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ISO 13485 vs. ISO 9001 - CAPA requirements |
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What a standard The ISO 13485. It's almost fascinating. We can assure you one thing: it requires a lot of work to get the certification even if you are already certified for the ISO 9001 Standard. The ISO 13485 documents control requirements are tougher, traceability is much more complex and not to mention the training requirements.
ISO 13485 INTRODUCTION
ISO 13485 is a special standard for manufacturers for medical devices (and services). The global village is becoming closer day by day; markets are exchanging goods and knowledge more often. It is true for medical devices and services as well. All around the world companies are exporting medical devices. The ISO 13485 Standard is here to verify that the manufacture and service supply is under supervised criteria. In order to maintain constant requirements the ISO organization developed this standard. The purpose of this standard is to establish a quality management system that is oriented towards the design, development, production, and installation of medical devices and related services. The ISO 13485 is not a product standard. It's process oriented. In addition, it's not enough to establish a quality management system that complies with the ISO 13485 standard; you also need to comply with all relevant products and service technical standards and regulations from the regional place of manufacturing or installing. That means that the organization is examined not only for the ISO 13485 Standard requirements but also for any regulations or legal requirements concerning the medical devices. ISO 13485 CORRECTIVE ACTION REQUIREMENTS In this article we will review the additional requirements for corrective actions (chapter 8.5.2 - corrective action) as specified by the ISO 13485 Standard with reference to the ISO 9001 Standard. The corrective action requirements within the ISO 13485 Standard are not so complex. The main differences are within the documentation requirements. We would have a nice table presenting the ISO 13485 documents control requirements vs. the ISO 9001 requirement for documents control. By the way, if you are really interested in the ISO 13485 Standard, check the next web site - www.13485quality.com. So let's start...
| ISO 9001 | ISO 13485
| Comment | | 8.5.2 - Corrective action | | | General - The organization must take actions to eliminate any cause for nonconformities in order to prevent them from happening again. The corrective actions would be appropriate to the nonconformity. Here are the specifications of the requirements:
| Same same. Until now, no changes.
| | a) The organization must review the nonconformities - including customer's complaints. | | | b) The organization should determine what the cause for the nonconformity is. | | | c) For any cause that was detected the organization must evaluate if a corrective action is required. The evaluation is required to ensure that the nonconformity would not occur again. | | | d) After determining that a corrective action is needed, you must determine what would be the corrective action and to implement it. | d) After determining that a corrective action is needed, you must determine what would be the corrective action and to implement it. You must also update records where it is appropriate. | Aha! First requirement. This requirements is to make sure that the corrective action taken would not only be implemented and documented, but also any documentation that is related to the nonconformity is changed. | e) The corrective action must be documented and the records should be covered by the records control procedure. | e) The investigation prior to the corrective action and the corrective action itself must be documented and their records should be covered by the records control procedure. | Don't get panic! The ISO 9001 Standard requires documenting the corrective action itself but not the investigation. The ISO 13485 Standard requires you to document the investigation as well. Any way you conduct it. Otherwise you won't find out what is the cause. So, document it as well. Don't forget to update the Corrective action procedure about documenting the investigation. | f) The corrective action must be reviewed periodically. | f) The corrective action and its effectiveness must be reviewed periodically. | It's not enough to document it as a success- you must prove it. How? By presenting data prior to the corrective action and after the corrective action. |
SUMMERY - The first three requirements of the corrective action a remained the same.
- The ISO 13485 requires performing changes in any documentation related to the nonconformity detected.
- As well as documenting the corrective action itself, you must document the investigation taken prior that led to this corrective action.
- Any corrective action must be closed with proof about its effectiveness.
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