Have you spent countless stressful hours preparing for ISO 13485 certification? You’re not alone. ISO 13485 is the internationally recognized quality management standard for medical device manufacturers.
Certification guarantees the trust of your regulators, stakeholders, and future customers while quickening your route to market. There’s no denying that it’s a complex process that needs to be done right. But with expert guidance and the right toolset, your company can release and bed-lasting ISO 13485 compliance.
This guide contains everything your team needs to kickstart and complete a successful ISO 13485 delegation trip and to get your medical device to market before your competitors. Let’s dive in.
What Does Iso 13485 Mean?
ISO 13485 is an internationally agreed-upon standard quality management system (QMS) requirement for any company involved in the design, product, installation, servicing, and manufacturing of medical devices.
ISO 13485 was first published in 1996 and revised in 2003 and 2016. The current interpretation, ISO 134852016, came into effect in March 2016. The end of these requirements is to ensure that medical devices and services constantly meet client prospects and relevant regulatory requirements.
Why Is Iso 13485 Certification Important?
The International Organization for Standardization (or ISO) is a transnational-governmental association of assiduity leaders who partake their knowledge and expertise to give results for global challenges.
ISO 13485 effectively covers ISO 9001 Certification with many fresh requirements. As a result, consumers and the life wisdom force chain have come to trust ISO and frequently refuse to buy medical device products from companies that lack ISO 13485 certification.
To gain CE marking, which indicates conformity with safety standards for products marketed in the European Economic Area — medical device manufacturers must either gain certification with a notified body or have a quality system.
Five Key Elements of Iso 13485
ISO 13485 includes requirements for design and development, risk management, and product and post-production processes for medical device companies. Below are five key requirements from ISO 13485 that are critical for companies seeking certification.
Quality Management System (QMS)
To be certified to ISO 13485, a company must apply and maintain a quality management system that meets the requirements set out in the standard. This section applies to general quality management system requirements and the attestation needed to apply and maintain an effective quality management system.
According to ISO, organizations need to Determine the processes the quality management system requires and what is needed to apply these processes throughout the association, taking into account the colourful places involved, apply a risk-based approach to the control of the relevant processes needed for the quality management system, and determine the sequence and commerce of these processes.
This section outlines management’s unique places and responsibilities concerning quality management system implementation and conservation.
In short, management should substantiate its commitment to developing and conserving the quality management system and its effectiveness. To do that, Communicate the importance of meeting regulatory requirements, establish a value quality policy to ensure quality objects are established and Conduct management reviews to ensure the availability of quality management system resources.
This phase outlines the resources life sciences organization should commit to applying the quality management system and maintain system effectiveness. In addition, it outlines the provisions needed to meet major regulatory and client requirements.
Resources outlined in this section include;
- The Provision of Resources
- Human Resources
- Work Terrain
- Impurity Control
In a rush to develop products as soon as possible, numerous organizations frequently need to pay more attention to the planning phase. Therefore, section 7.1 requires that you appropriately plan your realization efforts.
- More Specifically, It States That You Should Establish the Quality Requirements for Your Product (S)
- Define What Your Needed Processes Will Be and What Supporting Attestation Will Be Needed for Those Processes
- Outline the Company Infrastructure That Will Need to Be Created and What the Work Terrain Should Be Like
- Define Employee Qualification and Training Requirements
- Establish Your Processes for Verification, Confirmation, Measurement, Monitoring, Employing, Examination, Storehouse, Distribution, and Traceability
Eventually, you must organize all that information to be easily accessed and understood.
Measurement, Analysis, Improvement
According to ISO,” the association shall plan and apply the monitor, measurement, analysis, and improvement processes” related to the quality management system and products.
In this pursuit, organizations need to Demonstrate conformity to the product ensure conformity with the quality management system Maintain the effectiveness of the quality management system ISO 13485 clauses ISO 13485 contains eight clauses as part of its requirements. They are;
- Normative References
- Terms and Definitions
- General Requirements
- Management Responsibility
- Resource Management
- Product Realization
- Measurement, Analysis, and Improvement
Let’s Compactly Review Each Clause
The Scope sets out the intended issues of the modern medical device quality management system, including the importance of the process approach and continuous improvement.
Provides details of the reference standards or publications relevant to the particular standard, including ISO 90012015.
Terms & Definitions
Details Terms and Definitions relevant to the standard, including Definitions of Active Implantable Medical Device, Active Medical Device, Advisory Notice, client Complaint, Implantable Medical Device, Labelling, Medical Device, and Sterile Medical Device.
Lays out the broad requirements for a duly documented ISO 13485 QMS, including;
- Quality primer with clear QMS Scope
- Attestation control procedures
- Needed forms, records, and bribes
Enterprises the part of ‘top management,’ the group of people who direct and control your association at the highest position. client and patient satisfaction and safety should be overseen and maintained by top management with Clear responsibilities Frequent management reviews A clear quality policy with objects.
Requirements for how resources are managed and applied to meet your quality objectives, including Personnel, equipment, and training.
