CONSULTANCY
MH Tech Centre offers range of service on QMS, evaluate your needs carefully to understand whether you need a consultant. Working with top management and support staff
- Develop the project and define the roles and responsibilities.
- Assess the current state and define the desired state.
- Identify gaps related to ISO and relevant regulations.
- Develop implementation roadmap to close the gaps.
- Provide tools, and templates to build a fit-for-purpose
- Revisions to SOPs and/or work instructions.
ISO 13485:2016 Quality Management systems - requirements for regulatory purpose
ISO 13485 published in 2016, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices. Based on the ISO 9001 process model, proposes that the application and management of a system of processes is an effective way to ensure excellent quality management. Requirements of this Standard are specific to medical device company, regardless of the size or type of the company. The standard infers that clientele should consider using ISO 9001 to ensure understanding of the Process Model, and other elements.
Requirements of ISO 13485 are applicable to organizations regardless of their size and type except where explicitly stated. To know more about ISO 13485:2016 QMS please feel to contact us
ISO 9001:2015 Quality Management System-requirements
ISO stands for International Organization of Standardization, formed in 1947. It is a worldwide federation of “Member Bodies” it’s headquartering at Geneva, Switzerland. ISO 9001 QMS is the most recent version of QMS (quality management system) standard. It provides requirements for a QMS where an organization needs to:
- Demonstrate its competence to consistently supply product that meets customer and applicable product requirements as well as statutory & regulatory requirements.
- Address customer satisfaction through the effective use of the system, including processes for continual improvement of the system
The ISO 9001:2015 standard requirements include the following main sections:
- Context of organization
- Leadership
- Planning
- Support
- Operation
- Performance evaluation
- Improvement
To know more about ISO 9001:2015 QMS please feel to contact us
ISO/IEC 17025:2017 – The Standard for testing and calibration laboratories
ISO/IEC 17025:2005 Standard has all of the requirements that testing and calibration laboratories need to comply in order to show that:-
- They operate a quality system,
- They are technically competent and producing valid results.
The ISO 17025 requirements are specific to testing and calibration laboratories. This standard concentrate on use of well-defined test or calibration procedures, participation in proficiency testing, and contents of test reports and certificates.
The development of this standard was to harmonize laboratory accreditation and acceptance of test data internationally. All participating countries requires to accept the test results performed by accredited labs by other countries.
it sets out requirements for the competence, impartiality, and consistent operation of laboratories, ensuring the accuracy and reliability of the their testing and calibration results.
To know more about ISO/IEC 17025 please feel to contact us
ISO 15189:2022 – The Standard for Medical Laboratories
ISO 15189 Medical laboratories the quality management system requirements particular to medical laboratories. The standard was developed by the International Technical Committee 212 (ISO/TC 212). ISO/TC 212 assigned ISO 15189 to a working group to prepare the standard based on the details of ISO/IEC 17025 general requirements for the competence of testing and calibration laboratories. This working group included provision of advice to users of the laboratory service, the collection of patient samples, and interpretation of test results, adequate turnaround times, and the lab's role in the educating and training of health care staff.
While the standard is based on ISO/IEC 17025 and ISO 9001, it is a unique document that takes into consideration the specific requirements of the medical environment and the importance of the medical laboratory to patient care.
To know more about ISO 15189 please feel to contact us
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