Académique Documents
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Objectives
Overview of ISO 13485:2003 Background / History of the new standard Structure Permissible exclusions from the standards Regulatory/Industry/International acceptance
Current ISO 13485:96 standard is based on ISO 9001:94. As of December 15, 2003 ISO 9001:94 will be obsolete
every 5 years
The Medical Device Industry did not agree with all the changes to ISO 9001:2000 Harmonizing with the QSR (GMP) requirements ISO 9001:2000 places an emphasis on Continual Improvement and Customer Satisfaction Harmonizing EN 4600X Standards with ISO 1348X Not user friendly Lacked Process orientation Could not tailor ISO to scope of registration (service)
Useable by organizations of all sizes Specific to the Medical Device Community Easily Understood Compatible with other management systems
ISO 9000: Quality management system fundamentals and vocabulary Except as noted in section 3 of 13485 ISO 13485: Quality Management System Requirements combines ISO 13485 and 13488 limitations will be indicated on certificate ISO/TS 14969: Quality Management Systems-Medical Devices-Guidance on the Application of ISO 13485
Adopted process approach Emphasis is now on regulatory requirements for a quality management system rather than a quality assurance system. Increased attention to production of a conforming product and delivery of a conforming service is included in and is part of the quality management system. There is now only one management system requirement standard, i.e. ISO 13485, where previously there were two requirement standards: ISO 13485 and ISO 13488.
Organization replaces supplier to refer to the company implementing the standard Supplier replaces subcontractor when referring to companies that your company purchases goods and services from
Top Management must be involved in establishing and communicating the purpose and direction of the organization
The management system begins and ends with objectives established by Top management Top management responsibility for profit or loss*
Top Management needs to create an atmosphere in which people are not afraid to become involved, and desire to help the company meet its goals and objectives
Why Cant the FDA change Part 820 to harmonize it with 9000:2000
The FDA and medical device regulators take issue with following ISO 9001:2000 philosophies: Customer Satisfaction- goes above and beyond the safety and efficacy of medical devices. Evaluating customer satisfaction beyond safety is not FDAs purpose Continuous Improvement- done simply for the sake of operating more efficiently is outside the scope of medical device regulatory agencies. Documentation- documentation is needed to know what a company intends to do and what they actually did- ISO 9001:2000 requires less documentation than does 13485:2003 Process Approach- FDA does not feel its necessary for companies to change the structure of their documentation. FDA is assuming the purpose of the change in ISO is a change in documentation and that companies do not already use the process approach.
The FDA is planning on some level of harmonization with ISO 13485 in late 2002 early 2003.
Provided that ISO 13485 will remain more true to the medical device/regulatory viewpoint
FDA and device regulatory agencies from other countries can more readily rely on one another's inspections and exchange inspection reports if the quality system requirements are similar.
Why Would Medical Device Manufacturers want to maintain ISO 9001:2000 Certification as well as 13485:200X
Customers (Doctors, Hospitals, OEMs) perceive a level of security in knowing they are buying from a manufacturer that has an ISO 9001 certified system. Helps companies obtain product certification CE mark, Companies do not have to be ISO certified to get CE Mark Depending on the product or service companies could opt for ISO 17025
(7.5.3) Identification and traceability - only partially applicable where there is no specific traceability requirement for the organizations product (7.5.2) Customer property - Nothing is provided from the customer to the supplier in the realization of its products or processes (7.6) The organizations needs no measuring and test equipment to provide evidence of conformity
Differences:
Guidance:
ISO
ISO
Duration must be for the life of the device or as specified by relevant regulatory requirements (GMP/GLP)
Differences: Section 5
Section 5.1 of 13485:2003 does not require "Continually Improving its effectiveness"
Differences: Section 5
Section 6.2.2 of 13485:2003 Requires a procedure for training where as ISO 9001:2000 does not. Section 6.4 Work Environment of 13485:2003 is more detailed (i.e. health records, cleanliness of clothing and personnel, environmental monitoring) than the same section in 9001:2000
Differences: Section 7
Section 7.3 Design and Development of 13485:2003 references ISO 14971 (Risk Analysis) 9001:2000 does not. Section 7.5.1 of 13485:2003 has added sub-clause G, which talks about packaging and labeling. Section 7.5.1.1 Cleanliness of Product and contamination control (Cleaning of product) is added for 13485:2003 Section 7.5.1.2 Installation (Installing the Device) is added for 13485:2003 Section 7.5.1.3 Servicing (After the Device is installed) is added for 13485:2003
Section 7.5.3 Identification and Traceability- additional requirements for 13485: Particular requirements for active implantable medical devices and implantable medical devices: a) When defining the extent of traceability, the organization shall include all components and materials used, and records of the environmental conditions when these could cause the medical device not to satisfy its specified requirements. b) The organization shall require that its agents or distributors maintain records of the distribution of medical devices with regard to traceability and that such records are available for inspection. c) The organization shall ensure that the name and address of the shipping package consignee is recorded (see 4.2.4).
Differences: Section 8
Section 8.1 Measurement, analysis and Improvement- additional Requirements for 13485:
If statistical techniques are used, organization shall establish and maintain documented procedures to implement and control their application.
The organization shall establish and maintain a documented feedback system to provide early warning of quality problems and for input into the corrective and preventive action system [see 7.2.3c)]. If regulations require the organization to gain experience from the post-production phase, the review of this experience shall form part of the feedback system (see 8.5.1).
Quality Manual 4.2.3 Control of Documents 4.2.4 Control of Records 8.2.2 Internal Audit 8.5.2 Corrective Action 8.5.3 Preventive Action
Quality Manual 4.2.3 Control of Documents 4.2.4 Control of Records 6.2.2 Competence, awareness and training 7.3 Design and Development 7.4.1 Purchasing Process 7.5.1.2 Installation activities (if applicable) 7.5.1.3 Servicing activities (when required) 7.5.3.1 Identification 7.5.3.2 Traceability 7.5.5 Preservation of Product 7.6 Control of Measuring and Monitoring Devices 8.1 Statistical Techniques (if used) 8.2.2 Internal Audits 8.3 Control of nonconforming product 8.4 Analysis of Data 8.5 Improvement 8.5.2 Corrective Action 8.5.3 Preventive Action
Primary objective of ISO13485 is to facilitate harmonized medical device regulatory requirements. Includes some particular requirements for medical devices and excludes some of the ISO 9001:2000 requirements These exclusions prevent users from claiming conformity with ISO9001:2000!
13485:2003 Registration
it would make for more efficient audits if a company did or at least provided a cross-reference of documents from the old standard to the new
Certified companies will have 9 months from the release date of ISO 13485:2003 to update to the new revision
Certification Options
ISO 13485 (8):96 becomes ISO 13485:2003 EN 4600X:94 will be replaced by ISO 13485:2003