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	<title>Vicente Catal&aacute;n Lab Consulting</title>
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		<title>Interim Management: Key to Laboratory Innovation and Growth</title>
		<link>https://vclabconsulting.com/en/strategic-laboratory-management/interim-management-key-to-laboratory-innovation-and-growth/</link>
		
		<dc:creator><![CDATA[admin]]></dc:creator>
		<pubDate>Fri, 03 May 2024 17:37:22 +0000</pubDate>
				<category><![CDATA[Strategic Laboratory Management]]></category>
		<category><![CDATA[Inglés]]></category>
		<guid isPermaLink="false">https://vclabconsulting.com/?p=4490</guid>

					<description><![CDATA[<p>Interim Management: A Key to Laboratory Innovation and Growth</p>
<p>The post <a href="https://vclabconsulting.com/en/strategic-laboratory-management/interim-management-key-to-laboratory-innovation-and-growth/">Interim Management: Key to Laboratory Innovation and Growth</a> appeared first on <a href="https://vclabconsulting.com/en/home">Vicente Catal&aacute;n Lab Consulting</a>.</p>
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					<h1 class="elementor-heading-title elementor-size-default">Interim Management: Key to Laboratory Innovation and Growth</h1>				</div>
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									<p><strong>The Interim Manager</strong> is a role that is increasingly employed in various business sectors, <strong>especially in highly competitive markets like testing laboratories,</strong> where accelerating the company&#8217;s growth and consolidating productive activities are necessary.</p><p>Interim management in a laboratory involves <strong>hiring a temporary manager or management team to direct and oversee the laboratory&#8217;s operations for a specific period</strong>. This may be necessary in situations such as staff transitions, periods of organizational change, implementation of new systems or processes, or when specialized expertise that is not available within the organization is required.</p><p>Interim Managers are experienced professionals who can <strong>temporarily fill leadership roles, bringing their knowledge and skills to help the laboratory overcome challenges and achieve its objectives.</strong> They often have extensive experience in specific areas such as research and development, project management, legislation, market, and business development, among others. This experience enables them to quickly understand the laboratory&#8217;s challenges and opportunities.</p><p>Their approach is usually pragmatic and results-oriented, working closely with the existing team to ensure a smooth and effective transition during their management period.</p><p>The temporary nature of the Interim Manager <strong>provides flexibility and agility to organizations,</strong> which is especially important in a competitive market like that of laboratories, where needs and priorities can change rapidly. This allows organizations to adapt more easily to changes in the market or strategic direction.</p><p>Interim Managers can bring a fresh perspective and new ideas to laboratories. Coming from different organizations and having faced a variety of challenges in the past, they <strong>can introduce innovative practices, emerging technologies, and creative approaches to problem-solving.</strong> In crisis situations, such as quality issues, regulatory compliance problems, or financial difficulties, Interim Managers can <strong>provide the leadership and expertise needed to quickly resolve problems and restore stability in the laboratory.</strong></p><p>During their time in the laboratory, Interim Managers must <strong>transfer knowledge and skills to internal employees.</strong> This can include<strong> training in new methodologies, implementing best practices, and developing technical and management capabilities</strong>. The ultimate goal is for their knowledge and experience to remain as a valuable asset for the company after their departure.</p>								</div>
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									<p>&#8220;We will see in the coming years how this way of driving innovation and business development in commercial laboratories will grow and gain more followers.&#8221;</p>								</div>
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		<p>The post <a href="https://vclabconsulting.com/en/strategic-laboratory-management/interim-management-key-to-laboratory-innovation-and-growth/">Interim Management: Key to Laboratory Innovation and Growth</a> appeared first on <a href="https://vclabconsulting.com/en/home">Vicente Catal&aacute;n Lab Consulting</a>.</p>
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		<title>Expansion of the Scope of Accreditation in the Microbiological Field of a Testing Laboratory</title>
		<link>https://vclabconsulting.com/en/quality-systems/regulatory-compliance-and-accreditation/expansion-of-the-scope-of-accreditation-in-the-microbiological-field-of-a-testing-laboratory/</link>
		
		<dc:creator><![CDATA[admin]]></dc:creator>
		<pubDate>Mon, 08 Apr 2024 14:08:20 +0000</pubDate>
				<category><![CDATA[Quality Systems]]></category>
		<category><![CDATA[Regulatory Compliance and Accreditation]]></category>
		<category><![CDATA[Sample Quality Control]]></category>
		<category><![CDATA[Staff Training]]></category>
		<category><![CDATA[Technical Support]]></category>
		<guid isPermaLink="false">https://vclabconsulting.com/?p=4605</guid>

					<description><![CDATA[<p>A laboratory in the agri-food and water sectors decided to expand its ISO 17025 accreditation scope in the microbiological field.</p>
<p>The post <a href="https://vclabconsulting.com/en/quality-systems/regulatory-compliance-and-accreditation/expansion-of-the-scope-of-accreditation-in-the-microbiological-field-of-a-testing-laboratory/">Expansion of the Scope of Accreditation in the Microbiological Field of a Testing Laboratory</a> appeared first on <a href="https://vclabconsulting.com/en/home">Vicente Catal&aacute;n Lab Consulting</a>.</p>
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										<content:encoded><![CDATA[		<div data-elementor-type="wp-post" data-elementor-id="4605" class="elementor elementor-4605" data-elementor-post-type="post">
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					<h1 class="elementor-heading-title elementor-size-default">Expansion of the Scope of Accreditation in the Microbiological Field of a Testing Laboratory</h1>				</div>
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					<h3 class="elementor-heading-title elementor-size-default">01. Context</h3>				</div>
