ISO 13485:
Medical Device Management System Certification
ISO 13485 certification is a standard that applies specifically to medical devices.
ISO 13485 is designed for use by organizations involved in the design, production, installation and maintenance of medical devices.
What is ISO 13485?
“ISO 13485 Certification” means that the organization has implemented the ISO 13485 Quality Management System and has successfully met all of the requirements of ISO 13485.
ISO 13485 assesses whether your quality management system is appropriate and effective with a focus on the safety and effectiveness of medical devices.
الايزو 13485 is a standard for medical device organizations, covering all stages, from design to installation, maintenance, and related services.
It requires organizations to carry out these processes in accordance with the relevant regulatory requirements of the markets they aim to enter.
The importance of ISO 13485
If you wish to sell your products in other countries, you must comply with local laws and regulations.
For example, most European countries require medical device manufacturers to obtain CE marking before they can market their products within those regions.
In addition, many states require medical device manufacturers to register their products with state agencies.
Therefore, obtaining ISO 13485 certification can help you stay ahead of the game when marketing your products around the world.
But without the ISO 13485 certificate, you will not be able to export your products outside your country.
This standard and its certification process help regulate the production and marketing of products before they are distributed in the market.
This coincides with the bigger picture of following Good Manufacturing Practices (GMP), which are established under the authority of the Federal Food, Drug, and Cosmetic Act by the US Food and Drug Administration (FDA).
ISO 13485 certification requirements
ISO 13485:2016 specifies requirements for a quality management system for the production of ISO medical devices and related services that consistently meet customer and applicable regulatory requirements.
To keep up with the changing times, reviewing the standards of the quality management system is essential to check if there are things that need to be reviewed, deleted or improved.
With its current version known as ISO 13485:2016, market updates, technological changes and regulation revisions are taken into account.
An overview of ISO 13485 consists of the following items:
structure is divided into eight clauses:
Clause 1: Scope
– Explains the purpose of the standard, who can use it, and additional guidance for other provisions
Clause 2: Normative references
– Discusses introductory details and how to reference ISO 9001:2015 in the standard
Clause 3: Terms and definitions
– Defines terms used throughout the standard
Clause 4: Quality management system
– Determines the general requirements for the organization’s quality management system for manufacturing medical devices.
– It targets two very specific aspects of the quality management system: general requirements and documentation requirements.
Adherence to the standard
Implement and monitor record keeping and documentation processes
Providing a standard quality guide to define all policies and guidelines
Document what needs to be documented.
Maintain what is required of you.
Implement written procedures and ensure the effectiveness of the system you implement.
Consider risk factors in all activities.
Provide steps to reduce the identified risks, aiming not to cause catastrophic events.
Clause 5: Management responsibility
– Describes management involvement to ensure successful implementation of the standard
Management must demonstrate its commitment by demonstrating that it can be held accountable for operations within its organization.
They have to ensure that their focus does not hinder the needs of the end user, and that all laws are followed in the manufacturing process.
Management has ultimate responsibility to uphold the quality policy, ensure its compliance with the laws of the country of employment, and communicate the mission to employees.
It is their responsibility to plan, delegate authority and communicate effectively.
Clause 6: Resource management
– Ensures that resources such as staff, infrastructure and equipment are adequate and available to carry out operations
Senior management is responsible for ensuring that the quality management system is compliant with ISO 13485 and adheres to local regulatory requirements.
As a requirement within ISO 13485, senior management must ensure that sufficient resources are available to perform the work promised to the organization.
Resourcing can refer to personnel, infrastructure, consumables, equipment, succession planning, and risk aversion.
Clause 7: Product realization
– Addresses the overall journey of a medical device product from conception to implementation and how each stage should follow quality protocols
The organization must plan the journey from conception to implementation.
This can include developing a process to document how ideas are initiated, concepts are verified, and products are designed and developed, as well as how they verify and validate that ISO 13485 requirements are met.
Clause 8: Measurement, analysis and improvement
Now that your product is manufactured and released for public use, it’s your responsibility to make sure people get what they want.
According to paragraph 8, developing a procedure to effectively monitor and measure the success of the product must include:
Dealing with complaints
Report incidents to regulatory authorities
Subject to internal evaluations through auditing
Continuous process and product evaluation internally
Identify and monitor products that do not meet the original design requirements (non-conforming product).
Analyze the resulting data and continuously improve the process.
Steps to obtain ISO 13485 certification
If you are in the business of manufacturing medical devices, or the components used to build them, obtaining ISO 13485 certification is a must.
The certification is a quality management system (QMS) standard that ensures organizations comply with regulatory requirements and safety standards.
It is a globally recognized certification that demonstrates an organization’s ability to provide safe and effective medical devices.
Step 1: Understand ISO 13485 certification
Before you can understand how to obtain ISO 13485 certification, it is important to understand the requirements.
You can find this information on the official website of the International Organization for Standardization (ISO).
Once you have a comprehensive understanding of the requirements, you can begin preparing for the ISO 13485 certification process.
Step 2: Gap analysis
It is important to conduct a gap analysis.
This includes comparing your current quality management system or quality policies to the requirements of the ISO 13485 standard.
A gap analysis will help you identify areas where you need to improve to comply with the standard.
Step 3: Implement the quality management system
Implementing a quality management system is at the heart of how to achieve ISO 13485 certification.
A management system is a set of policies, processes, and procedures that support quality and performance practices and meet regulatory requirements.
