Correspondence Between ISO 13485:2016 and 21 CFR Part 820 QMS Requirements

Transcription

1 Correspondence Between and 21 CFR Part 820 QMS Requirements Corporate Drive, Suite 102, Pleasant Prairie, WI rcainc.com

2 2 4 Quality Management System 4.1 General Requirements The organization shall document a quality management system and maintain its effectiveness in accordance with the requirements of this International Standard and applicable regulatory requirements. The organization shall establish, implement, and maintain any requirement, procedure, activity, or arrangement required to be documented by this International Standard or applicable regulatory requirements. The organization shall document the role(s) undertaken by the organization under the applicable regulatory requirements. NOTE. Roles undertaken by the organization can include manufacturer, authorized representative, importer, or distributor The organization shall: a) determine the processes needed for the quality management system and the application of these processes throughout the organization taking into account the roles undertaken by the organization; b) apply a risk based approach to the control of the appropriate processes needed for the quality management system; c) determine the sequence and interaction of these processes For each quality management system process, the organization shall: a) determine criteria and methods needed to ensure that both the operation and control of these processes are effective; b) ensure the availability of resources and information necessary to support the operation and monitoring of these processes; c) implement actions necessary to achieve planned results and maintain the effectiveness of these processes; d) monitor, measure as appropriate, and analyze these processes; Subpart A--General Provisions Sec Quality System. Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured, and that meets the requirements of this part. Subpart B--Quality System Requirements Sec Management Responsibility. (a) Quality Policy. Management with executive responsibility shall establish its policy and objectives for, and commitment to, quality. Management with executive responsibility shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization. (b) Organization. Each manufacturer shall establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the requirements of this part. (1) Responsibility and Authority. Each manufacturer shall establish the appropriate responsibility, authority, and interrelation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks. (2) Resources. Each manufacturer shall provide adequate resources, including the assignment of trained personnel, for management, performance of work, and assessment activities, including internal quality audits, to meet the requirements of this part. (3) Management Representative. Management with executive responsibility shall appoint, and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for: (i) Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and (ii) Reporting on the performance of the quality system to management with executive responsibility for review. (c) Management Review. Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer's established quality policy and objectives.

3 3 e) establish and maintain records needed to demonstrate conformance to this International Standard and compliance with applicable regulatory requirements (see 4.2.5) The organization shall manage these quality management system processes in accordance with the requirements of this International Standard and applicable regulatory requirements. Changes to be made to these processes shall be: a) evaluated for their impact on the quality management system; The dates and results of quality system reviews shall be documented. (d) Quality Planning. Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured. The manufacturer shall establish how the requirements for quality will be met. (e) Quality System Procedures. Each manufacturer shall establish quality system procedures and instructions. An outline of the structure of the documentation used in the quality system shall be established where appropriate. b) evaluated for their impact on the medical devices produced under this quality management system; c) controlled in accordance with the requirements of this International Standard and applicable regulatory requirements When the organization chooses to outsource any process that affects product conformity to requirements, it shall monitor and ensure control over such processes. The organization shall retain responsibility of conformity to this International Standard and to customer and applicable regulatory requirements for outsourced processes. The controls shall be proportionate to the risk involved and the ability of the external party to meet the requirements in accordance with 7.4. The controls shall include written quality agreements The organization shall document procedures for the validation of the application of computer software used in the quality management system. Such software applications shall be validated prior to initial use and, as appropriate, after changes to such software or its application. The specific approach and activities associated with software validation and revalidation shall be proportionate to the risk associated with the use of the software. Records of such activities shall be maintained (see 4.2.5). 4.2 Documentation Requirements General The quality management system documentation (see 4.2.4) shall include: a) documented statements of a quality policy and quality objectives; b) a quality manual; Subpart A General Provisions Sec Quality System. Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured, and that meets the requirements of this part. Subpart B--Quality System Requirements Sec Management Responsibility.

