ISO 13485

ISO13485 is an ISO Standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices. It's the quality management standard specifically designed for organizations that provide medical devices or related services to ensure that customer and regulatory requirements are consistently met.

While it remains a stand-alone document, ISO13485 is generally harmonized with the ISO9001 standard. Though based on ISO9001, ISO13485 removes ISO9001's emphasis on continual improvement and customer satisfaction. In its place is an emphasis on meeting regulatory as well as customer requirements, risk management and maintaining effective processes, namely the processes specific to the safe design, manufacture and distribution of medical devices.

The primary objective of ISO13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO9001 that are not appropriate as regulatory requirements.

Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO9001 unless their quality management systems conform to all the requirements of ISO9001.

While being certified to ISO13485 does not fulfill the requirements of either the FDA or foreign regulators, the certification aligns an organization's management system to the requirements of the FDA's Quality System Regulation requirements as well as many other regulatory requirements found throughout the world.

If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with ISO13485:2003 reflect exclusion of design and development controls.

If any requirement(s) in Clause 7 of ISO13485:2003 is(are) not applicable due to the nature of the medical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system.

The processes required by ISO13485:2003, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system.

Like any ISO certification, medical device manufacturers wishing to obtain ISO13485 certification first need to educate themselves on the requirements of regulators and customers, as well as what an ISO13485-compliant management system will entail. Then a management system that conforms to the standard's requirements needs to be implemented within the organization.

Benefits

Gaining certification to ISO13485 will help your organization do business in this highly regulated sector as it demonstrates your organization is committed to quality, customers, and your willingness to work towards improving efficiency.

ISO13485 promotes harmonization of regulatory requirements for manufacturers of medical devices on an international scale.

ISO13485 incorporates many of the quality management principles and delivers the benefits of an ISO9001:2000 based quality management system including:

• Customer satisfaction - through delivery of products that consistently meet customer requirements as well as quality, safety and legal requirements.
• Improved stakeholder relationships - including staff, customers, and suppliers.
• Proven business credentials - through independent verification against recognized standards.
• Reduced operating costs - through continual improvement of processes and resulting operational efficiencies.
• Improved risk management - through greater consistency and traceability of products and use of risk management techniques.
• Legal compliance - by understanding how statutory and regulatory requirements impact the organization and its customers.
• Ability to win more business - particularly where procurement specifications require certification as a condition to supply in a highly regulated sector.

Other benefits of ISO13485:2003 management are:

• Is recognized globally as the best quality practices from organizations within the medical device industry.
• Enables you to work within many countries where it is a regulatory requirement and with many organizations where it is a contractual obligation or expectation.
• Helps to create a systematic framework in which organizations monitor, measure, and analyze their processes and customer feedback.
• Helps provide a framework for implementation of actions (where necessary) to ensure achievement of planned results and to ensure maintenance of effectiveness of those processes with applicable customer, quality and regulatory requirements.
• Can provide improved performance measurable in key metric areas such as increased sales, increased timeliness in getting products to the global marketplace, reduced costs, fewer errors, less waste, better use of time and resources, and lower product failures.
• Demonstrates the existence of an effective quality system that satisfies the rigors of an independent, external audit and addresses the additional safety, regulatory, and quality concerns specific to the medical device industry.
• Enhances the company image in the eyes of customers, employees, and shareholders alike.
• Gives competitive advantage in marketing efforts.
• And many others.

The Challenge

One of the challenges when implementing an effective management system is the effective carrying over of the requirements of the series of standards into your business. ISO13485:2003 exhibits a strong, process-oriented structure and demands the process-oriented observance by a business during implementation.

For medical manufacturers seeking new market-entry opportunities, conformity with regulatory requirements is most often a prerequisite.

To meet these requirements, companies must implement and document QMS processes involving staff training, product design and processes, materials and services purchasing, and product and services delivery.

Due to the nature of medical devices, safety is of course of the highest rank. Therefore ISO13485, unlike other standards based on ISO9001, modifies key terminology to remove the concepts of "continuous improvement" and replace it with "effectiveness". The result is that ISO13485 does not allow for companies to have poor quality or ineffective systems that it then takes steps to "improve", but rather, it demands a high quality product and effective systems at the time of registration.

The focus on safety through product quality and system effectiveness will not come as a surprise to companies already producing a regulated product. However, it is still a challenge to create a Quality Management System that is not only effective, but efficient.

