Determine, define and maintain general requirements for the QMS
Establish the QMS scope
Define and control documentation requirements all aspects of the QMS
QUALITY MANUAL - embedded within master QMS for all registrations
REQUIRED PROCEDURES - required procedures will be referenced per reference or clause
REQUIRED FORMS & RECORDS - shall be identified per reference or clause
LINKED PROCEDURE 4.1.6 SOFTWARE VALIDATION
LINKED PROCEDURE 4.2.4 CONTROL OF DOCUMENTS
LINKED PROCEDURE 4.2.5 CONTROL OF RECORDS
Triad has authored a quality management system and will maintain its effectiveness in accordance with the requirements of the ISO 13485 standard and applicable regulatory requirements.
4.1.1 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 and requirements, 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; may include manufacturer, authorized representative, importer or distributor.
4.1.2 The organization shall:
4.1.2a 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;
4.1.2b apply a risk based approach to the control of the appropriate processes needed for the quality management system;
4.1.2c determine the sequence and interaction of these processes.
4.1.3 For each quality management system process, the organization shall:
4.1.3a determine criteria and methods needed to ensure that both the operation and control of these processes are effective;
4.1.3b ensure the availability of resources and information necessary to support the operation and monitoring of these processes;
4.1.3c implement actions necessary to achieve planned results and maintain the effectiveness of these processes;
4.1.3d monitor, measure as appropriate, and analyze these processes;
4.1.3e establish and maintain records needed to demonstrate conformance to this International Standard and compliance with applicable regulatory requirements.
4.1.4 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:
4.1.4a evaluated for their impact on the quality management system;
4.1.4b evaluated for their impact on the medical devices produced under this quality management system;
4.1.4c controlled in accordance with the requirements of this International Standard and applicable regulatory requirements.
4.1.5 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.
4.1.6 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 shall be maintained.
Triad has documented all statements regarding the QMS including: policy and objectives, a quality manual, procedures and records, and any documents that are deemed necessary for planning, operation and control of the organization's process.
4.2.1 General: The quality management system documentation shall include:
4.2.1a documented statements of a quality policy and quality objectives;
4.2.1b a quality manual;
4.2.1c documented procedures and records required by this International Standard
4.2.1d documents, including records, determined by the organization to be necessary to ensure the effective planning, operation, and control of its processes;
4.2.1e other documentation specified by applicable regulatory requirements.
4.2.2 Quality Manual: The organization shall document a quality manual that includes:
4.2.2a the scope of the quality management system, including details of and justification of any exclusion or non-application;
4.2.2b the documented procedures for the quality management system, or reference to them;
4.2.2c a description of the interaction between the processes of the quality management system. The quality manual shall outline the structure of the documentation used in the quality management system.
4.2.3 Medical Device File:
EXCLUDED from requirements; Triad is not the manufacturer of record therefore the QMS is justified to exclude this application of the standard and all sub-clause of 4.2.3 therein.
4.2.4 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 4.2.5
A document procedure shall define the controls needed to:
4.2.4a review and approve documents for adequacy prior to issue;
4.2.4b review, update as necessary and re-approve documents;
4.2.4c ensure that the current revision status of and changes to documents are identified;
4.2.4d ensure that relevant versions of applicable documents are available at points of use;
4.2.4e ensure that documents remain legible and readily identifiable;
4.2.4f 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;
4.2.4g prevent deterioration or loss of documents;
4.2.4h 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 or as specified by applicable regulatory requirements.
4.2.5 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 (does not apply).
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.