4 4 c) documented procedures and records required by this International Standard; d) documents, including records, determined by the organization to be necessary to ensure the effective planning, operation, and control of its processes; e) other documentation specified by applicable regulatory requirements. (a) Quality Policy. Management with executive responsibility shall establish its policy and objectives for, and commitment to, quality. Management with executive responsibility shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization. (e) Quality System Procedures. Each manufacturer shall establish quality system procedures and instructions. An outline of the structure of the documentation used in the quality system shall be established where appropriate. Subpart D--Document Controls Sec Document Controls. Each manufacturer shall establish and maintain procedures to control all documents that are required by this part. The procedures shall provide for the following: (a) Document Approval and Distribution. Each manufacturer shall designate an individual(s) to review for adequacy and approve prior to issuance all documents established to meet the requirements of this part. The approval, including the date and signature of the individual(s) approving the document, shall be documented. Documents established to meet the requirements of this part shall be available at all locations for which they are designated, used, or otherwise necessary, and all obsolete documents shall be promptly removed from all points of use or otherwise prevented from unintended use. (b) Document Changes. Changes to documents shall be reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval, unless specifically designated otherwise. Approved changes shall be communicated to the appropriate personnel in a timely manner. Each manufacturer shall maintain records of changes to documents. Change records shall include a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective Quality Manual The organization shall document a quality manual that includes: a) the scope of the quality management system, including details of and justification for any exclusion or non-application; b) the documented procedures for the quality management system, or reference to them; c) a description of the interaction between the processes of the quality management system. Subpart B--Quality System Requirements Sec Management Responsibility. (a) Quality Policy. Management with executive responsibility shall establish its policy and objectives for, and commitment to, quality. Management with executive responsibility shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization. (b) Organization. Each manufacturer shall establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the requirements of this part.

5 5 The quality manual shall outline the structure of the documentation used in the quality management system. (1) Responsibility and Authority. Each manufacturer shall establish the appropriate responsibility, authority, and interrelation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks. (2) Resources. Each manufacturer shall provide adequate resources, including the assignment of trained personnel, for management, performance of work, and assessment activities, including internal quality audits, to meet the requirements of this part. (e) Quality System Procedures. Each manufacturer shall establish quality system procedures and instructions. An outline of the structure of the documentation used in the quality system shall be established where appropriate Medical Device File For each medical device type or medical device family, the organization shall establish and maintain one or more files either containing or referencing documents generated to demonstrate conformity to the requirement of this International Standard and compliance with applicable regulatory requirements. The content of the file(s) shall include, but is not limited to: a) general description of the medical device, intended use/purpose, and labelling, including any instructions for use; b) specifications for product; c) specifications or procedures for manufacturing, packaging, storage, handling and distribution; d) procedures for measuring and monitoring; as appropriate, requirements for installation; e) as appropriate, procedures for servicing. Subpart M--Records Sec Device Master Record. Each manufacturer shall maintain device master records (DMR's). Each manufacturer shall ensure that each DMR is prepared and approved in accordance with The DMR for each type of device shall include, or refer to the location of, the following information: (a) Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications; (b) Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications; (c) Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used; (d) Packaging and labeling specifications, including methods and processes used; and (e) Installation, maintenance, and servicing procedures and methods. Subpart K--Labeling and Packaging Control Sec Device Labeling. Each manufacturer shall establish and maintain procedures to control labeling activities. (a) Label Integrity. Labels shall be printed and applied so as to remain legible and affixed during the customary conditions of processing, storage, handling, distribution, and where appropriate use.

6 6 (b) Labeling Inspection. Labeling shall not be released for storage or use until a designated individual(s) has examined the labeling for accuracy including, where applicable, the correct unique device identifier (UDI) or universal product code (UPC), expiration date, control number, storage instructions, handling instructions, and any additional processing instructions. The release, including the date and signature of the individual(s) performing the examination, shall be documented in the DHR. (c) Labeling Storage. Each manufacturer shall store labeling in a manner that provides proper identification and is designed to prevent mix-ups. (d) Labeling Operations. Each manufacturer shall control labeling and packaging operations to prevent labeling mix-ups. The label and labeling used for each production unit, lot, or batch shall be documented in the DHR. (e) Control Number. Where a control number is required by , that control number shall be on or shall accompany the device through distribution. Sec Device Packaging. Each manufacturer shall ensure that device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution. Subpart L--Handling, Storage, Distribution, and Installation Sec Handling. Each manufacturer shall establish and maintain procedures to ensure that mix-ups, damage, deterioration, contamination, or other adverse effects to product do not occur during handling. Sec Storage. (a) Each manufacturer shall establish and maintain procedures for the control of storage areas and stock rooms for product to prevent mix-ups, damage, deterioration, contamination, or other adverse effects pending use or distribution and to ensure that no obsolete, rejected, or deteriorated product is used or distributed. When the quality of product deteriorates over time, it shall be stored in a manner to facilitate proper stock rotation, and its condition shall be assessed as appropriate. (b) Each manufacturer shall establish and maintain procedures that describe the methods for authorizing receipt from and dispatch to storage areas and stock rooms. Sec Distribution. (a) Each manufacturer shall establish and maintain procedures for control and distribution of finished devices to ensure that