The tendency to create a detail rich document system for ISO13485 is common, but it must be tempered with practicalities of ensuring personnel can comply with the requirements on a regular basis, giving personnel flexibility where needed, and providing for the efficiencies needed by company goals.

The above common challenges faced by companies seeking to meet the ISO13485 requirements are not difficult to overcome, but do require focus and attention. They do not require large continuing investments in time or money if a company just consistently invests small amounts of resources and continues with a focus on quality when managing their jobs and business.

The Solution

SoftExpert Excellence Suite ensures compliance with many regulations including the ISO13485. SoftExpert Excellence Suite allows you to increase efficiency for your quality processes, minimize the high costs of compliance, and quickly bring new products to market.

With SoftExpert Excellence Suite your organization will be able to:

• Create and maintain all of your quality system documentation including Device Master Records, Device History Records, and Design History Files.
• Perform corrective and preventative actions.
• Record and resolve customer complaints.
• Manage nonconforming products and material.
• Improve product and process quality.
• Perform effective employee training.
• Create, execute, and track assessments.
• Evaluate suppliers.
• Manage gage calibration and preventative maintenance.
• Drive advanced product quality planning (APQP) throughout your entire product life cycle.
• Improve communication, both internal and external.
• Promote close collaboration between workers.
• Reduce or eliminate customer audits.
• Become and/or remain competitive in the market.
• Eliminate work redundancy.
• Detect defects earlier and correct them at a lower cost.
• Dramatically simplify the management processes required for compliance.
• Improve data integrity and accountability controls.
• Reduce cost for storage and control of records.
• Meet and/or exceed customer satisfaction, and most importantly, gain customer loyalty.
• And much more.

 

Each SoftExpert module addresses key compliance issues as shown below:

