MB Healthcare Services Ltd is very serious about compliance and delivering high quality services. We are committed to quality with an attitude to meeting compliance obligations.
By doing so, we promise our Stakeholder :
Our Service Users
- Are safe in the knowledge that the care provided respects their wishes as encompassed in the compliance framework
The relatives of our Service Users
- Peace of mind that the care of their relatives is governed by a system designed to enable high standards of care
Our Staff
- Know that a system is in place to support them in providing high quality care, right down to the very last detail
- Know that HR processes are fair and even-handed
- Know the system supports on-going training processes, CPD and career development
Quality Compliance Systems (QCS)
MB healthcare Services Ltd is working with Quality Compliance Systems (QCS) to develop great policies and procedures in order to comply with different quality management system.
International Standardization Organization (ISO)
ISO9001:2015
ISO 9001 is a globally recognized standard for quality management systems (QMS). It is one of the many standards developed and published by the International Organization for Standardization (ISO). The ISO 9001 standard sets out the criteria for establishing, implementing, maintaining, and continually improving an effective quality management system within an organization.
The main purpose of ISO 9001 is to help organizations consistently meet customer requirements and enhance customer satisfaction while also ensuring that the organization’s processes and operations are efficient and well-controlled. By adopting ISO 9001, organizations can demonstrate their commitment to providing products and services that meet regulatory requirements and conform to applicable standards.
Key principles of ISO 9001 include:
- Customer Focus: Understanding and meeting customer needs and expectations.
- Leadership: Providing clear direction and demonstrating commitment to the QMS.
- Engagement of People: Involving and empowering employees to contribute effectively.
- Process Approach: Managing activities and resources as interconnected processes.
- Improvement: Continually striving to enhance performance and processes.
- Evidence-Based Decision Making: Making informed decisions based on data and information.
- Relationship Management: Managing relationships with interested parties, such as suppliers and partners.
The ISO 9001 standard consists of specific requirements that organizations must fulfil to become certified. The certification process involves an external audit by a certification body, which assesses the organization’s QMS to ensure compliance with the ISO 9001 standard.
ISO 9001 certification is not mandatory, but many organizations choose to pursue it to demonstrate their commitment to quality and improve their overall performance. Being ISO 9001 certified can also be a requirement for participating in certain industries or contractual agreements.
It’s important to note that ISO standards are periodically revised and updated to reflect changes in industry practices and emerging best practices. As of my last update in September 2021, the current version of ISO 9001 is ISO 9001:2015. However, there might be newer versions or updates beyond that date. For the most current information, I recommend checking the official ISO website or relevant accreditation bodies.
ISO27001:2017
ISO 27001 is another internationally recognized standard, but it focuses on information security management systems (ISMS) rather than quality management systems. Like ISO 9001, ISO 27001 is developed and published by the International Organization for Standardization (ISO).
The main purpose of ISO 27001 is to provide a systematic approach for organizations to manage and protect their information assets. This standard is particularly crucial in today’s digital age, where organizations face numerous threats to their information, such as cyberattacks, data breaches, and other security incidents.
ISO 27001 provides a framework for identifying, assessing, and managing information security risks within an organization. By implementing ISO 27001, organizations can establish a robust information security management system that ensures the confidentiality, integrity, and availability of their sensitive information.
Key components of ISO 27001 include:
- Risk Assessment: Identifying and evaluating information security risks.
- Risk Treatment: Implementing controls and measures to mitigate identified risks.
- Information Security Policy: Defining a set of policies and objectives related to information security.
- Management Commitment: Demonstrating leadership and support for information security initiatives.
- Resources Management: Allocating adequate resources for the ISMS implementation and maintenance.
- Training and Awareness: Providing training and raising awareness among employees about information security.
- Incident Management: Establishing procedures for responding to information security incidents.
- Monitoring and Continual Improvement: Regularly monitoring the ISMS and making improvements as necessary.
ISO 27001 is applicable to all types of organizations, regardless of size or industry. Just like with ISO 9001, organizations can seek ISO 27001 certification from accredited certification bodies. The certification process involves an external audit to assess the organization’s compliance with the ISO 27001 standard.