7 7 only those devices approved for release are distributed and that purchase orders are reviewed to ensure that ambiguities and errors are resolved before devices are released for distribution. Where a device's fitness for use or quality deteriorates over time, the procedures shall ensure that expired devices or devices deteriorated beyond acceptable fitness for use are not distributed. (b) Each manufacturer shall maintain distribution records which include or refer to the location of: (1) The name and address of the initial consignee; (2) The identification and quantity of devices shipped; (3) The date shipped; and (4) Any control number(s) used. Sec Installation. (a) Each manufacturer of a device requiring installation shall establish and maintain adequate installation and inspection instructions, and where appropriate test procedures. Instructions and procedures shall include directions for ensuring proper installation so that the device will perform as intended after installation. The manufacturer shall distribute the instructions and procedures with the device or otherwise make them available to the person(s) installing the device. (b) The person installing the device shall ensure that the installation, inspection, and any required testing are performed in accordance with the manufacturer's instructions and procedures and shall document the inspection and any test results to demonstrate proper installation. Subpart M--Records Sec General Requirements. All records required by this part shall be maintained at the manufacturing establishment or other location that is reasonably accessible to responsible officials of the manufacturer and to employees of FDA designated to perform inspections. Such records, including those not stored at the inspected establishment, shall be made readily available for review and copying by FDA employee(s). Such records shall be legible and shall be stored to minimize deterioration and to prevent loss. Those records stored in automated data processing systems shall be backed up. (a) Confidentiality. Records deemed confidential by the manufacturer may be marked to aid FDA in determining whether information may be disclosed under the public information regulation in part 20 of this chapter.

8 8 (b) Record Retention Period. All records required by this part shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution by the manufacturer. (c) Exceptions. This section does not apply to the reports required by (c) Management review, Quality audits, and supplier audit reports used to meet the requirements of (a) Evaluation of suppliers, contractors, and consultants, but does apply to procedures established under these provisions. Upon request of a designated employee of FDA, an employee in management with executive responsibility shall certify in writing that the management reviews and quality audits required under this part, and supplier audits where applicable, have been performed and documented, the dates on which they were performed, and that any required corrective action has been undertaken. Subpart N--Servicing Sec Servicing. (a) Where servicing is a specified requirement, each manufacturer shall establish and maintain instructions and procedures for performing and verifying that the servicing meets the specified requirements. (b) Each manufacturer shall analyze service reports with appropriate statistical methodology in accordance with (c) Each manufacturer who receives a service report that represents an event which must be reported to FDA under part 803 of this chapter shall automatically consider the report a complaint and shall process it in accordance with the requirements of (d) Service reports shall be documented and shall include: (1) The name of the device serviced; (2) Any unique device identifier (UDI) or universal product code (UPC), and any other device identification(s) and control number(s) used; (3) The date of service; (4) The individual(s) servicing the device; (5) The service performed; and (6) The test and inspection data.

