Quality Management System Based on ISO-9001*

 

Regulatory Compliance

At the heart of the Quality Management System is ChemWare’s commitment to supporting, complying with, and enforcing applicable regulatory requirements, including:

  • Record audits
  • Electronic signatures
  • Data retention
  • Chain of custody
  • QC limit versioning
  • Employee certifications
  • Security features

Quality System Documentation

  • Quality Manual
  • SOPs by department
  • Employee handbook – expectations for employee relations with customers
  • Project Implementation Plans
  • Project specifications and RSSCs
  • Product standards documents
  • SCRs 

QM Objectives

  • Maintain an effective QMS modeled after ISO 9001 – our Westinghouse audit was modeled after ISO 9001
  • Achieve and maintain level of quality that enhances our reputation with our customers
  • Ensure compliance with applicable regulatory agencies – take great pride in ensuring we are on top of regulation changes and, whenever necessary, issuing software changes as quickly as possible to maintain compliance
  • Maximize customer satisfaction with all products and services provided – really sums it up, we are very customer focused, at the end of the day it’s really all about the customer

Overview of QM

Sections of the quality manual are, again, modeled after the ISO standard and include:

  • Quality Management System overview
  • Contract review
  • Design control
  • Document and data control
  • Purchasing/use of subcontractors
  • Control of customer-supplied materials and data
  • Product identification and traceability
  • Process control
  • Inspection and testing
  • Corrective and preventive action
  • Handling, storage, packaging, preservation, and delivery
  • Quality records
  • Training
  • Audits

Development Life Cycle SOP

The main SOP driving the development and quality areas is the development life cycle SOP.  Key components of this SOP are:

  • Design – RSSCs and product specifications
  • Development – SCRs, revision control
  • Testing – test plans, final product revision release testing – a special round of testing we do at the very end (copy of testsheet completed for last release is in the binder)
  • Documentation – release notes, on-line documentation
  • Also includes provisions for release and patch procedures – criteria for determining when a patch is necessary as well as notification procedures for all affected clients

More Information…
Additional portal content is available on Certifications and Compliance.
System Validation

Login to access Certificates of System Validation (compliance with ISO-9001)