Quality Management System Development
The Catalyst Connection Difference
Catalyst Connection has worked with manufacturers in all types of industries providing tools for success for the certification process including audits, documentation, training and maintenance. We can support the process as much as is needed by the client – from just providing basic guideline up to and including serving as an onsite Quality Manager during the process.
Tools for Success
- Quality Systems Audit– Gap analysis to determine the actions needed to achieve the goal of certification and realizing significant business benefits.
- Effective Root Cause/Corrective Action – The best approach to corrective action involves a thorough examination of possible causes, followed by careful analysis to isolate the root cause(s).
- Failure Mode and Effects Analysis – By assessing the severity of a potential failure, the likelihood that the failure will occur, and the probability of detecting the failure, potential issues can be prioritized for improvement.
- Statistical Process Control – Properly applied, Statistical Process Control (SPC) will allow for more effective tracking and evaluation of output data, facilitate timely response to process issues and drive quality improvement.
- Risk Management – Raising basic awareness of risk management concepts and mechanisms so that participants can effectively identify and manage risks within their own organizations.
- Internal Auditor
- AS9100 (Aviation, Space and Defense) – Quality management system for the aerospace industry that takes the ISO 9001 requirements and supplements them with additional quality system requirements in order to satisfy aviation, space and defense quality requirements.
- IATF 16949 (Automotive) – Defines the quality management system requirements for the design and development, production and, when relevant, installation and service of automotive-related products.
- ISO 9001 (Quality Management Principles) – Requirements for a strong customer focus, the motivation and implication of top management, the process approach and continual improvement. QMS Consulting can be used by any organization, large or small, regardless of its field of activity to prepare for the certification. ISO 9001 is implemented by more than one million companies and organizations in over 170 countries.
- ISO 13485 (Medical Device) – Requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
- ISO 14001 (Environmental) – An environmental management system that provides assurance that environmental impact is being measured and improved. This includes: reduced cost of waste management, savings in consumption of energy and materials, lower distribution costs, improved corporate image among regulators, customers and the public.
- ISO 45001 (Occupational Health and Safety Management) – Health and safety management system designed to: create best possible working conditions across your organization, identify hazards and put in place controls to manage them, reduce workplace accidents and illness to cut related costs and downtime, engage and motivate staff with better, safer working conditions and demonstrate compliance to customers and suppliers.
- ISO 17025 (Testing and Calibration Laboratories) – Specifies the general requirements for the competence, impartiality and consistent operation of laboratories.