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									<p>A laboratory providing analytical services for the agri-food and water sectors decided to expand its <strong>ISO 17025 accreditation</strong> <strong>scope in the microbiological field.</strong></p><p><strong>In the case of water</strong>, it had a very limited accreditation scope that included total Coliforms, Escherichia coli, and heterotrophic plate count at 22°C and 37°C in drinking water. The intention was to expand the scope to include Enterococci, Clostridium perfringens, and Legionella spp. by culture in drinking water, total Coliforms and Escherichia coli in wastewater, and heterotrophic plate count at 22°C and 37°C and Legionella spp. by culture in surface water.</p><p><strong>For food,</strong> the laboratory had accreditation for Coliforms, Escherichia coli, and microorganism count at 30°C in food and feed, and aimed to expand the scope to include Salmonella spp., Listeria monocytogenes, and coagulase-positive Staphylococci in food and feed.</p><p>Due to limited resources focused on day-to-day operations, limited experience in the microbiological field, and the need to obtain accreditation <strong>within a 4-month period</strong>, they decided to seek the support of an external consultant with experience in accreditation processes and technical expertise.</p>								</div>
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					<h3 class="elementor-heading-title elementor-size-default">02. Challenge</h3>				</div>
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									<p>The challenge of the project was clear.</p>								</div>
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									<p>&#8220;Achieve the expansion of the accreditation scope in a short period, while also consolidating technical knowledge in microbiology.&#8221;</p>								</div>
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					<h3 class="elementor-heading-title elementor-size-default">03. Approach</h3>				</div>
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									<p>Given that the laboratory was already<strong> ISO 17025 accredited</strong>, the work focused on preparing the testing procedures. These procedures were drafted by the laboratory staff based on a foundation provided by the Consultant, and through an iterative process, the procedures were reviewed and refined until the final version was achieved.</p><p>The Consultant provided the experimental design for the validations and guided the laboratory until the expanded accreditation scope was obtained.</p><p>However, the unique value was not just in supporting the preparation of the documentation, but also in simultaneously conducting technical training sessions. These sessions aimed to deepen the concepts and consolidate technical knowledge in the field of microbiology.</p>								</div>
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					<h3 class="elementor-heading-title elementor-size-default">04. Results</h3>				</div>
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									<p>Within a month, the testing procedures were in place, the corresponding method validations were completed, and the reports were prepared. An internal audit was also conducted, and finally, the accreditation scope was requested from the Accreditation Body, which took place in person two months later. The audit report included two minor non-conformities that were satisfactorily resolved.</p><p>In parallel, from the beginning of the project until the audit, a remote training session of 2 hours per week was organized, totaling 34 hours. This training covered specific topics on the parameters and analytical methodologies included in the accreditation scope, as well as topics of interest for a water microbiology laboratory. These included aspects of hygiene and safety, internal and external quality evaluation, statistical calculations, handling and preservation of strain collections, calibration of temperature-controlled equipment, etc.</p><p>As a result, the management of this project allowed the company to:</p><ol><li>Achieve the accreditation scope expansion in a very short time.</li><li>Reduce the internal resources needed to obtain accreditation and focus them on day-to-day activities.</li><li>Expand knowledge in the area of microbiology through highly personalized training, allowing for the practical consolidation of the acquired knowledge.</li></ol>								</div>
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		<p>The post <a href="https://vclabconsulting.com/en/quality-systems/regulatory-compliance-and-accreditation/expansion-of-the-scope-of-accreditation-in-the-microbiological-field-of-a-testing-laboratory/">Expansion of the Scope of Accreditation in the Microbiological Field of a Testing Laboratory</a> appeared first on <a href="https://vclabconsulting.com/en/home">Vicente Catal&aacute;n Lab Consulting</a>.</p>
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		<title>Preparation of an Efficiency and Cost Savings Plan in a Commercial Laboratory</title>
		<link>https://vclabconsulting.com/en/strategic-laboratory-management/preparation-of-an-efficiency-and-cost-savings-plan-in-a-commercial-laboratory/</link>
		
		<dc:creator><![CDATA[admin]]></dc:creator>
		<pubDate>Sun, 07 Apr 2024 14:27:51 +0000</pubDate>
				<category><![CDATA[Strategic Laboratory Management]]></category>
		<guid isPermaLink="false">https://vclabconsulting.com/?p=4622</guid>

					<description><![CDATA[<p>Design of a Strategic Efficiency Improvement Plan, tailored to the specific activities of a commercial laboratory.</p>
<p>The post <a href="https://vclabconsulting.com/en/strategic-laboratory-management/preparation-of-an-efficiency-and-cost-savings-plan-in-a-commercial-laboratory/">Preparation of an Efficiency and Cost Savings Plan in a Commercial Laboratory</a> appeared first on <a href="https://vclabconsulting.com/en/home">Vicente Catal&aacute;n Lab Consulting</a>.</p>
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										<content:encoded><![CDATA[		<div data-elementor-type="wp-post" data-elementor-id="4622" class="elementor elementor-4622" data-elementor-post-type="post">
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					<h1 class="elementor-heading-title elementor-size-default">Preparation of an Efficiency and Cost Savings Plan in a Commercial Laboratory</h1>				</div>
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					<h3 class="elementor-heading-title elementor-size-default">01. Context</h3>				</div>
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									<p>A laboratory providing analytical services for the agri-food sectors launched a project aimed at improving process efficiency, reducing production costs, and increasing productivity.</p><p>The reasons for launching this project included a significant <strong>increase in sample volume, increasingly stringent regulatory requirements regarding quality, and the growing complexity of interactions between the technical department and other departments such as finance, commercial, marketing, etc.</strong> In this context of rising demands, where available human and technical resources were limited and investments were quite constrained, the logical solution was to enhance the efficiency of production processes, cut costs, and boost productivity.</p><p>Initially, the project was designed and managed internally by the company’s staff. However, after a year, management realized the project was not progressing as expected. The laboratory identified a clear problem of <strong>resource constraints</strong>, as they had to prioritize daily operations. Another common issue was <strong>resistance to change among the staff</strong>, coupled with <strong>insufficient knowledge</strong> and experience in managing such projects among some team members. This led to a lack of sufficient data and, at times, inadequate analysis for an optimal design of the strategic efficiency plan.</p>								</div>
