Building quality systems is one area where Lean RAQA Systems, LLC lives up to the “Lean” in its name. Quality systems are not one size fits all. Clients get the quality system they need to conduct business. No more no less.
For Lean RAQA Systems, building a quality system begins with an assessment of the scope of activities the client conducts themselves and the activities that are outsourced. Finally, markets where product is sold are considered to further tailor procedures. The documents contain no unnecessary requirements or resources but yet are built for growth. Procedures are customized around the scope of the client’s activities and market objectives, then controls put in place around in-house versus contracted services. Using this philosophy, clients get procedures that are sustainable with minimum resources.
By eliminating unnecessary requirements and focusing on core company activities, clients get a personalized quality management system that is value add from both a quality and a business perspective. Most importantly, whether the client’s markets include the US and 21 CFR 820, the EU and MDD 93/42/EEC, Health Canada and SOR 98-282, the multiple markets requiring ISO 13485, or other international markets and regulations, the system is easy for the company to maintain compliance without undue resource burden.