ISO 13485: Audit Criteria and Certification Process

ISO 13485 is a globally recognised standard that defines the standards for a quality management system (QMS) in the medical device industry. It specialises in the design, development, production, installation, and maintenance of medical devices and related services. ISO 13485 is based on the ISO 9001 standard; however, it adds some sector-specific features. The standard prioritises regulatory compliance, risk management, and process control for medical device design, production, and distribution.

What is the ISO 13485 Certification?

ISO 13485 certification demonstrates that the certified company has implemented appropriate, independently inspected processes and controls to assure the safety, efficacy, and quality of medical devices throughout their lifecycle. This includes process control from design and development to manufacture, installation, maintenance, and end-of-life. To acquire ISO 13485 certification, an organization must establish an internal QMS process that meets the standard. After implementing the QMS, a recognised certification authority conducts a full audit of the company. The audit evaluates the organization’s compliance with ISO 13485 regulations and the efficacy of its QMS.

What is the ISO 13485 Audit Criteria?

Here are the primary ISO 13485 audit criteria:

• Document Review: The auditor evaluates the organization’s QMS documentation (policies, procedures, work instructions, and records) to determine that it satisfies ISO 13485 requirements.
• On-site Audit: The audit is designed to evaluate the described system’s implementation and effectiveness as a standards-compliant QMS. It assesses processes, procedures, and records, as well as conducts interviews with employees to ensure their comprehension and participation.
• Process Evaluation: All processes must be documented, managed, and ISO 13485 compliant. This comprises all stages, including design and development, risk management methods, supplier management techniques, and other relevant processes.
• Regulatory Conformity: The audit certifies conformity with regulatory requirements, such as those set by the FDA in the United States or the Medical Devices Directive in the European Union.
• Noncompliance and Corrective Actions: Any audit deficiencies must be identified and resolved. The non-compliant components will then have to be re-audited. The organization’s process for addressing these issues may also be evaluated.
• Management Review: Auditors examine top management’s internal QMS evaluation and improvement strategies.

ISO 13485’s Audit and Certification Process

The ISO 13485 auditing and accreditation process typically includes the following steps:

• Preparation: The applicant must create and implement a QMS that meets the standards. This often needs a significant cultural transformation within the firm. This need support from the entire organization.
• Documentation: The applicant team must document how their QMS meets the standard. This necessitates comprehensive policies, processes, work instructions, records, and other documents.
• Internal Audit: This is used to test initial compliance. Members of the applying organization frequently execute this task to assist the complete company in preparing for the certification audit. This internal audit identifies any shortcomings so that the organization can enhance internal processes before to the actual audit.
• Certification Audit: A certified certification organization is invited (and paid for) to audit the company’s quality management system. The first stage of the audit focuses solely on ISO 13485 documentation; auditors analyse the company’s plan and processes to ensure that it conforms with ISO 13485 on documents. This document assessment is supplemented by internal interviews to determine readiness for the stage-two audit and, if necessary, establish a corrective action plan. Stage two audits evaluate the operational effectiveness of the QMS after any initial corrective actions have been undertaken. This comprises additional interviews and, in most cases, an on-site inspection to ensure compliance and check quality records.
• Nonconformity Management: Any feature that auditors identify as lacking is deemed a nonconformity. To acquire certification, the company must take corrective actions.
• Certification Decision: When an organization is found to be in comply, it is granted ISO 13485 certification.   
• Surveillance Audits: A certification authority conducts these on a regular (usually annual) basis to ensure that the organization’s QMS is still operating by ISO 13485 standards.

Understand the Documents Specifications of the ISO 13485 Standard for QMS – Medical Devices

The ISO 13485 standard quality management system (QMS) criteria are a globally accepted set of guidelines for any business engaged in the design, manufacture, distribution, installation, and maintenance of medical devices. The first edition of ISO 13485 was released in 1996, and updates followed in 2003 and 2016. The most recent version of the ISO 13485 standard, becomes applicable in March 2016. These specifications are meant to guarantee that medical products and services constantly live up to consumer expectations as well as pertinent legal and regulatory requirements.