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					<h3 class="elementor-heading-title elementor-size-default">02. Challenge</h3>				</div>
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									<p>The challenge of the project was clear.</p>								</div>
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									<p>&#8220;To design a strategic efficiency improvement plan, tailored to the specific activities of the laboratory and the available resources, that would yield tangible and measurable results in the shortest possible time&#8221;.</p>								</div>
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					<h3 class="elementor-heading-title elementor-size-default">03. Approach</h3>				</div>
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									<p>Initially, the work completed on the project up to that point was analyzed, and subsequently, a structured plan was implemented in three phases over a duration of three months. In the first phase, an analysis of the initial situation was conducted, which involved reviewing the internal context of the company. This included an assessment of the scope of analytical services offered, both accredited and non-accredited, as well as the facilities and equipment, human resources, competencies, qualifications, and organization. A detailed study of the analytical operations and their interrelation and integration with other support activities was included, for which the existing workflow diagrams and indicators were evaluated.</p><p>It is important to highlight that this initial evaluation covered not only the analytical phase but also the pre-analytical phase, focusing on sample collection, commercial activities, financial aspects, and client contracts, as well as the post-analytical phase, which includes financial aspects and both technical and management support for the client.</p><p>In the second phase, a detailed analysis of the collected data was performed, identifying areas for improvement and bottlenecks.</p><p>In the third phase of the project, a strategic plan was developed based on the identified needs, and strategic objectives and their corresponding indicators were defined. Finally, once the strategy and scope of the project were defined, an action plan was prepared. This included defining the necessary human and technical resources, organizing using a RACI matrix, outlining the tasks to be performed, their objectives and milestones, follow-up actions, and deliverables, all integrated into a work schedule.</p>								</div>
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															<img fetchpriority="high" decoding="async" width="398" height="684" src="https://vclabconsulting.com/wp-content/uploads/2024/04/Imagen-caso-2.png" class="attachment-large size-large wp-image-3198" alt="imagen caso 2" srcset="https://vclabconsulting.com/wp-content/uploads/2024/04/Imagen-caso-2.png 398w, https://vclabconsulting.com/wp-content/uploads/2024/04/Imagen-caso-2-175x300.png 175w" sizes="(max-width: 398px) 100vw, 398px" />															</div>
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					<h3 class="elementor-heading-title elementor-size-default">04. Results</h3>				</div>
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									<p>From the analysis of the project&#8217;s progress, the following issues were identified:</p><ol><li>The project suffered from a lack of team organization.</li><li>It operated in bursts based on the laboratory&#8217;s workload and available time.</li><li>The analysis of production processes and the indicators used were not detailed enough to detect deficiencies and areas for improvement.</li><li>The perspective was very insular and lacked an external, critical, and independent viewpoint.</li></ol><p>In light of this initial analysis of the situation, existing workflows were detailed, and additional new indicators were implemented to provide valuable data on the current situation. Figure 1 shows the flow diagram corresponding to sample reception.</p><p>The main areas for improvement identified were:</p><ol><li><strong>Sample collection process and its reception in the laboratory:</strong> Although the LIMS used had a module for sample collection management, it did not integrate this process well, and its capabilities were limited. There was no complete traceability of the samples, nor did it assist in the logistics of sample collection. Sample reception was a clear bottleneck, as many of the received samples were unscheduled. With a low level of digitalization, registering the samples in the LIMS often required contacting the client to collect necessary information.</li><li><strong>Workflow inefficiencies:</strong> Sometimes workflows contained illogical actions and had room for improvement, such as unnecessary movements and prolonged waiting times. The search for samples shared by several departments was identified as a significant area for improvement.</li><li><strong>Low automation and digitalization:</strong> While there were autosamplers for analytical equipment for parameters such as metals or organic compounds, the generation of results was not integrated with the LIMS, and many processes were manual.</li><li><strong>Lack of a client portal:</strong> There was no client portal for direct contracting or downloading reports or raw data.</li><li><strong>Complex procurement process:</strong> Although integrated with the finance department, procurement was a complex process that consumed time from the personnel designated for analyses.</li></ol><p>With the identification of these areas for improvement, a strategic plan was prepared where the proposed improvement actions were prioritized based on the necessary resources, estimated implementation time, and expected benefits. In collaboration with the company, a phased action plan was defined, spanning three years, during which 15 of the identified actions would be implemented.</p><p>As a result, the management of this project allowed the company to:</p><ol><li>Develop a strategic efficiency plan in just three months.</li><li>Reduce the internal resources needed to prepare this plan.</li><li>Enrich the plan with expert, external, and independent insight.</li></ol>								</div>
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		<p>The post <a href="https://vclabconsulting.com/en/strategic-laboratory-management/preparation-of-an-efficiency-and-cost-savings-plan-in-a-commercial-laboratory/">Preparation of an Efficiency and Cost Savings Plan in a Commercial Laboratory</a> appeared first on <a href="https://vclabconsulting.com/en/home">Vicente Catal&aacute;n Lab Consulting</a>.</p>
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		<title>UNE-EN ISO/IEC 17020. Conformity assessment. Requirements for the operation of various types of bodies performing inspection</title>
