach
- Continual improvement
The Roadmap for ISO 9001
Certification Experts’ method to obtain your QMS certification varies from client to client. In most cases our team implements the following 6-step plan:
- Gap analysis: The performance of your business unit is assessed to determine whether business requirements or objectives are being met and, if not, what steps should be taken to meet them. Based on the gap analysis, your company has a clear view on how much time is spent, which costs are associated with this and how much effort it will take
- Management system: Set up and implement a practically manageable, digital management system in accordance with the standard and your needs
- Internal audit: Testing of the management system against standards, the law and your own requirements. The internal audit is also the preparation for the certification audit
- Management review: Assessment of the effectiveness of the management system by management or management
- Guidance and certification: Guidance during the external audit by the certification body. Your company is now certified
- Maintenance: Periodically update and update the management system, so that your organisation continues to meet the requirements of the standard
Check out our ISO 9001 services
ISO 9001
Our team of experts can aid in helping you to achieve the ISO 9001 QMS and ensure that your company meets the requirements that ensure that your devices and services consistently meet customer expectations and relevant regulatory requirements.
- Gap Analysis (see what you have and what you still need)
- Setting up a Quality Management System (QMS) with all applicable procedures, work instructions, standard forms and supporting documentation
- Implementation session with presentation
- Internal audit training and risk management training (optional)
- Internal audit – checking if the QMS has been implemented well and according to the ISO 9001 requirements
- Support with the certification audit (accredited Certification body for ISO 9001 certification)
- Maintenance of QMS
Internal Audit
Our team of experts can provide aid via the Testing of your management system against standards, the law and your own requirements. The internal audit is also the preparation for the certification audit.
- Internal Audit
Management Review
Certification Experts will support the management in assessing the effective operation of the quality management system and help identify opportunities for improvement and risks.
- Management Review
Certification Audit
Certification experts will support with certification audit. During the on-site audit our experts will provide on-site support to assist with any queries that arise during the audit. With our guidance, companies can approach the QMS certification audit with confidence, knowing that they are well-prepared and supported every step of the way.
- Advise and support during certification audit
Non-Conformance Procedure
A Non-Conformance Procedure within a Quality Management System (QMS) is a structured and documented process that outlines the steps to be taken when a non-conformance is identified within the organization’s quality processes. A non-conformance refers to any instance where a product, process, or activity does not meet the specified requirements, standards, or expectations.
- Identifying and documenting the non conformity (With evidence/proof in the form of photos)
- Root Cause analysis of the con conformity (by applying the 5 way method or the Ishikawa method (fishbone)
- Corrective and preventive actions (CAPA’s)
- Preventative actions which will stop the non conformance from occurring again
- Effectiveness check on the taken actions
- Close out signatures once both or all parties have rectified and closed the non conformance
QMS Maintenance
The basis of a quality management system is the continuous improvement and optimisation of the organisation. Once the certificate has been obtained, the quality must be continuously maintained. By engaging with our Medical Team, you can enhance the effectiveness of your QMS, maintain compliance with regulatory standards, and ensure the continued safety and quality of your medical devices in the market.
- Maintenance QMS
All the answers you might need!
ISO 13485 includes elements of ISO 9001, but it is a specific standard tailored for the medical device industry. ISO 13485 is based on the ISO 9001 structure and shares some common requirements, such as those related to the documentation of a quality management system, management responsibility, resource management, and continuous improvement. Both standards emphasize the importance of a process-based approach to quality management.
However, ISO 13485 has additional requirements and specific clauses that are unique to the medical device industry. It includes provisions for aspects like design and development, risk management, validation of processes, and regulatory compliance specific to medical devices.
In summary, while ISO 13485 incorporates some of the general quality management principles found in ISO 9001, it is a specialized standard tailored to the unique needs and regulatory requirements of the medical device industry. Organizations in the medical device sector may choose to implement both standards or focus specifically on ISO 13485 depending on their business objectives and regulatory obligations.
