A Short Guide To ISO 13485 Compliance

The landscape of medical device quality management can be very complicated. From documentation and risk management to product development and post-market surveillance, ensuring safety, quality, and regulatory compliance is paramount. This is where a globally accepted standard, like ISO 13485, acts as a roadmap for businesses trying to fulfill strict quality control standards in this sector.  

The ISO 13485 standard significantly benefits companies manufacturing medical devices and associated services. It boosts organizational efficiency and guarantees a dedication to quality. ISO 13485 certification will help you grow your customer base, lower production downtime, and remove obstacles to entering outside markets. Thus, whether you’re a medical device manufacturer, supplier, or healthcare professional, understanding ISO 13485 compliance is crucial.

In this blog, we will provide a brief overview of the ISO 13485 standard, who needs to comply with it, the benefits of this compliance framework, and the steps to implement it for your medical devices business.

What is ISO 13485 Compliance?

The ISO 13485 guidelines govern medical device-related service quality management systems. It was first published by the International Organization for Standardization in 1996, followed by two version updates—one in 2003 and the most recent one in 2016. The ISO 13485 guidelines address:

  • Quality assurance
  • Law observance
  • Risk assessment
  • Functional effectiveness
  • Improvement of processes and products
  • Capacity to track and retrieve products and equipment

The ISO 9001 quality management system certification is the source of ISO 13485, accessible to companies across numerous industries. Some of the ISO 9001 criteria, however, are challenging to implement due to the unique requirements of the pharmaceutical and medical device industries. ISO 13485 was developed to meet these needs.

Who Needs To Comply with the ISO 13485 Guidelines?

Here is a list of entities that need to comply with the ISO 13485 guidelines:

  1. Medical Device Manufacturers: To guarantee that their goods fulfill quality and safety standards, businesses that design, develop, manufacture, or distribute medical devices must adhere to ISO 13485. This comprises companies that produce a range of medical devices, from surgical instruments to implantable devices and diagnostic equipment.
  2. Suppliers and Sub-contractors: Companies who provide parts, materials, or services to makers of medical devices may also be required to adhere to ISO 13485 if their goods or services directly impact the quality of the finished medical device. This guarantees that quality standards are met throughout the supply chain.
  1. Medical Regulatory Authorities: Regulatory bodies in different countries may require medical device manufacturers to comply with ISO 13485 as part of the registration or approval process for marketing and selling medical devices. This compliance demonstrates a commitment to quality and safety.
  1. Notified Bodies: As part of the CE marking procedure, manufacturers may need to collaborate with notified bodies (independent third-party organizations) in some areas, such as Europe, to evaluate and certify their conformity with ISO 13485. The CE mark means that the manufacturer takes responsibility for the compliance of a product with all applicable European health, safety, performance, and environmental requirements. CE stands for “Conformité Européenne,” the French for European conformity.
  1. Importers and Distributors: Depending on the legislative framework in the particular nation or area, importers and distributors of medical devices may also be subject to ISO 13485 regulations. They have a part to play in ensuring the gadgets they import or distribute adhere to quality and safety regulations.
  1. Healthcare Organizations: While ISO 13485 is primarily intended for manufacturers and their supply chains, healthcare-related organizations that handle the reprocessing and servicing medical devices may find it necessary or encouraged to adhere to pertinent standards to guarantee the security of the equipment they use.

To guarantee the caliber, security, and efficacy of medical equipment, ISO 13485 compliance is crucial. Organizations must familiarize themselves with the regulatory environment in their target markets and modify their quality management systems appropriately, as country-specific rules and laws may differ.

In this next section, we will talk about the benefits that businesses can reap by complying with the ISO 13485 guidelines.

Benefits of ISO 13485

Here are the benefits of adhering to the ISO 13485 compliance guidelines:

  1. Sub-contract from Bigger Businesses: Large medical device companies often prefer working with ISO 13485-certified vendors. The 2016 upgrade has increased demand for certification. According to the modifications, big businesses are now in charge of making sure that all subcontractors follow ISO 13485 criteria; subcontractors that already hold this certification will probably get preference.
  1. Show Your Commitment to Excellence: ISO 9001 and ISO 13485 are markers of an organization’s dedication to quality. Obtaining a quality management accreditation proves to clients and authorities that your business places a high importance on quality.
  1. Expand to Newer Markets: International medical device standards, such as ISO 13485, are designed to guarantee that medical equipment exhibits the same level of quality and dependability across various locations. A benefit to contemplating product exports is the ISO 13485 accreditation. Not only does it show prospective customers the quality of the product, but it is also the first step towards regulatory approval in important regions like the EU and Canada.
  1. Make Documentation Readily Available: This standard’s documentation requirements are made to make sure that every member of a development team always has access to the data they require, which can cut down on the time and costs involved in developing new products.
  1. Deepen Product and Business Knowledge: Many compliant customers say that by recording the procedures related to their medical device, the company may create a centralized knowledge base. This information can pinpoint issues, enhance the final product, and expedite the production process. It also facilitates the onboarding process for new hires.
  1. Achieve Customer Trust: A medical device quality management system (QMS) enables you to offer more consistent quality in your goods and services, enhancing their dependability and capacity to satisfy consumer demands. The improved quality makes customers happier.