		<link>https://vclabconsulting.com/en/quality-systems/regulatory-compliance-and-accreditation/une-en-iso-iec-17020-conformity-assessment-requirements-for-the-operation-of-various-types-of-bodies-performing-inspection/</link>
		
		<dc:creator><![CDATA[admin]]></dc:creator>
		<pubDate>Wed, 27 Mar 2024 08:46:48 +0000</pubDate>
				<category><![CDATA[Quality Systems]]></category>
		<category><![CDATA[Regulatory Compliance and Accreditation]]></category>
		<guid isPermaLink="false">https://vclabconsulting.com/?p=4659</guid>

					<description><![CDATA[<p>The ISO 17020 standard establishes the requirements for the proper functioning of entities that perform inspections, their technical competence, and their ability to make value judgments according to the required level of independence.</p>
<p>The post <a href="https://vclabconsulting.com/en/quality-systems/regulatory-compliance-and-accreditation/une-en-iso-iec-17020-conformity-assessment-requirements-for-the-operation-of-various-types-of-bodies-performing-inspection/">UNE-EN ISO/IEC 17020. Conformity assessment. Requirements for the operation of various types of bodies performing inspection</a> appeared first on <a href="https://vclabconsulting.com/en/home">Vicente Catal&aacute;n Lab Consulting</a>.</p>
]]></description>
										<content:encoded><![CDATA[		<div data-elementor-type="wp-post" data-elementor-id="4659" class="elementor elementor-4659" data-elementor-post-type="post">
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					<h1 class="elementor-heading-title elementor-size-default">UNE-EN ISO/IEC 17020. Conformity assessment. Requirements for the operation of various types of bodies performing inspection</h1>				</div>
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									<p>This standard contains the requirements that enable inspection entities to demonstrate their technical competence, impartiality, and consistency in their inspection activities. It has become the international reference standard for inspection entities that want to demonstrate their ability to obtain reliable results and develop management systems for their quality, administrative, and technical activities.</p><p>Inspection is an evaluation activity aimed at determining the conformity of products, installations, buildings, machinery, and even plans or projects with established requirements or specifications. The goal is to provide information regarding compliance with legislation, standards, specifications, or contractual commitments. Inspection can include visual checks, functional measurements or tests of physical objects, documentary examinations of specifications, and comparisons of results with specific requirements or best practices in the field.</p><p>Inspection entities can operate as first-party, inspecting products or installations supplied or installed by their own organization; second-party, when acting on behalf of the buyer of the inspected item; or third-party, when acting on behalf of a third party, such as an insurance company or, in the regulatory field, the government. Choosing accredited inspection entities provides both the market and the administration with the highest guarantees, as they are the only ones that have demonstrated the necessary technical reliability by complying with the international ISO/IEC 17020 standard, which establishes the requirements for technical competence in this type of activity.</p>								</div>
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					<h3 class="elementor-heading-title elementor-size-default">01. Objetive</h3>				</div>
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									<p>This standard establishes the general requirements for technical and human competence, impartiality, and consistent operation of inspection entities. It sets out general requirements such as impartiality, independence, and confidentiality, as well as requirements related to structure, resources, processes, and the management system.</p>								</div>
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					<h3 class="elementor-heading-title elementor-size-default">02. Structure</h3>				</div>
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									<p>The ISO 17020 standard establishes the requirements for the proper functioning of inspection entities, their technical competence, and their ability to make value judgments according to the required level of independence.</p><h4>Main Sections of the Standard:</h4><p>The current version of the standard is structured into five groups of requirements:</p><ul><li>General Requirements: Impartiality, independence, and confidentiality.</li><li>Structural Requirements: Administrative, organizational, and management.</li><li>Resource Requirements: Including personnel, facilities, equipment, and subcontracting.</li><li>Process Requirements: Including inspection methods and procedures, handling of inspection items and samples, inspection records, inspection reports and certificates, complaints and appeals, and the complaints and appeals process.</li><li>Management System Requirements: Options, documentation, document control, record control, management review, internal audits, corrective actions, and preventive actions.</li></ul>								</div>
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					<h3 class="elementor-heading-title elementor-size-default">03. Advantages</h3>				</div>
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									<ul><li>Demonstrate technical competence and ensure excellence in the services offered. It guarantees the validity and technical reliability of the inspections conducted.</li><li>Opens doors to new markets: accredits the quality of your entity at both national and international levels.</li><li>Provides the opportunity for continuous improvement: constantly evaluates personnel, methods, equipment, calibration, and report preparation.</li><li>Gains recognition and enhances the image and reputation of your organization.</li><li>Competitive advantage: technical reliability helps you differentiate from the competition.</li><li>Serves as a reference for implementing new accreditations and quality management standards.</li><li>Increases customer confidence.</li><li>Boosts productivity: improves operational efficiency and reduces errors.</li><li>Enhances the competence of technical personnel.</li></ul>								</div>
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					<h3 class="elementor-heading-title elementor-size-default">04. Frequently Asked Questions</h3>				</div>
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												<a class="elementor-toggle-title" tabindex="0">What is the scope and application of ISO 17020?</a>
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					<div id="elementor-tab-content-9621" class="elementor-tab-content elementor-clearfix" data-tab="1" role="region" aria-labelledby="elementor-tab-title-9621"><p>This standard establishes the requirements that inspection entities must meet to demonstrate their technical competence, impartiality, and consistency in their inspection activities.</p></div>
