COMPLETE SYSTEM DEVELOPMENT THAT RESULTS IN CERTIFICATION
CEO’s Stan Dachinger, with his staff, discuss directly with your staff and employees to determine exactly how your management, quality personnel, employees, etc. perform their tasks. We then write the Manual, the top Tier 1 procedures and all of the supporting procedures and work instructions. We make sure they describe what you do, but also in compliance with the ISO standard, you require. We then go back over each document with your people and have them agree to each document and fully understand what they have to change in order to be ISO compliant. The result is a full set of documentation that now must be implemented, measured in terms of audits for compliance and supported during eventual certification. Certification is the goal. You select the certification firm. We support you during this effort.
DEVELOP SUPPORTING QUALITY SYSTEMS
Stan, with his staff, can fully prepare, or show your personnel how to prepare, supporting FDA operating procedures for ISO 13485 or mil spec procedures to support ISO systems. Such procedures become a supporting system to the applicable ISO Quality System, developed as describe above.
The key is to define and implement the detailed methods and procedures that represent how you want each function to perform, introduce the ISO requirements, and make sure they are followed. The key is not to utilize “canned” systems just so you can pass a certification inspection. What you really want is to have the employees do their tasks once and do them correctly. This reduces cost and improves profits. Canned systems do not accomplish this at all. The whole system is structured to how you actually accomplish your detailed tasks, with the introduction of improvements where necessary.
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