SIGMA BMC

Projects

QMS & GDP Consultancy Services for Glosarij KS

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To provide comprehensive consultancy and auditing services to Glosarij KS, a pharmaceutical wholesale company representing MSD, to establish, implement, and ensure compliance with an integrated Quality Management System (QMS) aligned with ISO 9001 and Good Distribution Practices (GDP). This aimed to meet the stringent requirements of both international standards and a key pharmaceutical partner.

Year

November 2023-March 2025

Country

Kosova

Type of Activity

Pharmaceutical Quality Management System (QMS) Consulting; Good Distribution Practices (GDP) Compliance Consulting; Regulatory Affairs Consulting (focused on GDP)
Auditing Services; Training and Development (QMS & GDP); Certification Support Consulting (ISO 9001 & GDP)

Activities:

Engineered and deployed a comprehensive Integrated Management System framework, aligning it precisely with ISO 9001 and GDP.

Designed and implemented a robust document management system that rigorously met the requirements of both standards (policies, SOPs, programs, work instructions, etc.).

Conducted thorough risk assessments to pinpoint and evaluate potential threats to pharmaceutical product quality and safety.

Developed and implemented meticulously defined processes for product storage, handling, distribution, and recall, integrating specific cold chain management protocols for thermolabile medicinal products.

Delivered comprehensive training programs to Glosarij KS staff, equipping them with in-depth knowledge of QMS and GDP principles and their practical application.

Conducted regular internal audits to assess the level of compliance with ISO 9001 and GDP standards across all relevant operations.

Established and managed a proactive system that identified, documented, investigated, and resolved non-conformities through effective corrective and preventive actions.

Provided dedicated support and expert guidance to the Glosarij KS team, ensuring their readiness for the second-party audit conducted by MSD.

Provided dedicated support and expert guidance to the Glosarij KS team, facilitating their successful navigation of the certification audit conducted by Bureau Veritas.

Results:

Achieved a successful second-party audit by MSD, validating adherence to their stringent quality expectations.

Secured ISO 9001 and GDP certification from Bureau Veritas, attaining formal recognition of adherence to international standards.

Empowered staff with the necessary knowledge and skills through targeted training, fostering a culture of quality and compliance.

Bolstered credibility and trust with partners, clients, and regulatory authorities, enhancing the company’s reputation.

 

Improving waste management & climate friendly measures

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The project aimed to support the Association of Kosovo Municipalities, i.e., support municipalities in identifying the key challenges and barriers of cooperation with Regional Waste Management Companies (RWC). The specific objectives included:

  • Evaluate the service provision agreements between municipalities and RWCs or other service providers, focusing on waste collection, transport, disposal, etc.
  • Assess the performance of RWCs in service provision.
  • Identify gaps in service quality and areas where cooperation between municipalities and RWCs is underperforming.
  • Evaluate current service contracts and reporting systems used by municipalities and RWCs.
  • Review communication practices related to awareness campaigns and citizen engagement.
  • Propose improvements to the communication channels between municipalities and RWCs, ensuring transparent and efficient information exchange.
  • Identify RWC’s capacities for integrated waste management and Inter-Municipal Cooperation (IMC), analyzing the potential benefits of IMC in terms of cost-sharing, operational efficiency, and service improvement.

Year

November 2024 – April 2025

Country

Kosovo

Type of Activity

Public Sector Consulting; Operational Improvement and Efficiency Consulting with a strong focus on Environmental Consulting and Governance/Institutional Strengthening, commissioned by the Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ) GmbH.

Activities:

Phase 1: Research and Interviews
Phase 2: Assessments, Performance Analysis and Opportunities for enhanced inter-municipal cooperation
Phase 3: Presentation along with actionable recommendations for improvement

Results:

Identified key challenges and Gaps in municipality-RWC cooperation.

Actionable recommendations were proposed to enhance service provision agreements with clear KPIs, improve communication channels through diverse methods, and outlined a roadmap for implementing Inter-Municipal Cooperation (IMC) to optimize waste management.

Capacity building needs identified for municipal and RWC staff.

 

Hands-on implementation of IMS

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Process Improvement

The project aimed to improve AnchorzUp’s efficiency, information security, reputation, and ultimately market performance by introducing a QMS&ISMS management system in compliance with ISO 9001:2015 and ISO 27001:2022. The specific objectives included:

  • Demonstrate AnchorzUp’s ability to provide qualitative services to its clientele;
  • Improve quality and information security processes and efficiency;
  • Ensure the Confidentiality, Integrity, and Availability (CIA) of in-scope client and company information.
  • Prevent information breaches and ensure the security of in-scope data traffic;
  • Increase reputational standing among existing and potential clients, and
  • Increase competitiveness through improved service quality, operational efficiency, and security.

Year

October 2024-March 2025

Country

Kosovo

Type of Activity

Management Systems

Activities:

Phase 1: GAP Analysis & Training
Phase 2: Documentation of the integrated management system (IMS)
Phase 3: Implementation and system certification

Results:

Successful certification in compliance with ISO 9001:2015 (Quality Management System) and ISO 27001:2022 (Information Security Management System) by TUV Austria.

Increase in turnover by 65%.

Increase in productivity by 8%.