Quality Management Systems
Obtain your Quality Management System with us to guarantee a compliant QMS
Certification Experts is your full-service compliance partner and guides you through the complete Quality Management System (QMS) process according to the various types of QMS standards. With over 25 years of experience, our team of experts will help your organisation to continuously develop the quality of your products and services.
A quick overview of this page
Who We Serve
Your partner for Quality Management Systems
What is a Quality Management System?
The most commonly used and referenced type of quality management system is the ISO system. The ISO family of quality standards is used in various industries and deals with both quality and sustainability. Whilst the ISO 9001 is the most common standard that companies seek and achieve, there are also other accreditations and standards which can be more applicable to specific industries. These can be read below:
| Industry | Management System |
|---|---|
| All Industries | ISO 9001 |
| Automotive | IATF 16949 |
| Medical Device | ISO 13485 Article 10 Quality Management System of the MDR |
| Food | ISO 22000 |
| Services | ISO 200000 |
| IT | ISO 27001 |
| Aerospace | AS 9100D |
The biggest challenge of implementing a QMS is defining and writing down the relevant processes for the organisation and the products/services. Quality is often thought of as a subjective concept, making it difficult to define in measurable terms. However, quality is essential to the success of any product startup. A product that is of poor quality will likely be unsuccessful in the marketplace. The challenges of implementing a quality management system in a product startup can be overcome by taking the time to properly define quality processes for your product/service. By doing so, you will be able to develop a QMS that is tailored to the unique needs of your product and your company. Certification Experts can ease this process for through the following steps:
- Determine baseline of current state (performance) and relevant processes
- Set-up and implement a quality management system
- Internal audit
- Management review
- Guiding the QMS certification process
- Maintenance QMS
Ensure and maintain your Quality!
QMS Audit and Consulting
Different management systems require different audits, making this a difficult and time consuming process that often requires expertise and knowledge. Therefore, it is essential for most manufacturers to involve a third party to guide or carry out an internal audit before the official QMS certification. With a QMS audit checklist we can evaluate an organisation’s existing system to ascertain its conformance with company policies, contract commitments, and regulatory requirements and verify your systems are consistent and manufacture safe products. At Certification Experts, our team of experts can provide QMS consulting with an assessment of the management system against standards, law and your own requirements, QMS training and an internal audit, which is also the preparation for the certification audit. This will ease the difficult and lengthy process for you. Our team specialises in Quality Management Systems for Medical Devices based on the following procedures:
How to implement the applicable QMS with Certification Experts?
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 Quality Management System services
Quality Management System
Quality Management System services help businesses establish and maintain effective quality management processes. This involves implementing procedures, training, auditing, and continuous improvement to meet customer expectations and industry standards. Our team at CE Medical (part of Certification Experts) can set up, implement, review and maintain a Quality Management System (QMS) for your organisation. Additionally, we can provide an appropriate QMS based on your situation and wishes.
- ISO 13485
- ISO 9001
- Article 10 Quality Management System MDR
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
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
Art. 10 of MDR
Our team of experts can aid in helping you to achieve the Article 10 of MDR requirements. This article outlines the requirements for the QMS that all manufacturers must follow in order to be able to put their product or service into the market. Our team of experts can aid in helping you to implement the applicable QMS according to Article 10 of MDR and guide you through this process.
- Gap Analysis (see what you have and what you still need)
- Set up a quality system with all applicable procedures, work instructions, standard forms and supporting documentation according to article 10
- Implementation session with presentation
- Internal audit – checking if the QMS has been implemented well and according to the standard
- 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!
The 7 principles of quality management are:
- Engagement of people
- Customer focus
- Leadership
- Process approach
- Improvement
- Evidence-based decision making
- Relationship management
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.
A Risk Management System for medical devices is a structured and systematic approach to identifying, assessing, controlling, and monitoring risks associated with the entire lifecycle of medical devices. Guided by standards like ISO 14971, it involves the systematic identification of potential hazards, evaluation of risks, implementation of control measures, clear communication about risks, ongoing monitoring, comprehensive documentation, and integration with Quality Management Systems. The objective is to proactively manage risks to ensure the safety and performance of medical devices, meeting regulatory requirements and addressing potential concerns throughout the product lifecycle.
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 purpose of a Quality Management System (QMS) is to establish a systematic framework within an organisation, ensuring consistent and high-quality products or services that meet or exceed customer expectations. It aims to enhance customer satisfaction, comply with industry standards and regulations, foster continuous improvement, increase efficiency and productivity, manage risks, achieve cost savings, gain a competitive advantage, engage employees, establish traceability and accountability, adapt to changes, facilitate informed decision-making, strengthen supplier relationships, contribute to a positive brand reputation, and simplify audits and certifications. Ultimately, a well-implemented QMS is central to achieving customer satisfaction and sustained organisational success.
A Quality Management System (QMS) is vital for organisations as it ensures consistent product or service quality, enhances customer satisfaction, and facilitates compliance with regulations. It fosters a culture of continuous improvement, increases efficiency, and manages risks effectively. The benefits include cost savings, competitive advantage, employee engagement, traceability, adaptability to change, and informed decision-making. Additionally, a robust QMS contributes to positive supplier relationships, brand reputation, and simplifies audits and certifications. Overall, a QMS is essential for achieving and sustaining high-quality standards and organisational success.
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