ISO 15189, QMS for Medical Laboratory

Management Structure

Assistance will be provided to the 'Top Management' in the development &/or review of the facility management structure as per the HAAD standards with regards to vision, mission, values, objectives, organizational charts and scope of services [for each medical specialty provided] • Strategic plan

DEVELOPMENT OF JOB DESCRIPTIONS AND PRIVILEGES

'ADIQC' team will work with each staff in order to gain information on their scope practice and prepare job descriptions accordingly. For Doctors, Pathologist and Radiologist; clinical privileges will be developed according to their specialties.

DEVELOPMENT OF POLICIES, PROCEDURES AND GUIDELINES

'ADIQC' Consultant will provide full assistance for the development of documentation, both generic and specific to the scope of services, for inpatients, outpatients and emergency department according to the requirements of HAAD standards and the facility practices

TRAINING AND IMPLEMENTATION

The management and staff will be trained on how to implement the developed policies, procedures and guidelines. Subsequently, each Head of the area will be responsible for the implementation of these manuals; where as the 'ADIQC' consultant will conduct random audits to check whether the QMS have been implemented effectively or not & help close the gaps, if any

DEVELOPMENT AND IMPLEMENTATION OF CLINICAL PRACTICE GUIDELINES

One of the comments received usually in HAAD inspection report is the development & implementation of 'Clinical Practice Guideline'; so, 'ADIQC' consultants will assist Doctors for the development of CPGs as per their scope of practice. As a right-hand rule, each specialty should have at least two CPGs.

What We Offer

Provision of consultancy for the development of Quality Management Systems (QMS) against ISO 15189:2012 (Management and Technical Part)

Risk Assessment and Management through Failure Mode & Effects Analysis (FMEA)

Performance monitoring and measurement through key performance indicators (KPI's)

Incident investigation and reporting

Help initiate &/or perform performance improvement project through using different quality models such as PDCA, Lean philosophy, Six Sigma etc.

Why Choose 'ADIQC'

We effectively train our customer at the implementation stage, thereby enabling them to maintain & improve their QMS independently after accreditation

We provide enough time to our customer to discuss & clarify issues & concerns, as needed during our meeting sessions

We are flexible and work according to customer' convenience

we attend the call any time during the working hours, if needed by the customer, for expertise assistance

Goal oriented – Keeping on track through developed 'Action Plan'

The Benefits of Accreditation against ISO 15189

“Laboratory accreditation provides a benchmark for performance, a range of marketing advantages, and international recognition of technical competence” - ILAC

Fulfillment of regulatory requirement

Providing quality of service which enhances patient safety, security, and satisfaction

Once accredited, it assures you or your customers that your laboratory’s test or calibration data are accurate and reliable

The process - How'll we do it for your prestigious organization?

Management Structure

DEVELOPMENT OF JOB DESCRIPTIONS AND PRIVILEGES

DEVELOPMENT OF POLICIES, PROCEDURES AND GUIDELINES

TRAINING AND IMPLEMENTATION

DEVELOPMENT AND IMPLEMENTATION OF CLINICAL PRACTICE GUIDELINES

Deliverable from 'ADIQC'

Gap analysis report

Awareness training on ISO 15189 standard

Documentation including policies & procedures, plans & programs, satisfaction surveys & evaluation (staff, customer, supplier)

Training on how to implement the documented Laboratory QMS

Tracer and mock survey reports

Support to rectify the 'Findings' consequent upon the assessment by the Accreditation Body