By obtaining ISO 27001 certification, organizations can demonstrate to customers, partners, and stakeholders that they have taken appropriate measures to safeguard their sensitive information and maintain a strong security posture.
As with any ISO standard, it’s essential to check for the most current version or updates beyond my last update in September 2021. The latest version of ISO 27001 was ISO/IEC 27001:2013. To get the most recent information, please refer to the official ISO website or relevant accreditation bodies.
ISO14971:2019
ISO 14971:2019 is an international standard developed by the International Organization for Standardization (ISO) and is titled “Medical devices – Application of risk management to medical devices.” It provides guidelines for applying risk management to medical devices throughout their lifecycle.
The primary goal of ISO 14971 is to help medical device manufacturers and other stakeholders identify and assess potential risks associated with medical devices and implement appropriate measures to mitigate or control those risks. The standard is an essential part of the regulatory compliance process for medical device manufacturers and is widely recognized and adopted in the healthcare industry.
Key components and requirements of ISO 14971:2019 include:
- Risk Management Process: Establishing a systematic process for risk management that includes risk identification, risk analysis, risk evaluation, risk control, and risk communication.
- Risk Analysis: Identifying and analysing potential hazards and hazardous situations related to the medical device and its use.
- Risk Evaluation: Evaluating the identified risks based on criteria such as severity, probability of occurrence, and detectability.
- Risk Control: Implementing appropriate risk control measures to minimize or eliminate risks to an acceptable level.
- Residual Risk Evaluation: Assessing the remaining risks after implementing risk control measures.
- Risk Management Report: Documenting the risk management process and outcomes in a risk management report.
- Post-Market Surveillance: Establishing a process for monitoring the medical device's performance in the market and addressing any newly identified risks.
- Risk Communication: Ensuring effective communication of risk-related information to all relevant stakeholders, including users, patients, and regulatory authorities.
ISO 14971:2019 is an essential tool for medical device manufacturers to demonstrate compliance with regulatory requirements related to risk management. It helps organizations ensure the safety and effectiveness of their medical devices and contributes to improving patient safety and healthcare outcomes.
As with other ISO standards, it’s essential to check for the most current version or updates beyond my last update in September 2021. The latest version of ISO 14971 is ISO 14971:2019. To obtain the most recent information, please refer to the official ISO website or relevant accreditation bodies.
ISO22301:2019
ISO 22301:2019 is an international standard developed by the International Organization for Standardization (ISO) and is titled “Societal security – Business continuity management systems – Requirements.” It provides guidelines for establishing, implementing, maintaining, and improving a business continuity management system (BCMS) within an organization.
The main objective of ISO 22301:2019 is to help organizations prepare for and respond to disruptive incidents, emergencies, and disasters in a structured and effective manner. The standard emphasizes the importance of business continuity planning and risk management to ensure that organizations can continue their critical functions and minimize the impact of disruptions on their operations and stakeholders.
Key components and requirements of ISO 22301:2019 include:
- Business Impact Analysis (BIA): Identifying critical business functions, their dependencies, and the potential consequences of disruptions to those functions.
- Risk Assessment and Treatment: Identifying and assessing risks that may affect business continuity and implementing measures to mitigate or manage these risks.
- Business Continuity Strategy: Developing a strategy and approach to ensure the continuity of critical functions during and after a disruption.
- Business Continuity Plans: Creating detailed plans and procedures to manage specific incidents and disruptions.
- Resource Management: Ensuring that necessary resources, including personnel, infrastructure, and communication tools, are available to implement the BCMS effectively.
- Business Continuity Exercises and Tests: Conducting regular exercises and tests to evaluate the effectiveness of the BCMS and to identify areas for improvement.
- Performance Evaluation: Monitoring and measuring the performance of the BCMS and taking corrective actions as needed.
- Continual Improvement: Continuously reviewing and improving the BCMS to enhance its effectiveness and alignment with the organization's objectives.
ISO 22301:2019 is applicable to organizations of all sizes and sectors, as business continuity management is crucial for any entity facing potential disruptions. By adopting ISO 22301, organizations can demonstrate their commitment to ensuring the continuity of their critical functions, building resilience, and safeguarding their reputation and stakeholder confidence.
