Category: ISO 13485

The healthcare sector is ever-changing and ever-evolving. Since the pandemic era, the healthcare market has been experiencing growth across the world. Further, it’s expected to grow at a CAGR of 6.05% during 2024 – 2033 and reach around $22.57 trillion by 2033. But that alone can’t make the sector trustworthy, as not all hospitals or healthcare centers are the same. Well, getting ISO 13485-certified with the latest ISO 13485 audit checklist can help your hospital build trust among patients.

In today’s ever-changing society, getting an ISO 13485:2016 certification can ensure the safety of patients alongside the dependability of using the medical equipment(s). While most hospitals seek to offer the best healthcare services to their patients. Ensuring ISO 13485 compliance to establish the QMS (Quality Management Systems) in your hospital can be an essential factor in fostering healthcare confidence among consumers.

Wondering how getting ISO 13485-certified can help your hospital to increase patient confidence?

Let’s explore more about that in the following blog post.

The role of ISO 13485 certification in boosting healthcare confidence for hospitals

ISO 13485 is internationally recognized for specifying the rules for QMS for medical device-specific industries.

Sectors that manufacture, distribute, and deal with the use of medical devices must be ISO 13485-certified to confirm their dedication to offer the highest level of safety while ensuring regulatory and efficiency compliance.

Thus, hospitals should also get this ISO certification to boost patient confidence. Achieving the ISO 13485 certification can help you in a lot of ways.

Here are the following benefits:

1.It can help you ensure end-to-end quality management

Implementing ISO 13485 comes with a complete QMS starting from the initial ideas of design to post-market surveillance (PMS). Hospitals complying with the latest ISO 13485 guidelines ensure that they’re committed to maintaining the highest quality services across the full life cycle of medical equipment(s), which, on the other hand, can instill trust among patients, regulatory agencies, and the healthcare providers of your hospital.

Achieving the ISO 13485 certification can also help you get better positions to engage with global business partners, stakeholders, and suppliers by strengthening your hospital’s dedication to safety and quality.

2.It can help you improve the performance of your organization.

The ISO 13485 certification can help your hospital focus on enhancing the overall performance through efficiency and process optimization.

Being ISO 13485:2016-certified can provide a higher degree of operational excellence to your hospital. Aside from assuring the quality of medical equipment(s) used in your hospital, it also ensures the overall dependability and efficiency of your healthcare providers.

3.It can help you maintain regulatory compliance and patient safety.

Managing the potential risks and deploying corrective measures to assure the efficacy and safety of the medical equipment(s) is one of the key ISO 13485 guidelines.

Achieving this ISO certification can help your hospital demonstrate its commitment to meet the international regulatory requirements to build confidence among healthcare consumers while ensuring that medical equipment(s) used in your hospital meet all the quality requirements.

4.It can act as a complementary approach to ISO 9001 certification.

Both ISO 13485 and ISO 9001 share similar ideas like continual improvements, customer focus, and process methodologies.

Though the ISO 13485 standard addresses the concerns for specific industries that are associated with medical devices, the ISO 9001 standard focuses on a larger QMS across various sectors.

However, since ISO 13485 also deals with a specific type of QMS, implementing this ISO standard would help your hospital to get complementary benefits of ISO 9001 as well. Even though you will still need to achieve the ISO 9001 certification, the connection between these 2 ISO certifications helps you make your quality management more simplified and effective.

How to find the right ISO auditing firm to get your hospital ISO 13485-certified?

If you want to get your hospital ISO 13485-certified, you should conduct internal audits to make sure that your organization complies with all the requirements.

For that, you’ll have to hire a professional ISO auditing firm to ensure ISO 13485:2016 compliance and achieve certification.

When companies look for the right ISO auditing firm, they often look for years of experience of the team.

Well, let us tell you that these are not the only things you should consider when you’re looking for one.

The following are some vital factors you must consider when looking for an ISO auditing firm:

1.Check the knowledge of the team on the ISO 13485 guidelines.

2.Be sure that the ISO auditing team is up-to-date with the latest ISO 13485 requirements.

3.Check the track record of the ISO auditing agency and ask for referrals from them.

4.Even if the company sounds promising, never forget the online reviews of the team from present and former clientele on Google and their company sites.

5.Ensure that the company itself is ISO-certified.

6.Last, but not least, ask about the overall budget and timelines for the ISO 13485 audit.

Bottom line

Wondering how to boost patient confidence to choose your hospital over others? Well, getting ISO 13485:2016-certified by following the latest ISO 13485 audit checklist can help you. We hope this blog can help you understand that.