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												<a class="elementor-toggle-title" tabindex="0">Which body accredits in Spain according to ISO 17020?</a>
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					<div id="elementor-tab-content-9622" class="elementor-tab-content elementor-clearfix" data-tab="2" role="region" aria-labelledby="elementor-tab-title-9622"><p>ENAC (Entidad Nacional de Acreditación) is the body designated by the Government in application of Regulation (EC) No 765/2008, which regulates the operation of accreditation in Europe based on five fundamental principles: Non-profit; Independence; Non-competition; International evaluation; Mutual recognition.</p></div>
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												<a class="elementor-toggle-title" tabindex="0">What activities and organizations can be accredited under ISO 17020?</a>
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					<div id="elementor-tab-content-9623" class="elementor-tab-content elementor-clearfix" data-tab="3" role="region" aria-labelledby="elementor-tab-title-9623"><p>Any inspection entity or body, regardless of the activities it performs or its size.</p></div>
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												<a class="elementor-toggle-title" tabindex="0">What is the difference between ISO 17025, ISO 9001, and ISO 17020?</a>
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					<div id="elementor-tab-content-9624" class="elementor-tab-content elementor-clearfix" data-tab="4" role="region" aria-labelledby="elementor-tab-title-9624"><p>ISO 9001 focuses on general quality management, ISO 17025 addresses the technical competence of testing and calibration laboratories, and ISO 17020 pertains to the technical competence of inspection bodies.</p></div>
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												<a class="elementor-toggle-title" tabindex="0">"What is an inspection entity or body?"</a>
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					<div id="elementor-tab-content-9625" class="elementor-tab-content elementor-clearfix" data-tab="5" role="region" aria-labelledby="elementor-tab-title-9625"><p>They are entities (natural or legal persons) that perform an evaluation activity aimed at determining the conformity of products, installations, buildings, machinery, and even plans or projects with established requirements or specifications, in order to provide information regarding compliance with legislation, standards, specifications, or contractual commitments. Inspection can include visual checks, functional measurements or tests of physical objects, documentary examinations of specifications, and comparisons of results with specific requirements or best practices in the area.</p></div>
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												<a class="elementor-toggle-title" tabindex="0">What types of inspection entities or bodies exist?</a>
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					<div id="elementor-tab-content-9626" class="elementor-tab-content elementor-clearfix" data-tab="6" role="region" aria-labelledby="elementor-tab-title-9626"><p>Three types are established based on their degree of independence:</p><ul><li>Type A: They offer their services as a third party.</li><li>Type B: They offer their services as a first party.</li><li>Type C: They offer their services as a first party but also provide inspection services to other organizations.</li></ul></div>
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															<span class="elementor-toggle-icon-closed"><svg xmlns="http://www.w3.org/2000/svg" id="bc25d017-75b1-4825-af0a-8a5ef3b77000" data-name="Layer 1" width="11.707" height="6.5605" viewBox="0 0 11.707 6.5605"><polygon points="11 0 5.854 5.146 0.707 0 0 0.707 5.854 6.561 11.707 0.707 11 0"></polygon></svg></span>
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												<a class="elementor-toggle-title" tabindex="0">What characteristics does a Type A inspection body have?</a>
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					<div id="elementor-tab-content-9627" class="elementor-tab-content elementor-clearfix" data-tab="7" role="region" aria-labelledby="elementor-tab-title-9627"><p>A Type A Inspection Body is expected to:</p><ul><li>Not be involved in the design, manufacture, supply, installation, use, or maintenance of the inspected items or similar competitive products.</li><li>Be accessible to all parties interested in their services.</li></ul></div>
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												<a class="elementor-toggle-title" tabindex="0">What characteristics does a Type B inspection body have?</a>
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					<div id="elementor-tab-content-9628" class="elementor-tab-content elementor-clearfix" data-tab="8" role="region" aria-labelledby="elementor-tab-title-9628"><p>A Type B Inspection Body is expected to:</p><ul><li>Have a clear separation of responsibilities between the inspection personnel and the personnel performing other activities within the parent organization.</li><li>Ensure that the organization and its personnel do not engage in activities that could compromise their impartiality and independence.</li></ul></div>
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												<a class="elementor-toggle-title" tabindex="0">What characteristics does a Type C inspection body have?</a>
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					<div id="elementor-tab-content-9629" class="elementor-tab-content elementor-clearfix" data-tab="9" role="region" aria-labelledby="elementor-tab-title-9629"><p>A Type C Inspection Body is expected to:</p><ul><li>Ensure that the design, manufacture, provision, installation, service, maintenance, and inspection of the same item are not carried out by the same person.</li><li>Provide assurances within the organization to ensure an appropriate separation of functions and responsibilities in the provision of inspection services, through its organizational structure and documented procedures.</li></ul></div>
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		<p>The post <a href="https://vclabconsulting.com/en/quality-systems/regulatory-compliance-and-accreditation/une-en-iso-iec-17020-conformity-assessment-requirements-for-the-operation-of-various-types-of-bodies-performing-inspection/">UNE-EN ISO/IEC 17020. Conformity assessment. Requirements for the operation of various types of bodies performing inspection</a> appeared first on <a href="https://vclabconsulting.com/en/home">Vicente Catal&aacute;n Lab Consulting</a>.</p>
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		<title>UNE-EN ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories</title>
		<link>https://vclabconsulting.com/en/quality-systems/regulatory-compliance-and-accreditation/une-en-iso-iec-17025-general-requirements-for-the-competence-of-testing-and-calibration-laboratories/</link>
		
		<dc:creator><![CDATA[admin]]></dc:creator>
		<pubDate>Mon, 25 Mar 2024 08:28:42 +0000</pubDate>
				<category><![CDATA[Quality Systems]]></category>
		<category><![CDATA[Regulatory Compliance and Accreditation]]></category>