With the help of the ISO 13485 standard, organizations may create safer and more cost-effective workplaces while also removing any potential legal issues. Because ISO 13485 is an internationally recognized standard of quality and safety for the manufacturing of medical equipment, having it helps firms be perceived as more dependable, trustworthy providers. However, many businesses begin creating the ISO 13485 Documents before beginning implementation in the organization to gain an idea of what truly needs to be done and how to accomplish it. So, to assist everyone to understand the ISO 3485 standard better, here are a few of the necessary ISO 13485 documentation requirements:

For every implementation process, documentation of ISO 13485 QMS for medical devices is crucial. The purpose of documentation should be to specify processes and keep the records necessary to prove they are being followed. Objective evidence requires documentation. Provide your staff with unbiased help while they design, develop, produce, and maintain medical devices. proof that can be objectively used to prove that requirements are being met One of the most significant core components of a QMS is the establishment of comprehensive yet practical document management practices for your company.  

Quality Manual: The quality handbook is a vital component of your quality management system. Making a lengthy policy-level document that deconstructs various sections of ISO 13485 and provides a high-level overview of how the medical device business treats the clauses is the typical method for achieving this need for a quality manual. This method is appropriate. The following requirements must be met by the quality manual:

• Describe the scope of the QMS. Include any clauses that are avoided or non-applications that are justified.
• Identify or include the QMS processes in the procedures.
• Describe the methods by which QMS processes interact.
• A brief description of the QMS documentation’s structure.

Medical Device File: Each type or category of a medical device must have its medical device file. A medical device file’s material must consist of:

• Description of the product, including intended use and indications for use.
• Product labeling and instructions for use.
• Specifications for the product.
• Specifications and procedures for manufacturing, inspection, labeling, packaging, storage, handling, and distribution.
• Measurement and monitoring specifications.
• Conditions and procedures for product installation (if relevant).
• Actions for product servicing (if relevant).

Document Control: Documentation is an essential component of a quality management system. A document control procedure must establish as per the company’s document control criteria. This includes ensuring that papers are evaluated and approved before implementation, methods for revising documents and recognizing changes, and ensuring that current versions are available at the point of usage.

Control of Records: Strict limits are needed for records as for documents. Additionally, there are situations when the difference between a document and a record can be a little unclear. Records serve as proof that specific procedures were followed. There are other notes on records scattered throughout this manual. Regarding review and approval, the same kind of requirements are applied. However, records are usually not versioned.

Key Steps Involved in ISO 13485 Internal Auditing Practices

ISO 13485:2016 specifies necessities for a quality management system where an organization wants to prove its capability to deliver medical devices and related services that constantly meet consumer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, with design and development, production, storage and supply, installation, or servicing of a medical device and design and development or provision of associated activities. ISO 13485:2016 can also be used by suppliers or external parties that deliver product, including quality management system-related services to such organizations.

The ISO 13485 internal audit process as one more essential evil required for ISO 13485 certification and maintenance. Some think of it as a waste of time, simply duplicating the work of the certification body; others see it as a witch hunt, looking for mistakes, or searching for someone to blame or discipline. In truth, the internal audit is neither of these things, these are certainly not the intent.

Steps to Follow During ISO 13485 Audit

The purpose of the internal audit is to inspect processes more closely and try to identify areas for improvement. As a process owner, it can be very helpful to step away for a moment and permit a second set of eyes to look for opportunities that may have missed. The purpose is not to criticize, but rather to find ways to streamline processes so that they work more efficiently. So, here are the five key steps in the internal audit process, with tips for how to best use this process to the advantage of company.

• Plan and announce the ISO 13485 audit schedule: The audit is not about surprising people so “catch them in the act” of doing something wrong. When do that, top management sends a clear message that they don’t trust their employees, and in turn, employees may try to protect themselves by hiding data or giving false information. So, with this in mind, it is significant to set up a clear audit schedule, and make sure that everybody knows when each process will be audited – even if it’s just a rough guideline to start. The ISO 13485 Audit shows an assurance from management to supporting employees in their efforts to improve their processes. It also permits those in charge of a process to finish up any improvements they are currently working on, so they can get a clear view of the influence of those changes, and also process owners may wish to make special requests for the auditor to look for particular information associated to other planned improvements.
• Plan the individual process audits: Now that everybody has an idea of when to expect an ISO 13485 audit, need to plan and schedule the audits of each individual process. This permits both auditor and auditee to find a time that works for each, and a timeline that is comfortable. This is also a good time to go over previous ISO 13485 audit checklist reports to determine what follow-up might be required, and to talk about any areas that either party would like to pay extra attention to. Taking the time to plan the audit well is the best way to make sure that both the company and the process owner will advantage from the audit process.
• Conduct the ISO 13485 audit: To begin, the auditor and process owner should meet to discuss the audit plan, and make sure it is complete and ready to go. Then, the auditor can go to work gathering the evidence they want to determine whether the process is functioning as it should, according to the Quality Management System for Medical devices, and if it is producing the desired results. This information can be assembled through analyzing key process data, reviewing records, talking with employees, or observing the process itself. During the process, it is appreciated if the ISO 13485 auditor can point out any areas that do not have sufficient evidence that they are functioning as expected, or any areas they notice that could be enhanced.
• Report on the audit: The ISO 13485 audit is complete, then the auditor should hold a closing meeting with the process owner to communicate any findings right away, such as any faintness in the process, any particularly positive observations, or any areas that are functioning as expected, but that could be better. A written report should be provided as documentation.
• Improvements: Of course, just like any other part of the QMS in medical device manufacturers, improvements are key to a successful audit. If problems were found, and corrective actions taken, it is critical to follow up and assure that the problems were truly addressed. If improvement projects were implemented based on opportunities found during the audit, then assembly data to see just how much the process has enhanced will motivate employees and management to look for more opportunities for improvement.

