Aspects to look out for in your ISO 13485 Quality Manual

Aspects to look out for in your ISO 13485 Quality Manual

Each and every organization that implements ISO 13485, an important ISO standard, has to have a Quality Manualin place. The ISO 13485 sets out requirements for a complete management system for organizations that are in the business of designing and manufacturing of medical devices.

Since ISO is essentially about documentation; a medical device company’s objectives must be clearly defined and documented in its Quality Manual. ISO 13485 states that a Quality Manual must be created and maintained. Three very critical aspects need to be documented:

  • procedural requirements
  • planning, operation and control of processes
  • records that are required to comply with the ISO 13485 Standard

Management Commitment and Responsibility

As part of ISO 13485, a medical device company’s management is responsible for implementing an effectiveQuality Management System (QMS). This, along with its commitment to enforce it, should be part of the Quality Manual. The Quality Manual should reflect commitments of the Quality Policy, which should be on these lines:

It should establish aQuality Policy. This policy should reflectthe purposes of the organization and should be aligned to it.

The Quality Policy must make sure that the organization’s quality objectives are established and adhered to.

The management should periodically conduct management reviews.

It should ensure that resources are made available for this work.

It should meet customer requirements.

Management should identify, document and communicate to the rest of the organization the responsibility and authority to define, implement and monitor processes.

Management has to appoint a representative whowill be assigned the oversight of creating awareness of customer requirements. This representative should also ensure that the processes needed to implement and maintain aQMS are put in place and maintained.

Management should take every step towards facilitating internal communication.

One of the most important tasks for the management is to review the QMS to ensure that it is suitable, adequate and effective. This review is based on a number of parameters, the most important of which are feedback, process performance and product conformity. It should also ensure CAPA.

 

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