Quality Policy
Introduction
Quality policy is the foundation of our organization’s quality system and is incorporated in our
Quality Manual. It focuses on our management’s commitment to quality and our customers’
expectations as well as to safety of all clinical trial subjects participating in any projects managed by
our organization.
Definitions:
Quality Assurance (QA) focuses on preventing defects and maintaining the overall quality
management system through process implementation and improvement. It ensures that
proper processes are in place to avoid issues.
Quality Control (QC) focuses on detecting and correcting defects. Quality control is the
process by which services are tested and measured to ensure they meet a standard. Through
this process, a business can evaluate, maintain, and improve service quality. QC processes:
reviews, questionnaires, surveys, inspections, and audits.
Quality System (QS) involves both QC and QA elements ensuring appropriate quality during
all activities and performance of the organization and prevents / identifies possible quality
issues during the organizational activities.
Importance of QS at our company:
– to safeguard our company’s reputation,
– prevent our services from being unreliable,
– increase trust at our partners.
It ensures that the company looks at evidence-based data and research to ensure that the services
live up to the standards.
Key reasons of importance: customer satisfaction, error prevention, cost reduction, compliance and
regulation (QC ensures that services adhere to industry standards and regulatory requirements,
avoiding legal issues and penalties), brand reputation, increased efficiency, risk mitigation,
continuous improvement, international competitiveness, customer loyalty and retention.
General objectives/goals of QS:
The primary objective of Quality Control is to identify and correct any deviations from the established
quality standards. This process involves monitoring and inspecting services at various stages to
ensure that they meet the desired level of quality. QC is also concerned with preventing defects or
errors from occurring in the first place by implementing measures to control and improve the
production or service delivery processes.
Primary goals of QC:
-
- to ensure that services are as uniform as possible and
- to minimize errors and inconsistencies
Key components of Quality Control at our company include:
-
- Inspection: Regularly examining materials or services to identify defects, non-compliance, or
deviations from quality standards. - Testing: Conducting various tests and measurements to assess the performance,
functionality, or characteristics of services. - Statistical Process Control (SPC): Employing statistical techniques to monitor and control the
production processes, ensuring that they remain within acceptable quality limits. - Documentation and Records: Keeping detailed records of inspections, tests, and corrective
actions taken to maintain traceability and accountability. - Corrective and Preventative Actions: Implementing appropriate measures to address any
identified quality issues and prevent their recurrence. - Training and Education: Providing employees with the necessary skills and knowledge to
maintain quality standards in their services effectively. - Quality Improvement: Constantly analyzing data and feedback to identify areas for
improvement and enhancing the overall quality management system.
- Inspection: Regularly examining materials or services to identify defects, non-compliance, or
Steps of Quality Control
-
- to set your quality standards and decide which ones to focus on
- establish operational processes to deliver optimal quality and implementation.
- review results and identify gaps.
- get feedback.
QC techniques
inspections, audits (internal, external, authority)
checks – before, during and on completion
Mission Statements
N&SZ StudyMaster consistently provides services that meet or exceed the requirements and
expectations of our customers. We will actively pursue ever improving quality through programs that
enable each employee to do their job right the first time and every time.
N&SZ StudyMaster provides accurate, planned, high quality Clinical Trial Management services
within agreed timelines and deliverables like number of enrolled patients, number, and quality of
data.
N&SZ StudyMaster Human Outsourcing services ensures experienced and trained team for long term
cooperation and flexible adjustment for resource needed. The company working relationship based
on faith, transparency, and cooperation.
N&SZ StudyMaster started developing a quality management system certified with ISO 9001:2015.
N&SZ StudyMaster committed to
- comply with the national and international legal regulations,
- keep customer satisfaction at the highest level,
- work in cooperation and confidence with our suppliers and customers,
- ensure clinical trial subjects’ safety is put at first in all projects we participate,
- provide employees’ education with high know how and experience we have in our business,
- comply with the terms of quality management system and continuously improve its
effectiveness, - be the preferred organization in our sector with our quality services,
- perform financial growth, and increase the number of its staff (employees or contractors),
- make improvement at work by assessing customer satisfaction and complaints,
- maintain the availability, integrity, and privacy of knowledge by reducing the effect of
information security threats, - adhere to global environmental and sustainability objectives and initiatives,
- ensure our employees work in compliance, in a safe and healthy environment without
differentiation among our employees on language, religion, race, gender, political thought,
sectarian, age, and physical status, - ensure our employees and relevant parties work within the framework of ethical rules,
- ensure our employees take the relevant trainings.
Quality Principles at our company:
-
- Client needs – our services should meet our customer needs and patient safety.
- Client preferences – our services should be set to suit our clients’ preferences.
- Service and experience – our services should be on high standards through experienced
staff. - Listening – we are committed to listen to our clients using their input to improve quality.
- Compliance – we are committed to comply to applicable regulations and standards.
- Health and Safety – we are dedicated performing all activities to ensure health and safety to
all trial subjects and our co-workers. - Excellence – we are dedicated performing our services at highest standards and keep defects
at zero levels. - Accuracy – we are committed providing accurate, honest, and clear information to our
partners at any circumstances. - Quality checks and inspections – we are committed to check and regularly inspect our
services provided to our partners. - Environment and sustainability – we are committed to provide our services responsibly by
adhering global environmental and sustainability standards. - Improvement – we are dedicated to improving our work continually and constantly.
- Communities and society – we are committed to operate on the benefit of people,
communities, and the society. - Privacy – we are committed to handle client and other data secure and private by applicable
regulations and standards. - Sourcing – we are committed to source personal resources and material goods in a
responsible manner.
Our references
