Basic info for those not in the field:
ISO 13485/13488, ISO 9000 and FDA cGMP QSR (Quality Management Systems Requirements)
Note - EN 46000 was retired, mid 2001.
Medical Devices and ISO 13485 / EN 46001FDA QSR, and alike ISO 13485, requires the implementation and maintaining a quality management system appropriate for the production, installation and servicing of medical device(s) class (I, II, III) designed or manufactured (21 CFR Part 820 - labeling part 801.4).
FDA cGMP QSR requirements are harmonized with the International Organization for Standardization ISO 9001 (and ISO 13485/ISO 13488).
The quality management system must address planning at the earliest stages in every significant area that has an effect on quality, product safety, and device performance (effectiveness). Planning involves identifying, defining and implementation concurrent with documented practices and records to demonstrate objective evidence and thus propitiate effective actions (from the field or internally).
After the implementation of a management system for quality, this managerial system must remain dynamic. The system remains dynamic through continuous feedback, verifying effectiveness through audits, reviewed by management, a continuous improvement scheme must be implemented (e.g., see kaizen, IKB Performance), and must be prevention focused. Competent personnel through education, training, and experienced must realize the product ensuring that the quality activities are in tune with the organization's objective, mission and (quality) policy. An effective functioning management system results in increased safety and operational effectiveness in realizing the device, reduced liability and regulatory exposure (risk), increased customer satisfaction, less generation of waste (e.g. scrap), lower costs, improved communications, higher employee morale thus resulting in being competitive (globally) and generating higher profits, whilst assuring risk reduction.
FDA cGMP QSR is a US government mandated management system for quality in the activities related in producing medical devices. Includes aspects relevant to labeling, packaging and process design and others linked directly to manufacturing: purchasing, facilities, equipment, design development, design and production documentation, correct design transfer, production control, production records, treaceability and feedback.
QSR is based on the International Standard ISO 9001 and which covers design, production, servicing and corrective/preventive activities, the FDA GMP QSR are more extensive/specific. Alike ISO 13485 addresses the aspects and requirements to produce and provide safe devices. An organization that does not design may exclude the relevant clauses of section 7 (7.3.1-7.3.7, accordingly as required) of ISO 9001:2000. The ISO 13485 scheme retains the ISO 9000 specification protocol.
Under FDA GMP QSR, ISO 13485 / ISO 9001:2000... the management system must include a documented scheme initiated by a policy and its objectives in a documented manual that sets the directive and command to be addressed at procedural and operational level sustained by objective evidence. Further, ISO 13485 / ISO 13488:2001 retain the documentation requirements of ISO 9001:1994, specifically for the US FDA QSR requirements.
Elements of a Quality System
The policy and its objectives and documented procedures are set by management. The generic objective is to produce a safe and effective devices (at a profit).
Controlled documentation is comprised of: product-specific technical documentation such as engineering drawings, component purchase specifications, procedures for manufacturing processes and testing; labels, etc.; and system documentation in levels, such as procedures and instructions applicable for all products. Activities and product performance and conformance to specifications are monitored; and any deviations from device and process specifications and company policies are fed back into the system where the deviations are corrected through a corrective action protocol providing one of the vehicles for prevention. The FDA requires manufacturers of medical devices to operate in a state-of-control.
An implemented management system, such as the one required by the QSR, and concurrent with ISO 9001 / ISO 13485 will assist in preventing defective design and product (ISO 13485:2002, while flowing to ISO 9001:2000 format it does retain the procedural requirements of ISO 9001/ISO 9002:1994, and ISO 13488 prevails).
Inspection and testing provide information and converted to knowledge through actions that can be taken to correct root causes of problems and further prevention of others alike. Identifying and solving quality problems is a requirement of the QSR (quality system requirements) regulation and management system improvements that provides continual effectiveness and safer products.
