
Partnership in Compliance, Commitment to Quality & Success in Certification
MEDICAL DEVICE MANAGEMENT SYSTEM
MDMS – ISO 13485
ISO 13485 is an international standard that represents the needs for a comprehensive quality management system for the design and manufacture of medical devices. ISO 13485 is based on the ISO 9001:2008 procedure model approach and is a management systems standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonized medical device regulatory needs.
ISO 13485 was written to support medical device 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 medical devices that are safe for their intended purpose.
Benefits of MDD – Quality Management System include
Few of the benefits of implementing MDD – QMS include
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Ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements
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Reduction of operating costs, decrease of nonconforming products costs, raw materials, energy and other resources savings
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Simplifying the procedure of attestation of conformity to needs of EU directives and corresponding Government Orders
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Improving trust of public and public monitoring bodies in respect of the medical devices manufacturer
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Attestation of efficiency and helpfulness of the established quality management system by a self-governing third party
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Guarantee of production procedure stability and thus steady and high quality of services and products supplied to clientele
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Integration of multiple standards ISO 14001, ISO 45001, IATF 16949, AS 9100, etc.)
Consulting Methodology
A proven Quality Management System development and implementation approach should be used based on project management methodologies. A structured approach should be used for defining project plans, specific responsibilities and verification of results. The result will be a development and implementation strategy that is more efficient and provides for first time compliance or registration to the ISO 9001 requirements.
Following phases are involved in development and implementation of an effective Quality Management System
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Development of Project Plan
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Review and Gap Assessment
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Process Mapping and Management System Development
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Management System Implementation
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Internal Assessment and Management Review
Benefits of QMS Consulting include
Best practices and depth of knowledge and experience significantly impacts the QMS design and ability to meet the organizations’ business goals. An experienced consultant helps your organization live and own the QMS and operate it at its optimal level.
Following can be some of the benefits of having and experienced consultant for development of management system
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An effective and reliable management system
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Increased objectivity and impartiality
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Reduced number of operational process defects
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Increasing business opportunities
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Reduced QMS development and implementation time
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QMS designed to suit the organization and your customers’ requirements
Quality Management System
QMS – ISO 9001
The ISO 9001 standard outlines requirements for organizations to establish, implement, maintain, and improve a Quality Management System. ISO 9001 standard has become the international indicator for quality and consistency.
Using a process-based approach, the ISO 9001 standard lays out tools for companies to assess, and improve their day-to-day processes that make them run. Conforming to the ISO 9001 standard can help organizations ensure that everything that reaches its customers meets their requirements and has the levels of quality desired.
Benefits of Quality Management System include
Few of the benefits of implementing QMS include
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Ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements
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Increased productivity and better financial performance
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Increased profits as a result of reduced warranty claims, improved processes, reduced rework and rejections
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Improved Customer Satisfaction
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Better and effective management of risk
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Advantage over competitors when tendering for business
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Integration of Quality Management Principles through its design
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Integration of multiple standards (ISO 14001, ISO 45001, IATF 16949, AS 9100, etc.)
Consulting Methodology
A proven Quality Management System development and implementation approach should be used based on project management methodologies. A structured approach should be used for defining project plans, specific responsibilities and verification of results. The result will be a development and implementation strategy that is more efficient and provides for first time compliance or registration to the ISO 9001 requirements.
Following phases are involved in development and implementation of an effective Quality Management System
-
Development of Project Plan
-
Review and Gap Assessment
-
Process Mapping and Management System Development
-
Management System Implementation
-
Internal Assessment and Management Review
Benefits of QMS Consulting
Best practices and depth of knowledge and experience significantly impacts the QMS design and ability to meet the organizations’ business goals. An experienced consultant helps your organization live and own the QMS and operate it at its optimal level.