		<guid isPermaLink="false">https://vclabconsulting.com/?p=4650</guid>

					<description><![CDATA[<p>The ISO 17025 standard has become the international reference standard for testing and calibration laboratories that want to demonstrate their ability to obtain reliable results and develop management systems for their quality, administrative, and technical activities.</p>
<p>The post <a href="https://vclabconsulting.com/en/quality-systems/regulatory-compliance-and-accreditation/une-en-iso-iec-17025-general-requirements-for-the-competence-of-testing-and-calibration-laboratories/">UNE-EN ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories</a> appeared first on <a href="https://vclabconsulting.com/en/home">Vicente Catal&aacute;n Lab Consulting</a>.</p>
]]></description>
										<content:encoded><![CDATA[		<div data-elementor-type="wp-post" data-elementor-id="4650" class="elementor elementor-4650" data-elementor-post-type="post">
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					<h1 class="elementor-heading-title elementor-size-default">UNE-EN ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories</h1>				</div>
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									<p>This standard has been developed with the aim of promoting confidence in the operation of laboratories. It contains requirements that allow laboratories to demonstrate that they operate competently and have the capability to generate valid results.</p><p>The ISO 17025 standard has become the international reference standard for testing and calibration laboratories that want to demonstrate their ability to obtain reliable results and develop management systems for their quality, administrative, and technical activities.</p>								</div>
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					<h3 class="elementor-heading-title elementor-size-default">01. Objective</h3>				</div>
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									<p>This standard specifies the general requirements for technical competence, impartiality, and consistent operation of laboratories. It establishes general requirements such as impartiality and confidentiality, as well as requirements related to the structure, resources, processes, and management system.</p>								</div>
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					<h3 class="elementor-heading-title elementor-size-default">02. Structure</h3>				</div>
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									<p>The standard was updated in 2017 to cover technical changes in laboratories and computer techniques. The main changes in the ISO 17025 standard were:</p><ul><li>The scope has been revised to encompass all laboratory activities, including testing, calibration, and sampling.</li><li>A new structure has been adopted to align the new standard with the rest of the conformity assessment standards in the ISO/IEC 17000 series.</li><li>Inclusion of the general requirements section addressing confidentiality and impartiality.</li><li>Terminology update: Changes in the International Vocabulary of Metrology (VIM) have been included, and the new standard aligns with ISO terminology, which has a series of common terms and definitions for all conformity assessment standards. A definition of “laboratory” has been included.</li><li>Alignment with ISO 9001:2015: The process approach now matches that developed in newer standards such as ISO 9001 (quality management), ISO 15189 (for clinical laboratories), and the ISO/IEC 17000 series (for conformity assessment activities), emphasizing process outcomes rather than detailed descriptions of tasks and steps.</li><li>Inclusion of the concept of “Risk-Based Thinking” in line with the new version of ISO 9001 on quality management systems, allowing a less prescriptive and more performance-based formulation of requirements. The laboratory is now responsible for deciding which risks to address and how to manage them.</li><li>Incorporation of new sections on result analysis and declaration of conformity, as well as new considerations on measurement uncertainty and traceability.</li><li>Increased flexibility in requirements for processes, procedures, documented information, and organizational responsibilities.</li><li>Integration of computerized systems for data and information management. The standard is more focused on the use of information technologies. As manuals, records, and paper reports are being gradually phased out, it incorporates the use of computer systems, electronic records, and the production of electronic results and reports.</li></ul><h4>Main Sections of the Standard</h4><p>The current version of the standard is structured into five groups of requirements:</p><ol><li><strong>General Requirements:</strong> Impartiality and confidentiality.</li><li><strong>Structural Requirements:</strong> The laboratory must be a legal entity, define its organization and management structure, and have personnel with the authority and resources necessary to carry out their tasks.</li><li><strong>Resource Requirements:</strong> Including personnel, facilities and environmental conditions, equipment, metrological traceability, and externally provided products and services.</li><li><strong>Process Requirements:</strong> Including the review of requests, tenders, and contracts, selection, verification and validation of methods, sampling, handling of test or calibration items, technical records, evaluation of measurement uncertainty, ensuring the validity of results, reporting of results, complaints, non-conforming work, and control of data and information management.</li><li><strong>Management System Requirements:</strong> The laboratory must establish, document, implement, and maintain a management system capable of supporting and demonstrating consistent achievement of the requirements of this document and ensuring the quality of laboratory results.</li></ol>								</div>
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					<h3 class="elementor-heading-title elementor-size-default">03. Advantages</h3>				</div>
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									<p>Demonstrate technical competence and ensure excellence in the services offered. It guarantees the validity and technical reliability of results and diagnostics.</p><ul><li>Opens doors to new markets: accredits the quality of your laboratory nationally and internationally.</li><li>Provides the opportunity for continuous improvement: constantly evaluates personnel, methods, equipment, calibration, and report preparation.</li><li>Gains recognition and improves your organization&#8217;s image and reputation.</li><li>Competitive advantage: technical reliability helps differentiate you from the competition.</li><li>Acts as a reference for implementing new accreditations and quality management standards.</li><li>Increases customer and regulatory body confidence.</li><li>Reduces some costs, for example, by decreasing the need for test repetition.</li><li>Increases productivity: improves operational efficiency and reduces errors.</li><li>Meets the demands of both private and public clients.</li></ul>								</div>
