Eliminating waste, improving customer satisfaction, regulatory compliance and increasing shareholder value through a well documented and practiced Quality System.
Creating and auditing Quality Management Systems - writing and editing SOPs for 21 CFR 820, ISO 13485, ISO 14971 and others. Hands-on training of your staff to each required SOP as required. Training your staff to take this on for future SOP revisions. Helping you establish supplier auditing process as required.
Support for Risk-based decision-making and follow-up (e.g., Health Hazard Evaluation, recall determinations and execution). We have authored and executed escalation processes that assure well documented risk-based decision making was being considered at all levels.
Authored Health Hazard Evaluations for a myriad of product types and associated issues. Escalation procedures were also written to assure timely and collaborative decisions were reached and documentation of all decisions were clearly written and considered all aspects of product issues including safety, as well as Regulatory Compliance risks.
We helped assure excellence in customer satisfaction through the development and execution of compliant procedures and processes for complaint handling. Also developed and executed processes and practices to assure that customer’s voice was acknowledged and acted on.