Module	KEY Compliance
SE Document	Manage the creation, review, approval, and distribution of documents. Document the organization's quality management system. Automate document protection and retention rules . Enterprise-wide involvement in the process of document changes. Ensure only the latest document reversions are used. Document responsibilities and authorities. Approve documents before you distribute them. Provide the correct version of documents at points of use. Review and re-approve documents when you update them. Specify the current revision status of your documents. Monitor documents that come from external sources. Prevent the accidental use of obsolete documents. Preserve the usability of your quality documents. Retain obsolete documents for medical devices. Ensure that your medical device records are useable. Retain records related to medical devices.
SE Action	Nonconforming products are controlled to prevent inadvertent use or installation. Review and disposition of nonconforming products is formalized. Ensure that appropriate corrective actions are decided upon and implemented. Ensure that responsibility for corrective actions is clearly defined. Keep records of all complaints and follow-up actions. Correct any deficiencies before they can cause defects in products or processes. Generate actions to improve your organization's products. Keep records of defects, the investigation of their cause, and the corrective actions. Examine: Corrective and preventive actions. Feedback from customers. Product conformity data. Generate actions to improve maintenance of quality system. Generate actions to address your resource needs. Eliminate or correct product nonconformities. Prevent the delivery or use of nonconforming products. Avoid the inappropriate use of nonconforming products. Document your product nonconformities. Describe the actions taken to deal with nonconformities.
SE Audit	Ensure corrective actions are carried out on time. Plan regular reviews of your quality system. Evaluate the effectiveness of your quality system. Maintain a record of your management reviews. Results of audits are automatically communicated to management. All findings are quickly corrected and registered. Set up an internal audit program. Develop an internal audit procedure. Plan your internal audit projects. Perform regular internal audits. Solve problems discovered by audits. Verify that problems have been solved. Manage any required corrective actions. Examine: Audit results. Product conformity data. Opportunities to improve. Process performance information. Changes that might affect your system. Changes in your regulatory requirements. Previous quality management reviews.
SE Process	Ensure production (and installation) processes are defined, planned, and documented. Production shall be carried out under controlled conditions: documented. instructions, in-process controls, approval of processes and equipment, and criteria for workmanship. Ensure processes are monitored and controlled. Develop a process to control communications with customers. Make sure that your process controls customer advisory notices. Implement your customer communications process. Validate production and service processes. Validate product sterilization processes. Take action when processes fail to achieve planned results.
SE Competence	Identify training needs. Keep records of all trainings. Ensure staff performance are regularly appraised and recorded. Ensure lack of skills and qualifications are found. Keep information up to date enabling staff to adequately operate equipment they are responsible for. Ensure qualified individuals are assigned to proper tasks. Ensure that your personnel have: The right experience. The right education. The right training. The right skills. Define acceptable levels of competence. Identify your training and awareness needs. Establish training needs assessment procedures. Deliver your training and awareness programs. Evaluate effectiveness of training and awareness. Maintain records of competence.
SE Calibration	Identify the monitoring and measuring that should be done. Select devices that meet monitoring and measuring needs. Establish procedures to control monitoring and measuring. Implement procedures to control monitoring and measuring. Maintain procedures to control monitoring and measuring. Ensure unique identification of each device. Easily identify devices with due calibration. Calibrate instruments (procedures and status indicators). Check calibration frequency. Ensure no unregistered or overdue equipment is used. Assess measurement validity. Ensure measurement uncertainty and equipment capability are known. Trace equipment measurements to national or international standards. Document calibration steps for each piece of device or equipment. Keep record of each calibration. Safeguard your devices from unauthorized adjustment. Safeguard your devices from damage or deterioration.
SE MSA	Provide all the necessary tools for managing measurement systems within the organization. Compare equipment performance before and after repair. Ensure complete analysis through the use of graph charts, such as average/range, errors, whiskers chart, scatter, histogram, linearity, and others. Provide guidance for developing a formal gauge management system. Allows fixed and variable calibrations. Identify testers and inspectors.
SE SPC	Verify acceptability of process capability and product characteristics. Ensure that required characteristics of processes and products are monitored and measured. Document procedures to implement and control the statistical techniques identified. Ensure action plans are taken when out-of-control signals are detected. Take action when processes fail to achieve planned results. Monitor and measure characteristics.
SE Inspection	Ensure incoming materials are inspected and/or verified before use. Keep records of all inspections. Ensure final inspection is performed prior to release of finished product. Keep record of supplier evaluation results and follow-up action. Ensure that your purchased products meet requirements. Create a procedure to ensure purchases meet requirements. Ensure that your suppliers meet requirements. Describe the products being purchased. Specify the requirements that purchases must meet. Maintain purchasing information for traceability purposes. Maintain a record of your product verification activities.
SE Maintenance	Keep records of all maintenance work and activities. Ensure unique identification of each piece of equipment. Keep records of equipment calibration and maintenance. Document equipment instructions - usually supplied by the manufacturer. Ensure that equipment operates within specifications. Provide maintenance schedule to ensure no equipment is overlooked. Maintain your: Utilities. Maintenance services. Equipment.
SE Risk	Identify product realization risk management requirements. Make sure that definitions include risk management outputs. Establish, document, and maintain risk management process to: Identify hazards and hazardous conditions. Estimate and evaluate the associated risks. Control those risks. Monitor the effectiveness of the controls put in place throughout the product life cycle.
SE Performance	Performance deviations are automatically detected and management notified. Record and control action plans. Analyze causes and effects (strategy map). Ensure that objectives: Are set for all functional areas. Are set at organizational levels. Facilitate product realization. Support the quality policy. Are measurable.
SE PDM	Identify product: Quality objectives and requirements. Realization needs and requirements. Realization risk management requirements. Realization record keeping requirements. Develop product realization documents. Develop product realization record keeping systems. Develop methods to control quality during product realization. Define your product design and development stages. Establish procedures to control product design and development. Clarify design and development responsibilities and authorities. Manage interactions between design and development groups. Update your design and development plans as changes occur. Document your planning outputs as changes occur. Specify product design and development inputs. Record product design and development input definitions. Evaluate product design and development input definitions. Make sure that definitions support the product's intended use. Make sure that definitions include risk management outputs. Review input definitions before you approve them. Create product design and development outputs. Approve design and development outputs prior to release. Use design and development outputs to control product quality. Maintain a record of your design and development outputs. Perform product design and development reviews. Involve specialists in design and development review process. Record your product design and development reviews. Carry out product design and development verifications. Record your product design and development verifications. Perform product design and development validations. Conduct clinical evaluations of medical devices (if required). Conduct performance evaluations of devices (if required). Record product design and development validations. Identify changes in product design and development. Record changes in product design and development. Review changes in product design and development. Verify changes in product design and development. Validate changes in product design and development. Approve changes before they are implemented.