Following can be some of the benefits of having and experienced consultant for development of management system
-
An effective and reliable management system
-
Increased objectivity and impartiality
-
Reduced number of operational process defects
-
Increasing business opportunities
-
Reduced QMS development and implementation time
-
QMS designed to suit the organization and your customers’ requirements
Educational Organizations Management System
EOMS – ISO 21001
ISO 21001 is an international standard developed by the International Organization for Standardization which provides management tools for organizations that offer educational products and services. It intends to help educational providers meet students’ requirements and needs.
ISO 21001 is based on ISO 9001 – Quality Management Systems, but it provides a specific framework for educational organizations that aim to enhance the satisfaction of their learners by improving the educational processes and ensuring conformity to learners’ requirements. The standard can be applicable to all organizations that provide a curriculum for the development of knowledge, skills and attitudes by means of different lecturing methods.
Benefits of Educational Organization Management System (EOMS)
Few of the benefits of implementing EOMS include
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The objectives and activities of the educational organization will be more aligned with policy, mission and vision statement;
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The organization will be able to provide Inclusive and equitable education for all;
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Learners, including learners with special education needs and distance learners will get more personalized learning;
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Organization can demonstrate and increase effectiveness and efficiency through consistent processes and evaluation tools;
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Increased credibility of the organization leading to more market share and profitability;
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Organizations will be able to demonstrate their commitment to effective quality management practices;
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Applicable regional, national, open and proprietary standards will be harmonized within an international framework.
Consulting Methodology
A proven EOMS development and implementation approach should be used based on project management methodologies. A structured approach should be used for defining project plans, specific responsibilities and verification of results. The result will be a development and implementation strategy that is more efficient and provides for first time compliance or registration to the ISO 21001 requirements.
Following phases are involved in development and implementation of an effective Information Security Management System
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Development of Project Plan
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Review and Gap Assessment
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Process Mapping and Management System Development
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Management System Implementation
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Internal Assessment and Management Review
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Continual Improvement
Benefits of EOMS Consulting include
Best practices and depth of knowledge and experience significantly impacts the EOMS design and ability to meet the organizations’ business goals. An experienced consultant helps your organization live and own the EOMS and operate it at its optimal level.
Following can be some of the benefits of having and experienced consultant for development of management system
-
An effective and reliable management system
-
Increased objectivity and impartiality
-
Reduced number of operational process errors
-
Increasing business opportunities
-
Reduced EOMS development and implementation time
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EOMS designed to suit the organization and your customers’ requirements
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Effective system implementation to ease the process of accreditation
Tourism Quality Management System
TQMS – ISO 22483
ISO 22483 establishes quality requirements and recommendations for hotels regarding staff, service, events, entertainment activities, safety and security, maintenance, cleanliness, supply management and guest satisfaction.
The requirements are applicable regardless of their classification and category, and whether the services are provided directly by internal staff or by a subcontractor.
Benefits of Tourism Quality Management System include
Few of the benefits of implementing TQMS include
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Increase customer confidence
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Increasing the quality of services and products
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Reduce waste and losses
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Reducing the number of complaints
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Improve performance, increase productivity
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Global competition
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Measure and improve service quality
Consulting Methodology
A proven Tourism Quality Management System development and implementation approach should be used based on project management methodologies. A structured approach should be used for defining project plans, specific responsibilities and verification of results. The result will be a development and implementation strategy that is more efficient and provides for first time compliance or registration to the ISO 22483 requirements.
Following phases are involved in development and implementation of an effective Tourism Quality Management System
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Development of Project Plan
-
Review and Gap Assessment
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Process Mapping and Management System Development
-
Management System Implementation
-
Internal Assessment and Management Review
-
Continual Improvement
Benefits of TQMS Consulting include
Best practices and depth of knowledge and experience significantly impacts the TQMS design and ability to meet the organizations’ business goals. An experienced consultant helps your organization live and own the TQMS and operate it at its optimal level.