Step 4: Implement the changes
Based on the results of the gap analysis, you may need to implement changes to your quality management system.
This may include updating policies and procedures, providing training to employees, or investing in new equipment or technology.
It is important to keep track of all changes you make, and document them in your quality management system.
Step 5: Internal audit
It is important to conduct internal audits to ensure that your quality management system is effective and complies with ISO 13485 requirements.
Internal audits involve reviewing your procedures, records, and processes to identify any non-conformists.
You may need to take corrective action to address non-conformists before continuing with the ISO 13485 certification process.
Step 6: Choose an ISO 13485 certification body
Once you have implemented the necessary changes to your quality management system, you will need to choose a certification body, such as QRS.
The certification body will evaluate your quality management system to ensure that it meets the requirements of the ISO 13485 standard.
It is important to choose an accreditor that is accredited by a recognized accreditation body, such as the International Accreditation Forum (IAF), that has significant experience, and provides strong customer service.
Remember to take your time, document everything, and work with a reputable accreditation body to ensure a successful accreditation process.
To get started in the ISO 13485 certification process, request a quote from one of our experts, or to learn more contact us directly with any questions you may have.
Benefits of ISO 13485 certification
ISO 13485 is a valuable tool for organizations in the medical device industry, offering many benefits that positively impact product quality, regulatory compliance, customer satisfaction and overall business performance. Let’s explore the most important benefits of implementing ISO 13485.
- Improve product quality
ISO 13485 strongly emphasizes risk management and quality control throughout the product life cycle.
By implementing this standard, organizations create robust processes that ensure consistent product quality, reducing the risk of defects and improving patient safety.
- Global reach
The ISO 13485 standard complies with global regulatory requirements for medical devices.
Implementing these standards helps organizations meet regulatory obligations, simplify audits, and facilitate market access.
- Customer trust
ISO 13485 certification is a mark of quality and reliability.
Customers, healthcare professionals and regulatory bodies place their trust in organizations that adhere to this standard.
Example: A medical device supplier with ISO 13485 certification has a competitive advantage in the market.
- Ability to win more business
ISO 13485 promotes efficient operations, ensuring smooth operations throughout the organization.
Organizations can eliminate redundancy, reduce errors, and improve resource allocation by standardizing these procedures.
It’s focus on documentation, traceability and risk management ensures that the necessary processes and controls are in place to meet regulatory requirements.
- Improve risk management
ISO 13485 certification is a powerful tool for instilling confidence in customers, healthcare professionals and regulatory bodies.
By adhering to this standard, organizations demonstrate their commitment to providing safe and effective medical devices, which leads to increased customer confidence.
- Access to a broader and global market
ISO 13485 certification opens doors to international markets.
Many countries and regulatory bodies recognize this standard as a prerequisite for market entry, enabling organizations to expand their reach and access new business opportunities.
- Promotes a culture of continuous improvement (CI).
ISO 13485 promotes a culture of continuous improvement within organizations.
By establishing metrics, conducting regular audits, and implementing corrective actions, organizations can drive continuous improvements to their quality management system.
- Improving stakeholder relationships
ISO 13485 emphasizes the importance of evaluating and monitoring suppliers.
By implementing stringent supplier management processes, organizations can ensure the quality and reliability of third-party raw materials, components, and services.
- Post-market scanning is effective
ISO 13485 imposes effective post-market controls.
Organizations must monitor and analyze comments, complaints, and adverse events related to their products, enabling them to take rapid corrective action and improve product safety.
- Competitive advantage and business growth
ISO 13485 certification provides organizations with a competitive advantage in the medical device industry.
It enhances brand reputation, increases market share, and opens opportunities for collaborations and partnerships.
- What is the cost of obtaining ISO 13485 certification?
One of the most important benefits of ISO 13485 certification for medical device manufacturers is the potential reductions in costs.
Depending on the size and complexity of the organization, the cost of certification may vary, although it is often much less expensive than traditional quality management methods.
In addition, organizations with ISO 13485 certification may often achieve their quality goals at a lower cost than non-certified organizations.
It’s cost will vary widely depending on the size and complexity of your organization and your product offering.
The fee is payable directly to the notified body conducting your ISO 13485 assessment.
- Who needs an ISO 13485 certificate?
The requirements of ISO 13485:2016 apply to organizations regardless of their size and regardless of type, except as expressly stated.
Where requirements are specified as applying to medical devices, the requirements apply equally to related services provided by the organization.
You will need الايزو 13485 certification if you are developing medical solutions and want to reduce time to market. By following this standard, you will enter the healthcare industry and put your product on the same level as other successful companies in the medical field.
Some companies require their technical partners to obtain ISO 13485:2016 certification to ensure they comply with quality standards.
long to obtain ISO 13485 certification?
If you already have ISO 9001:2015 and ISO 27001:2022, it will take a short time to obtain ISO 13485 certification.
However, if ISO 13485 is the first certification you intend to obtain, it will take some time as you will have to wait in the registration queue, analyze and change your company policies, and wait for the two audit stages to be completed.
Obtain ISO 13485 with QRS
QRS is a leading الايزو 13485 certification services company in the Middle East and helps companies ensure the effectiveness of their ISO 13485 quality management system by conducting conformity assessments with certified experts who are experienced auditors.
How to contact us?
There are many ways to reach us.
Visit our website: www.qrsegy.com
Send us your inquiry through our website
Send an email to qrscert@gmail.com
Or contact us directly for a free discussion about your organization’s audit process.