Executive Summary / Purpose
This document states the Diagnostics 360 Pathology Quality Statement in terms of its relationship with the overall corporate objectives of Diagnostics 360. The laboratory commits to provide its users with a high-quality service taking the users’ needs into consideration.
1.1 Instructions to recipients
Recipients shall identify individuals within the company who should have sight of this document and distribute it via the appropriate channels.
Recipients for this document should read and understand the contents of the document, where applicable acknowledge understanding of the document.
Scope/Roles & Responsibilities
This document has been produced for use by all our staff members, as it contains information regarding the organisation as a whole and the Diagnostics 360 Pathology place within the company. This guide provides a backbone of the laboratory’s commitment to provide a service of the highest quality and comply with the international standards ISO 15189 set by UKAS.
Our dedicated, state-of-the-art laboratory in Chiswick offers the finest in pathology testing solutions across many disciplines including clinical biochemistry, immunology, haematology, viral PCR and sexual health screening. More information on the tests and services we provide can be found on our website: http://www.diagnostics360.co.uk. Our partner clinics, GPs and pharmacies provide phlebotomy services.
2.2. Roles and Responsibilities
It is the responsibility of the member of staff following this procedure to ensure they fully understand the procedure. Any queries regarding procedure or Health and Safety must be raised with the Quality Manager or the Health and Safety Officer.
Notify the Quality Manager of any amendments required to this protocol. All changes must be made under change control by the Quality Manager.
The Pathology Service shares the corporate objectives of Diagnostics 360 and contributes to their fulfilment by providing an analytical service which meets the standards laid down by professional and other appropriate bodies. The department is committed to providing a service of the highest quality and shall be aware of and take into consideration the needs and requirements of its users. The Pathology Service has developed a quality management system and is working towards application and assessment to ISO 15189:2012. The purpose of the quality management system is to provide a framework for directing and managing activities carried out by all our healthcare staff, which is essential to providing a high-quality service that meets the needs and requirements of our users.
In order to ensure that the needs and requirements of users are met, Diagnostics 360 will:
- Operate a quality management system to integrate the organisation, procedures, processes, and resources.
- Establish quality objectives and plans to achieve them and review these objectives periodically.
- Ensure that all personnel are familiar with the Quality Policy, the Quality Manual, and related processes, to ensure user satisfaction.
- Commit to the health, safety and welfare of their entire staff, and visitors to the laboratories.
- Comply with the relevant environmental legislation.
- Be committed to meeting the requirements of the standards set by Medical Laboratories to ensure compliance with UKAS Standards (ISO15189:2012) and Care and quality commission (CQC).
- Uphold professional values and commit to good professional practice and conduct.
The laboratory is committed to ensuring compliance with the requirements of the ISO 15189:2012 Standard, and to the standards of accrediting bodies. This includes a commitment to:
- Staff recruitment, training, development, and retention at all levels to provide a full and effective service to its users.
- The proper procurement and maintenance of such equipment and other resources as are needed for the provision of the service.
- The collection, transport, and handling of all specimens in such a way as to ensure the correct and safe performance of laboratory examinations.
- The use of examination procedures that will ensure the highest achievable quality of all tests performed, in conjunction with CE-marked kits and validation of in-house assays.
- Reporting results of examinations in ways which are timely, conﬁdential, accurate and clinically useful.
- The assessment of user satisfaction, in addition to internal audit and external quality assessment, in order to produce continual quality improvement.
- Set quality objectives and plans to implement this quality statement.
- Ensure that all personnel are familiar with this quality statement to ensure user satisfaction.
- Commit to the health, safety, and welfare of its entire staff. Visitors to the department will be treated with respect and due consideration will be given to their safety while on site.
Policies are reviewed as a minimum on a 2-year basis. In addition to the 2-year review, results of audits, complaints, and incidents may identify a requirement for the document to be amended. All documented procedures fall under Diagnostics 360’s Quality Assurance Internal Audit programme which requires services to select documented procedures for internal review as part of ongoing audit programmes. Where changes are required, the author is responsible for undertaking the review prior to the formal 2-year review.
Policy Author Declaration
The policy author is responsible for ensuring that the documented procedure has been developed in line with Diagnostics 360’s policies and also ensures the author confirms they have complied with Diagnostics 360’s Diversity requirements.
Author Declaration The document style and format are consistent with policy (including the footer and explanation of terms used) and are relevant to the document type e.g. policy, SOP, and protocol. The title/outcome/objective/target audience and monitoring arrangements are clear and unambiguous The relevant expertise has been used and the evidence base is relevant, and up to date. There are supporting references and a cross-reference to associated documents e.g. other policies. Stakeholder, user and ratification forum consultation confirms the accuracy and clarity of document/statements Superseded documents have been referenced in the reader box, and the master location for this document has been documented Equality and Diversity Statement: I confirm that this document does not discriminate on the basis of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, sex or sexual orientation.
ISO 15189:2012 / 184.108.40.206 Quality policy