ISO - MANAGEMENT SYSTEM

Service Details:

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system by monitoring, maintaining, and controlling the processes.

If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to ISO 13485:2016 reflect any exclusion of design and development controls.

 

Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.

 

Benefit of ISO 13485:2016- MDQMS 

Promotes harmonization of regulatory requirements for the manufacturers of medical devices on an international scale.

ISO 13485 is a quality system standard for organizations include in design and development, production, storage and distribution, installation, or servicing of a medical device.   All requirements of ISO 13485 are specific to organizations manufacturing medical devices, regardless of the type or size of the organization.

Companies that achieve ISO 13485 certification enjoy the benefits of an increased amount of customers who have more reason to trust and purchase products of consistent high quality.

 

ISO 13485 certification is advantageous to medical device companies which export their products to global markets. Some of the additional requirements relate to design controls, process controls (including environmental controls), special processes, traceability, record retention, and regulatory actions, which are more critical for the medical device industry.

ISO 13485 compliant management systems adopt a risk management approach which includes assessment to identify & estimate risk, uses risk controls and techniques with a view to eliminate hazardous situations throughout product realization.

Assures the customers that the product complies with all relevant product & service-oriented technical standards & regulations.

 

Certification process of ISO 13485:2016 (MDQMS):- The certification process is a multiple-step process. The certification cycle is described briefly:

• Application for certification from client
• Offer from Skymoon Management Services PVT.LTD.
• Offer acceptance from client and order confirmation by Skymoon
• Pre audit (optional)
• Certification audit - (Stage 1 + Stage 2)
• Issue of certificate on successful completion of certification audit
• Surveillance audits at defined interval
• Recertification audit after 3 years

Service Details:

ISO 20000-1-2018 Certification Service this standard has been prepared to specify requirements for establishing, implementing, maintaining and continually improving a service management system (SMS). An SMS supports the management of the service lifecycle, including the planning, design, transition, delivery and improvement of services, which meet agreed requirements and deliver value for customers, users and the organization delivering the services.The adoption of an SMS is a strategic decision for an organization and is influenced by the organization’s objectives, the governing body, other parties involved in the service lifecycle and the need for effective and resilient services.Implementation and operation of an SMS provides ongoing visibility, control of services and continual improvement, leading to greater effectiveness and efficiency. Improvement for service management applies to the SMS and the services.This document is intentionally independent of specific guidance. The organization can use a combination of generally accepted frameworks and its own experience. The requirements specified in this document align with commonly used improvement methodologies. Appropriate tools for service management can be used to support the SMS.

Benefit of ISO 20000-1-2018 ( ITSMS) 

• Preservation of confidentiality, integrity and availability of information 
• Ability of a service  or service component  to perform its required function at an agreed time or over an agreed period of time.
• Assurance to improve the design, transition, delivery and improvement of services by the implementation and operation of the SMS.
• Assurance to improve the design, transition, delivery and improvement of services by the implementation and operation of the SMS.
• Set of capabilities and processes  to direct and control the organization’s activities and resources for the planning, design, transition , delivery and improvement of services to deliver value 

_{Role of SKYMOON in ISO 20000-1:2011 Certification}

Skymoon management services Private Limited ( SMSPL) having the team of Auditor, Lead Auditor and Technical Experts who can conduct a implementation ,  value added Audit and contribute in the continual improvement of your organization.

SMSPL team can provide the two step audit and you are entitled for the certification of ISO 20000-1:2011 which is required by your customer or in tender purpose.

Service Details:

The long-term success of an organization relies on many things, from continually assessing and updating their offering to optimizing their processes. As if this weren’t enough of a challenge, they also need to account for the unexpected in managing risk. That’s why we’ve developed ISO 31000:2009 Certification Service for risk management.

ISO 31000, Risk management - Guidelines, provides principles, a framework and a process for managing risk. It can be used by any organization regardless of its size, activity or sector.

Using ISO 31000 can help organizations increase the likelihood of achieving objectives, improve the identification of opportunities and threats and effectively allocate and use resources for risk treatment.

However, ISO 31000 cannot be used for certification purposes, but does provide guidance for internal or external audit programmes. Organizations using it can compare their risk management practices with an internationally recognized benchmark, providing sound principles for effective management and corporate governance.

Benefits of using ISO 31000 include using enterprise-wide risk management processes to:

• Increase competitive advantage by adopting a globally accepted risk management standard;
• Increase awareness and understanding of the organization''s risks;
• Improve the reduction, mitigation and/or elimination of those risks

Service Details:

ISO 41001:2018 Certification Service is the international standard for a Facility Management (FM) system . It provides a framework to develop, implement and maintain effective facilities management across different sectors worldwide.

Benfits:
Improved safety, health, well-being and productivity of workforce. better efficiency and effectiveness, hence improving organisational cost benefits. enhanced communication of FM methodologies and requirements among and between public and private sector organizations. improved consistency of service levels delivered.

Service Details:

Through regular improvement, we are offering an exclusive collection of ISO 27001:2013 ISMS Certification Service. This certification service is completed within the scheduled time-frame. In addition to this, the offered array of certification services is performed using best grade inputs.