ISO 13485

Services according to the Quality Management System ISO 13485

Our team of experts have over 25 years of experience and can help you implementing the Quality Management System (QMS) according to ISO 13485.

ISO-13485-Services-Quality-Management-System
Summary

A quick overview of this page

Achieving your ISO 13485 Quality Management System

A Quality Management System (QMS) is implemented in order to help an organisation to continuously develop the quality of their products and services. Thus, it is important when building a quality system that one conforms to the requirements and guidelines set in a standard, such as ISO 13485.

Challenges of obtaining an ISO 13485 Quality Management System

Obtaining an ISO 13845 QMS can be a complicated process. Herein, time and knowledge of the ISO 13485 QMS requirements for any company involved in the design, production, installation, servicing and manufacturing of medical devices must be taken into account during the process to be able to be in compliance with this QMS.  

Guidance from start to finish

Our team of experts can aid in helping you to achieve the ISO 13485 Quality Management System and ensure  that your company meets the requirements that ensure that your medical devices and services consistently meet customer expectations and relevant regulatory requirements.  

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ISO 13485

Your partner for ISO 13485 Quality Management System (QMS)

What is ISO 13485?

ISO 13485 is an international standard that manufacturers, suppliers and distributors of medical devices can meet to demonstrate their compliance with legal requirements related to medical devices. This standard can also be applied for other companies involved in the chain process of a medical device, such as design and development, storage, treatment, distribution, maintenance, installation, service and cleaning/sterilisation of medical devices. Using ISO 13485 can help to standardise and systemise the medical device development process. Regardless of this, the European Medical Device Regulation does require that a Quality Management System (QMS) is in place, even though it does not identify with ISO 13485 directly. Certification Experts can act as your QMS consulting advisor to determine the applicable Quality Management System for your organisation.

When is an ISO 13485 required?

An ISO 13485 certificate is issued by an independent, impartial and expert certification body. When CE marking medical devices is applied parallel to the ISO 13485 certification, the certification is done by a Notified Body (NoBo), who will then provide an ISO 13485 accreditation. This certification shows that your organisation meets the legal requirements and that you have increased the reliability of your medical device. Once you have obtained the ISO 13485 certification, your company complies with all relevant ISO 13485 clauses.

However, it is important to note that the ISO 13485 certification is not mandatory by regulation, unless a Notified Body (NoBo) is involved. This is the case when a medical device has a risk classification higher than class I. ISO 13485 is a harmonised standard for quality management systems for regulatory purposes. Therefore a Notified Body uses this standard to assess if a manufacturer meets the requirements for a quality management system.

For class I manufacturers it is not mandatory, also for distributors, importers and other parties involved in the chain of the production (not being legal manufacturer). However, it is often a market requirement.

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Difference between ISO 9001 and ISO 13485

Manufacturers can or must be ISO 13485 certified if their company is involved with medical devices. This is because they will then require more documentation regarding their procedures and registrations. ISO 13485 is the standard that is set specifically for medical devices, which states that a company must guarantee the quality, safety and effectiveness of 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. ISO 13485 certification can only be achieved when you are involved in the life cycle of a medical device.
Every company can acquire an ISO 9001 certification. The ISO 9001 standard defines general quality requirements whereas ISO 13485 explicitly addresses the requirements for medical devices and the processes for design, development, production and post-productive activities. The ISO 9001 is more focused on how the company is organised to keep customer satisfaction and continuous improvement central, whilst ISO 13485 validation mostly focuses on the following:

  • The safety and efficacy of the medical device and its maintenance
  • Post market surveillance (feedback) with regards to the medical devices
  • Compliance with laws and regulations regarding medical devices

The Roadmap for ISO 13485 by Certification Experts

Our team of experts use a six step approach to implement the ISO 13485 QMS.