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					<h3 class="elementor-heading-title elementor-size-default">04. Frequently Asked Questions</h3>				</div>
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												<a class="elementor-toggle-title" tabindex="0">What activities and organizations can be accredited by ISO 17025?</a>
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					<div id="elementor-tab-content-2001" class="elementor-tab-content elementor-clearfix" data-tab="1" role="region" aria-labelledby="elementor-tab-title-2001"><p>Any testing and calibration laboratory, regardless of the activities it performs or its size.</p></div>
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												<a class="elementor-toggle-title" tabindex="0">Which body accredits according to ISO 17025 in Spain?</a>
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					<div id="elementor-tab-content-2002" class="elementor-tab-content elementor-clearfix" data-tab="2" role="region" aria-labelledby="elementor-tab-title-2002"><p>ENAC (Entidad Nacional de Acreditación) is the body designated by the Government in application of Regulation (EC) No 765/2008, which regulates the operation of accreditation in Europe based on five fundamental principles: Non-profit; Independence; Non-competition; International evaluation; Mutual recognition.</p></div>
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												<a class="elementor-toggle-title" tabindex="0">How is ISO 17025 maintained and updated?</a>
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					<div id="elementor-tab-content-2003" class="elementor-tab-content elementor-clearfix" data-tab="3" role="region" aria-labelledby="elementor-tab-title-2003"><p>A Technical Committee of experts reviews the current standard and proposes changes and improvements to adapt it to technical and scientific advancements. The update of the standard in a new version requires accredited laboratories to comply with the new requirements included in the latest version.</p></div>
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												<a class="elementor-toggle-title" tabindex="0">What is the difference between accrediting and certifying my laboratory?</a>
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					<div id="elementor-tab-content-2004" class="elementor-tab-content elementor-clearfix" data-tab="4" role="region" aria-labelledby="elementor-tab-title-2004"><p>Certification guarantees compliance with the requirements of a standard, while accreditation is a process in which an organization performing evaluation activities submits those activities to inspection by an external body (accreditation entity). Accreditation verifies the compliance and conformity of these evaluation activities with established standards.</p></div>
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								<span class="elementor-toggle-icon-opened"><svg xmlns="http://www.w3.org/2000/svg" id="fb3c1172-b7c4-4109-975c-9033d03c4c4d" data-name="Layer 1" width="11.707" height="6.5605" viewBox="0 0 11.707 6.5605"><polygon points="5.854 0 0 5.854 0.707 6.561 5.854 1.414 11 6.561 11.707 5.854 5.854 0"></polygon></svg></span>
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												<a class="elementor-toggle-title" tabindex="0">What is the scope and application of ISO 17025?</a>
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					<div id="elementor-tab-content-2005" class="elementor-tab-content elementor-clearfix" data-tab="5" role="region" aria-labelledby="elementor-tab-title-2005"><p>This standard establishes the requirements to demonstrate the technical competence of testing and calibration laboratories, regardless of their size and scope of operation.</p></div>
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												<a class="elementor-toggle-title" tabindex="0">What is the difference between ISO 17025, ISO 9001, and ISO 17020?</a>
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					<div id="elementor-tab-content-2006" class="elementor-tab-content elementor-clearfix" data-tab="6" role="region" aria-labelledby="elementor-tab-title-2006"><p>ISO 9001 focuses on general quality management, ISO 17025 addresses the technical competence of testing and calibration laboratories, and ISO 17020 pertains to the technical competence of inspection bodies.</p></div>
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		<p>The post <a href="https://vclabconsulting.com/en/quality-systems/regulatory-compliance-and-accreditation/une-en-iso-iec-17025-general-requirements-for-the-competence-of-testing-and-calibration-laboratories/">UNE-EN ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories</a> appeared first on <a href="https://vclabconsulting.com/en/home">Vicente Catal&aacute;n Lab Consulting</a>.</p>
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		<title>Consolidation of Analytical Activities for a New Water Microbiology Laboratory</title>
		<link>https://vclabconsulting.com/en/quality-systems/consolidation-of-analytical-activities-for-a-new-water-microbiology-laboratory/</link>
		
		<dc:creator><![CDATA[admin]]></dc:creator>
		<pubDate>Mon, 18 Mar 2024 08:18:20 +0000</pubDate>
				<category><![CDATA[Quality Systems]]></category>
		<category><![CDATA[Regulatory Compliance and Accreditation]]></category>
		<guid isPermaLink="false">https://vclabconsulting.com/?p=4642</guid>

					<description><![CDATA[<p>Currently, the business managed by the laboratory is around €400,000 annually, with a growth perspective of 14% per year.</p>
<p>The post <a href="https://vclabconsulting.com/en/quality-systems/consolidation-of-analytical-activities-for-a-new-water-microbiology-laboratory/">Consolidation of Analytical Activities for a New Water Microbiology Laboratory</a> appeared first on <a href="https://vclabconsulting.com/en/home">Vicente Catal&aacute;n Lab Consulting</a>.</p>
]]></description>
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					<h1 class="elementor-heading-title elementor-size-default">Consolidation of Analytical Activities for a New Water Microbiology Laboratory</h1>				</div>
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									<h2>Regulatory Compliance and Accreditation</h2><p>General requirements for the competence of testing and calibration laboratories. This standard has been developed to promote confidence in the operation of laboratories. It contains requirements that allow laboratories to demonstrate that they operate competently and have the capability to generate valid results.</p><p>The ISO 17025 standard has become the international reference standard for testing and calibration laboratories that want to demonstrate their ability to obtain reliable results and develop management systems for their quality, administrative, and technical activities.</p>								</div>
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					<h3 class="elementor-heading-title elementor-size-default">01. Context</h3>				</div>
