The core of the ISO 9000 Quality System Standard consists of four international standards that provide guidance in the development and implementation of an effective quality management system. These standards are applicable to both manufacturing and service industries.
A quality management system refers to the activities you carry out within your organization to satisfy the quality related expectations of your customers.
The ISO 9001 standards on quality management systems have rapidly become the de facto standard for measuring the quality level of a product delivery system for both service and manufacturing companies. The standard has already been adopted by more than 100 countries and more than 343,000 firms worldwide, in effect making ISO 9000 certification a prerequisite for doing business both domestically and internationally.
Companies looking to become certified to be in conformance with the ISO 9001 standard experience a high failure rate on their first attempt. Considering the high price associated with the certification audit, failing to become certified due to a non-conforming quality management system can prove to be very costly with regards to both time and money. The development of a value-added system that meets or exceeds the requirements of ISO 9001 and can be certified as conforming can greatly benefit your organization by improving cycle time, reducing scrap and rework and keeping operating costs down. An effective quality management system is the grease that helps firms run smoothly and profitably.
CVGA can help you implement an ISO 9001 QUALITY MANAGEMENT SYSTEM, by providing skilled, knowledgeable people who are ASQ or RAB certified.
As with ISO 9001, ISO 14001 does not dictate the actual performance standards to be met for air and water quality, but coordinates processes and procedures for verifying that systems exist for controlling national environmental performance standards. ISO 14001 consists of:
Environmental Management System Requirements
Implementation and operation
Checking and corrective action
CVGA can help you implement an Environmental Management System that conforms to IISO 14001:2004 by providing skilled, knowledgeable people for training, consulting or auditing.
For many years, DaimlerChrysler, Ford, General Motors and other North American automotive manufacturers have required their suppliers not only to meet product specifications but also follow prescribed quality systems and procedures.
These practices cover the spectrum form product development through statistical control, to effective response to customer feedback. These automotive companies have years of experience in determining which quality systems their suppliers should follow to provide assurance that they are capable of delivering products that meet the companies' requirements.
These requirements were called QS9000 when they were combined with ISO 9000 system standards. The ISO/TS 16949 international automotive standard incorporates QS9000 Quality System Requirements with some additional requirements.
CVGA can help you implement an ISO/TS16949 QUALITY MANAGEMENT SYSTEM, by providing skilled, knowledgeable people who are ASQ, RAB OR AIAG certified.
FDA CFR820 and CGMP
The FDA Quality System Regulation (QSR) 21 CFR Part 820 was published on Monday October 7th, 1996, and came into effect on June 1st, 1997, while the Design Control requirements came into full effect on June 1st, 1998.
FDA has stated that this major revision was necessary to make medical devices safer and more effective. In effect, it imposed significant new requirements on device manufacturers. In many cases manufacturers have not satisfactorily established compliance with the regulation and have received adverse FDA inspections, Warning Letters and Import Alerts. According to FOI data in 2001, 56% of foreign medical device manufacturers inspected by FDA, were issued with a form 483 listing objectionable conditions and practices.
Good Manufacturing Practices (GMP) and Hazard Analysis And Control Plans (HAACP) are also part of a safe food and working environment. We can help your organization develop these environments and Audit the processes for compliance
CVGA can help your organization by training or consulting to assist in the following areas:
FDA Organisation History.
Overview of the Quality System Regulation.
Quality System Inspection Technique (QSIT) & the inspection of QSIT sub-systems
Corrective & Preventive Action
Production & Process Controls
Design Control Requirements and Risk Analysis.
Nonconformity, Corrective and Preventive Action.
How to Prepare for and Host an FDA Inspection.
Complaint Handling and MDR Reporting
21 CFR 11 Status & Requirements
How to communicate with FDA
How to develop a HAACP
Over the last few years our country has experienced a number of natural disasters that have damaged and interrupted many businesses ability to continue daily operations. Research has shown that 80% of these businesses fail to recover within a year of a major disruption. The ability of an organization to maintain its critical operations during and following a disastrous event can be the difference between survival and total loss.
For the first time there is a business continuity standard available from BSI that addresses all parts of the business. BS 25999 is a holistic management system that has been designed and developed to be suitable for any organization large or smal