ISO Compliance and ISO Standards

ISO Compliance and ISO Standards

ISO is a set of global quality standards that are geared to companies providing products or services as a framework for achieving customer satisfaction through implementing a quality management system. The ISO set of standards have become an important mechanism to allow companies to inform their customers and competitors that they have implemented an externally-accepted quality system in addition to enabling companies to increase conformity and efficiency in their operations. ISO is continually increasing its global presence and becoming a regulatory requirement for many industries.

mdi Consultants has assisted over 150 companies achieve ISO compliance across a wide array of ISO standards (e.g. ISO 9001:1994, ISO 9001:2000, ISO 13485 (EN 46001), ISO 13488 (EN46002)). We have guided many companies across the following industries: medical device, pharmaceutical, clinical research organizations (CRO), food and other manufacturing (e.g. parachute manufacturer, aerospace, defense). Our customer testimonials will provide you a glimpse of the experience of working with mdi on ISO. In addition, mdi guarantees, if you follow our program, you will achieve ISO compliance on your first audit by a certifying registrar.


Our ISO program includes the following services:

GAP ANALYSIS
GAP Analysis is a pre-determined partial review of a company’s current quality management system to determine what would be required to bring the company into compliance with the applicable standard(s) (e.g. ISO 9001/ISO 13485). This Analysis reviews the present policies , procedures, staffing, level of expertise, products being made and complexities of the operations. When we do the Gap Analysis, we will be cognizant of other compliance requirements (e.g. GMP, GCP) and we can adjust the Analysis to ensure all standards/regulations are met. It is always advisable to have a GAP Analysis performed prior to any implementation of a quality system to assure that the implementation can be fairly determined within a realistic timeframe.

PROJECT PLAN DEVELOPMENT
In order to assure the successful implementation of a quality system like ISO, it is important that a plan be laid out and structured with the company’s staffing and resources in mind. This Planning assists in determining if the company should be certified to ISO 9000, and which operations should achieve certification first, how long the process will take and the amount of manpower that would be required to reach the target certification date. As part of this analysis, we will define the scope of the operations that will need to be ISO certified. Our consultants will assist with setting up work plans and flow charts for the preparation of documenting operating procedures.

PROJECT MANAGEMENT
Our consultants will manage the entire project for you. Particularly when multiple sites or business units are involved, ensuring that activities are underway and on target for completion are critical. We will stay on top of the project an