The internal audit as a necessary evil for maintaining compliance in the organization, a management or quality personnel can use the ISO 13485 internal auditor training as a way to understand, monitor and improve upon company’s processes. As ISO 13485 places heavy emphasis on process improvement within the Quality Management System, this should be a key motivator for company, not to mention the other benefits that go along with improvement, like enhanced efficiency in terms of costs and time. Allow internal audit to bring value to QMS, and to company.

Mandatory Steps for Effective ISO 13485 Certification

ISO 13485:2016 specifies for a quality management system where an organization wants to prove its capability to deliver medical devices and associated services that constantly meet client and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, with design and growth, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities. ISO 13485:2016 can also be used by sellers or external parties that provide product, including quality management system-related services to such organizations.

Who is ISO 13485 for?

ISO 13485 is designed to be used by organizations complex in the design, production, installation and service of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help with their auditing processes.

Steps to follow during ISO 13485 Certification

To confirm medical products will pass certification, here are the key steps that organization should follow during the ISO 13485 implementation and certification:

• Conduct a Gap Analysis:

This is an audit that controls the level of compliance versus the standards that are being held.

• Develop a project plan:

After the audit and gap analysis, describe a corrective plan which lists all non-conformities, including how to fix problems to comply with ISO 13485 necessities and related regional standard implementation.

• Develop documentation:

Put together the ISO 13485 documents that includes a Quality Manual, procedures, work instructions and documentation with proof of implementation.

• Develop & conduct training:

This is one of the most significant steps in checklist. Delivery of training to anyone who will be complicated in any stage of the production of the medical device is mandatory. The first training educates the team on appropriate requirements of the ISO 13485 standards, with those relevant to regional and product certifications. The next training is to set in place a Quality Management System that delivers a standard for complying with work instructions and required sanitary procedures, as well as recording of proof of execution on specific documentation.

• System Implementation:

A period of three to six months is specified to implement the new Quality Management System as per ISO 13485 requirements and preparation of documentation to prove compliance.

• Conduct an internal audit:

The dealer should conduct an internal medical device audit to measure agreement and accurate any noted deviations. Internal audit can also be performed by a third-party auditor.

• Conduct a management review:

If the Quality Management System is not executed according to ISO 13485 procedure, and does not meet the well-defined policy and objectives, it must be adjusted to meet the essential requirements.

• Apply for ISO 13485 certification:

An external audit of ISO 13485 is the concluding step. This external audit is typically directed by certification bodies. Based on the willingness of organization, the certification body will issue the ISO 13485 certificate if pass, or issue a non-conformance report that will need corrective actions. Once all non-conformance items are closed, the organization can then re-apply for certification.

ISO 13485 Certifications Supports Medical Device Companies:

The medical device sector is a high-pressure industry where people admiration innovation as long as it doesn’t sacrifice user safety. Moreover, creators must respond to demand spikes, as examples like the flow in ventilator needs during the COVID-19 pandemic showed. Getting an ISO 13485 certification can help a business make positive, permanent quality and process developments. Thus, representatives from certified companies often find that ISO 13485 contributes to organizational flexibility. It’s not right for every association, but the associated advantages make it well worth consideration.

ISO 13485 Requirements for Improvement of Medical Device Management System

ISO 13485 Certified means an organization has implemented an ISO 13485 Quality Management System and has successfully encountered all of the requirements in ISO 13485. ISO 13485 assesses whether Quality Management System is proper and effective while emphasizing the safety and efficacy of medical devices.