As with any ISO standard, it’s essential to check for the most current version or updates beyond my last update in September 2021. The latest version of ISO 22301 is ISO 22301:2019. For the most up-to-date information, please refer to the official ISO website or relevant accreditation bodies.
ISO14001:2015
ISO 14001 is an internationally recognized standard developed by the International Organization for Standardization (ISO). The full title of the standard is “Environmental management systems – Requirements with guidance for use.” It provides a framework for organizations to establish, implement, maintain, and continually improve an effective environmental management system (EMS).
The main objective of ISO 14001 is to help organizations minimize their environmental impact and manage their environmental responsibilities in a systematic and sustainable manner. The standard is designed to be flexible and adaptable, allowing organizations of all sizes and types to apply it to their specific environmental challenges.
Key components and requirements of ISO 14001 include:
- Environmental Policy: Establishing a clear and comprehensive environmental policy that reflects the organization's commitment to environmental protection.
- Environmental Aspects and Impacts: Identifying and assessing the organization's significant environmental aspects and their potential impacts on the environment.
- Legal and Other Requirements: Ensuring compliance with relevant environmental laws, regulations, and other requirements.
- Objectives and Targets: Setting environmental objectives and targets that are measurable, achievable, and aligned with the organization's environmental policy.
- Environmental Management Programs: Developing and implementing action plans and programs to achieve the established objectives and targets.
- Resources and Competence: Allocating adequate resources and ensuring that employees have the necessary competence to carry out environmental management tasks.
- Communication: Establishing internal and external communication mechanisms to inform stakeholders about the organization's environmental performance and initiatives.
- Documentation and Control: Maintaining appropriate documentation to support the EMS and ensuring control over the documentation.
- Monitoring and Measurement: Implementing procedures to monitor and measure environmental performance and progress toward achieving objectives and targets.
- Auditing: Conducting internal audits to assess the effectiveness of the EMS and identify areas for improvement.
- Management Review: Conducting periodic management reviews to evaluate the performance of the EMS and make necessary adjustments.
ISO 14001 certification is voluntary, but many organizations seek it to demonstrate their commitment to environmental responsibility and sustainability. Achieving ISO 14001 certification involves an external audit by a third-party certification body to verify that the organization’s EMS meets the requirements of the standard.
As with any ISO standard, it’s essential to check for the most current version or updates beyond my last update in September 2021. The latest version of ISO 14001 is ISO 14001:2015. For the most up-to-date information, please refer to the official ISO website or relevant accreditation bodies.
ISO13485:2016
ISO 13485 is an international standard developed by the International Organization for Standardization (ISO) and is titled “Medical devices – Quality management systems – Requirements for regulatory purposes.” Unlike ISO 9001, which is a general quality management standard, ISO 13485 specifically focuses on quality management systems for medical devices.
The primary objective of ISO 13485 is to provide a framework for medical device manufacturers and other organizations involved in the medical device industry to establish, implement, and maintain a quality management system that meets regulatory requirements and ensures the safety and effectiveness of medical devices.
Key components and requirements of ISO 13485 include:
- Management Responsibility: Demonstrating leadership and commitment to quality management throughout the organization.
- Resource Management: Ensuring that the necessary resources, infrastructure, and competent personnel are available for the effective implementation of the quality management system.
- Product Realization: Establishing processes for the design, development, production, and service of medical devices.
- Measurement, Analysis, and Improvement: Implementing processes to monitor and measure the performance of the quality management system, analyse data, and take corrective and preventive actions as needed.
- Documentation and Record Keeping: Maintaining appropriate documentation and records to demonstrate compliance with the standard and regulatory requirements.
- Risk Management: Identifying, evaluating, and managing risks associated with the safety and performance of medical devices.
- Supplier Management: Establishing processes for selecting, evaluating, and monitoring suppliers to ensure the quality of purchased components and services.
ISO 13485 is widely recognized as a critical standard for medical device manufacturers seeking to demonstrate compliance with regulatory requirements and best practices in the industry. It helps organizations ensure the consistent quality and safety of their medical devices and fosters confidence among customers, patients, and regulatory authorities.