  1. 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.  
  2. Management system: Set up and implement a practically manageable, digital management system in accordance with the standard and your needs. 
  3. 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.
  4. Management review: Assessment of the effectiveness of the management system by management or management. 
  5. Guidance and certification: Guidance during the external audit by the certification body. Your company is now certified.
  6. Maintenance: Periodically update and update the management system, so that your organisation continues to meet the requirements of the standard.
Portfolio

Check out our ISO 13485 services

ISO 13485

Our team of experts can aid in helping you to achieve the ISO 13485 QMS  and ensure  that your company meets the requirements that ensure that your medical devices and services consistently meet customer expectations and relevant regulatory requirements.

  • Gap Analysis
  • Set up a quality system
  • Implementation session with presentation
  • Training ISO 13485, risk management and internal audit training 
  • Internal audit 
  • Support with certification audit 
  • 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

Capa Training

Our service offers customised CAPA training for medical devices, led by expert instructors. We focus on regulatory aspects such as ISO 13485, share best practices, and provide interactive sessions with practical scenarios.

  • CAPA Training
  • CAPA discussion
Frequently asked questions

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.

ISO 13485 is a company certification, not a product certification. Medical equipment classified as medical device needs to have a technical file according to the MDR. Depending on the risk class a ISO 13485 certification is optional or mandatory. However, a Quality Management System (QMS) is always required for all legal manufacturers according to Article 10 MDR. An ISO 13485 certificate is issued by an independent, impartial and expert certification body or when higher than class I, a Notified Body must be used.

In the context of EU MDR compliance, ISO 13485 certification is not a mandatory requirement. While the EU MDR law does not explicitly mention ISO 13485, it does mandate the implementation of a Quality Management System (QMS). The EU has outlined a set of harmonised standards to guide companies in understanding applicable standards for medical devices in the EU. Notably, ISO 13485:2016 is the sole QMS standard listed, making it kind of mandatory for medical device Class IIA, IIB and III.

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 13485 is an international standard that outlines the requirements for the Quality Management System (QMS) of organisations engaged in the design, development, production, and distribution of medical devices. Notable aspects include the establishment of a QMS addressing regulatory requirements, a focus on legal compliance, incorporation of risk management practices, guidelines for traceability and thorough documentation, and an emphasis on continuous improvement. Adherence to ISO 13485 is especially pertinent for organizations in the medical device sector, and certification serves as evidence of conformity to globally recognized quality standards.

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).

The EU MDR is a regulation which is mandated by the European Union that dictates what needs to be done by a company that wants to manufacture or import medical devices into the European Union. The mandate provides information on how medical devices need to be marked and in conformity with regulations, along with updates on what information needs to be submitted to the updated Eudamed database, which stores regulatory information for each medical device. ISO 13485 is an internationally recognised standard for creating a Quality Management System for medical device companies anywhere in the world. Using ISO 13485 as a standard will enable any organisation to illustrate that their products meet customer and regulatory requirements.

ISO 13485 certification is a formal recognition that a company’s Quality Management System (QMS) complies with the requirements outlined in the ISO 13485 international standard. This certification is specifically designed for organisations involved in the design, development, production, and servicing of medical devices.

For Class IIA, IIB and III a ISO 13485 certification is mandatory. ISO 13485 certification is not a legal requirement for Class I medical devices, but it is widely recognised and can be a strategic decision for organisations seeking to demonstrate their commitment to quality and regulatory compliance in the medical device industry.

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Carolina Koster Operations Manager
Your expert conducted an internal audit for ISO 13485 at our company. The pre-audit communication was clear and brought valuable expertise. Despite some challenges, your expert was understanding and fostered a relaxed atmosphere. The audit was thorough and effectively pinpointed our areas for improvement. We are grateful and will be working on the feedback.

Van Heek Medical

Wilma Peereboom Quality Coordinator
The cooperation with Certification Experts is satisfactory. They are decisive from the start and one of their main strengths is their excellent problem-solving skills.

Ensure and maintain your Quality!

ISO27001 & ISO9001 – Trusted by 300+ Clients.