Control of production and service provision of ISO 13485
Control of production and service provision of ISO 13485
Clause 7.5.1
7.5.1.1 General requirements
The organization shall plan and carry out production and service provision under controlled conditions.
Controlled conditions shall include, as applicable
a) the availability of information that describes the characteristics of the product,
b) the availability of documented procedures, documented requirements, work instructions, and reference materials and reference measurement procedures as necessary,
c) the use of suitable equipment,
d) the availability and use of monitoring and measuring devices,
e) the implementation of monitoring and measurement,
f) the implementation of release, delivery and post-delivery activities, and
g) the implementation of defined operations for labeling and packaging.
The organization shall establish and maintain a record (see 4.2.4) for each batch of medical devices that provides traceability to the extent specified in 7.5.3 and identifies the amount manufactured and amount approved for distribution. The batch record shall be verified and approved.
NOTE A batch can be a single medical device.
7.5.1.2 Control of production and service provision — Specific requirements
7.5.1.2.1 Cleanliness of product and contamination control
The organization shall establish documented requirements for cleanliness of product if
a) product is cleaned by the organization prior to sterilization and/or its use, or
b) product is supplied non-sterile to be subjected to a cleaning process prior to sterilization and/or its use, or
c) product is supplied to be used non-sterile and its cleanliness is of significance in use, or
d) 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 a) and 6.4 b) do not apply prior to the cleaning process.
7.5.1.2.2 Installation activities
If appropriate, the organization shall establish documented requirements which contain acceptance criteria for installing and verifying the installation of the medical device.
If the agreed customer requirements allow installation to be performed other than by the organization or its authorized agent, the organization shall provide documented requirements for installation and verification.
Records of installation and verification performed by the organization or its authorized agent shall be maintained (see 4.2.4).
7.5.1.2.3 Servicing activities
If servicing is a specified requirement, the organization shall establish documented procedures, work instructions and reference materials and reference measurement procedures, as necessary, for performing servicing activities and verifying that they meet the specified requirements.
Records of servicing activities carried out by the organization shall be maintained (see 4.2.4).
NOTE Servicing can include, for example, repair and maintenance.
7.5.1.3 Particular requirements for sterile medical devices
The organization shall maintain records of the process parameters for the sterilization process which was used for each sterilization batch (see 4.2.4). Sterilization records shall be traceable to each production batch of medical devices (see 7.5.1.1).
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