QMS Policy
Field of Application
This policy defines Zeroframe S.r.l.’s guiding principles and commitments for quality management. It applies to all processes and personnel involved in the supply of Smoke Study services, in accordance with the requirements of the ISO 9001 standard and stakeholder expectations.
QMS Policy
Regulatory and Terminological Framework
Regulatory References
- ISO 9001: Quality management systems — Requirements
- Good Manufacturing Practices (GMP)
Terms and Definitions
- Quality Management System (QMS): Set of related or interacting elements of an organisation for establishing policies, goals and processes for achieving these goals, with reference to quality.
- Continuous Improvement: Recurrent activities aimed at improving performance.
- Stakeholder: Person or organisation who can affect, be affected by or perceive they are being affected by a decision or an activity.
- Quality: Extent to which a set of intrinsic characteristics of an object meets requirements.
QMS Policy
Roles and Responsibilities
Top Management: Defines the organisation's strategic goals, establishes this Policy and commits to ensuring its implementation, providing support and ensuring it is always suitable and up-to-date. Promotes the culture of continuous improvement and ensures the availability of the necessary resources for the operation of the Quality Management System.
Quality Management System Manager: Ensures the correct management, application and distribution of the documentation of the QMS, including this Policy. Supports Top Management in monitoring the system's performance and promoting awareness of its requirements at all levels of the organisation.
QMS Policy
Quality Management System Goals and Commitment
Zeroframe S.r.l.’s Top Management establishes, implements and supports this Quality Policy as an expression of its strategic policies and as a guide for the entire Management System. The Policy is based on the following fundamental commitments and principles, considered essential for the success of the organisation and for satisfying the stakeholders.
QMS Policy
Principles and Commitments
Suitability for the Context and the Strategic Policies
The Top Management is committed to guaranteeing that this Policy is always appropriate for the goals and contexts in which Zeroframe operates. The primary goal is to provide Smoke Study services for the visualisation of air flows in controlled-contamination environments, such as cleanrooms and sterile areas, supporting clients in the pharmaceutical sector and other regulated sectors. The Policy is aligned with the analyses and strategies defined in the Contextual Analysis document, and is regularly reviewed to ensure its continued suitability.
Framework of Reference for Goals
This Policy represents the framework of reference for the definition and review of the quality goals. The Top Management ensures that the goals are measurable, consistent with the commitments defined herein, and planned in accordance with the procedure "PRO Goals and Planning to Meet Them".
Meeting Applicable Requirements
Zeroframe is committed to meeting all applicable requirements, including:
- Explicit and implicit client requirements.
- Regulatory and legislative requirements for the sector, such as Good Manufacturing Practices (GMP).
- Voluntary standards to be met, such as ISO 9001.
- Expectations of relevant stakeholders.
Continuous Improvement
The Top Management actively promotes a culture of continuous improvement at all levels of the organisation. This commitment aims to constantly increase the effectiveness of the Quality Management System, through performance assessment, risk management, auditing, and systematic review of processes. The improvement activities are managed in accordance with the procedures "PRO Management Review Management" and "PRO Management Procedure for Findings and Events".
QMS Policy
Communication and Application of the Policy
Availability and Distribution: The Top Management, with the support of the Quality Management System Manager, ensures that the Quality Policy is:
- Maintained as documented information, according to the methods defined in "PRO Management Procedure for Documented Information".
- Distributed to, understood by and applied to/by all personnel at all levels of the organisation. The distribution and training activities are managed via "PRO Human Resources Management Procedure".
- Made available to all relevant stakeholders (e.g. clients, suppliers, supervisory bodies) through the corporate communication channels, such as the website, or on specific request.
Each member of staff has the responsibility to ensure they have understood and apply the principles of this policy in carrying out their day-to-day tasks.
QMS Policy
Archiving and Updates
This Policy is managed as documented and controlled information. It is reviewed at least once per year, during the Management Review, and updated whenever significant changes occur in the context, strategic policies or applicable requirements, to ensure its continued suitability and effectiveness.