Following can be some of the benefits of having and experienced consultant for development of management system
-
An effective and reliable management system
-
Increased objectivity and impartiality
-
Reduced number of operational process errors
-
Increasing business opportunities
-
Reduced TQMS development and implementation time
-
TQMS designed to suit the organization and your customers’ requirements
-
Effective system implementation to ease the process of accreditation
Security Operations Management System
SOMS – ISO 18788
ISO 18788 specifies the requirements and provides guidance for organizations that conduct or contract security operations. Moreover, it provides a framework for establishing, implementing, operating, monitoring, reviewing, maintaining and improving a Security Operations Management System (SOMS).
It enables the constant development of security services, while ensuring customer safety and respect for human rights. This standard demonstrates compliance with laws and regulations, respect for human rights, and the establishment of professional security operations to better meet the customer’s and stakeholder’s needs.
Security Operations Management System (SOMS) include
Few of the benefits of implementing SOMS include
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Provides reliability and establishes effective Corporate Governance
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Strengthens credibility and protection of reputation
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Ensures the quality and professionalism of security organizations
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Establishes sustained customer relations
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Increases the potential of operational success
Consulting Methodology
A proven Security Operations Management System (SOMS) development and implementation approach should be used based on project management methodologies. A structured approach should be used for defining project plans, specific responsibilities and verification of results. The result will be a development and implementation strategy that is more efficient and provides for first time compliance or registration to the ISO 18788 requirements.
Following phases are involved in development and implementation of an effective Security Operations Management System (SOMS)
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Development of Project Plan
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Review and Gap Assessment
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Process Mapping and Management System Development
-
Management System Implementation
-
Internal Assessment and Management Review
-
Continual Improvement
Benefits of SOMS Consulting include
Best practices and depth of knowledge and experience significantly impacts the SOMS design and ability to meet the organizations’ business goals. An experienced consultant helps your organization live and own the SOMS and operate it at its optimal level.
Following can be some of the benefits of having and experienced consultant for development of management system
-
An effective and reliable management system
-
Increased objectivity and impartiality
-
Reduced number of operational process errors
-
Increasing business opportunities
-
Reduced SOMS development and implementation time
-
SOMS designed to suit the organization and your customers’ requirements
-
Effective system implementation to ease the process of accreditation
Automotive Quality Management System
AQMS – IATF 16949
IATF 16949:2016 represents an innovative document, given the strong orientation to the customer, with inclusion of a number of consolidated previous customer specific requirements.
IATF 16949:2016 is a technical specification aimed at the development of a quality management system which provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the automotive industry supply chain and assembly process. It is based on the ISO 9001 standard.
Benefits of Automotive Quality Management System include
Few of the benefits of implementing IATF include
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Credibility
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Global reach
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Customer satisfaction
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Process integration
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Evidence-based decision making
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Continual improvement culture
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Employee engagement
Consulting Methodology
A proven IATF Quality Management System development and implementation approach should be used based on project management methodologies. A structured approach should be used for defining project plans, specific responsibilities and verification of results. The result will be a development and implementation strategy that is more efficient and provides for first time compliance or registration to the IATF 16949 requirements.
Following phases are involved in development and implementation of an effective IATF Quality Management System
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Development of Project Plan
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Review and Gap Assessment
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Process Mapping and Management System Development
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Management System Implementation
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Internal Assessment and Management Review
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Continual Improvement
Benefits of IATF 16949 Consulting include
Best practices and depth of knowledge and experience significantly impacts the IATF Quality Management System design and ability to meet the organizations’ business goals. An experienced consultant helps your organization live and own the QMS and operate it at its optimal level.
Following can be some of the benefits of having and experienced consultant for development of management system
-
An effective and reliable management system
-
Increased objectivity and impartiality
-
Reduced number of operational process errors
-
Increasing business opportunities
-
Reduced QMS development and implementation time
-
QMS designed to suit the organization and your customers’ requirements
-
Effective system implementation to ease the process of accreditation