ISO 37301:2021
ISO 37301:2021 Compliance Management System INTERNATIONAL CERTIFICATION. CONSULTING AND IMPLEMENTATION. TRAINING. Request a Quote Leave a request and we will prepare a commercial offer for you. Get a Quote System Management — your
ISO/IEC 13485 Certification in Kazakhstan
1. We organise training courses.
2. We provide support in preparing documentation.
3. We conduct international certification for ISO/IEC 27001:2019 and GDPR. ISO/IEC 15489.
System Management specialises in the international certification of management systems.Our mission is to provide certification services that go beyond standard audits and deliver real value to our clients. We strive for a cost-effective and flexible approach that takes into account the unique needs and specific activities of each client. System Management partners with leading international certification bodies such as Unicert (Germany), Baltum Buroo (Estonia), Swiss Approval (Switzerland), and is also accredited as a partner by the European Bank for Reconstruction and Development (EBRD).
SYSTEM MANAGEMENT | ISO 9001, ISO 45001, ISO 22000, ISO 14001, ISO 13485, ISO 50001, ISO/IEC 27001, ISO/IEC 27701, ISO 17100, GDPR, ISO 18587
Clients
Over the past year, System Management has attracted more than 80 new clients, reflecting the company’s dynamic growth and development.
Team
System Management includes over 20 professionals listed in the international auditors’ register, demonstrating our commitment to the highest standards of quality.
Recognition
Certificates issued by System Management are recognised and respected worldwide, opening the doors to quality and trust.
Countries
System Management is establishing its presence and expanding operations in countries such as Ukraine, Estonia, Germany, Georgia, and Kazakhstan, demonstrating global reach and local focus.
About ISO/IEC 13485 Certification
ISO 13485:2016 is an international standard for the quality management systems of organisations working with medical devices. It is sometimes searched for as ISO/IEC 13485; however, the official designation is ISO 13485:2016. The standard helps organisations manage design, production, supply, servicing, risks, and documentation.
Benefits of ISO/IEC 13485 Certification
Implementing ISO 13485 helps establish a controlled process management system in the medical device sector and reduce operational risks. The key benefits include:
- systemising production, supply, and servicing processes;
- improving quality control and traceability;
- strengthening the management of risks, non-conformities, complaints, and CAPA;
- enhancing control over suppliers and documentation;
- increasing trust among customers, partners, and international markets;
- preparing the company for audits, tenders, and international supply activities.
ISO 13485 certification in Kazakhstan confirms that the company’s quality management system complies with internationally recognised requirements for the medical device sector.
Why choose SYSTEM MANAGEMENT?
EXPERIENCE
With over a decade of experience in the international certification services arena, System Management proves its expertise and reliability.
PRICING POLICY
System Management offers a balanced pricing policy with reasonable and competitive rates.
PRESTIGE
System Management's international recognition ensures the use of advanced practices and approaches.
ACCREDITATION
The presence of international accreditation confirms the high standards of work of “System Management”
PERSONNEL
System Management carefully selects and registers qualified auditors at the international level.
TRAINING
System Management has its own online academy, providing knowledge and skills anywhere in the world.
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Stages of collaboration
Application submission
We identify certification needs and prepare the corresponding agreement.
Documentation development
We determine requirements, conduct training seminars, and develop and implement documented procedures for the Information Security Management System.
Audit
We perform an on-site inspection of the management system to ensure full compliance with the standards.
Certification
We prepare a report on the audit and make a decision regarding the issuance of the certificate.
Get a
ISO/IEC 13485 certification
Fill out the application form, and we will create a proposal perfectly tailored to your business needs.
Useful information
The importance of certification body accreditation
Benefits of accredited certification for regulatory authorities
All About ISO
Management system certification conducted by independent parties often becomes a criterion for operating in global markets. It confirms compliance with international standards, ethical business principles, and legal requirements, and can serve as a powerful incentive for the development and improvement of business processes.
The use of accredited certification procedures also contributes to the development of international trade and economic progress. The accreditation process standardises the competency criteria for certification bodies at the international level — an approach that has been widely adopted in many countries.
ISO forms a global network of national standards bodies. Membership in ISO means that national standards bodies participate in representing their country’s interests within ISO and in promoting ISO standards at the national level.
CERTIFICATION
in accordance with international ISO standards
We offer comprehensive certification services
for ISO standards tailored to businesses across various industries,
ensuring compliance with global and local
regulatory requirements.
ISO 9001:2015
A quality management system is the key to improving customer satisfaction through high standards of service and product quality.
ISO 14001:2015
Environmental management reflects responsibility for the environment and a commitment to sustainable development.
ISO 22000:2018
The food safety management system ensures safety at every stage of the food chain, from production to the consumer.
