Compliance & Legal

Baltimore Innovations is an ISO 9001 and ISO 13485 approved supplier, and we have stringent policies in relation to equal opportunities, ethical standards,  human rights, the environment, health & safety and quality.

ISO 9001 Quality Management (QMS)
ISO 9001 is the world’s most widely recognized Quality Management System (QMS) utilised to meet the expectations and needs of our customers in the UK and Internationally.

Being compliant to the ISO 9001 quality management system ensures that Baltimore Innovations continually monitor and manage quality across all operations, providing customers with consistent performance.

ISO 13485 Quality Management (QMS)
ISO 13485 is the best internationally accepted model a supplier to medical device organizations can implement to help demonstrate compliance to laws and regulations of the medical device industry.

ISO 13485 was written to support manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of products that are safe for their intended purpose.

The ISO 13485 standard is an effective solution enabling us to meet the comprehensive requirements for manufacturers whilst addressing the Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.  Globally supported by BSI experts, ISO 13485 certificates are known and trusted in the medical device industry by authorities, suppliers and manufacturers around the world.

Drug Master File
All desiccants supplied to customers in the Pharmaceutical, medical device, diagnostic, health and medical industries have US FDA Type III Drug Master File (DMF) accreditation. The main objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product.

Reach Compliance
REACH is the European Community Regulation on chemicals and their safe use (EC 1907/2006). It deals with the Registration, Evaluation, Authorisation and Restriction of Chemical substances. The aim of REACH is to improve the protection of human health and the environment through the better and earlier identification of the intrinsic properties of chemical substances.

A major part of REACH is the requirement for manufacturers or importers of substances to register them with a central European Chemicals Agency (ECHA). The deadline for required registration of substances manufactured and imported into the European Union was 30th November 2008 and registration obligations follow between 2010 and 2018. Baltimore Innovations are committed to meeting all requirements of this timetable, and have successfully completed registration of the following products:

Aluminium Oxide:  CAS#: 90669-62-8 ENICS#: 215-691-6
Submission Number: YV219509-93
Registration Number: 05-2114543922-47-0000
Reach Full Submission date: Nov-2018
Calcium Chloride:  CAS#: 10043-52-4 ENICS#: 233-140-8
Submission Number: CG219571-54
Registration Number: 05-2114544054- 57-0000
Reach Full Submission date: Nov-2018
Molecular Sieves (Zeolites): CAS#: 1318-02-1 ENICS#: 215-283-8
Submission Number: SQ371403-18
Full Registration Number: 01-21194-XXXXX-49-XXXX
Reach Full Submission date: Jan-2013
Silica Gel: CAS#: 7631-86-9 ENICS#: 231-545-4
Full Registration Number: 01-21193XXXXX-16-XXXX
Reach Full Submission date: Jan-2011

 

For more information on Baltimore Innovations registration of chemicals under REACH or to request a copy of our certificate please click here.