Several companies are certified to ISO 9001 and ISO 13485 standards. It is much simpler to become certified to ISO 9001 if your company already holds ISO 13485 accreditation. These two standards have almost similar requirements, so they are very compatible. While ISO 13485 does not address certain standards relating to business clauses, you will have completed most of the work already with ISO 9001.

Last but not least, let us find out how you can implement the ISO 13485 guidelines for your organization.

How To Implement ISO 13485?

Here is a step-by-step guide for implementing ISO 13485 compliance in your business:

Step 1: Gather Documentation and Study Requirements

Once you decide that you would like to comply with the ISO 13485 guidelines, the first thing to do would be to learn about the requirements of this standard. First, make sure you have a copy of the standard and any supplementary materials. These are the materials that you will need to consult when drafting your implementation plan and that the auditor will consult when evaluating your QMS. 

You should ensure that you have access to the 2016 edition of the standard, as it has a number of significant updates. For instance, the most recent edition mandates that companies make sure all of the companies they deal with adhere to ISO 13485 standards.

Step 2: Perform a Gap Analysis

Doing a gap analysis is one of the most crucial phases in putting ISO 13485 into practice. A gap analysis is the evaluation of your business’s current procedures in comparison to ISO 13485 standards. By doing this, you will see where your company’s present system needs to catch up to what has to be put in place to comply.

Your implementation plan will be informed by the data you collect for your gap analysis. More significant adjustments will be needed to achieve compliance if the gaps you detect are larger. The adjustments you must make will be less if they are smaller.

In carrying out a gap analysis, you will 

  • Compare your present QMS with the requirements of ISO 13485;
  • Note how your current system satisfies and fails to satiate the standards of ISO 13485 and,
  • Choose what to include in your implementation strategy based on your findings.

After finishing a gap analysis, you usually generate a report that contains an op

  • the areas where your business satisfies the standards of the standard;
  • the areas where your business does not meet the standards of the standard; and,
  • suggestions for what to put in your implementation strategy.

Step 3: Draft an Implementation Plan

This plan, which outlines your implementation of ISO 13485, should include well-defined, measurable goals with reasonable timelines.

As part of creating your strategy, you must build your quality manual and policy, which will require reviewing your current procedures and making any necessary updates to comply with the standard’s requirements. Establishing procedures for managing your design processes, including documentation, will also be required.

Your QMS must include a few specific procedures as required by ISO 13485. You must take note of the topics that ISO 13485 emphasizes and make sure they are included in your strategy while considering the particular requirements of your company.

Determining the scope of your plan is an important step in the development process since it will clarify your objectives and the parameters of its execution. By properly defining your scope, you may prevent your QMS from being applied too narrowly, which can reduce its efficacy, as well as to irrelevant elements of your business. You can specify your scope with your quality policy and handbook. It should include relevant sections of ISO 13485, key stakeholders, required documentation, approvals, resources, and training, expected date of completion, and the benefits and costs of implementation.

Step 4: Designing the Documentation

You must use documentation to control your operations if you want to apply ISO 13485 successfully. It is vital to create documentation for the processes you have established or updated. You can use this paperwork to support your processes and demonstrate your compliance. You should ensure your documentation satisfies all ISO 13485 requirements, but you have considerable leeway in how you create it, and it is optional to document every step.

Starting with the minimum standards outlined in ISO 13485, which include a quality manual and multiple documented procedures, is the best course of action. Additional documentation can be added as needed. Make sure your implementation plan covers all documentation requirements.

Step 5: Provide Training

You have to inform all employees that your organization will implement ISO 13485 far enough in advance that they can adequately prepare with minimal disruption to their daily work. Additionally, you should also inform employees about how implementation will affect them, how it will benefit them, and what their responsibilities are. Remembering to include information about the benefits can help to win buy-in from managers and other key stakeholders.

The team members who will be part of the implementation process should receive the necessary training. Ensure employees have sufficient time to complete training and answer any questions before they take action to enable implementation.

Step 6: Implement the Plan

Now, you can finally start implementing the plan. Each company’s adoption of ISO 13485 will be unique based on its current procedures and the specifics of its plan, and thus, can take up varying timelines.

You must keep a close eye on the installation process and adjust as necessary. Remember to keep track of any modifications and notify the appropriate staff members. Run your QMS for a few months, changing as necessary and thoroughly documenting the procedure.

Step 7: Conduct an Internal Audit

Once the plan is running efficiently, you have to perform an internal audit and a management review before going through the third-party audits required to become certified. These procedures will assist you in assessing the functionality of your system and making sure it conforms with ISO 13485 criteria.

You can start by making an internal ISO 13485 audit checklist and use it to assess your QMS’s performance to conduct internal audits comprehensively. Make sure you thoroughly record your results. This paperwork will demonstrate that your procedures are following the right procedures and operating as intended. 

