Regulatory Compliance Documentation
Even though all industries share commonalities with regards to this subject, Regulatory Compliance means different things to different industries. For any individual business, Regulatory Compliance equates to an amalgamation of requirements for its product or service type, geographic location, industry and customer specific requirements.
With each of these categories comes a plethora of regulations, codes, standards and/or specifications which serve local, country and/or international governmental requirements as well as industry and/or customer specific requirements. Although, there is no single source of requirements, each individual requirement or group of requirements may have a single or multiple external drivers. Therefore, the comprehensive requirements do not singularly apply to a product, a process or a business entity; they apply to the combination of the product, process and business.
Depending upon the breadth of a company's product or offering, including their geographical presence, the regulatory requirements can quickly seem unmanageable.
QSI has deployed methodologies which allow Regulatory Requirements to be documented and integrated in the Management System and integrated with specific Technical Applications within a single management system. Our approach focuses on integration and not fragmentation of requirements whether it be management system requirements, technical requirements or regulatory compliance requirements.
This means that the management system will address Regulatory Compliance issues at the highest levels throughout the system and across the organization including the levels where the work is being performed to ensure that compliance is addressed at all facets within a company.
QSI's methodology allows a company to flow down the requirements from the top tier of the management system to the working levels of the system, allowing for successful system implementation, monitoring, reporting and management feedback. This allows a company to:
- Understand the requirements
- Minimize noncompliance
- Detect and correct noncompliance if it occurs
- Effect corrective and preventive actions
- Maintain documentation to demonstrate compliance to requirements
