ISO/IEC Consultancy

About TraSa:

The Trade Safe (TraSa) Project is funded by the United States Department of Agriculture (USDA) and implemented by the non-profit organization Improving Economies for Stronger Communities (IESC). This project seeks to improve the efficiency, coordination, and transparency of agricultural trade, as well as food safety, through the development and implementation of measures, standards, and sanitary and phytosanitary regulations based on both science and risk analysis.

Background:

The global expansion of trade has led to an increase in market entry requirements, including various standards and technical regulations. While compliance with these standards is essential, it can sometimes serve as a barrier to trade. For example, when importing countries do not trust their trading partners' conformity assessment process, they may require additional laboratory testing, duplicating efforts already undertaken in the exporting nation.

In cases where a country adopts regulatory measures based on non-accredited laboratory test results, affected parties may challenge this action. Such problems arising from the absence of a credible conformity assessment infrastructure can cause significant delays in the movement of goods.

International recognition of laboratory technical competence is essential to determine the acceptability of products in international trade. In this context, the international standard ISO/IEC 17025:2017 was developed to instill confidence in laboratory competence. ISO/IEC 17025:2017 accreditation serves as proof that a laboratory maintains an effective quality management system and possesses the capability and competence to provide test results that are mutually accepted by multiple regulatory authorities.

In the Dominican Republic, many national conformity assessment bodies lack accreditation. As a result, many analyses required by international markets are carried out by foreign laboratories.

Recognizing the need to improve the quality and reliability of results, facilitate trade and give the Dominican Republic a competitive advantage, the National Trade Facilitation Committee (NTFC) Laboratory Working Group has sought the support of TraSa to achieve the preparation and proper organization with the objective of certifying the institution in ISO/IEC 17025:2017.

It is worth noting that in 2020, the Dominican Accreditation Body (ODAC), an active member of the NTFC Laboratory Working Group, achieved the status of signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangements (ILAC MRA) for calibration and testing (ISO/IEC 17025:2017). This status allows ODAC to grant ISO/IEC 17025:2017 accreditation for specific tests submitted by Dominican laboratories.

Consulting objectives:

Support to take the necessary steps for the implementation of the preparation and establishment process of the ISO/IEC 17025:2017:2017 management system for the Laboratory for the Evaluation of Human Consumption Products (LEPCH), in Santo Domingo, Dominican Republic, according to the diagnosis and evaluation carried out by the survey made for the identification of the SWOT of the LEPCH, covering the following scope:

Documentation and document management system development: Assist and implement the creation and review of the necessary documentation, including policies, procedures and manuals to meet the requirements of ISO/IEC 17025:2017. The documentation must be clear, accessible and comply with the standards of the standard, to facilitate implementation and compliance.

Staff Training and Awareness: Provide specific training for key personnel, ensuring they understand the principles of ISO/IEC 17025:2017 and its importance. This fosters a culture of quality within the organization and prepares the team to face internal and external audits.

Implementation of Quality Management Systems and Processes: Guidance and support in the implementation of a quality management system with processes and practices aligned with the requirements of the standard. This includes the optimization of workflows and the integration of quality management in all necessary operational areas.

Audit Preparation and Pilot: Plan and conduct audit simulation(s) to assess the organization's readiness prior to official certification, identifying and correcting potential non-conformities and thus increasing the chances of success in the certification process.

Accreditation process: Support in the application process for the accreditation of tests of the Laboratory for the Evaluation of Products for Human Consumption (LEPCH) before the ODAC.

Responsibilities

Update of Diagnosis and evaluation prepared:

Diagnostic update and initial assessment to establish a baseline on which future actions will be built based on the requirements of ISO/IEC 17025:2017, identifying gaps and areas for improvement.

Strategy Development:

Design a work schedule and a clear and structured action plan that includes all stages of the certification process.

Establish deadlines and assign responsibilities for each activity within the plan.

Training and Capacity Building:

Develop and deliver training/education programs for key personnel on the requirements of the standard and quality management practices in reference to ISO/IEC 17025:2017

Assistance in Documentation:

Provide guidance in the creation and review of necessary documentation, ensuring that it meets the regulatory requirements for ISO/IEC 17025:2017 and is aligned with the organization's operations.