In addition, a management evaluation must be carried out. Management should assess data from your QMS procedures during this review and ensure that these processes have the resources to continue to be efficient and develop over time. By carrying out these audits and reviews, you can identify places where your procedures aren’t operating as they should. Following that, you can arrange for these problems to be fixed before any third-party certification body audits are scheduled.

Step 8: Select Your Independent Certification Body

Once your QMS is complete and you feel it is ready, you may look into third-party certification bodies to partner with. This will involve completing the necessary audits and reviews. Selecting the appropriate auditor helps expedite the auditing procedure and lessen issues brought on by linguistic or cultural differences.

You can start by seeking out auditors with a local presence, as an audit is essentially an on-site confirmation of your quality management procedures. Examine the requirements of each choice, including their accreditation status, background and training, knowledge and experience dealing with ISO 13485 certifications, and even other medical device standards. Choosing an auditor with the appropriate qualities may maximize the benefits of the audits and ensure a smooth certification process.

Step 9: Complete the Third-Party Audit and Certification Procedures

Once you have selected the auditor you want to work with, you can begin the audit process, where the certification body verifies that you meet ISO 13485 requirements. If you pass the audits, you will become certified to ISO 13485.

To get started, apply with the auditor you selected, including the following:

  • background information about your organization;
  • which standard you want certification for; and,
  • relevant details about your implementation process.

The initial certification audit requires two visits from the auditor.

The stage one assessment, which determines whether your company is prepared for the full assessment, will be carried out by the auditor during the initial visit. Your documentation will be reviewed as part of the stage one assessment at your management system center.

In this initial evaluation, the auditor will verify

  • the accuracy of the application’s details;
  • the scope of the certification as stated previously;
  • the adherence to the laws and regulations;
  • that your QMS satisfies the criteria of ISO 13485; and,
  • that the QMS has been in operation for a minimum of three months.

The auditor will give you a report detailing any non-compliance or possible improvements discovered during the visit after this inspection. In response to that, you need to put together a corrective action plan to rectify any serious problems found.

You can set up your next assessment if your QMS passes the audit.

The auditor will finish the stage two audit, which confirms whether your QMS satisfies all of ISO 13458’s requirements, on the following visit. This audit includes all of the locations covered by your certification.

Following completion of this assessment, the auditor will:

  • use unbiased evidence to document whether your QMS satisfies ISO 13485 criteria;
  • perform exemplar audits of pertinent procedures and undertakings;
  • examine any distant locations as well as other places to determine how the QMS functions off-site; and,
  • keep track of any non-compliance issues and possible corrections.

Before providing the certification, an auditor must confirm that your organization has taken corrective action if the audit finds any significant non-conformances. Before being certified, you must pass another stage two examination if the required remedial action is done after six months.

Once you pass the stage two audit, a three-year certification will be issued by the third-party audit and certification organization.

Step 10: Maintain Compliance 

To keep your certification valid for the three-year certification cycle, you must finish an annual surveillance audit. A surveillance audit is a partial audit that confirms the enhancements to the QMS and your organization’s adherence to the standard.

You must notify your certification authority as soon as possible if your company undergoes changes during the certification cycle, such as adding or eliminating locations or scaling back on staff. Following that, you can adjust your QMS, your certification’s scope, and other aspects as necessary.

ISO 13485 Compliance, Risk Management and Readiness with Akitra!

Establishing trust is a crucial competitive differentiator when courting new SaaS businesses in today’s era of data breaches and compromised privacy. Customers and partners want assurances that their organizations are doing everything possible to prevent disclosing sensitive data and putting them at risk, and compliance certification fills that need.

Akitra offers an industry-leading, AI-powered Compliance Automation platform for SaaS companies. Using automated evidence collection and continuous monitoring, together with a full suite of customizable policies and controls as a compliance foundation, our compliance automation platform and services help our customers become compliance-ready for ISO 13485 compliance framework, along with other security standards like SOC 1, SOC 2, HIPAA, GDPR, PCI DSS, ISO 27001, ISO 27701, ISO 27017, ISO 27018, NIST CSF, NIST 800-53, NIST 800-171, FedRAMP, CCPA, CMMC, SOX ITGC, and more such as CIS AWS Foundations Benchmark, Australian ISM and Essential Eight etc. In addition, companies can use Akitra’s Risk Management product for overall risk management using quantitative methodologies such as Factorial Analysis of Information Risks (FAIR) and qualitative methods, including NIST-based for your company, Vulnerability Assessment and Pen Testing services, Trust Center, and AI-based Automated Questionnaire Response product to streamline and expedite security questionnaire response processes, delivering huge cost savings. Our compliance and security experts will provide customized guidance to navigate the end-to-end compliance process confidently. Akitra Academy provides easy-to-learn short video courses on security, compliance, and related topics of immense significance for today’s fast-growing companies.

The benefits of our solution include enormous savings in time, human resources, and cost savings, including discounted audit fees with our audit firm partners. Customers achieve compliance certification fast and cost-effectively, stay continuously compliant as they grow, and can become certified under additional frameworks using a single compliance automation platform.

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