These days, many organizations associated with manufacturing of Medical devices decide to implement ISO 13485 system and get registration because it assures customers that the company has a good Quality Management System (QMS). An organization with an effective QMS, as per ISO 13485 requirements will characteristically meet customer expectations and it will be always better than an organization that does not have one.  This is because the Goals and Purposes of the QMS take the customer needs into account.  As goals focus on the customer, the organization spends less time concentrating on individual goals of departments and more time working together to meet customer needs.

ISO 13485:2016 provides the requirements for measurement, analysis and improvements of these processes including:

• General.
• Monitoring and Measurement.
• Control of nonconforming product.
• Analysis of data.
• Improvement.

General:

All organizations are essential to create a plan and then apply to the monitoring, measurement, analysis and improvement processes required in order to meet the conformity needs of the product, to ensure the conformity of the QMS, and maintain the efficiency of the QMS. Today experienced consultancy group sell a readymade ISO 13485 documents on the website that can help such organization in preparing and maintaining the records and documents.

Monitoring and Measurement:

As part of the requirements each organization is essential to monitor and measure a variety of information in order to improve their process and meet customer requirements this includes:

• Customer Feedback.
• Complaint Handling.
• Reporting to Regulatory Authorities.
• Internal Audit.
• Monitor and Measure processes and products.

Control of nonconforming product:

Organizations are essential to react to any product that is not in compliance to product requirements. Organizations want to identify and control these products to confirm that they are not used and distributed further. This process wants to be documented and maintained. Corrective and Preventive Action (CAPA) processes is an important part of the ISO 13485:2016 Quality Management System, it helps to precise non-conformances requires doing something different than the action that caused them.

Analysis of data:

The organization needs to collect and analyze proper data to determine the efficiency of the QMS. The procedures to determine this essential to include data collection and analysis, including statistics to help understand the extent of the QMS productivity. The analysis wants to include at a minimum: feedback; conformity to product requirements, characteristics and trends of processes and products, suppliers, audits, service reports.

Improvement:

Improvements are a critical part of the quality management system. ISO 13485:2016 needs all organizations to focus on continually improving. Overall, the organization wants to identify and implement any changes essential to maintain the effectiveness of the QMS, and the medical device safety and performance. Organizations essential to do this by quality policy, quality objectives, audit results, post-market surveillance, analysis of data, corrective actions, preventive actions, and management review.

5 Key elements of the ISO 13485 Medical devices Quality management system

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to prove its capability to provide medical devices and related services that constantly meet customer and appropriate regulatory requirements. ISO 13485 is intended to help medical device manufacturers create a Quality Management System (QMS) that confirms quality and safety of complete products.

ISO 13485 internal auditor training provide that need to know about the Quality management system and fulfill all the requirements as an ISO 13485:2016 QMS auditor. ISO 13485 auditor training will guide management as well as employees of organization in the field of manufacturing, supply of a medical device or its components for Quality management system based on ISO 13485:2016 standard. The standard delivers a step-by-step framework for creating a QMS and evaluating gaps in current system in terms of monitoring and controlling processes.

5 Key elements of ISO 13485:

1. Quality Management System (QMS):General quality management system requirements, as well as the documentation required to implement and maintain an effective quality management system. According to ISO, organizations need to:
   • Control the processes the quality management system needs and what’s required to apply these processes throughout the organization, taking into account the various roles involved.
   • Apply a risk-based method to the control of the appropriate processes required for the quality management system.
   • Determine the categorization and interaction of these processes.
2. Management Responsibility: The unique roles and responsibilities of management as it pertains to quality management system execution and maintenance. Management should provide evidence of its assurance to the development and maintenance of the quality management system and its efficiency. to do that:
   • Communicate the importance of meeting regulatory requirements.
   • Create high-value quality policy.
   • Confirm that quality objectives are established.
   • Conduct management reviews.
   • Confirm availability of quality management system resources.
3. Resource management: The resources life sciences organizations should oblige to implement the quality management system and maintain system efficiency. It outlines the provisions required to meet major regulatory and customer requirements.
   • The provision of resources.
   • Human resources.
   • Infrastructure.
   • Work environment.
   • Contamination control.
4. Product realization: In a rush to get products into expansion as soon as possible, many organizations often overlook the planning stage. plan realization efforts properly.
   • Launch the quality requirements for products.
   • Describe what essential processes will be and what supporting documentation will be required for those processes
   • Framework the company infrastructure that will essential to be created and what the work environment should be like.
   • Describe employee qualification and training requirements.
   • Establish processes for verification, validation, measurement, monitoring, handling, inspection, storage, supply, and traceability.
5. Measurement, analysis, improvement: The organization shall plan and implement the monitor, measurement, analysis, and development processes, related to the quality management system and products. Organizations need to:
   • Establish conformity of product.
   • Confirm conformity of the quality management system.
   • Maintain the efficiency of the quality management system.