While ISO 9001 is a general quality management standard that is applicable to various industries, it is not specifically tailored for the unique regulatory requirements of the medical device industry. For organisations involved in the design, development, manufacturing, and distribution of medical devices, a more specific standard known as ISO 13485 is often preferred.
ISO 13485 is an international standard that specifies requirements for a Quality Management System (QMS) specific to the medical device industry. It covers aspects such as design control, risk management, validation of processes, and regulatory compliance relevant to medical devices. ISO 13485 is designed to ensure the safety and efficacy of medical devices and is often a regulatory requirement for companies operating in this sector.
In summary, while ISO 9001 provides a general framework for quality management that can be applied across various industries, organisations in the medical device sector typically choose ISO 13485 to meet the specific regulatory and quality management needs of their industry.
A Quality Management System (QMS) offers numerous benefits to organisations across various industries. Some of the key advantages include:
- Enhanced Customer Satisfaction: By consistently delivering high-quality products or services, organisations can enhance customer satisfaction and loyalty.
Improved Product or Service Quality: A QMS helps organisations identify and address issues in their processes, leading to improved product or service quality.
Increased Efficiency and Productivity: Streamlining processes and reducing errors through a QMS can lead to increased efficiency and productivity.
Regulatory Compliance: Implementing a QMS helps organisations comply with industry regulations and standards, reducing the risk of legal and regulatory issues.
Risk Management: QMS includes risk management practices, allowing organisations to identify, assess, and mitigate risks, thereby minimizing potential negative impacts.
Cost Savings: Effective quality management can lead to cost savings by reducing waste, rework, and the need for corrective actions. - Continuous Improvement:A QMS promotes a culture of continuous improvement, encouraging organisations to regularly review and enhance their processes.
Employee Engagement: Involving employees in quality management processes fosters a sense of ownership and engagement, leading to improved morale and teamwork.
Competitive Advantage: Organisations with a robust QMS often gain a competitive advantage by demonstrating their commitment to quality and customer satisfaction.
Better Decision-Making: Access to accurate and timely information through a QMS enables informed decision-making at all levels of the organisation.
Enhanced Supplier Relationships: A QMS helps organisations work closely with suppliers, ensuring the quality of inputs and fostering strong partnerships.
Brand Reputation: Consistently delivering high-quality products or services contributes to a positive brand reputation and can lead to increased market share.
Easier Audits and Certifications: Organisations with a QMS find it easier to undergo audits and obtain certifications, demonstrating compliance with industry standards.
Traceability and Accountability: A QMS provides traceability of processes and products, enhancing accountability and facilitating root cause analysis when issues arise.
Adaptability to Change:Organisations with a QMS are often more adaptable to changes in the business environment, allowing them to respond effectively to market demands and challenges. - In summary, a well-implemented Quality Management System is a strategic asset that contributes to organisational success, customer satisfaction, and sustained improvement.
ISO 9001 certification is a formal recognition that an organisation’s Quality Management System (QMS) complies with the requirements outlined in the ISO 9001 international standard. ISO 9001 is a widely recognised standard that sets out the criteria for establishing, implementing, maintaining, and continually improving an effective QMS within an organisation.
ISO 9001 certification is not a legal requirement, but it is often pursued by organizations to demonstrate their commitment to quality, enhance customer confidence, and improve overall organizational performance. Certification is typically valid for a specified period, after which organizations undergo recertification audits to maintain their ISO 9001 status.
A Quality Management System (QMS) is a structured set of activities and processes that an organization establishes to manage and enhance the quality of its products or services. It involves key elements such as a quality policy, objectives, documentation, process management, risk mitigation, continuous improvement, and a focus on customer satisfaction. The QMS aims to meet customer requirements consistently and can be certified based on international standards like ISO 9001, tailored to specific industries such as medical devices (ISO 13485), or automotive (ISO/TS 16949). The system involves regular audits, training, and a commitment to ongoing improvement to ensure effectiveness and compliance with established standards.
Certification Experts provides a range of QMS services tailored to the medical device industry, covering areas such as Article 10 MDR, ISO 9001, ISO 13485, and Good Distribution Practice (GDP) Quality Management Systems (QMS).
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