We can assist you in a wide range of activities: from Quality Manual generation through implementation of the quality documents.

We plan with your Quality Manager, if present, and/or other members of the Management Team the necessary documentation, which must be generated to become certified according to ISO 9001:2008 and ISO 13485:2003. Responsibilities for writing the necessary documents are attributed. BioTop Medical will write some of the documents if requested. This decision will be taken in discussion with the company Quality Manager or Management Team member. We manage the project until certification.

Quality Manual Development

Generation of a compliant quality manual to satisfy the requirements of the standards and reflecting the processes and the policy of the company:

• All of the 8 clauses of the standard must be addressed.
• The exceptions in clause 7 must be defined based on the company operation.
• Reference or inclusion of the relevant procedures and work instructions must be part of the manual.
• The critical and normal processes within the company must be identified and referenced.
• The control and maintenance of the quality manual must be defined within the document control process.

Procedure Generation

Development of the value-added quality documentation required to support your Quality Management System. No over-documentation, only what is needed to satisfy the standard requirements.

• Defining the activities and tasks to be performed within each process of the Quality System.
• Documenting these activities and tasks in a controlled procedure or work instruction together with the employees performing the tasks.
• Ensuring that each process contains or references the required procedures and relevant work instructions.