Picking a supplier with ISO 9001 or 13485? What’s the difference?

ISO 9001

The goal of the ISO 9001 international standard for quality management systems is continuous improvement. We make sure that every part we produce satisfies our OEM customers’ needs.

Our robust QMS is certified to efficiently monitor and improve our processes. We first acquired ISO 9001 certification in 2007, and the latest version is 9001:2015.

What is ISO 13485 and do I need it?

The newer ISO 13485:2016 standard applies specifically to the medical device industry. Generally, it’s ISO 9001 with additional requirements for medical applications, which include greater documentation, traceability, and safety.

Unlike 9001, the medical device standard focuses on the product development process. The level of safety risk involved determines whether your parts need it.

• Do the parts need to be sterile, manufactured in a clean room environment?
• Could patients potentially contact the parts?
• Are they considered consumables?

Trays for medical consumables packaging (produced by thin gauge thermoforming) require ISO 13485 certification. For example, these trays may be used for prepared vaccination kits, which get disposed after a single use.

On the other hand, heavy gauge thermoformed parts usually serve in the field for up to 20 years. Medical technicians may contact parts like the cover of an X-ray machine while patients normally do not. And the equipment is cleaned and disinfected after each use.

How we support you

Profile supplies best-in-class heavy gauge thermoformed components to OEMs, including cover panels and internal components for medical equipment. Our engineering assistance helps customers take full advantage of our processes.

We work with engineers to adapt their own parts designs for the thermoforming process. We don’t produce high-risk or sterile medical device parts, which necessitate ISO 13485 certification.

The quality we keep: measurement & validation requirements

Profile’s quality system quantifies and evaluates several different customer requirements. We can focus on different areas at the customer’s discretion.

Our capabilities for measurement, inspection, and validation documentation include:

• First Article Inspection Reports (FAIRs)
• Production Part Approval Process (PPAP)
• Process Capability Analysis (Cpk)

FAIR:

A first article inspection (FAI) makes sure it meets design specifications before production. The FAIR verifies initial part samples. A full FAIR validation is done for a new product introduction: reviewing the design, the manufacturing process, and all documentation. Partial or verification FAI is performed for changes to existing products or changes in the production cycle.

A first piece approval reviews a sampling of the new part direct from the production line after a change is made. As part of the FAIR process, sample sizes can range from 1-5 parts.

PPAP:

This quality measurement provides assurance that the entire production process can produce parts that will consistently meet requirements throughout the life cycle. It shows that we can scale up production to fulfill your order.

Customers tell us the level of PPAP that they want us to meet successfully. There are 5 levels of stringency, based on submission and documentation requirements. These range from a submission warrant (certificate), to warrant and samples, up to warrant and samples with supporting data and on-site review.

Process Capability Analysis:

Using data from an initial production run allows us to predict whether the process can produce parts that repeatably and reliably meet specifications. It measures how consistently parts are produced within specifications. Customers can request this study as part of a PPAP.

The Cpk value measures the center of the process as well as the range relative to the specification tolerances. A higher Cpk number indicates that a process is more capable of consistently producing parts within limits, leading to fewer defects and better quality.

Summary

The Profile Plastics QMS is designed to provide you with total assurance. We measure our commitment to quality by meeting or exceeding your requirements and providing consistently reliable thermoformed parts.