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. 

Attributes of ISO 13485 Medical Device management system

ISO 13485 officially appointed and can be used by organizations in the design, development and production process for medical devices as well as related services. It can also be used by the reporting institutions to meet regulatory requirements.

ISO 13485 defines the requirements that medical device manufacturers must incorporate into their management systems to ensure compliance in the medical device industry. Based on ISO 9001, the focus on continuous improvement is replaced with a focus on meeting regulatory and customer requirements, risk management and maintaining effective processes, namely design safe, manufacture, and distribution of medical devices.

What are ISO 13485 and Its Key Attributes?

ISO 13485 defines the regulatory requirements or when specified customer requirements for a management system for medical devices or services. The primary objective of ISO 13485 is to harmonize regulatory requirements for medical devices quality management systems. The standard is specific to organizations providing medical devices or services, regardless of the type or size of organization. Based on the ISO 9001 quality management process approach ISO 13485 focuses on what manufacturers must do to deliver safe and effective medical devices.

Following are the main attributes of ISO 13485 Medical Device management system

• Access to the wider market – National regulatory authorities require or strongly prefer that manufacturers that sell medical products in their countries have a third party audited and certified management system in place. Investing in such a system speeds access in countries that need it, and faster access to the market in the other.
• Reduced cost of sales – Your certification establishes credibility and commitment of your company to quality. Because the task of explaining the specifics and demonstrating the effectiveness of your quality system is simpler, requires less time to gain the trust of your future customers.
• Improved performance – Based on a widely accepted uniform process control system and the certified management system of your company to help you improve your products and processes. This can foster improved relationships with suppliers, business partners and customers, and give you a real advantage in the marketplace.

Ready reference ISO 13485 Documentation Kit available with Free DEMO, that guide you better about requirements and documents for certification.

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.

How to Developed ISO 13485 Audit Checklist for Quality Management System

The ISO 13485 audit checklist is an integrated part of the quality management system suite that enables medical device organizations to electronically streamline and manage their entire audit process, including the development of easy to use ISO 13485 audit checklist that can be customized to address a variety of audit types of external, internal, and supplier and regulatory ISO 13485 international standards and requirements. An ISO 13485 audit checklist is just one of many checklists and tools that can be leveraged in QMS 13485 systems Audit to meet your organization’s specific auditing needs. This unrivaled audit offering enables auditors to:

• Effortlessly plan and schedule audit resources. The simple drop and drag calendar is easy-to-use and allows auditors to quickly change audit dates and times, which makes staying on top of multiple audits easier. The tool’s advanced scheduling and routing capabilities not only streamline audit schedule management, but also allow audit resources to be allocated based on desired frequency and risk.
• Use familiar tools like Microsoft Word and Outlook to conduct audits and create, modify, and score a variety of checklists, including an ISO 13485 checklists. These comprehensive checklists promote audit consistency, which helps to ensure that the organization is in compliance with applicable regulations and standards.
• Create robust audit reports thanks to rich text data that is maintained all the way from auditor entry and peer review through to automated report generation.
• Utilize powerful online analytics and reporting tools to spot trends of potential systemic issues that allow management to make faster, more productive decisions. Increased management visibility can help prevent costly regulatory delays in getting products to market.
• Easily connect with other parties involved in the audit process. The Audit’s Web-based platform allows companies with global audit teams to easily access important audit summaries, findings, and QMS 13485 documentation, such as an ISO 13485 audit checklist, from virtually anywhere.
• Enjoy seamless connections that enable stress-free management, suppliers, and risk, allowing an organization to monitor its entire quality system and continuously improve it.