The regulatory world is vast and can be confusing.  Let me take a moment to explain where Vergent Products sits in the Quality Management System regulatory landscape.

First and foremost, it’s important to understand that some regulations are voluntary, and some are not.  For instance, in the Medical Products world, Vergent Products voluntarily conforms to ISO13485.  In fact, we even pay people to come to audit us so they can certify that we are fully conforming!  However, medical products also require compliance to 21 CFR 820.  That’s a federal law – non-compliance means a Law Enforcement action could be taken.  Not following ISO13485 means we could lose our Certification.  Not following 21 CFR 820 means someone can be arrested.  It’s important to understand the difference!

So, what are all the quality regulatory systems Vergent Products uses?  (These are just about the quality management system; we’re not venturing into OSHA/EPA/RoHS/Cyber/Product Safety/others here.)

The big three:

ISO9001:2015 –   This is the baseline of quality management systems.  It requires a company to “Say what you do, Do what you say, and Prove that you did.”  Every product we manufacture or design at Vergent Products is compliant is ISO9001:2015. The standard is written and maintained by the International Organization of Standardization.

AS9100D – This standard is intended to be used for aviation, space, and defense products.  It is inclusive of ISO9001, but it goes further and adds quite a few requirements related to risk mitigation, supplier flow downs, traceability, and safety.  Vergent Products will manufacture your product to AS9100 if you tell us that is your requirement.  We are not certified to design to AS9100. The standard is written and maintained by SAE.

ISO13485:2016 – This is the standard for Medical Devices.  It is a completely different document from ISO9001.  It has similar requirements but goes much further into risk mitigation, record keeping, and verification and validation.  Vergent Products will manufacture or design your product to ISO13485 if you request it.  Some clauses are out of scope for us, see the table below. The standard is written and maintained by the International Organization of Standardization.

Several other standards we also follow:

 

AS9102 – This standard is specific to AS9100 products and details how a First Article process will be performed.  We will deliver a First Article Inspection Report conforming with the AS9102 standard if the client requests it.  It is an extensive process, so it does need to be requested during quoting.

AS5553C – This covers Counterfeit Mitigation.  The avoidance, detection, mitigation, and disposition of counterfeit Electrical, Electronic, and Electromechanical (EEE) parts. All EEE components Vergent Products purchases conform to this standard. The standard is written and maintained by SAE.

ANSI/ESD S20.20-2014 – This covers the Electrostatic Discharge Control (ESD) program for the protection of electrical and electronic parts, assemblies, and equipment. The standard is written and maintained by the Electrostatic Discharge Association (ESDA).

IPC Standards – This is a group of standards that covers the acceptability of circuit boards, electronics assemblies, cable and wire harness assemblies, test methods, and more.  It defines acceptance criteria for three classes of quality.  Vergent Products defaults to Class 2 for all products.  We will build to Class 3 if the client requests it.  These standards are written and maintained by IPC – Association Connecting Electronics Industries®.

What sections are included and excluded in our QMS system for each standard?  A summary:

Standard ISO 9001:2015 ISO 13485:2016 AS9100D
Scope Product Commercialization Services for Consumer Products and Medical/Industrial Equipment. The manufacture of printed circuit board assemblies and electromechanical assemblies for Aerospace applications.
Exclusions None.
  • Clause 7.3.7 Design and Development Validation 
  • Clause 7.5.3 Installation Activities
  • Clause 7.5.5 Requirements Sterile Medical Devices
  • Clause 7.5.7 Validation of Processes for Sterilization and Sterile Barrier Systems
  • Clause 7.5.9.2 Requirements for Implantable Medical Devices 
  • 8.3   Design and Development of Products and Services
  • 8.3.1   General
  • 8.3.2   Design and Development Planning
  • 8.3.3   Design and Development Inputs
  • 8.3.4   Design and Development Controls
  • 8.3.5   Design and Development Outputs
  • 8.3.6   Design and Development Changes

 

That’s a lot to take in.  If you are unsure which standards your products need, our Sales Team will be happy to help you better define the requirements.

 

By

Sarah Johnson, CLM, CSSBB