Skip to main content

Halco Is Now ISO 13485 Quality Certified For Medical Devices

Halco’s quality Management System

Halco is committed to maintaining and continuously improving quality in our production methods and in hook and loop converting projects managed on behalf of our customers.  Customer specific requirements, applicable regulatory requirements, monitoring and measurement, procedures, risk management and excellent technical documentation and are all essentials part of our quality management system. 

Halco’s quality processes already met or surpassed ISO 9001 2015 requirements and, we are pleased to announce, now meet the acceptance criteria to be awarded ISO 13485 2016 certification for the manufacturing of medical devices. Halco does not manufacture medical devices, but we do provide high-quality custom converting services for the manufacture of medical device components using our hook and loop fasteners. This proves that Halco will consistently demonstrate compliance to customer quality expectations, relevant regulations and medical device specifications.

James Fussell, head of Quality & Engineering at Halco, comments:

Our recent ISO13485 accreditation put us in a unique position as a leading supplier and converter of hook and loop fasteners. For our medical customers, being able to write SOP’s in line with 13485 requirements sets us in a strong position to not only deliver a certified product, but also implement process controls that we know meet customer and ISO specs.

What is ISO 13485 and What are Its Requirements?

ISO 13485 2016 is a set of requirements and standards for medical device manufacturers and their suppliers, at any stage of the life cycle, to show that they can consistently meet customer and relevant regulatory requirements.

ISO 13485 2016 has eight different sections to it. The first three sections, or “clauses” are introductory and the final five define what is required.

  • Clause 4. This section covers general quality management systems (QMS) requirements and documentation requirements. In the QMS section, the basic principle is that the organization does what it says it’s going to do from a quality management perspective and that it adheres to the principles of a good quality management organization. In the documentation requirements, the critical element is the creation of a “medical device file” for each device and a control plan for the management and retention of that file.
  • Clauses 5-8. These sections deal with the subjects of management responsibility, resource management systems, the product realization processes that ranges from conceptualization to implementation, and, finally, how an organization does measurement, analysis and improvement.

What is a Medical Device File?

ISO 13485 2016 requires that a medical device file be created that comprehensively stores all documents for each medical device or medical device family. This file contains all documents that describe the product design, product specifications, manufacturing and assembly processes, medical device usage, quality monitoring and measurement, regulatory compliance, and quality standards. If relevant, the file also will contain records and documentation related to services, maintenance, and installation. Finally, a clear control plan will be created to control, protect and retain the file.

What is the Difference Between ISO 9001 and ISO 13485?

ISO 9001 2015 and ISO 13485 2016 have many similarities. The 13485 standard, though, was developed based on the ISO 9001 2008 standard. There are a range of differences that are specific to the medical device industry and those differences can be found here. Many anticipate that the 13485 requirements will be updated to be more aligned to ISO 9001 2016.

ISO 9001 Logo

What Is the Benefit to Halco’s Medical Customers?

Halco is already a trusted, high-quality ISO certified supplier to many medical device manufacturers. With ISO 13485 certification, medical device OEMs can trust and communicate with confidence that Halco manufactures and supplies converted hook and loop fastening components that meet the quality and regulatory requirements of ISO 13485 2016 and their customer requirements.

What Can You Expect From Halco Moving Forward?

Halco continues to invest in product development and die-cutting capabilities for medical device manufacturing. Our expertise in segments such as wearables, patient positioning, gown and drape manufacturing, sleep apnea and tube securement industries with re-closeable fasteners suited for these applications is second to none. During 2023 Halco expects the launch of new products including specialty adhesives and significant equipment investment to stay at the forefront of the hook & loop fastening industry.

For more information about Halco’s products for the medical device industry, visit us here. Halco also provides samples for evaluation in your design and specializes in high performance converting services for hook and loop fastening components.

Tell us a bit more about your project and request our medical device hook & loop sample kit!