9 Control of Documents Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in A documented procedure shall define the controls needed to: a) review and approve documents for adequacy prior to issue; b) review, update as necessary and re-approve documents; c) ensure that the current revision status of and changes to documents are identified; d) ensure that relevant versions of applicable documents are available at points of use; e) ensure that documents remain legible and readily identifiable; f) ensure that documents of external origin, determined by the organization to be necessary for the planning and operation of the quality management system, are identified and their distribution controlled; g) prevent deterioration or loss of documents; Subpart D--Document Controls Sec Document Controls. Each manufacturer shall establish and maintain procedures to control all documents that are required by this part. The procedures shall provide for the following: (a) Document Approval and Distribution. Each manufacturer shall designate an individual(s) to review for adequacy and approve prior to issuance all documents established to meet the requirements of this part. The approval, including the date and signature of the individual(s) approving the document, shall be documented. Documents established to meet the requirements of this part shall be available at all locations for which they are designated, used, or otherwise necessary, and all obsolete documents shall be promptly removed from all points of use or otherwise prevented from unintended use. (b) Document Changes. Changes to documents shall be reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval, unless specifically designated otherwise. Approved changes shall be communicated to the appropriate personnel in a timely manner. Each manufacturer shall maintain records of changes to documents. Change records shall include a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective. h) prevent the unintended use of obsolete documents and apply suitable identification to them. The organization shall ensure that changes to documents are reviewed and approved either by the original approving function, or another designated function that has access to pertinent background information upon which to base its decisions. The organization shall define the period for which at least one copy of obsolete documents shall be retained. This period shall ensure that documents to which medical devices have been manufactured and tested are available for at least the lifetime of the medical device as defined by the organization, but not less than the retention period of any resulting record (see 4.2.5), or as specified by applicable regulatory requirements.

10 Control of Records Records shall be maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. The organization shall document procedures to define the controls needed for the identification, storage, security and integrity, retrieval, retention time and disposition of records. The organization shall define and implement methods for protecting confidential health information contained in records in accordance with the applicable regulatory requirements. Records shall remain legible, readily identifiable and retrievable. Changes to a record shall remain identifiable. The organization shall retain the records for at least the lifetime of the medical device as defined by the organization, or as specified by applicable regulatory requirements, but not less than two years from the medical device release by the organization. Subpart M--Records Sec General Requirements. All records required by this part shall be maintained at the manufacturing establishment or other location that is reasonably accessible to responsible officials of the manufacturer and to employees of FDA designated to perform inspections. Such records, including those not stored at the inspected establishment, shall be made readily available for review and copying by FDA employee(s). Such records shall be legible and shall be stored to minimize deterioration and to prevent loss. Those records stored in automated data processing systems shall be backed up. (a) Confidentiality. Records deemed confidential by the manufacturer may be marked to aid FDA in determining whether information may be disclosed under the public information regulation in part 20 of this chapter. (b) Record Retention Period. All records required by this part shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution by the manufacturer. (c) Exceptions. This section does not apply to the reports required by (c) Management review, Quality audits, and supplier audit reports used to meet the requirements of (a) Evaluation of suppliers, contractors, and consultants, but does apply to procedures established under these provisions. Upon request of a designated employee of FDA, an employee in management with executive responsibility shall certify in writing that the management reviews and quality audits required under this part, and supplier audits where applicable, have been performed and documented, the dates on which they were performed, and that any required corrective action has been undertaken. Subpart M--Records Sec Device Master Record. Each manufacturer shall maintain device master records (DMR's). Each manufacturer shall ensure that each DMR is prepared and approved in accordance with The DMR for each type of device shall include, or refer to the location of, the following information: (a) Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications; (b) Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications;

11 11 (c) Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used; (d) Packaging and labeling specifications, including methods and processes used; and (e) Installation, maintenance, and servicing procedures and methods. Subpart M--Records Sec Device History Record. Each manufacturer shall maintain device history records (DHR's). Each manufacturer shall establish and maintain procedures to ensure that DHR's for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part. The DHR shall include, or refer to the location of, the following information: (a) The dates of manufacture; (b) The quantity manufactured; (c) The quantity released for distribution; (d) The acceptance records which demonstrate the device is manufactured in accordance with the DMR; (e) The primary identification label and labeling used for each production unit; and (f) Any unique device identifier (UDI) or universal product code (UPC), and any other device identification(s) and control number(s) used. Subpart M--Records Sec Quality System Record. Each manufacturer shall maintain a quality system record (QSR). The QSR shall include, or refer to the location of, procedures and the documentation of activities required by this part that are not specific to a particular type of device(s), including, but not limited to, the records required by Each manufacturer shall ensure that the QSR is prepared and approved in accordance with

