4.            Equipment/Software

1.             No additional equipment or software required.

5.            Instructions

1.             Product realization processes are controlled and managed to achieve product conformance and continual improvement.

2.             Production and service provision is carried out under controlled conditions including:

1.            Availability of information that describes the characteristics of the product,

2.            Availability of documented procedures, documented requirements, work instructions and reference materials

3.            Use of suitable equipment

3.             Criteria for workmanship, expressed as product specifications or characteristics are documented in the quality plan or specification sheet for the product.

4.             Quality control measures that specify appropriate monitoring and control guidelines and inspection and test requirements are documented in procedures or work instructions.

1.            The Measuring and Monitoring procedure identifies process inspection and test points, process monitoring requirements, tests performed, responsible person, and action criteria.

5.             Management approves all processes and equipment by approving all process and equipment quality plans, procedures, or work instructions.

6.             The written work instructions are presented in a clear and practical manner.

1.            Illustrations, flowcharts, tables or other presentation tools are used, as appropriate, to provide clear instructions.

7.             The need for validation is identified during the Planning of Product Realization Processes. If the planning identifies the need for validation, responsibility is assigned to a qualified employee, and performed according to the Process Validation work instruction.

8.            Product release criteria and product release authority are documented on the Measuring and Monitoring Table.

9.            Trained delivery personnel, following written work instructions and documented customer delivery requirements, provide all delivery services provided by Your Company.

10.    Post delivery activities include installation, activities relating to service contracts, and warranty repairs. Post delivery activities are performed following documented work instruction, prints or contracts.

11.      A record if maintained for each batch of medical devices to provide traceability and identifies the amount manufactured and amount approved for distribution. The batch record is verified and approved by Quality Control.

12.    Cleanliness

1.            Requirements for cleanliness are documented in Procedures and Work instructions where:

a.            Product is cleaned prior to sterilization or use

b.            Product is supplied non-sterile and is cleaned before sterilization or use

13.      Servicing

1.            Servicing activities and verification are done according to documented procedures and work instructions. Records are marinated for all service activities. Reference these records in servicing procedures or work instructions.

14.      Sterile Devices

1.            Records of process parameters for sterilization used for each batch are maintained and traceable to each production batch.

1.            Forms and Records

1.             Batch Records

2.             Installation and Verification Records

3.             Sterilization Process Records

1.            Attachments

1.             None

1.            Related Documents

1.            Product Realization Procedures and Work Instructions

2.             AP-622 Competence, Awareness and Training Procedure

3.            Process Validation Work Instruction

4.             MP-824 Monitoring, Measuring and Analysis of Product and Realization Processes

2.            References

1.             None