In the case of contact between personnel or work environment and the product. sub-clause 7.5.1ĭocument requirements for health, cleanliness and clothing of personnelĬf. sub-clause 4.2.4. Especially if the work environment can negatively affect the quality of the product. sub-clause 4.2.4. Anything that can have an impact on product conformity (motivation, work organization, workplace ergonomics, lighting, hygiene, temperature, safety)ĭocument the requirements for the work environment and the procedures to monitor and control itĬf.
Design and development files (sub-clause 7.3.10).Design and development changes (sub-clause 7.3.9).Design and development validation (sub-clause 7.3.7).Design and development verification (sub-clause 7.3.6).Design and development review (sub-clause 7.3.5).Design and development outputs (sub-clause 7.3.4).Design and development inputs (sub-clause 7.3.3).Communication with the customer (sub-clause 7.2.3).Review of product requirements (sub-clause 7.2.2).Compliance of processes and product (sub-clause 7.1 d).Control of contamination (sub-clause 6.4.2).Maintenance of infrastructure (sub-clause 6.3).Management review (sub-clauses 5.6.1 and 5.6.3).Responsibilities, authorities and independence (5.5.1).Regulatory requirements (sub-clause 4.2.1 e).General QMS documentation (sub-clause 4.2.1).Validation of software applications (sub-clause 4.1.6).Process control (subclauses 4.1.3 e and 4.2.1 d).Role of the organization (sub-clause 4.1.1).In accordance with the requirements of the company or applicable regulatory requirements but more than 2 years after the distribution of the medical device. Retain records at least at least equal to the lifetime of the medical device Keep records legible, readily identifiable and retrievableĮach record is clear, easy to understand, easy to categorize including electronic files In accordance with the applicable regulatory requirements The procedure for records answers questions who, when, how, under what conditions identify, store, implement measures for security and integrity, retrieve, retain and delete recordsĭefine and apply methods for protecting confidential health information Control of nonconforming product (sub-clause 8.3.1)ĭocument the procedure for control of recordsĬf.Reporting to regulatory authorities (sub-clause 8.2.3).Control of monitoring and measuring equipment (sub-clause 7.6).Product preservation (sub-clause 7.5.11).Identification and traceability (subclauses 7.5.8 and 7.5.9).Process validation (sub-clauses 7.5.6 and 7.5.7).Control of design and development changes (Sub-Clause 7.3.9).Design and development transfer (sub-clause 7.3.8).Design and development (sub-clause 7.3).Control of the working environment (sub-clause 6.4.1).Control of documents (sub-clause 4.2.4).Validation of software applications (sub-clauses 4.1.6, 7.5.6 and 7.6).Outdated (obsolete) documents are identified, stored, archived, locked or destroyed so that they cannot be used normallyĮnsure that changes to documents are reviewed and approved by authorised personsĮither by the original approving function or by a person with pertinent informationĭefine the period for which obsolete documents will be retainedĮnsure a period for which documents will be retained at least equal to the lifetime of the medical device, but no less than the retention period as specified by applicable regulatory requirements Prevent the unintended use of obsolete documents