12 12 5 Management Responsibility 5.1 Management Commitment Top management shall provide evidence of its commitment to the development and implementation of the quality management system and maintenance of its effectiveness by: a) communicating to the organization the importance of meeting customer as well as applicable regulatory requirements; b) establishing the quality policy; c) ensuring that quality objectives are established; d) conducting management reviews; e) ensuring the availability of resources. Subpart B--Quality System Requirements Sec Management Responsibility (a) Quality Policy. Management with executive responsibility shall establish its policy and objectives for, and commitment to, quality. Management with executive responsibility shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization. (b) Organization. Each manufacturer shall establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the requirements of this part. (1) Responsibility and Authority. Each manufacturer shall establish the appropriate responsibility, authority, and interrelation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks. (2) Resources. Each manufacturer shall provide adequate resources, including the assignment of trained personnel, for management, performance of work, and assessment activities, including internal quality audits, to meet the requirements of this part. (3) Management Representative. Management with executive responsibility shall appoint, and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for: (i) Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and (ii) Reporting on the performance of the quality system to management with executive responsibility for review. (c) Management Review. Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer's established quality policy and objectives. The dates and results of quality system reviews shall be documented. (d) Quality Planning. Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured. The manufacturer shall establish how the requirements for quality will be met.

13 Customer Focus Top management shall ensure that customer requirements and applicable regulatory requirements are determined and met. 5.3 Quality Policy Top management shall ensure that the quality policy: a) is applicable to the purpose of the organization; b) includes a commitment to comply with requirements and to maintain the effectiveness of the quality management system; (e) Quality System Procedures. Each manufacturer shall establish quality system procedures and instructions. An outline of the structure of the documentation used in the quality system shall be established where appropriate. No specific equivalent in 21 CFR Part 820 related to Customer Focus. Subpart B--Quality System Requirements Sec Management Responsibility. (a) Quality Policy. Management with executive responsibility shall establish its policy and objectives for, and commitment to, quality. Management with executive responsibility shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization. c) provides a framework for establishing and reviewing quality objectives; d) is communicated and understood within the organization; e) is reviewed for continuing suitability. 5.4 Planning Quality Objectives Top management shall ensure that quality objectives, including those needed to meet applicable regulatory requirements and requirements for product, are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy Quality Management System Planning Top management shall ensure that: a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives; b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. Subpart B--Quality System Requirements Sec Management Responsibility. (a) Quality Policy. Management with executive responsibility shall establish its policy and objectives for, and commitment to, quality. Management with executive responsibility shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization. (d) Quality Planning. Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured. The manufacturer shall establish how the requirements for quality will be met. Subpart B--Quality System Requirements Sec Management Responsibility. (d) Quality Planning. Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured. The manufacturer shall establish how the requirements for quality will be met.

14 Responsibility, Authority, and Communication Responsibility and Authority Top management shall ensure that responsibilities and authorities are defined, documented, and communicated within the organization. Top management shall document the interrelation of all personnel who manage, perform, and verify work affecting quality, and shall ensure the independence and authority necessary to perform these tasks Management Representative Top management shall appoint a member of management who, irrespective of other responsibilities, has responsibility and authority that includes: a) ensuring that processes needed for the quality management system are documented; b) reporting to top management on the effectiveness of the quality management system and any need for improvement; c) ensuring the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization. Subpart B--Quality System Requirements Sec Management Responsibility. (b) Organization. Each manufacturer shall establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the requirements of this part. (1) Responsibility and Authority. Each manufacturer shall establish the appropriate responsibility, authority, and interrelation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks. Subpart B--Quality System Requirements Sec Management Responsibility. (b) Organization. Each manufacturer shall establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the requirements of this part. (3) Management Representative. Management with executive responsibility shall appoint, and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for: (i) Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and (ii) Reporting on the performance of the quality system to management with executive responsibility for review Internal Communication Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system. Subpart B--Quality System Requirements Sec Management Responsibility. (b) Organization. Each manufacturer shall establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the requirements of this part. (1) Responsibility and Authority. Each manufacturer shall establish the appropriate responsibility, authority, and interrelation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks.

15 Management Review General The organization shall document procedures for management review. Top management shall review the organization s quality management system at documented planned intervals to ensure its continuing suitability, adequacy and effectiveness. The review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. Subpart B--Quality System Requirements Sec Management Responsibility. (c) Management Review. Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer's established quality policy and objectives. The dates and results of quality system reviews shall be documented. Records from management reviews shall be maintained (see 4.2.5) Review Input The input to management review shall include, but is not limited to, information arising from: a) feedback; b) complaint handling; c) reporting to regulatory authorities; d) audits; Subpart B--Quality System Requirements Sec. Management Responsibility. (c) Management Review. Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer's established quality policy and objectives. The dates and results of quality system reviews shall be documented. e) monitoring and measurement of processes; f) monitoring and measurement of product; g) corrective action; h) preventive action; i) follow-up actions from previous management reviews; j) changes that could affect the quality management system; k) recommendations for improvement; l) applicable new or revised regulatory requirements Review Output The output from management review shall be recorded (see 4.2.5) and include the input reviewed and any decisions and actions related to: a) improvement needed to maintain the suitability, adequacy, and effectiveness of the quality management system and its processes; Subpart B--Quality System Requirements Sec Management Responsibility (c) Management Review. Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer's established quality policy and objectives.