Establish a work plan for the implementation of an effective document management system.

Process Implementation:

Support the implementation of processes and procedures that comply with ISO/IEC 17025:2017 standards.

Provide tools and resources to facilitate the integration of quality management into the organizational culture.

Internal Audits and Evaluations:

Plan and perform internal audit(s) to assess the compliance of the management system with ISO /IEC 17025:2017.

Continuous improvement based on audit results.

Certification Preparation:

Assist in preparing the organization for the certification audit, including simulations and correction of identified non-conformities.

Act as a liaison between the organization and the certification body, facilitating communication and the process.

Monitoring and Continuous Improvement:

Establish monitoring mechanisms (e.g. indicators, others) to evaluate the effectiveness of the implemented processes and their alignment with the standard.

Promote a culture of continuous improvement, suggesting actions and strategies to optimize the management system.

Deliverables

All deliverables must be provided in Spanish and in an editable format. *The delivery dates proposed below are estimates.

Deliverable 1. Work plan and schedule of activities with key dates and important milestones in the certification process.

This deliverable must have:

A list of all activities necessary to carry out the consultancy, sequenced in chronological order, including the names of the team members assigned to carry out each activity.

An estimate of the time required to complete each activity.

An estimate of the delivery date for each deliverable.

A strategy for conducting periodic follow-up reviews.

Deliverable 2. Report with initial findings and recommendations derived from the update of the diagnosis and evaluation.

This deliverable must contain:

Methodology: description of the techniques and tools used for the diagnosis (interviews, documentary reviews, audits, etc.) and scope of the evaluation (areas and processes analyzed).

Findings: Detail key findings organized by areas or processes.

ISO/IEC 17025:2017 requirements

Observations on strengths and weaknesses of the current management system - SWOT Matrix

Recommendations and Risk Analysis:

Matrix of identified risks that may affect compliance with ISO/IEC 17025:2017

Specific suggestions to address the identified gaps and weaknesses.

Priority of each recommendation (high, medium, low).

Identification of steps and/or resources necessary to implement each recommendation.

Plan of action Suggested:

Action plan for the implementation of the recommendations.

Deadlines for the execution of the suggested actions.

Deliverable 3. Documentation

Implement the creation and/or review of documentation, including policies, procedures and manuals necessary to comply with the requirements of ISO/IEC 17025:2017. This deliverable must have the following elements:

Policies:

Quality Policy:

Statement of commitment to quality and quality objectives, referencing competence, impartiality and consistent operation of the laboratory (ISO/IEC 17025, 8.2)

Risk Management Policy:

Focus on identifying and managing risks in all applicable areas in accordance with the Standard.

Procedure that indicates how to address Risks and Opportunities.

Procedures:

Procedures Operational :

Details of the key processes that must be followed to comply with the requirements of the standard.

Review and update control matrices and calibration maintenance as applicable

Procedure for handling test items

Equipment coding procedures.

Process traceability policy, as applicable

Internal Audit Procedures :

Methods and frequency for conducting internal audits and monitoring non-conformities.

Customer Service Procedure

Receiving customer requests and requirements, including clear mechanisms for receiving testing or calibration requests, confirming that customer requirements are understood and feasible to meet, and procedures for documenting and analyzing specific customer requirements.

Customer communication management

Identification of those responsible for maintaining contact with the client and defined communication channels for queries, clarifications and updates on the status of the service.

Confidentiality and protection of customer information

Guarantees that the information obtained during the provision of the service will be treated as confidential.

Provision of clear and transparent information

Explanation of the results of tests or calibrations in a comprehensible manner and inclusion of interpretations, if applicable, in accordance with the agreements made.

Complaints and claims management

Establish a process for receiving, documenting and resolving customer complaints or claims and define response times and measures to address complaints in an objective and impartial manner.

Feedback management and customer satisfaction

Collecting feedback on customer experience with the laboratory. Surveys.

Using feedback to implement process improvements.

