Kvalitetsmanual (bare på engelsk)
The Quality Manual demonstrates and documents BioAcive Foods AS’ commitment to maintaining a high-level of quality and strong customer service within an environment that has product quality and product safety as a first priority.
The manual is divided into sections, and correlates to the Quality Management System sections of ISO 9001:2008. It provides an overview of the quality policies and key requirements for BioActive Foods AS. It is the source of reference for all matters dealing with quality.
This manual is used internally to guide the company’s employees through the various requirements that must be met and maintained in order to ensure customer satisfaction, product quality and continuous improvement.
The manual is used externally to introduce the Quality Management System to customers, third party quality auditors, authorities and other external organizations.
Statutory requirements and regulations
The quality system described in this Quality Manual shall ensure that BioActive Foods AS complies with the following laws, regulations and guidelines:
- 21 CFR Part111
BioActive Foods AS was established in 2010. The Company business activities are based on The Omega Balance Health Concept that restore normal balance between the essential fatty acids Omega-6 and Omega-3 in whole blood within 120 days, as recommended by Nordic Council of Ministers (Nordic Nutritional Recommendations, 2005). All productions and storage are outsourced. Products are sold through distributors. Analytical quality control is conducted in cooperation with Vitas AS. Research, product development, quality assurance, economy control, invoicing and customer contact are conducted by internal resources.
The employees hold more than 50% of the shares in the company.
The purpose of this Quality Manual is to establish and state the general policies governing BioActive Foods AS’s Quality Management System. These policies define management’s intentional provision for managing the operations and activities in accordance with the current GMP-guidelines. These are the top-level polices representing the company’s plans or protocols for achieving quality products and customer satisfaction. All written procedures must conform and parallel these policies.
BioActive Foods AS is registered in Bærum, Norway (Company ID: 996 740 498).
Address: Hoslegata 3, 1356 Bekkestua, Norway.
In order for BioActive Foods AS to achieve a position in providing high quality products, BioActive Foods AS shall develop and implement a Quality Management System fully compliant with the requirements of current Good Manufacturing Practise (cGMP) for dietary supplements. This will result in the overall product improvement over time.
BioActive Foods AS shall be working for increased satisfaction of all interested parties, including customers, personnel, suppliers, authorities and owners, by establishing their needs and expectations and by acting in a balanced way for fulfilling them.
- Sub-contract the manufacturing only to companies with a well-established quality system.
- Only use high quality raw materials which are traceable to the original manufacturer.
- Develop good relations to suppliers ensuring that the services do not compromise BioActive Foods AS´ requirements and expectations.
- Ensure the protection of all customer's confidential information and proprietary rights.
- Avoid involvement in any activities that would diminish confidence in our competence, impartiality, judgment or operational integrity.
- Ensure that management and other personnel are free from any undue internal and external commercial, financial and other pressures that may adversely affect the quality of the work. This is achieved by sub-contracting the quality control to independent 3. parties.
- Have adequately educated and trained staffed.
- Ensure compliance with all statutory requirements and regulations applicable to BioActive Foods AS’ organization or the provided services.
Continually improve the effectiveness of the quality management system by periodical review.
To meet the objectives defined in the quality policy, BioActive Foods AS has implemented a Quality Management System in compliance with cGMP for dietary supplements. The Quality management System is described in this quality manual and in a number of SOPs.
The Quality Management System shall thus ensure that the company meets the quality requirements set by customers, authorities and own routines, and enable further development of the company’s quality level. The Quality Management System and the implemented routines ensure a high product quality.
Quality Management System
BioActive Foods AS has defined and documented quality procedures consistent with the requirements of the standard. The quality procedures further describe criteria, methods, detail activities, responsibilities and the quality assurance measures that are required to ensure effective operation, high product quality and control of the business processes. The Quality Management System also includes other documents and records required by the organization to ensure effective operation and control of the product. The Quality Management System at BioActive Foods AS
- Is documented
- Is regularly reviewed
- Describes all critical processes and activities
The management is actively participating in the Quality Management System. The Managing director has appointed a QA manager with responsibility and authority as described in the designation of occupation and in detailed in the job description.
The Quality Management System consists of independent systems which also describes processes and monitor the effectiveness:
- Organization, incl. job description
- Production and process control
- Deviation, complaints
Inputs to the continuous improvement of the Quality Management System are:
- Customer requirements
- Authority inspections
- Customer complaints
- Internal requirements
Responsibility and authority in the organisation is defined and communicated by:
- Organization chart
- Routines in the quality manual and in SOPs
- Job descriptions
BioActive Foods AS strives to identify current and future customer needs, to meet customer requirements and exceed customer expectations.
The management ensures focus to be on improving customer satisfaction is maintained by setting and reviewing objectives related to customer satisfaction at management review meetings. The specific needs of our customers are determined through continual verbal and written communications.
Production and service provision
Risk management (e.g. HACCP) is an integrated part of the Quality Management System. This implies identification and assessment of microbial, chemical or body hazards and its risks during manufacturing, distribution and use of a particular product, including definition of a means for their control.
BioActive Foods AS manufactures the products solely by using pre-approved sub-contractors. BioActive Foods AS maintains a record for each batch of product that provides traceability and identifies the amount manufactured and released for distribution.
Certificate of analysis is received from the product manufacturer, and samples are sent to an independent 3. party laboratory for analysis. A final batch certification is performed by BioActive Foods AS upon release for distribution based on documents from the sub-contractors and independent 3. party laboratory analysis.