16 16 b) improvement of product related to customer requirements; The dates and results of quality system reviews shall be documented. c) changes needed to respond to applicable new or revised regulatory requirements; d) resource needs. 6 Resource Management 6.1 Provision of Resources The organization shall determine and provide the resources needed to: a) implement the quality management system and to maintain its effectiveness; b) meet applicable regulatory and customer requirements. Subpart B--Quality System Requirements Sec Management Responsibility (b) Organization. Each manufacturer shall establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the requirements of this part. (1) Responsibility and Authority. Each manufacturer shall establish the appropriate responsibility, authority, and interrelation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks. (2) Resources. Each manufacturer shall provide adequate resources, including the assignment of trained personnel, for management, performance of work, and assessment activities, including internal quality audits, to meet the requirements of this part. Sec Personnel. (a) General. Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed. 6.2 Human Resources Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills, and experience. The organization shall document the process(es) for establishing competence, providing needed training, and ensuring awareness of personnel. The organization shall: a) determine the necessary competence for personnel performing work affecting product quality; b) provide training or take other actions to achieve or maintain the necessary competence; c) evaluate the effectiveness of the actions taken; Subpart B--Quality System Requirements Sec Personnel. (a) General. Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed. (b) Training. Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented. (1) As part of their training, personnel shall be made aware of device defects which may occur from the improper performance of their specific jobs.

17 17 d) ensure that its personnel are aware of the relevance and importance of their activities and how e) they contribute to the achievement of the quality objectives; f) maintain appropriate records of education, training, skills and experience (see 4.2.5). NOTE. The methodology used to check effectiveness is proportionate to the risk associated with the work for which the training or other action is being provided. (2) Personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions. Subpart G--Production and Process Controls Sec Production and Process Controls. (d) Personnel. Each manufacturer shall establish and maintain requirements for the health, cleanliness, personal practices, and clothing of personnel if contact between such personnel and product or environment could reasonably be expected to have an adverse effect on product quality. The manufacturer shall ensure that maintenance and other personnel who are required to work temporarily under special environmental conditions are appropriately trained or supervised by a trained individual. 6.3 Infrastructure The organization shall document the requirements for the infrastructure needed to achieve conformity to product requirements, prevent product mix-up and ensure orderly handling of product. Infrastructure includes, as appropriate: a) buildings, workspace and associated utilities; b) process equipment (both hardware and software); c) supporting services (such as transport, communication, or information systems). The organization shall document requirements for the maintenance activities, including the interval of performing the maintenance activities, when such maintenance activities, or lack thereof, can affect product quality. As appropriate, the requirements shall apply to equipment used in production, the control of the work environment and monitoring and measurement. Records of such maintenance shall be maintained (see 4.2.5). Subpart G--Production and Process Controls Sec Production and Process Controls (b) Production and Process Changes. Each manufacturer shall establish and maintain procedures for changes to a specification, method, process, or procedure. Such changes shall be verified or where appropriate validated according to , before implementation and these activities shall be documented. Changes shall be approved in accordance with (f) Buildings. Buildings shall be of suitable design and contain sufficient space to perform necessary operations, prevent mixups, and assure orderly handling. (g) Equipment. Each manufacturer shall ensure that all equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use. (1) Maintenance Schedule. Each manufacturer shall establish and maintain schedules for the adjustment, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met. Maintenance activities, including the date and individual(s) performing the maintenance activities, shall be documented. (2) Inspection. Each manufacturer shall conduct periodic inspections in accordance with established procedures to ensure adherence to applicable equipment maintenance schedules. The inspections, including the date and individual(s) conducting the inspections, shall be documented. (3) Adjustment. Each manufacturer shall ensure that any inherent limitations or allowable tolerances are visibly posted

