The CODE

Codemurray implements excellent communication, organization, documentation, and education to ensure high quality, full compliance, and successful project completion.

Communication

Professional communication using both modern technology and personal interaction between Codemurray, top management, and the subject matter experts builds the knowledge database.

Organization

The knowledge database is analyzed, reviewed, filtered, categorized, and synchronized to match the organizational structure of the customer.

Results
  • Obsolete information removed
  • Missing data identified
  • Task list clarified
  • Knowledge database is current and validated

Documentation

Codemurray is a documentation specialist and helps you create a system based on customer-specific requirements for:

  • Business process documentation and training guidelines
  • Knowledge database structure
  • Compliance with applicable regulations
  • Supporting the corporate identity
Results

Clarification of:

  • Business process overview
  • Roles and responsibilities
  • Organizational structure
  • Version control and tracking system
  • Training needs

This will simplify translations, eliminate misunderstandings, and improve audit results.

Documentation Management

Regardless of their size and type, an organization needs quality systems that demonstrate the ability to provide devices and related services that consistently meet customer and regulatory requirements. A clearly defined documentation management system is a key quality component.

Codemurray implements documentation management systems which include:

  • Format
  • Terminology
  • Preparation
  • Review
  • Approval
  • Issuance
  • Implementation
  • Distribution
  • Revision
  • Archiving
  • Security
Categories

Codemurray will help your company define the document categories that are right for your specific business processes. The following categories establish the foundation of a good documentation system:

  • Standard Operating Procedures
  • Work Instructions
  • Forms
  • Templates
  • Agreements

Education

We will analyze your training needs and create a customized training concept which maximizes efficiency, enhances operational performance, and satisfies regulatory requirements.

What does ISO 13485 say about training?

Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills, and experience. The organization shall document the processes for establishing competence, providing needed training, and ensuring awareness of personnel.

The organization shall:

  • determine the necessary competence for personnel performing work affecting product quality;
  • provide training or take other actions to achieve or maintain the necessary competence;
  • evaluate the effectiveness of the actions taken;
  • ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives;
  • maintain appropriate records of education, training, skills, and experience.