6.4.2 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.

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.

7.5 Production and service provision

7.5.1 Control of production and service provision

Production and service provision shall be planned, carried out, monitored and controlled to ensure that

product conforms to specification. As appropriate, production controls shall include but are not limited to:

a) documentation of procedures and methods for the control of production (see 4.2.4);

b) qualification of infrastructure;

c) implementation of monitoring and measurement of process parameters and product characteristics;

d) availability and use of monitoring and measuring equipment;

e) implementation of defined operations for labelling and packaging;

f) implementation of product release, delivery and post-delivery activities.

The organization shall establish and maintain a record (see 4.2.5) for each medical device or batch of

medical devices that provides traceability to the extent specified in 7.5.9 and identifies the amount

manufactured and amount approved for distribution. The record shall be verified and approved.

7.5.2 Cleanliness of product

The organization shall document requirements for cleanliness of product or contamination control of

product if:

a) product is cleaned by the organization prior to sterilization or its use;

b) product is supplied non-sterile and is to be subjected to a cleaning process prior to sterilization or

its use;

c) product cannot be cleaned prior to sterilization or its use, and its cleanliness is of significance in use;

d) product is supplied to be used non-sterile, and its cleanliness is of significance in use;

e) process agents are to be removed from product during manufacture.

If product is cleaned in accordance with a) or b) above, the requirements contained in 6.4.1 do not apply

7.5.3 Installation activities (NOT APPLICABLE)

7.5.4 Servicing activities (NOT APPLICABLE)

7.5.5 Particular requirements for sterile medical devices (NOT APPLICABLE)

7.5.6 Validation of processes for production and service provision

The organization shall validate any processes for production and service provision where the resulting

output cannot be or is not verified by subsequent monitoring or measurement and, as a consequence,

deficiencies become apparent only after the product is in use or the service has been delivered.

Validation shall demonstrate the ability of these processes to achieve planned results consistently.

The organization shall document procedures for validation of processes, including:

a) defined criteria for review and approval of the processes;

b) equipment qualification and qualification of personnel;

c) use of specific methods, procedures and acceptance criteria;

d) as appropriate, statistical techniques with rationale for sample sizes;

e) requirements for records (see 4.2.5);

f) revalidation, including criteria for revalidation;

g) approval of changes to the processes.

The organization shall document procedures for the validation of the application of computer software

used in production and service provision. 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, including the effect on the ability of the product to conform to

specifications.

Records of the results and conclusion of validation and necessary actions from the validation shall be

maintained (see 4.2.4 and 4.2.5).

7.5.7 Particular requirements for validation of processes for sterilization and sterile

barrier systems (NOT APPLICABLE)

7.5.8 Identification

The organization shall document procedures for product identification and identify product by suitable

means throughout product realization.

The organization shall identify product status with respect to monitoring and measurement

requirements throughout product realization. Identification of product status shall be maintained

throughout production, storage, installation and servicing of product to ensure that only product that

has passed the required inspections and tests or released under an authorized concession is dispatched,

used or installed.

If required by applicable regulatory requirements, the organization shall document a system to assign

unique device identification to the medical device.

The organization shall document procedures to ensure that medical devices returned to the

organization are identified and distinguished from conforming product.

7.5.9 Traceability

7.5.9.1 General

The organization shall document procedures for traceability. These procedures shall define the extent

of traceability in accordance with applicable regulatory requirements and the records to be maintained

(see 4.2.5).

7.5.9.2 Particular requirements for implantable medical devices (NOT APPLICABLE)

7.5.10 Customer property

The organization shall identify, verify, protect, and safeguard customer property provided for use

or incorporation into the product while it is under the organization’s control or being used by the

organization. If any customer property is lost, damaged or otherwise found to be unsuitable for use, the

organization shall report this to the customer and maintain records (see 4.2.5).

7.5.11 Preservation of product

The organization shall document procedures for preserving the conformity of product to requirements

during processing, storage, handling, and distribution. Preservation shall apply to the constituent parts

of a medical device.



The organization shall protect product from alteration, contamination or damage when exposed to

expected conditions and hazards during processing, storage, handling, and distribution by:

a) designing and constructing suitable packaging and shipping containers;

b) documenting requirements for special conditions needed if packaging alone cannot provide

preservation.

If special conditions are required, they shall be controlled and recorded (see 4.2.5).