As expert auditors with sufficient industry experience, it’s understandable when business owners get anxious before a third-party audit.

One of the most effective ways to deal with this unease and ensure you are following the correct path is creating a comprehensive ISO 13485 audit checklist and evaluating your medical device quality management system.

It can help you understand the additional requirements you have to meet, the potential room for improvements, and identify the flaws in the system.

To help you get started, we present a sample audit questionnaire or checklist for clause 4 of ISO 13485.

So, if you are seeking effective ways to evaluate your company’s environmental management system, delve into the below section now!

An Expert-Approved Audit Checklist For ISO 13485 Clause 4!

Clause 4 presents the first set of requirements of ISO 13485. It focuses on establishing a medical device QMS, documenting it and related roles and responsibilities, creating quality manuals and policies, and controlling documents as well.

Here’s an ISO 13485 audit checklist solely designed to help you ensure compliance with the Clause 4 quality management system.

So, let’s get started!

4.1 General Requirements

• Has your organization established, documented, implemented, and maintained an effective medical device quality management system? Have you improved the existing system according to the requirements of ISO 13485?

• Has your organization identified the processes required for the quality management system? Have you planned their application through your organization?

• Have you taken a risk-based approach to the control of the quality management system processes?

• Have you determined the interaction and sequence between the quality management system processes?

• What criteria and methods does your organization use to ensure the effectiveness of the control of quality management system processes and operations? Include them in your ISO 13485 audit checklist for a thorough review.

• Has your organization provided all the resources required to support the operation and monitoring of the medical device quality management system processes?

• How does your company monitor, measure, and analyze the ISO medical device quality management system processes?

• How has your company implemented the actions needed to achieve the QMS objectives and maintain its effectiveness?

• Are the processes of your medical device QMS managed according to the requirements of the ISO 13485 medical device quality management system?

• Does your organization outsource any processes that affect its products, services, or compliance? If yes, then how do you plan to control those processes?

• Where is the control of outsourced processes affecting product conformity in regard to the requirements of the ISO 13485 medical device QMS?

• Do you have a plan for validating software before using them? Include your processes for evaluating the plans in the ISO 13485 audit checklist.

4.2 Documentation Requirements

• Have you documented the statements of quality objectives and quality policy?

• Have you established a quality manual?

• Does your company have documented procedures required by ISO 13485?

• Do you have the appropriate documents to ensure effective planning, control, and operation of the organization’s processes?

• Have you considered the required records when creating the documentation?

• Are there any other documents required by laws and regulations?

• Can you show your auditors the medical file for each model of medical device, including documents with product specifications and meeting other ISO 13485 requirements?

• Does the quality manual include the scope of the QMS, including details of justification for excluding requirements that apply to your QMS?

• Where does the quality manual reference the documented procedures established for the QMS?

• Where does the quality manual contain a description of interactions between the processes of the QMS?

• Where does the QM outline the documentation structure of the quality management system?

• Have you established controls to prevent the deterioration and loss of documents as well as identify and distribute the documents? Then, be sure to include them in the ISO 13485 audit checklist!

A Few Details To Remember When Complying With ISO 13485 Clause 4!

Document control is a major feature of ISO 13485. Hence, ensure you make no mistake when complying with it. Note down these details to prevent errors when structuring the audit checklist.

Document Control Specifications In ISO 13485

• ISO 13485 recommends developing document control processes and procedures to

• Review and approve documents for appropriateness before using,

• Update and re-approve the documents as necessary,

• Identify the current revision status and changes made to the documents,

• Ensure the availability of relevant versions of the applicable documents,

• Ensure the accessibility, readability, and legibility of the documents,

• Identify and control the distribution of external origin documents,

• Prevent loss and unintended use of outdated documentation.

The Most Commonly Made Mistakes Regarding Documentation Control!

When crafting your ISO 13485 audit checklist, make sure to check on these three mistakes most organizations make when documenting control.

• Using obsolete documents or documents without prior approval or review,

• No defined controls to prevent the use of outdated documents or loss of documents,

• No procedure for tracking the revisions and changes in documentation.

Ensure to assign the ownership of key documents to named individuals to prevent their loss. Also, communicate the contents of the documents properly to your employees. Make sure they are able to answer queries from auditors.

Endnote

The extensivity of ISO 13485 can make it a challenging standard to meet. Hopefully, this ISO 13485 audit checklist will help you stimulate this process. Also, you can use this checklist to create similar lists for other clauses. Additionally, you can use it as a tool for readiness review or a pre-audit analysis.