18 18 on or near equipment requiring periodic adjustments or are readily available to personnel performing these adjustments. (h) Manufacturing Material. Where a manufacturing material could reasonably be expected to have an adverse effect on product quality, the manufacturer shall establish and maintain procedures for the use and removal of such manufacturing material to ensure that it is removed or limited to an amount that does not adversely affect the device's quality. The removal or reduction of such manufacturing material shall be documented. (i) Automated Processes. When computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol. All software changes shall be validated before approval and issuance. These validation activities and results shall be documented. 6.4 Work Environment and Contamination Control Work Environment The organization shall document the requirements for the work environment needed to achieve conformity to product requirements. If the conditions for the work environment can have an adverse effect on product quality, the organization shall document the requirements for the work environment and the procedures to monitor and control the work environment. The organization shall: a) document requirements for health, cleanliness and clothing of personnel if contact between such personnel and the product or work environment could affect medical device safety or performance; b) ensure that all personnel who are required to work temporarily under special environmental conditions within the work environment are competent or supervised by a competent person. NOTE. Further information can be found in ISO and ISO Contamination Control As appropriate, the organization shall plan and document arrangements for the control of contaminated or potentially contaminated product in order to prevent contamination of the work environment, personnel, or product. Subpart G--Production and Process Controls Sec Production and Process Controls. (b) Production and Process Changes. Each manufacturer shall establish and maintain procedures for changes to a specification, method, process, or procedure. Such changes shall be verified or where appropriate validated according to , before implementation and these activities shall be documented. Changes shall be approved in accordance with (c) Environmental Control. Where environmental conditions could reasonably be expected to have an adverse effect on product quality, the manufacturer shall establish and maintain procedures to adequately control these environmental conditions. Environmental control system(s) shall be periodically inspected to verify that the system, including necessary equipment, is adequate and functioning properly. These activities shall be documented and reviewed. (e) Contamination Control. Each manufacturer shall establish and maintain procedures to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality. (f) Buildings. Buildings shall be of suitable design and contain sufficient space to perform necessary operations, prevent mixups, and assure orderly handling. Subpart G--Production and Process Controls Sec Production and Process Controls. (e) Contamination Control. Each manufacturer shall establish and maintain procedures to prevent contamination of

19 19 For sterile medical devices, the organization shall document requirements for control of contamination with microorganisms or particulate matter and maintain the required cleanliness during assembly or packaging processes. 7 Product Realization 7.1 Planning of Product Realization The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system. The organization shall document one or more processes for risk management in product realization. Records of risk management activities shall be maintained (see 4.2.5). In planning product realization, the organization shall determine the following, as appropriate: a) quality objectives and requirements for the product; b) the need to establish processes and documents (see 4.2.4) and to provide resources specific to the product, including infrastructure and work environment; c) required verification, validation, monitoring, measurement, inspection and test, handling, storage, distribution and traceability activities specific to the product together with the criteria for product acceptance; d) records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.5). e) The output of this planning shall be documented in a form suitable for the organization s method of operations. NOTE. Further information can be found in ISO equipment or product by substances that could reasonably be expected to have an adverse effect on product quality. Subpart C Design Controls Sec Design Controls. (b) Design and Development Planning. Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process. The plans shall be reviewed, updated, and approved as design and development evolves. Subpart H--Acceptance Activities Sec Receiving, In-Process, and Finished Device Acceptance. (a) General. Each manufacturer shall establish and maintain procedures for acceptance activities. Acceptance activities include inspections, tests, or other verification activities. (c) In-Process Acceptance Activities. Each manufacturer shall establish and maintain acceptance procedures, where appropriate, to ensure that specified requirements for inprocess product are met. Such procedures shall ensure that inprocess product is controlled until the required inspection and tests or other verification activities have been completed, or necessary approvals are received, and are documented. (d) Final Acceptance Activities. Each manufacturer shall establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria. Finished devices shall be held in quarantine or otherwise adequately controlled until released. Finished devices shall not be released for distribution until: (1) The activities required in the DMR are completed; (2) the associated data and documentation is reviewed; (3) the release is authorized by the signature of a designated individual(s); and (4) the authorization is dated. (e) Acceptance Records. Each manufacturer shall document acceptance activities required by this part. These records shall include: (1) The acceptance activities performed;