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Hercules Montero
ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.
If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with ISO 13485:2003 reflect exclusion of design and development controls.
If any requirement(s) in Clause 7 of ISO 13485:2003 is(are) not applicable due to the nature of the medical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system.
The processes required by ISO 13485:2003, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system.
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Operations management influences every part of how you run a company. That includes how youproduce a product or service, how you track and improve your efficiency and how youcontribute to the bottom line. Simply put, operations management drives efficientworkforces, processes and supply chains.
This guide explores the types of operations management and how they bring value to abusiness. Explore the ins and outs of operations management strategy and learn the bestpractices to achieve success.
Operations management is the practice of handling day-to-day business functions in a mannerthat is efficient and that maximizes profitability. This discipline focuses on formulatingstrategies and taking actions to optimize production and supply chain performance.
Operations management also refers to how an organization coordinates and oversees the flow ofinformation among its departments; how successful it is at complying with business andregulatory requirements; how well it ensures customer satisfaction; and how efficiently itmanages daily operations, not just resolving problems that occasionally arise.
Operations management is necessary for companies to stay competitive in any industry, buthealthcare, technology and manufacturing firms often have a particular focus. Withoutefficient operations management, critical business functions like research, client servicedelivery, IT and inventory control may fall prey to mismanagement.
Some facets of operations management may require additional functions. For example, tasks mayconsist of planning and researching; creating operational budgets; and managing physicalinventory, supply chains and vendors.
Decentralized operations management uses multiple systems, including advancedinfrastructure and technology like web applications and cloud databases, tocoordinate work across global supply chains and multiple locations.
A hybrid operations management environment leverages the advantages of centralizedand decentralized operations. For example, you might have a centralized productioncenter with unified manufacturing and warehousing capabilities and equipped with anautomated infrastructure connected to cloud-based networks for real-time monitoring.
Strategic operations management focuses on long-term success, while tactical operationsdecisions are about reacting and adjusting in the short term. Use a combination of theseapproaches for the best results.
Strategic operations decisions involve estimates, predictions, goals andcomparative analyses. This approach concentrates on the future to meet long-term objectivesand ensure lasting success. One key aspect is using operational data to analyze results andadjust long-term strategic plans where necessary.
Tactical operations decisions, on the other hand, involve how the companyresponds to changing operational conditions. For example, an organization might need toadjust production schedules or workforce planning as the marketplace fluctuates.
Operations management is critical in companies that have complex supply chains because itprovides a framework for process-specific technology, tools and activities to support asteady flow of materials and finished goods and gives managers the means to efficientlydirect resources toward reaching goals. Operations managers rely on strong logisticsmanagement and supply chainmanagement.
A mature operations management practice helps create processes and systems to manage andmeasure supply chain activities. For example, when customers cancel orders or return goodsto the warehouse, the operations management team is responsible for having procedures inplace to reduce administrative overhead, adjust production levels and/or maximize the resalevalue of the items.
Effective operations management touches all aspects of essential work, including supplychain, and ensures the company is meeting key performance indicators(KPIs). Managers use operations management KPIs to make informed decisions andcoordinate efforts across the supply chain and organization as a whole.
The main functions of operations management are developing effective processes, ensuringproduction is efficient and determining the most cost-effective way to achieve goals.Operations managers help organize resources using sound HR concepts, the right technologyand up-to-date best practices.
The ideal operations management process for a given company varies by industry, company sizeand other factors. Generally, it captures the process of managing the daily flow of tasksand information to ensure consistent and effective performance across projects. This processcan include variables such as finance, human resources, information technology, facilitiesmanagement, inventory management and more.
Most companies have an operations department for this reason, although the specific role mayvary from company to company and industry to industry. The responsibilities of an operationsmanager include the overall direction of company operations, financial planning and resourceallocation for specific projects and service offerings.
Effective operations management requires a holistic view of the business, including resourceallocation, documentation review, quality control, coordination of efforts, sharinginformation across departments and initiating appropriate actions when needed. Typically,operations managers have a cross-departmental view, carry out duties assigned by leaders,ensure the efficient use of resources and help plan and prepare to achieve future goals.Day-to-day operational management tasks include record-keeping and operationalreporting.
Depending on company size and scope, ops managers may take on business development ormarketing roles. For example, ops management teams may include financial analysts, salesleaders, software developers and IT support. The practice typically includescross-functional coordination among department heads and units.
The field has evolved to include service-related tasks involved in making efficient,value-driven operational decisions. For example, IT operations management includesmaintaining the hardware and software to enable IT strategy, planning, decision-making,research and technical support.
Operations management best practices start with modern methods that allow employees to dotheir jobs efficiently and deliver a desirable product or service to customers. However,best practices may vary by company and need to evolve in tandem with changing priorities.
BPR for ops management refers to overhauling your critical businessprocesses using information and data gleaned from operations management performance metrics.BPR can improve return on investment, reduce operational costs, increase production capacityand enhance service capabilities.
BPA for ops management refers to using technology to assist with or replacemanual tasks and processes. BPA can increase efficiency, save time and money, reduce errorsand increase transparency. Automating ops management is most effective when replacing tasksthat involve inefficient use of time and resources.
Operations management is partly responsible for shaping the organizational policies andpractices essential for safe, efficient and secure departmental functions. It involvesplanning, controlling, supervising and controlling the work of assigned employees necessaryto accomplish set goals and objectives.
Research in this field from the Journal of Operations Management focuses on understandinghuman behavior to improve operations management and realize its benefits. For example, riskaversion is a behavioral issue that research shows can hinder ops management. This issuemanifests in many forms and can also harm performance.
Our pLG MAT system solution controls automated storage and conveyor systems. It receives its transport commands from the higher-level warehouse management system and forwards the control commands directly to the supporting control system. Thanks to the modular structure, it is possible to visualize processes and ensure a smooth flow in the warehouse through constant monitoring and control.
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