Quality & QMS

Product Resources has a comprehensive Quality system, appropriate to the type of work that we perform.  We have been audited multiple times, by 3rd parties and by our customers to the various quality standards that we utilize: 

ISO 9001 – we are audited and certified to the latest ISO 9001 quality standard by TUV SUD.  We have had a continuous ISO 9001 certification since 1995 and have found it to be fundamental to our success as a manufacturing company. 

ISO 13485 – we are audited and certified to the latest ISO 13485 quality standard by TUV SUD. We were first certified in 2015. ISO 13485 is the Medical Device quality standard and is used throughout the world. In the USA, 21 CFR 820 is the Federal Regulation that governs GMP (Good Manufacturing Practice) and although we comply with those requirements, there is no 3rd party audit or certification to be had. 

ISO 80079-34 – This is the quality standard that must be achieved to design or manufacture equipment for use in Explosive Atmospheres. We have been audited to this standard and we comply, but there is no certification, likely due to the product-specific nature of the auditing. 

To aid in the implementation of these standards, and to run the company efficiently, we have a computerized QMS (Quality Management System). We are currently using QT9 to implement aspects of our quality system from Document Control, Corrective Action, Engineering Change, and Internal Auditing through Training and Instrument Calibration. This system helps to automate the processing of the paperwork and has streamlined our processes. 

As an example, when we open a “job”, which cues our ERP system to call for the production of an assembly or product, the ERP system communicates with our QMS system and requests the documentation necessary from document control.  This documentation is assembled electronically and the correct documentation, at the correct revision, is placed in a folder so that the assembler working on the job can access all the documentation for the assembly. All necessary documents for the job (assembly drawings and procedures, test procedures, routing, bill of material, software, etc.) are included in the folder and all other related drawings (electrical schematics, custom part detail drawings, etc.) are available by selecting a link in the routing to retrieve the document and display it for reference. No one needs to intervene to allow the assembler or test technician to have all the documents for the task available immediately. 

Product Resources’ success relies on automating our Process Control and Quality. This automation streamlines the controls for faster response and reduces errors by delivering the correct document revisions every time.