Charts out requirements for the end-to-end medical device product realization process, including;
- Product and manufacture
- Capturing and actioning feedback
Measurement, Analysis, and Improvement
It breaks down how to cover and dissect your processes with a view to continuous refinement and improvement. Core considerations include;
- Non-Conformance Control
- Measuring and Maximizing Client Satisfaction and Patient/ Product Safety
ISO 13485 VS ISO 9001
ISO 9001 quality management system that can be applied no matter what assiduity you’re in or your product, service, or company size. First, however, you’ll need to seek ISO 13485 certification,
If your company intends to manufacture medical devices. ISO 13485 certification has new requirements not set up in ISO 9001 that are specific to medical device manufacturers. Let’s look at the parallels and differences between ISO 9001 and ISO 13485, so you can better understand where you need to raise the bar on quality as a medical device manufacturer.
- Parallels Between ISO 13485 and ISO 9001 certification
- Each Standard Helps the Organization Achieve a Quality Management System
- Both Place a Focus on Risk Mitigation and Assessment
- Both Use the Deming Cycle, Also Known as Plan Do Check Act
- They Each Place a Focus on Faculty and Infrastructure for Quality
- Both Emphasize Understanding the Client for the Realization of Quality Products
- Fresh Requirements for Iso 13485:2016
- Device Master Record Explicitly Defining Qms Requirements
- Feedback and Review System for Conformance Detection 18
- Product Quality Control (Monitoring and Measuring) Throughout the Production Process
- Set Quality Requirements Must Be Met Before Product Release and Delivery
- Advisory Notices, Rework Exertion, and Release of the Non-Conforming Product (Which Still Meets Regulatory Requirements) Must Be Documented
- Personnel Require Access to Procedures, Requirements, and Reference Accoutrements at the Point of Work
- Unique and Specific Records for Every Up-Documented and Vindicated Device Batch
- Installation and Verification Device Requirements
- Maintained Records of Device Installation, Verification, and Servicing Conditioning and Procedures
QMS contains product specification documents and quality policy, with a framework for reviews and updates controlled by the management team management must corroborate QMS goals and compliance documented procedures for shelf life, quality data collection/ analysis/ retention, conservation exertion, risk/ terrain management, adverse event flagging, product conformity, identification, returns, conservation, labelling, and packaging.
Tips to Prepare for ISO 13485 Certification
Now that we understand the key factors and clauses of ISO 13485 and the differences with ISO 9001, it’s time to look at medication for certification. This process can be simple and inviting. Follow these nine tips to help you get your certification briskly.
Familiarize Yourself with the Guidelines
Review the guidelines and ensure you understand what you need to become certified. You can then view an exercise and buy the complete document on ISO 13485 from ISO’s website.
Meet CAPA Standards
To ensure your company meets CAPA standards, relate to the FDA’s examination guidelines, ISO 134858.5.3 (forestalment) and ISO 134858.5.2 (correction). Failure to meet CAPA standards is the number one detector for FDA citations in medical device assiduity.
Apply Complaint Procedures
Establish complaint procedures following the guidelines in FDA CFR820.198 and ISO 134858.2.2. A lack of standard procedures for employing complaints or failure to substantiate that they followed procedures is the most common reason the organization entered a 483 observation.
Produce a written procedure for force chain management to reduce the risk of resistance or supplier pitfalls that could compromise your device quality.
Develop MDR (Medical Device Reporting) Procedures
MDR (Medical Device Reporting) should include events and periodic reports as detailed under FDA CFR803.17 and ISO 134852016. Nine ways to prepare for ISO 13485 certification 16 Written procedures and systems are critical for compliance with record-keeping guidelines for MDR.
Benefits of ISO 134852016 Delegation
While ISO 90012015 covers a broad range of businesses and diligence, ISO 134852016 has a narrower focus on medical device assiduity. By clinging to the guidelines set out in ISO 134852016, your association can enjoy several benefits, including;
- Bringing Quality and Nonstop Improvement into the Heart of Your Medical Device Association
- Advanced Patient/ Client Satisfaction – by Constantly Furnishing Safe Medical Devices That Meet Client Requirements
- Enhanced Character and Credibility – by Being ISO 134852016 Accredited, You Can Demonstrate to Customers, Suppliers, and Other Stakeholders That Your Association Is Serious About Quality.
Greater Effectiveness: ISO 134852016 can help streamline your processes, making your association more effective overall.
Reduced costs: ISO 134852016 can lead to reduced waste, rework, and other inefficiencies, thereby reducing your association’s overall costs and bettered risk management – by having a robust quality management system in place, you can more effectively identify and manage pitfalls associated with your medical devices.
A Stronger Foundation for Growth: ISO 134852016 can give a solid foundation for your association to grow and expand its management into new markets.
Enforcing a quality management system can only cure an association led by quality-driven management. Successfully shifting to a quality-driven culture requires full support from the leadership team and a commitment to change.
Quality management software offers a different range of business benefits. For example, when you apply a robust eQMS for your life sciences company, you’re one step closer to obtaining and keeping ISO 13485 certification.