Unless otherwise specified, ISO 13485 applies to companies of all sizes and types. ISO 13485 standard includes requirements for any business working at any level of the medical device and pharmaceutical supply chain, such as design, production, installation, storage, development, and servicing. ISO 13485 certification is especially important for manufacturers that want to demonstrate compliance with applicable regulatory standards, as well as firms that provide services to medical device makers. These businesses must obtain ISO 13485 certification.
Audits are an essential component of any quality management system (QMS), including those used by medical device makers. Regular audits by both internal and external agencies are required to ensure that their products meet all criteria. Medical device producers must always be ready for audits. Medical device makers may guarantee that their quality management system (QMS) is up to date and that their goods meet all criteria by preparing for audits.
What are the common nonconformities that are found in ISO 13485 audits?
So, here are the several most common nonconformities that are found in ISO 13485 audits. These include:
- Lack of documentation: This is one of the most prevalent issues discovered during ISO 13485 audits. To comply with the standard, you must have a complete set of ISO 13485 documents for your quality management system (QMS). Everything from your quality policy to your procedures and job instructions should be included.
- Poorly trained staff: Another prevalent issue is under-trained employees. To comply with ISO 13485, you must ensure that all of your employees have received ISO 13485 auditor training in the usage of your quality management system (QMS). Everyone from senior management to assembly line workers is included.
- Lack of control over outsourced processes: If you outsource any portion of your manufacturing process, you must understand how these operations are controlled. This entails having defined protocols in place that cover all areas of the outsourcing process.
- Poorly products: To comply with ISO 13485, you must design your products by the standard. This involves considerations such as user safety and biocompatibility.
- Non-conforming product: Finally, non-conforming items are one of the most typical issues discovered during ISO 13485 audits. This can be caused by a variety of factors, including poor quality control or improper assembly.
ISO 13485 addresses all phases of the medical device lifecycle, including the control of nonconforming items. It is a product or medical equipment that does not meet its set standards, such as consumer or regulatory requirements. It is critical to be identified as soon as possible. Furthermore, ISO 13485:2016 addresses the management of non-conformity in a medical device even after it has been used or delivered. The goal is to differentiate each medical equipment from other complying medical devices. When you separate it, you must:
- Recognize it
- Discrete it
- Exclude it or not deliver it
It is expected that your medical device manufacturer will have a predetermined approach for incidents such as nonconformity. When addressing non-conforming medical equipment, a written procedure indicating controls, authority, and duties must be established.
- Actions in response to nonconforming products detected before and after delivery: It is expected that your medical device manufacturer will have a predetermined approach for incidents such as nonconformity. When addressing non-conforming medical equipment, a written procedure indicating controls, authority, and duties must be established.
- Documenting non-conforming products: All information acquired about nonconformity should be organized in a way that will assist you in mapping the problem and determining the root cause. Remember that this documentation is only the first step in a process that will eventually lead to corrective action. It is advised that you record any features of the medical device (or service) at the time of the nonconformance when recording the nonconformity. It will be useful later on for assessing the effects of the nonconforming product.
- Rework: Corrections to nonconforming medical devices could be considered reworking. It covers medical device repair, reworks, reprocessing, and any other adjustments. If a medical device must be reworked (one or more times), your organization must document the rework process in a work instruction that has been authorized and approved in the same manner as the original work instruction. Before being submitted for execution, it must be reviewed and authorized in the same manner as the original work directive. Furthermore, each rework directive will allude to a specific nonconformity. The specifications of the rework, like everything else, may affect the quality. Each person involved with the medical device's design and development will analyze and provide their professional opinion on the effect of the rework.