ISO 50001:2018
Energy management system: standards and guidelines for the efficient use of energy resources.
ISO 45001:2018 / OHSAS 18001
Industrial safety standards: ensuring health protection and safe working conditions.
ISO/IEC 27001:2013
Information security management: a comprehensive approach to information protection and risk management.
ISO 20000:2011
IT service management: standards for achieving high-quality IT services.
ISO 50001:2018
Standards and guidelines for energy management systems aimed at improving the energy efficiency of organisations.
ISO 17100:2015
Standards for translation services: criteria for quality and professionalism in linguistic services.
ISO 18587:2017
Standards for post-editing machine translation: requirements for quality and editing processes.
ISO 13485:2016
Quality management for medical device manufacturers: stringent international requirements.
ISO 22301:2019
Business continuity management system: guarantees of stable company operations under any conditions.
GDPR
Standards and certification procedures for ensuring the confidentiality of personal data.
ISO/IEC 13485 Certification in Kazakhstan
ISO 13485:2016 is an international standard for the quality management systems of organisations working with medical devices. It is sometimes searched for as ISO/IEC 13485; however, the official designation is ISO 13485:2016. The standard helps organisations manage design, production, supply, servicing, risks, and documentation.
ISO 13485 certification in Kazakhstan may be important for companies that need to demonstrate effective process control to customers, partners, or international markets. A quality management system for medical devices should operate not only during an audit, but also in day-to-day activities.
Who Is ISO 13485 Suitable For
The standard is applicable not only to manufacturers. Depending on the company’s role, it may be relevant for:
- manufacturers of medical equipment, consumables, and components;
- developers and contract manufacturers;
- suppliers of components and specialised services;
- importers, distributors, and service companies;
- organisations participating in tenders and international supply activities.
Certification of medical device manufacturing helps demonstrate systematic process control. For importers and distributors, the scope of the QMS is defined with regard to their functions and responsibilities.
What ISO 13485 Implementation Includes
ISO 13485 implementation begins with an analysis of existing processes. The documentation is then refined, responsibilities are assigned, training is provided, and an internal audit and preparation for certification are carried out.
The work may include document, supplier, risk, non-conformity, CAPA, complaint, and traceability management. System Management can support either an individual stage or the entire project.
How certification works
Once preparation is complete, a certification audit is conducted. Auditors review not only the documentation but also objective evidence that the procedures are being followed in practice. If any non-conformities are identified, the organisation implements corrective actions.
To obtain ISO 13485 certification in Kazakhstan, the certification scope, sites, number of employees, and types of activities are defined in advance. These factors determine the amount of audit work required, the timeframe, and the cost.
ISO 13485 and Medical Device Registration
ISO 13485 is a quality standard for medical devices from a management system perspective. The certificate does not replace the state registration of a medical device in Kazakhstan: registration concerns the authorisation of a specific device for placement on the market, while ISO 13485 confirms that the QMS complies with the requirements of the standard.
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FAQ
Who Needs ISO 13485 Certification in Kazakhstan?
Manufacturers and other participants in the medical device supply chain may require ISO 13485 certification where this is required by regulatory conditions, customers, tenders, or business partners.
Is ISO 13485 Certification Mandatory?
Not in all cases. The requirement depends on the market, type of activity, applicable legislation, and contractual conditions.
Does ISO 13485 Replace Medical Device Registration?
No. QMS certification and state registration are separate procedures.
Is the Standard Suitable for Importers and Distributors?
Yes, if their activities affect the quality, storage, supply, servicing, or traceability of medical devices.
How Does ISO 13485 Differ from ISO 9001?
ISO 9001 is a general-purpose standard, whereas ISO 13485 is specifically focused on medical devices and places greater emphasis on regulatory requirements, risk management, and traceability.
What Documents Are Required for an Audit?
Auditors typically review the QMS scope, procedures, and records relating to training, suppliers, risks, CAPA, complaints, internal audits, and management review.
How Long Does Implementation Take?
Usually from several weeks to several months, depending on the size of the company, the complexity of its activities, and the maturity of its processes.
How Much Does ISO 13485 Certification Cost in Kazakhstan?
The cost is calculated individually, taking into account the number of employees, number of sites, certification scope, and complexity of the processes.
Can Part of the Work Be Carried Out Remotely?
Yes. Consultancy, training, and documentation review are often carried out online. The format of the certification audit is determined by the audit programme and the rules of the certification body.
How Can the Accreditation of a Certification Body Be Verified?
Check the scope of accreditation, information about the accreditation body, and whether the certificate can be verified in official registers.
System Management provides ISO 13485 implementation, training, internal audit, and certification preparation services in Kazakhstan, Uzbekistan, Georgia, and Kyrgyzstan. The scope and format of the work are tailored to the current maturity of the QMS and the company’s objectives.