Document Management Procedures:

Methods for creating, reviewing, approving, controlling and distributing documents.

Quality Manual:

Summary of the organization's quality management system.

Structure and content of the management system, including interactions between processes.

Data control and information management

Matrices:

Responsibilities Matrix specifying Roles and Responsibilities for each unit.

Task Assignment Matrix, indicating details of who is responsible for which specific tasks

Other matrices relevant and binding to the process.

Records:

Identification of records necessary to demonstrate compliance (audit reports, review reports, etc.).

Archiving and record keeping methods.

Formats and Templates:

Provision of necessary formats and templates for documentation and records, ensuring uniformity and consistency.

Work Instructions:

Detailed documentation that guides employees in specific tasks related to quality processes.

Review and Approval:

Process for reviewing and approving documents, including roles and responsibilities.

Training and Awareness:

Strategies to train staff on the policies and procedures developed.

Communication plan or protocol on changes and versions in documentation.

Deliverable 4. Process implementation

This deliverable must have the following elements:

Process Description:

List of processes to be implemented, including their purpose and relevance in the management system.

Process map illustrating the interactions between them.

Any other resource that contributes to the clear description of the processes

Procedures Detailed:

Documentation of each process, including:

Process Objectives: what is expected to be achieved.

Inputs and Outputs: resources and products of the process.

Activities: detailed steps that will be followed to carry out the process.

Responsibilities: who is responsible for each activity.

Performance Indicators:

Definition of KPIs (Key Performance Indicators) to measure the effectiveness and efficiency of the implemented processes.

Methods for data collection and analysis.

Resources Required:

Identification of the human, technological and material resources necessary for the implementation of the processes.

Implementation Plan:

Schedule with specific deadlines for the implementation of each process.

Stages of implementation, including key milestones.

Staff Training:

Strategy to train staff involved in new processes.

Training and awareness plan on the changes and their importance.

Evaluation and Monitoring:

Methods for monitoring the performance of implemented processes.

Periodic review process to assess the conformity and effectiveness of processes.

Non- Conformity Management:

Protocol for identifying, recording and correcting non-conformities in processes.

Strategies to prevent recurrence of problems.

Improvement:

Approach to continuous review and improvement of processes.

Foster an organizational culture that values feedback and innovation.

Deliverable 5. Preparation and pilot of Audits and Management Review Report

Audit Planning:

Audit Scope: Definition of the processes and areas to be audited.

Audit Schedule: Dates and duration of the audit, including simulation.

Audit Criteria:

ISO/IEC 17025:2017 standards and requirements to be assessed during the audit.

Specific criteria for the evaluation of each process or area.

Audit Team:

Identification of audit team members, including roles and responsibilities.

Pre-training of the team on the audit approach and requirements.

Documentation Preparation:

List of documents and records required for the audit.

Preparation of audit guides and checklists detailing the aspects to be evaluated.

Audit Pilot:

Description of the audit pilot process, including objectives and methodology.

Execution of the pilot, detailing schedule, activities and interviews conducted.

Identification of Non- Conformities:

Records of findings and non-conformities identified during the simulation.

Classification of nonconformities by severity and type.

Results:

Preparation of a report that includes:

Pilot audit summary.

Key findings and nonconformities.

Recommendations for addressing nonconformities.

Action Plan :

Proposal for an action plan to correct the non-conformities detected.

Assignment of responsibilities and deadlines for the implementation of corrective actions.

Method of payment:

TraSa will make payment upon delivery and approval of the deliverables.

Duration:

The consultant(s) or consulting firm will have a maximum of one (1) year to complete the consultancy. The consultancy is expected to begin in June 2025.

Application evaluation process:

Applications will be evaluated based on the criteria detailed below:

Consultant profile(s). Total weight: 60%

Offerors must include a profile description of the consultant(s) who would work directly on the assignment. In this profile description, offerors must demonstrate the extent to which the consultant(s) meet each of the criteria listed below. This profile description must be limited to 2 pages. CVs and certifications must be submitted as attachments to the profile description and are not included in the page limitations, but must be