Compliance and Quality Management
Regulations and Requirements during the entire product life cycle
Dealing efficiently with worldwide compliance requirements is a crucial part of the strategy to access a global market with safe products and to protect brand, revenue and market share.
Our tried and tested methods for complying with requirements at both national and international level will help your company to form a customized strategy including goals and efficient strategies.
We are specialized in managing compliance, regulations and quality scope of development and manufacturing in all industries and provide a full range of expertise within:
- Environmental Legislation
- Product Safety & Compliance
- Regulatory Outlook
Environmental Legislation & Chemical Compliance
Providing Project Managers, Subject Matter experts and recourses for areas such as:
- ISO 14001
- UK REACH
- China RoHS
- Conflict Minerals
Product Safety & Compliance
Providing Project Managers, Subject Matter experts and resources for areas such as:
- Machinery Directive, MD
- General Product Safety Directive, GPSD
- Low Voltage Directive, LVD
- Electromagnetic Compatibility Directive, EMC
- In Vitro Diagnostic Regulation, IVDR
- In Vitro Diagnostic, IVD
- Battery Directive
- Trade Compliance
With the Regulatory Outlook Service AFRY ensures that our clients’s business and products stays compliant.
- Mapping: We map regulations, standards and directives that is appropriate for your business.
- Reviewing & Planning: Business and products are reviewed to identify applicable parts of the requirements. Based on the review we suggest a brief action plan to comply with the requirements.
- Advisory & Training: Regulatory Advisory including annually information on updates and news in regulations and directives. Customized Training adapted for your business.
When the Quality Management System is at it’s best you forget that it’s there
In all aspects of an organization, regardless of product or service produced, well established Management systems ensures Business Excellence.
AFRY specialize in Managing regulations and quality expectations throughout product life cycle in all industries and provides a full range of expertise to form a Sustainable customized Compliance strategy.
Regardless of what type of products you develop or which market you place them on, your company must comply with an ever-increasing number of regulations and quality requirements related to product safety as well as environmental safety.
We advise and support your company with: Management systems, Supplier Quality Assurance, Quality Engineering, Audit
Regardless of product produced or service provided, ensuring Operational excellence throughout the organization by Management Systems ensures safe environment for workers, habitants or Globally.
A well established Management System is not a document system, it's the culture of your company. How to do business, smarter, more efficient and sustainable. We can support your organization to improve and establish a new culture according to:
- ISO 9001
- ISO 45001
- ISO 13485
- ISO 27001
- ISO 14001
Audits are an efficient way to evaluate a business, a project or supplier. Our aditors perform audits towards all common standards, legislations or other requirements such as Code of Conduct.
Our M3 Model, based on ISO 19600 & ISO 37301, is a systematical method to evaluate your organization's level of compliance to appropriate standards, legislations or processes.
Supplier Quality Assurance
To ensure you have a sustainable business we suggest establishing a Supplier Management Program. Code of Conduct, Supplier Evaluation and Audits are some of the tools we use to evaluate supplier performance. Sustainable Supplier Audits will focus on traditional aspects of technical ability and quality control, as well as aspects of environment, labor laws, work ethics and raw material origin.
To monitor and analyse Quality Performance we use tools and methods suitable for your organization and we are familiar with all common methods such as:
- Six Sigma
- Quality Control
- Root Cause Analysis
- Risk Assessment
- EN ISO12100