ISO Compliance for Medical Devices, Pharmaceutical and Food Services Industry

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.

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.

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 and can provide you a regular status update of how the project is performing relative to the plan. In addition, for large organizations, we will provide regular ISO newsletters to key managers and employees, so that they are abreast of the project’s status.

We have a well developed and field tested ISO compliance quality management system and manual that we can customize and implement for you. Our Quality Policy and Procedures Manual meets ISO 9000 standards as well as other important regulations (e.g. ISO 13485, CAMCAS, FDA cGMP, QSR). Our system has been implemented at numerous companies and has been through many successful Certification Audits. The manual is easy to understand and implement, that includes all quality procedures and forms.

We provide ISO training to all levels of staff from management to the production line employee. The training would be performed in-house by our consultants and uses your company operations as the basis of the program. Materials and Certificate of attendance will be given to all attendees meeting the requirements of the ISO standards. We can also set up electronic based training for all future ISO training requirements in order to minimize the cost of your ongoing training needs.

An Internal Audit training program is used to meet the requirements of the ISO standard. Internal Auditors are a select group of employees that will be trained on how to properly conduct internal audits. This training includes classroom sessions as well as application sessions of watching an audit and then performing an audit. Certification of the completion of this session will also be provided.

One of the necessities of obtaining ISO third party certification is the selection of a Registrar. mdi will assist you in the selection of a Registrar by thinking through all the key issues including industry expertise of the registrar and registrar location. We will also assist you with filling out the forms and negotiating a price with the Registrar.

Prior to any third party certification audit it is advisable for a pre-assessment audit to be performed – usually within 3 weeks of the certification audit. The quality system can be tested to address any corrective actions and assure certification by the third party registrar. If the company doesn’t meet requirements, mdi will help to postpone the certification audit. In addition, we will perform a short audit, 2 days prior to the certification audit to fix any minor issues and to better ensure a favorable certification audit.