What is ISO 13485?
ISO 13485 is a medical device standard. The standard promotes Safety and Quality in the medical device industry. It provides a baseline of Regulatory requirements since the requirements are increasingly becoming more stringent throughout every step of the product lifecycle. The standard helps with the increasing expectation to demonstrate their quality management processes and ensure best practice in everything they do.
The Differences Between ISO 9001 and ISO 13485.
ISO 13485 is a stand-alone standard similar to the ISO 9001:2015 standard, but focuses on Medical Devices, where ISO 9001 is more general and covers various industries.
ISO 9001:2015 took on the new common ISO structure with Clauses in the 4-10 range. ISO 13485 is a stand-alone standard that utilizes the old ISO 9001:2008 structure with Clauses in the 4-8 range.
The Importance of ISO 13485
ISO 13485 certification helps consolidate customer and employees' trust, which is an essential requirement in the medical device manufacturing industry. ISO 13485 has become the worldwide accepted standard in medical manufacturing industry and certifies the conformity to regulatory requirements. Organizations in the industry are expected to provide proof for quality management system implementation throughout the entire production cycle. The US Food and Drug Administration (FDA), the government department that regulates the medical devices sector, announced its intention to use ISO 13485 as the basis for its quality system legislation(source https://www.iso.org/news/ref2318.html)
The Benefits of ISO 13485
ISO 13485 is the gold standard for quality in the medical device industry. It’s a very powerful marketing tool to ensure your customers you company takes quality very seriously and you have the systems in place to enure it. It aligns your company to meet the requirements many countries and suppliers where required to show compliance.
ISO 13485 inherently builds a culture of Continual improvement internally to your company by providing a baseline for business process that can be measured and analysed. Provides a formal method to address areas of concern through corrective actions.
Provides more employee engagement where more formalized roles and responsibilities are established. This will lay out clearer responsibilities and in turn produce happier employees and better results.
Adopting a set of quality management principles, improves customer satisfaction. Providing consistency in process in a quality management world illustrates your company is making every effort to produce a product that meets stringent requirements.
Why is a consultant important?
Through the process of implementation, a company may encounter several road blocks such as: time, money and know-how. With the help of a consultant, you can expect to save time and money. Relying on their expertise guides you through the process in the most efficient way.
How We Can Help, What We Stand By
Encompass Consultants understand that time and money are a common concern in the process of implementation. Our expertise streamlines your priorities. The Quality Management system we help you achieve is much more than a certificate. We support your company into the future through our services and state-of-the-art tools.
Rely On Our Expertise
At Encompass, our processes are designed to save you money. We are family-owned and operated and have no excessive overhead like many of our competitors. We don’t rely on expensive advertising, instead focusing on word of mouth. As a result, we direct all of these cost savings to you, our customer.
ISO 13485 Cost Chart
Expertise is an important aspect in performing a clean, cost-efficient, timely implementation. At Encompass Consultants, our years of accumulated knowledge result in comprehensive certification.
Certified Lead Implementers and Auditor
ISO 9001:2015 - ISO 27001:2013
Encompass Consultants understand that time is of high priority. We have streamlined our process into six steps to achieve your goals quickly without sacrificing quality.
Encompass visits your site and creates a business snapshot of your current practices. We meet with your staff to understand roles and responsibilities and develop a plan.
We take all of the information from Discovery and create Documentation (Procedures and Policies) that follows your current business practice. We create or update existing required policies and procedures which meet the standard for your certification.
We perform On-site training for each department and explain in clear detail the required standards relating to work function.
We validate your entire system and perform audit training.
We walk you through the Management Review and gauge the effectiveness of your Quality Management System.
You can be confident in the knowledge of what to expect during your Certification Audit.
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