{"product_id":"excellence-beyond-compliance","title":"Excellence Beyond Compliance","description":"\u003cp\u003eMany companies limp along from day-to-day treating the quality side of the business as a necessary evil, and doing only what is minimally necessary for compliance to regulations. This kind of approach to compliance almost always results in inefficiencies and sometimes can result in a curious kind of noncompliance. Documentation created with compliance as the sole consideration often ends up confusing the employees who must use the documentation.\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003eThis book looks beyond what is necessary for compliance alone to address what makes a quality management system (QMS) both effective and efficient. This book also never forgets that real people must make any QMS work; the book provides a blueprint for creating a QMS that real people will find useful.\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003eAfter a review of the challenges that any medical device company faces in the world of today—the multiple sources of QMS requirements—the book poses a question: are we satisfied with the QMS we have now, or could we do better? If we want to do better, this book can help.\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003eThis book offers:\u003c\/p\u003e\u003cul\u003e\n\u003cp\u003e\u003c\/p\u003e\n\u003cli\u003eAdvice that will lead to an effective and efficient QMS.\u003c\/li\u003e\n\u003cp\u003e\u003c\/p\u003e\n\u003cp\u003e\u003c\/p\u003e\n\u003cli\u003eDetailed guidance on the key decisions to be made regarding the quality system being established.\u003c\/li\u003e\n\u003cp\u003e\u003c\/p\u003e\n\u003cp\u003e\u003c\/p\u003e\n\u003cli\u003eDetailed ideas on how to execute those decisions.\u003c\/li\u003e\n\u003cp\u003e\u003c\/p\u003e\n\u003cp\u003e\u003c\/p\u003e\n\u003cli\u003eUp-to-date information on compliance to current regulations and standards and guidance on staying up to date.\u003c\/li\u003e\n\u003cp\u003e\u003c\/p\u003e\n\u003cp\u003e\u003c\/p\u003e\n\u003cli\u003eSpecific examples of procedures.\u003c\/li\u003e\n\u003cp\u003e\u003c\/p\u003e\n\u003cp\u003e\u003c\/p\u003e\n\u003cli\u003eInformation regarding requirements for combination products, such as a drug + device combination.\u003c\/li\u003e\n\u003cp\u003e\u003c\/p\u003e\n\u003cp\u003e\u003c\/p\u003e\n\u003cli\u003eAdvice on incorporating risk management in the QMS.\u003c\/li\u003e\n\u003cp\u003e\u003c\/p\u003e\n\u003c\/ul\u003e","brand":"MediaPlace","offers":[{"title":"Default Title","offer_id":57310539743614,"sku":"NW9781138491472","price":44.03,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1379\/1261\/files\/9781138491472.jpg?v=1778583175","url":"https:\/\/mediaplace.com\/products\/excellence-beyond-compliance","provider":"MediaPlace","version":"1.0","type":"link"}