Communication
Organization
Documentation
Education
Install the right CODE for 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
We specialize in documentation tasks and will help 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 curriculum
This will simplify translations, eliminate misunderstandings, and improve audit results.
Documentation Management
Regardless of their size or type, every organization needs quality systems that ensure compliance with customer and regulatory requirements. A clearly defined documentation management system is a key component.
Our documentation management systems include:
- Format
- Terminology
- Preparation
- Review
- Approval
- Issuance
- Implementation
- Distribution
- Revision
- Archiving
- Security
Categories
We 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:
- Corporate Policies
- Operational Procedures
- Work Instructions
- Forms
- Templates
- Agreements
Education
We will create a consistent 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.