ISO 13485 Certification in Manila. Suppose you’re interested in acquiring a certification that guarantees you can meet the quality standards set by the International Organization for Standardization (ISO). In that case, you’ll have to understand the requirements of ISO 13485. This is especially true if you’re operating in Manila.
Implementing the ISO 13485 Certification in Manila
There are a lot of factors that you need to consider before you implement the ISO 13485:2016 standard in your medical device business. The benefits of this standard range from cost reduction to improving efficiency. You also need to ensure that you follow the correct procedures and methods.
Your first step should be to establish a documented quality management system. Aside from that, it would help if you did a proper audit of your processes. You can hire a professional to help you do that.
It is also a good idea to engage the services of an ISO Certification consultant. A certification consultant will guide you through implementing the standard in your medical device business.
The benefits of obtaining ISO 13485 certification in Philippines can include improved profitability, increased brand value, and reduced waste. A certified company also has better access to potential customers. Aside from that, the company also demonstrates compliance with regulatory requirements.
Meeting the three European medical device directives.
If you’re in the medical device industry, you’ve probably heard of ISO 13485, a quality management standard to ensure that your products are consistent. It is also a requirement for regulatory approval for certain types of devices. The latest version of this standard, known as ISO 13485:2016 , was published in March of this year.
To get ISO 13485 certification, an organization must implement a quality management system (QMS). It is a formal set of rules that governs how an organization conducts its business. It documents everything from the process structure to the people’s roles within the organization.
The QMS is a process-based model, with each step being planned and monitored. The activities that comprise the QMS are documented through work instructions and forms. The process is then reviewed for effectiveness, and corrective actions are taken.
A company that needs to be certified must undergo a full audit and a certification process. The entire procedure can take up to five years.
Cost of ISO 13485 certification in Manila
For medical device manufacturers in the Philippines, you will want to get ISO 13485 certification. It can help you gain credibility and make your business more efficient. This is because it outlines the requirements of a quality management system.
Obtaining this certificate is designed to be beneficial for any organization. However, you should be aware of the cost.
The cost of implementing an ISO 13485 certification will vary depending on your organization’s size, business model, and other factors. For a smaller company, it can be a daunting task. However, it can be a profitable endeavor if you are equipped with the right tools and knowledge.
You can opt for consulting services to avoid investing in the full-fledged process. These consultants can guide you through the entire process and provide support when it comes to preparing documentation and auditing. They will also identify any non-conformities you might be experiencing and help you correct them.
Stage 2 (Primary Audit)
ISO 13485 is an international standard for medical device manufacturers. It is designed to improve the quality of medical devices and reduce production downtime. In addition, it reduces the cost of manufacturing and provides a streamlined system for quality management.
ISO 13485 applies to all organizations involved in manufacturing, distributing, installing, maintaining, and supporting medical devices. It also applies to third-party organizations that provide raw materials, components, or sub-assemblies for medical devices.
Certification is not mandatory, but it helps your company attract more clients and reduce product liabilities. However, to meet the requirements, you must have a comprehensive quality management system. This includes risk management, post-market surveillance, and product traceability. In addition, your organization must demonstrate a commitment to quality.
To obtain certification, you must first undergo an audit. The auditor evaluates the performance of the overall quality system and assesses if the company meets regulatory requirements.
The Stage 1 Audit is an initial audit to determine your organization’s readiness for the Stage 2 Audit. This audit usually takes one day. The results of the audit will include positive findings and negative findings. You may need to implement corrective action plans to address the negative findings.