How an Effective ISO 13485 Audit Checklists Can Minimize Certification Process?

ISO 13485 is the global international standard for establishment and maintenance of a documented quality management system in the medical device industry. If a manufacturer has implemented ISO 13485, it will have a foundation upon which to certify for regional medical device regulations such as the EU Medical Device Directive. An effective ISO 13485 Audit Checklist can be always very important tool used during ISO 13485 system implementation and certification. Well defined ISO 13485 audit checklist can minimize repetitive job while certification in any organization. Medical devices – Quality management systems – Requirements for regulatory purposes represent the requirements that the medical device manufacturers must incorporate into their management systems and an ISO 13485 audit checklists assures that it effectively implemented.

What is the ISO 13485 Standard?

ISO 13485 standards are international standards set by the International Organization for Standardization (ISO) and are designed for organizations designed, manufactured, installed and serviced medical devices. ISO 13485: 2016 is the most current version. It places more emphasis on risk-based decision-making and changing regulatory changes in the supply chain.

These quality standards provide a practical foundation for QMS requirements. They are critically important for all stakeholders in the medical device industry to: 

• manage quality standards
• meet QMS compliance regulations
• demonstrate competency and consistency
• meet customer safety and regulatory requirements 

The Effective ISO 13485 Audit Checklist to Ensures Readiness

ISO 13485:2016 requires Stage 1 and Stage 2 audits. The best ISO 13485 audit checklist can help you prepare for both stages and an internal audit prior to certification or recertification. Stage 1 and Stage 2 audits differ in duration, depth, and scope.

Stage 1 ISO 13485 Audits:  An ISO auditor from your certifying body will provide a report of positive and negative findings to determine whether your company is ready to proceed to stage 2.

Stage 2 ISO 13485 Audits:  This is a comprehensive evaluation of your organization’s compliance with ISO 13485:2016 standards. The auditor will review documentation, controls, internal audits and management review, and all relevant processes. The auditor may produce a list of non-conformances which have to be corrected before you can be certified or receive recertification.

The ISO 13485 Audit Checklist contains a series of questions and status updates to ensure that everything matches the plans defined in the organization’s QMS regarding internal activities, supplier evaluation, and an evaluation of the supplier audit reports. 

Requirement of ISO 13485 Audit Checklists for Effective Quality Management System Audit

The set of ISO 13485 Audit Checklist and guide includes introductory description, how to apply and use the audit checklist, brief introduction to audit requirements, discerning minor verses of major or critical non-conformities, and how to summarize the respective findings and rate the overall performance.

So, before conducting a Quality management system audit to ISO 13485 for medical devices, you may be looking for some kind of an ISO 13485 audit checklist. The ISO 13485 audit checklist is a systematic, documented verification process of objectively obtaining and evaluating audit evidence to determine whether an organization’s QMS conforms to the QMS audit criteria, and the results of this process to the client. The QMS audit criteria are defined as the policies practices procedures or requirements.

The audit checklist of ISO 13485 is a very useful & important document for auditors, who are new or experienced. The ISO 13485 Audit checklist helps auditors to organize, plan, conduct and report audit observations in a consistent manner. The definition of ISO 13485 audit checklists is such a list of tasks that must be completed as part of ISO 13485 audit is an integral part of the evaluation process for the internal audit plan. Medical device manufacturer has to plan and carry out regular internal audits, for the requirement purpose of ISO 13485 audit checklists, which is essentially a list of tasks that must be completed during implementation.

As per the organization’s processes, and the requirements of the audit for ISO 13485 standard; the format of this Audit checklist encourages the ISO 13485 auditor to document objective evidence. The ISO 13485 audit checklist is created as well as managed by the ISO 13485 lead auditors.

Purpose of an ISO 13485 Audit Checklist is:

• To assist memory-nothing is missed inadvertently;
• To ensure comprehensive coverage of  all  applicable element ;
• To ensure continuity/repeatability/consistency of the audit;
• To manage time;
• To organize note taking; and subsequent review by auditors.
• Can become part of an Audit report.