Obtaining ISO 13485 certification involves an external audit by a certification body to assess the organization’s compliance with the standard’s requirements. The certification process includes evaluating the organization’s quality management system, processes, and documentation related to the design, production, and distribution of medical devices.
As with any ISO standard, it’s important to check for the most current version or updates beyond my last update in September 2021. The latest version of ISO 13485 is ISO 13485:2016. For the most up-to-date information, please refer to the official ISO website or relevant accreditation bodies.
UKAS / ISO15189
MB Healthcare Services Ltd is working towards UKAS/ISO15189 certification.
ISO 15189 is an international standard developed by the International Organization for Standardization (ISO) and is titled “Medical laboratories – Requirements for quality and competence.” It provides specific requirements for medical laboratories to demonstrate their competence in providing accurate and reliable testing, calibration, and diagnostic services.
The main purpose of ISO 15189 is to establish a quality management system tailored to the unique requirements of medical laboratories. It covers a range of aspects related to laboratory operations, including the competency of staff, equipment and facilities, testing procedures, result reporting, and continuous improvement.
Key components and requirements of ISO 15189 include:
- Management Requirements: This section covers the laboratory's quality management system, including document control, review processes, and addressing customer feedback.
- Technical Requirements: This section focuses on the technical competence of the laboratory, encompassing staff competency, equipment calibration and maintenance, testing procedures, and the interpretation of results.
- Pre-examination, Examination, and Post-examination Processes: These sections cover the entire laboratory testing process, including the handling of samples, testing procedures, result verification, and result reporting.
- Internal and External Quality Control: This aspect emphasizes the importance of implementing quality control measures to ensure the accuracy and reliability of test results.
- Laboratory Safety: Ensuring the safety of laboratory personnel and maintaining a safe working environment.
UKAS (United Kingdom Accreditation Service) is the national accreditation body for the United Kingdom. It is responsible for assessing and accrediting conformity assessment bodies, including testing laboratories, calibration laboratories, and certification bodies, to various international standards.
When a medical laboratory achieves ISO 15189 certification, it demonstrates that it has met the requirements of the standard and has been independently audited and accredited by a recognized accreditation body like UKAS. Accreditation by UKAS adds an extra level of confidence for the laboratory’s customers and stakeholders regarding the laboratory’s technical competence and adherence to international standards.
It’s important to note that accreditation to ISO 15189 by UKAS or any other national accreditation body is voluntary. However, many medical laboratories seek accreditation to demonstrate their commitment to quality, accuracy, and patient safety.
As with any ISO standard, it’s crucial to check for the most current version or updates beyond my last update in September 2021. The latest version of ISO 15189 is ISO 15189:2012. For the most up-to-date information on UKAS accreditation and ISO 15189, please refer to the official UKAS website or the International Organization for Standardization (ISO).
Care Quality Commission (CQC)
MB Healthcare Services Ltd is also working towards CQC certification.
CQC stands for the Care Quality Commission, which is the independent regulator of health and social care services in England. It was established under the Health and Social Care Act 2008 and is responsible for monitoring, inspecting, and regulating a wide range of healthcare and social care providers in England.
The primary role of the Care Quality Commission is to ensure that health and social care services meet essential standards of quality and safety. The CQC carries out inspections and assessments of various healthcare providers, including hospitals, clinics, care homes, home care agencies, dental practices, and general practitioners (GP) surgeries.
During inspections, the CQC evaluates how well services are delivering care, treatment, and support to patients and service users. They assess whether services are safe, effective, caring, responsive to people’s needs, and well-led. The CQC also takes into account feedback from patients, service users, and their families in its evaluations.
If a healthcare provider is found to be failing in meeting the required standards, the CQC has the authority to take enforcement actions, such as issuing warning notices, imposing conditions on registration, or even cancelling the provider’s registration, if necessary.
The Care Quality Commission plays a crucial role in maintaining and improving the quality of health and social care services in England. It provides transparency and accountability, helping patients and service users make informed decisions about their care options.
It’s important to note that the Care Quality Commission’s jurisdiction is limited to healthcare and social care services in England. Scotland, Wales, and Northern Ireland have their own separate regulatory bodies responsible for overseeing healthcare services in their respective countries.
