FAQs on ISO 13485:2016

ISO DEVELOPS THE STANDARDS LIKE ISO 9001, ISO 14001, OH&S 18001, ISO 22000, ISO 27001, ISO 13485 AND VARIOUS OTHER STANDARDS TO BE FOLLOWED AND MANAGE THE SYSTEM OF THE ORGANIZATION IN A MORE EFFICIENT MANNER.

“THE PURPOSE OF THE ISO CERTIFICATE IS NOT FOR THE BEAUTIFICATION OF THE WALL OF THE OFFICE.”

Its a quality management system which enhance and ensure customer satisfaction with quality delivery of product and services.

Business needs and expectations have changed significantly since the last major revision of ISO 9001 in the year 2000. Examples of these changes are ever more demanding customers, the emergence of new technologies, increasingly more complex supply chains and a much greater awareness of the need for sustainable development initiatives.

The concept of the standard has not changed; it’s applicable to any type of organization, regardless of the size, type or its core business.

A quality manual is no longer specifically required. The new standard requires the organization to maintain documented information necessary for the effectiveness of the quality management system (QMS). There are many ways to do this and a quality manual is just one. If it is convenient and appropriate for an organization to continue to describe its quality management system in a quality manual then that is perfectly acceptable.