ISO 9001:20015 Quality Standard

ISO 9001:2015 is used by organizations of all sizes to deliver high quality products and services. It is a quality standard maintained by the International Organization for Standardization (ISO) and is administered by accreditation and certification bodies like PRI Registrar.

Chemical Processing

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Heat Treating

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Non-Destructive Testing

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Welding

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“MedAccred defines world class controls necessary to enable world class quality at the critical process manufacturers.”

Scott Goolsbey

Procurement Programs

Sr. Program Manager

Stryker

It is very different—a QMS
audit is broad but shallow. A
MedAccred audit is deep in
terms of a process area—a mile deep, inch wide, versus an inch deep, mile wide.

David Vazquez

Director

Quality Engineering and Supplier Quality

Becton Dickinson

What is MedAccred?

Baxter
BD
Boston Scientific
Edwards Lifesciences
Johnson & Johnson

MedAccred is an industry managed, consensus-driven approach to ensuring critical manufacturing process quality throughout the medical device supply chain.

In today’s world of global manufacturing, the supply chain is multi-tiered and geographically remote, making oversight challenging and costly. To prevent output deficiencies, critical processes and products must be validated during manufacturing to prove that they are fit for purpose, satisfy regulatory requirements and reduce overall risk.

Getting started is easy.

Improved efficiency
Improved quality of products
Reduced scrap and rework
Opportunity to leverage MedAccred Accreditation to gain new business

What Are the Benefits to a MedAccred Audit?

a stethoscope rests on top of a medical device chip board

Only the best companies in the medical device supply-chain achieve MedAccred® accreditation. MedAccred audits are a rigorous technical assessment of compliance to customer requirements and industry standards, conducted by industry experts.

Current Subscribers

Subscribers provide governance over the MedAccred® program,
determine audit criteria, have full access to audit findings, and
determine who is granted MedAccred accreditation.

Medtronic
Phillips
Roche Diagnostic
Stryker

Benefits of becoming certified to

ISO 9001:2015

Creates a more efficient, effective operation
Employees can benefit from documented processes
Increases customer satisfaction and retention
Improves customer's propensity to do business with you
Raises quality awareness among employees and motivates them to attain quality objectives
Reduces waste and increases productivity leading to greater profits

DRS Technical Services, Inc.

Client of PRI Registrar since 2011

“PRI brings a reputation that enhances the standard to which our organization is certified to. The team at PRI is very professional and I would highly recommend them to a peer.”

Euro-Composites

Client of PRI Registrar since 2009

“We like the external point of view to our QA system. Their findings and comments had always been based on good practice. So we are happy to implement them. Over years few, we can see and measure an improvement in our system.”

What our customers are saying...

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