Tag: medical device industry

The Device History Record (DHR)

The Device History Record (DHR)

The US FDA states the following:

Each manufacturer should maintain DHR’s. For what steps in the manufacturing process are these records to be maintained? It is for establishing and maintaining procedures to ensure that DHR’s for each batch, lot, or unit. The purpose of this requirement is to show that the medical device is manufactured exactly as mentioned in the DMR and that the requirements are met. The FDA states that the DHR shall have in it, or will refer to where it locates these bits of information:

  • the manufacturedates
  • the manufacturedquantity
  • how much quantity was released for distribution
  • records showing acceptance that the device is manufactured in accordance with the DMR
  • the product’s primary identification label and labeling that went into each production unit; and
  • detail of all and any device identification(s) and control number(s) used in the manufacture of the device.

Important facts to remember about the DHR

It is not mandatory to keep the original DHR with the device. It is possible that due to frequent testing and other tasks carried out; the DHR can get tampered. However, before any DHR is removed, there should be a sound set of controls to retain or retrieve data. It should be kept intact, so that there is no loss of record. An authentic way of ensuring this is by having a person in the organization in charge of this aspect. That person can scan the DHR and store it into a repository.

A device that goes into distribution with a DHR is as considered a spurious one. Anyone responsible for doing this is liable for a year’s imprisonment or a penalty of up to $1000.

The manufacturer should ensure clarity on whether the product has an original DHR or the record of a rework. Rework in this case refers to the changes done on a nonconforming product to meet regulatory requirements.

On the other hand, alteration is the repair or servicing carried out on a product that has already entered distribution.

Finally, remanufacturing is the process carried out on a conforming product to make it nonconforming. Also included under this is anything that is done to the device to alter its characteristics. All these three types of work on the device should be recorded in the DHR and maintained.

References:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.184

http://www.mddionline.com/article/clarifying-device-history-record-issues

 

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ISO 13485 vs. ISO 9001

ISO 13485 vs. ISO 9001

One of the most commonly countered questions in the medical device industry is: ISO 13485 vs. ISO 9001. They are often confused for each other. But they are never the same, although they have many common requirements.

ISO 13485 is part of ISO 9001 family of regulations

When understanding ISO 13485 vs. ISO 9001, we have to understand that both standards are part of the ISO QMS, and must meet general requirements. These general requirements merely state that “the organization shall establish, document, implement and maintain a quality management system and maintain its effectiveness in accordance with the requirements of this International Standard”.

ISO 13485 flows from ISO 9001. While ISO 9001 is a general standard for third party assessment, ISO 13485 is that part of this standard that is specific to the medical devices industry.

Critical differences

The crux of ISO 13485 vs. ISO 9001 lies in the application. ISO 13485 includes some specific requirements for medical devices and excludes those requirements of ISO 9001 that are not appropriate for regulatory requirements. So, although similar on the surface, these two standards work in tandem, but are yet exclusive to each other in many respects.  Organizations which claim that their medical devices meet ISO 13485 requirements cannot claim that their organization automatically meet ISO 9001 as well.

The ISO wanted to make the 13485 specific to the medical devices industry. It wanted to remove the complexity associated with the 9001 and make a standard that was usable by organizations of varying sizes, was easily comprehended, was compatible with management systems such as ISO 14001, and had a direct relationship with the activities that went into running a business. The ISO 13485 standard has achieved all this, and thus is a continuum of the ISO 9001 standard with the necessary refinements.

Difference in terms of operation

ISO 13485 must define document retention times based on organizational and regulatory requirements, while 9001 must record retention times based on organizational and regulatory requirements.

Reference:

http://www.slideshare.net/riteshreddych/differences-between-iso-13485-and-iso-9001

 

Contact Detail

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801