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									<p>A company in the Testing, Inspection, and Certification (TIC) sector has three laboratories in a specific region, located at significant distances from each other. Two of these laboratories specialize in the investigation and remediation of contaminated sites, soil analysis, waste characterization, acceptance criteria testing for waste, wastewater effluent analysis, and landfill monitoring. The third laboratory focuses on analyzing physico-chemical and microbiological parameters in water, providing analytical services to companies in the water hygiene, water treatment, and hospital sectors, with a strong specialization in the detection of Legionella.</p><p>All three laboratories are accredited according to ISO 17025 and collectively have a broad accreditation scope in both microbiological and physico-chemical fields for different matrices.</p><p>A year and a half ago, for logistical and commercial strategy reasons, the company decided to establish a new microbiology laboratory within one of the contaminated soil laboratories. This decision aimed to reduce the need to transport samples to the water laboratory and simultaneously diversify the analytical services of the soil laboratory towards water microbiology, providing more local support for microbiological analytical services in that region.</p><p>After the design and construction phases of the facilities and their equipment, the company proceeded with the implementation of methods, validation, and staff training, with support from the water laboratory, which had the necessary experience for this implementation.</p><p>The new laboratory started with four staff members, and the initial accreditation scope requested from the accreditation body included total coliforms, Escherichia coli, Enterococci, aerobic bacterial count at 37ºC and 22ºC, Clostridium perfringens, Pseudomonas spp. and Pseudomonas aeruginosa, Legionella spp., and Legionella pneumophila, both by culture and qPCR.</p><p>With everything prepared, the company applied for ISO 17025 accreditation for the new laboratory. After the audit in the summer of 2023, the accreditation body expressed concerns about the weak implementation of the quality system and, primarily, the lack of experience of the staff, which compromised the technical competence of the laboratory for the analytical activities included in the requested accreditation scope.</p>								</div>
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					<h3 class="elementor-heading-title elementor-size-default">02. Challenge</h3>				</div>
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									<p>&#8220;The challenge of the project was clear.&#8221;</p>								</div>
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									<p>&#8220;Consolidate the laboratory&#8217;s analytical activities to acquire the necessary technical competence to manage the laboratory and achieve ISO 17025 accreditation, all in the shortest possible time.&#8221;</p>								</div>
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					<h3 class="elementor-heading-title elementor-size-default">03. Approach</h3>				</div>
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									<p>An action plan was prepared with three clear objectives:</p><ol><li>Consolidate the laboratory&#8217;s activities and the implemented quality system.</li><li>Implement an accelerated training program for both technical and laboratory management.</li><li>Directly supervise the analytical activities conducted during the project&#8217;s execution.</li></ol><p>The project was organized into eight phases over a total duration of three months, with both remote and on-site activities.</p><p>As shown in Figure 1, three sets of actions were identified: </p><ol><li><strong>Initial Assessment</strong>: Evaluating the maturity of the quality system, the methods used and their validations, and assessing the technical competencies of the staff.</li><li><strong>Staff Training:</strong> Focused on deep knowledge of ISO 17025, the basic principles of a microbiology laboratory, the methods included in the accreditation scope, and specific training on Legionella.</li><li><strong>Monitoring and Supervision:</strong> Detailed tracking of all activities performed in the laboratory, combined with practical daily training for the staff.</li></ol><p>Remote activities were carried out over eight weeks, consisting of two sessions per week, each lasting two hours. Additionally, in case of emergencies, the consultant was contacted by phone for immediate resolution.</p><p>Alongside the remote activities, the consultant interspersed four weeks of physical presence in the laboratory. This allowed for the consolidation of actions performed remotely and detailed monitoring of the project&#8217;s progress and the subsequent consolidation of the laboratory.</p>								</div>
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															<img decoding="async" width="1024" height="418" src="https://vclabconsulting.com/wp-content/uploads/2024/03/cronograma-de-trabajopng-1024x418.png" class="attachment-large size-large wp-image-2544" alt="Cronograma de trabajo" srcset="https://vclabconsulting.com/wp-content/uploads/2024/03/cronograma-de-trabajopng-1024x418.png 1024w, https://vclabconsulting.com/wp-content/uploads/2024/03/cronograma-de-trabajopng-300x123.png 300w, https://vclabconsulting.com/wp-content/uploads/2024/03/cronograma-de-trabajopng-768x314.png 768w, https://vclabconsulting.com/wp-content/uploads/2024/03/cronograma-de-trabajopng.png 1136w" sizes="(max-width: 1024px) 100vw, 1024px" />															</div>
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					<h3 class="elementor-heading-title elementor-size-default">04. Results</h3>				</div>
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									<p>Once the project was completed, an internal audit was conducted, followed by a request for an extraordinary audit by the accreditation body, which was successfully passed without any issues, ultimately achieving the accreditation.</p><p>Currently, the business managed by the laboratory is around <strong>€400,000 annually, with a growth perspective of 14% per year.</strong> Additionally, there are plans to expand the accreditation scope soon to further increase the business volume.</p><p>As a result, the management of this project allowed the company to:</p><ol><li>Achieve ISO 17025 accreditation in just three months.</li><li>Consolidate the laboratory&#8217;s analytical activities, forming a technically solid and competent team.</li><li>Focus internal resources from the other water laboratory on their daily analytical activities and business development.</li><li>Integrate the new laboratory&#8217;s activities with the existing one, homogenizing and making processes more efficient.</li></ol>								</div>
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		<p>The post <a href="https://vclabconsulting.com/en/quality-systems/consolidation-of-analytical-activities-for-a-new-water-microbiology-laboratory/">Consolidation of Analytical Activities for a New Water Microbiology Laboratory</a> appeared first on <a href="https://vclabconsulting.com/en/home">Vicente Catal&aacute;n Lab Consulting</a>.</p>
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