The ISO 13485 Audit should focus on the quality objectives and action plans of the organisations to allow problem areas to be identified so that remedial action can be taken.  Generally, the audit is a means of assisting managers at all levels to improve the performance of the operations under their control. There is no such kind of checking on how well people are doing their job!

Or we can say, within the overall quality management system for medical devices, ISO 13485 audit checklists are used to determine whether quality management activities conform to the stated program, whether these activities are effectively implemented system, and how effective the Quality management system is in fulfilling the quality policy.

The ISO 13485:2016 Audit Checklist for Quality management system certification of medical devices contains ISO 13485:2016 clause-wise as well as department-wise audit questionnaires. Punyam Academy’s Online ISO 13485 Auditor Training Course fulfils all the requirements of ISO 13485 audit and become a certified ISO 13485:2016 Auditor.

How to create Audit Checklist for an ISO 13485 audit for QMS

One of the most important checking tools in a Quality Management System for medical devices, or any management system, is the internal audit. The ISO 13485:2016 requirements are transparent for all that it’s a critical element of your QMS; and, since you want to know how your processes are performing, internal audits become a key resource.

ISO 13485 Audit checklists are not revealed as an ISO 13485:2016 standard’s requirements, popularly they are a used and important tool to ensure that when you perform an internal audit on a process, as well as you make sure that just don’t miss any elements of that process.

What are ISO 13485:2016 requirements for the audit?

To better understand the why and how of internal audit checklists, it is beneficial to understand what the ISO 13485:2016 requirements determine about why we do internal audits. As per clause 8.2.4 of the standard, the internal audit is to perform two functions:

• To ensure that the processes are meeting the planned arrangements and regulatory requirements that the company has identified for the process in the QMS
• To ensure that the process is implemented and maintained effectively

So, when you are creating an ISO 13485 audit checklist, you want to include the information needed to ensure that you successfully check these two outcomes of the process.

How to create an audit checklist to check conformance?

An ISO 13485 Audit is evidence to outcome of a process through a review of records of the employees, and then it is compared with the planned arrangements for the process to watch if what is being done is what was planned. There are two sets of planned arrangements to check: which are required by ISO 13485:2016, and those that the company has put in place for their process to function.

An ISO 13485 audit checklist is basically a set of questions that the auditor wants to ask, or activities that the auditor wants to observe, in order to verify the planned arrangements. The audit checklist is created by examining the ISO 13485:2016 standard and any documented procedures or undocumented processes for the activity to verify what happen. The audit checklist should cover questions on supplier evaluation, and an evolution of the supplier audit reports that have been collected, to see if they are done when examined by the QMS.

Why to use audit checklists in internal audit?

While the ISO 13485:2016 standard is beneficial and very effective way to make document the questions that require to ask to make sure that the process outputs meet the planned arrangements for your process. When you are discussing your process plans, you can write down what you require to check, and in this way you can ensure that nothing important is forgotten. When you have completed an internal audit, you do not want to search that you have omit to collect the proper information and require re-scheduling your audit to complete it.

So, such as many other tools in the QMS, the internal audit checklist is a time-saving tool that will benefit to prevent mistakes, and if you are interested in implementing a lean-but-useful QMS, then tools like the internal audit checklist are invaluable to help you in this endeavour.

How Does an ISO 13485 Internal Audit Checklists Help in Compliance?

ISO 13485 consultant discuss the compliance benefits of developing an effective ISO 13485 audit checklist, we must take a closer look at the standard itself. ISO 13485 is a quality management standard designed specifically for companies that provide medical devices or related services. Published in 2003, the standard was designed to facilitate the harmonization of regulatory requirements for medical device manufacturers on an international scale. ISO 13485 was based on the standard ISO 9001, but it differs from ISO 9001 in several ways. The main difference is that ISO 13485 is focused on ensuring medical device safety and efficacy rather than enhancing customer satisfaction and continual improvement.

The importance of auditing is addressed in Clause of the international standard: A manufacturer must plan and perform regular internal audits. An ISO 13485 audit checklist, which is essentially a list of tasks that must be completed as part of an ISO 13485 audit, is an integral part of the evaluation process for the internal audit plan. The format of this checklist encourages the auditor to document objective evidence based on: the organization’s processes, the characteristics of the process, and the requirements of the audit standard. Typically, the lead auditor creates and manages the ISO 13485 audit checklist.