ISO 13485, ISO 9000 and FDA cGMP QSR (Quality Management Systems Requirements) encompass legal requirements set within regulations such as 21 CFR. Other relevant requirements includes HIPAA, Sarbanes-Oxley, and for Canada - CMDCAS, and the European Union Directives MDD for the medical devices.

Note - Latest revision of ISO 13485:2003 is October 2003.

FDA QSR and MDD, and alike ISO 13485:2003, requires the implementation and maintaining a quality management system that is appropriate for the production, installation, and servicing of medical device(s) [whether class (I, II, III)] and includes design and manufacturing (as requirements see 21 CFR Part 820 - labeling part 801.4 and MDD).

Also, visit our page ISO 13485 page.

FDA cGMP QSR requirements harmonize with the International Organization for Standardization ISO 9001 into ISO 13485:2003. ISO 13485 focus in product - device and  requirements that meets and fulfill legal and regulatory requirements, in lieu of customer satisfaction as ISO 9001 does.

Planning is essential to the implementation of the quality management system, at the earliest stages of processing and applicable to every significant area that affects quality, product safety, and device performance (effectiveness). Planning involves identifying, defining, and implementation concurrent with documenting practices and providing records to demonstrate objective evidence and thus propitiates effective actions (deriving from the field or internally). In addition, risk analysis needs to occur deriving from the design stages resulting in information for manufacturing processes.

After the implementation of a management system for quality, this managerial system (ISO 13485, FDA QSR, MDD, and similar others), needs to remain dynamic through continuos updates. The system remains dynamic through feedback, verifying effectiveness in compliance through audits, management reviews, and identify the need to continuously improve (e.g., see Kaizen, IKB Performance, ISO 14971, and similarity such as HACCP principles - ISO 22000, and applying principles as "PERM" prevent > eliminate > reduce > mitigate | "PERM" is credit to the certification Body BRS). Thereof, reassessment of risks needs to remain part of the periodical reviews and updates. Part of risk assessment needs to involve competence of personnel through education, and training ensuring that the operational activities are in tune with the organization's objective, mission, and (quality) policy, and products / service risks. An effective management system results in increasing safety and operational effectiveness in the design, development, production, distribution and servicing of devices; which in turn reduces liability and assists in managing regulatory requirements (et al risk), increases market satisfaction, less generation of waste (e.g. scrap), lower costs, improves communications, elevates employee morale... Thus resulting in a competitive (globally), and generating higher profits, whilst assuring risk / hazards reduction.
 

ISO 14971 is the International Standard for the application of risk management to medical devices.

FDA cGMP QSR is a US government mandate (management system) that demands quality in the activities that relate to designing and producing medical devices, its equivalent also in Canada, which mandates ISO 13485 management system registration under CMDCAS. For medical devices ISO 13485 requires that the following be addressed; labeling, packaging, process design, market approval and others linking directly to manufacturing, encompassing assessment of risk, purchasing and contractor control, control of physical facilities, equipment, design of processes & development, design and production documentation, effective design transfer, production control, production records, packaging, treaceability, and feedback.

FDA QSR is compatible with the International Standard (ISO 9001) and mostly ISO 13485, which covers design, production, servicing and corrective/preventive (CAPA) activities. The requirements within  FDA GMP QSR are more extensive / specific. And alike ISO 13485 it address the aspects and requirements to produce and provide safe and effective devices, based on BRS^© "PERM" principles.

Under FDA GMP QSR, MDD, ISO 13485... the management system must have a document structure that initiates with a policy and objectives within a manual which sets the directives for follow-up at procedural and operational level as to sustain by objective evidence.

Elements of a Quality System

The policy and its objectives and documents in procedural format are set by management. The objective is to produce safe and effective devices.

Controlling the documentation comprises...

• Product-specific technical documentation such as engineering drawings, component purchase specifications, procedures for manufacturing processes and testing;
   
• Including labeling, packaging, etc.;
   
• System documentation levels structure, such as procedures and instructions applicable for all products; and
   
• Monitoring of activities and product performance and conformance to specifications; and any deviations from device and process specifications and company policies are feedback into the system for corrective action providing; and provide a vehicles for prevention. The FDA requires manufacturers of medical devices to operate in a state-of-control.

Implementation of a management system, such as FDA QSR, and concurrent with ISO 13485 is to assist organizations in the prevention of defective design, products and servicing.

Inspection and testing provide information that can flow into knowledge through actions by learning from correcting on the basis of root causes analysis and to enhance the prevent within the likelihood of other products and processes. Identifying and solving  problems is a requirement of the QSR (quality system requirements, CAPA) regulation and applying QSIT techniques. Further, management system improvements refers to providing ongoing effectiveness and safer products. Bodies and platforms for accreditation to conduct ISO 13485 includes IAF signatories, GOB | GCC Accreditation  - Recognition Platform, CMDCAS as well others with the necessary competence and impartiality within the medical sectors.