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WHITE PAPERConsidering ISO 9001 or ISO 55001certification? Implementing a CMMSsolution can be an important firststep for getting there.
Becoming and remaining an ISO-registeredmanufacturer ensures that your business is adheringto consistent standards that will likely drive overallquality. Having a product or system certified to an ISOstandard has many benefits that include a competitiveedge, expansion into new markets, higher customersatisfaction, reduced costs, improved safety, bettermanaged risks and assets, and fewer errors.Compliance with ISO standards is a requirement formany manufacturing contracts. Whether your companyis trying to acquire new business or form a partnershipwith another manufacturer, a robust CMMS programcan significantly improve your organization’s chancesof obtaining certification while reducing hassle andpersonnel costs.What is ISO?ISO stands for the International Organization for Standardizationwhich is an independent, non-governmental internationalorganization with a membership of over 160 national standardsbodies. While ISO develops international standards, it does notbecome involved in their certification. Certification is insteadperformed by external certification bodies who use ISO’sCommittee on Conformity Assessment (CASCO) standards relatedto the certification process.Whether your companyis trying to acquirenew business orform a partnershipwith anothermanufacturer, a robustCMMS program cansignificantly improveWhat is ISO 9001?The ISO 9000 series of standards specificallyaddress various aspects of a qualitymanagement system (QMS). Within the 9000family, ISO 9001 is the only standard thatrequires certification. Depending on theindustry, ISO 9001 certification is a legal orcontractual requirement. The most currentversion of the ISO 9001 standard is 9001:2015. It is based onseveral quality management principles and the idea of continualimprovement. An organization must be re-certified every threeyears to maintain its ISO 9001 certification status. A wide range ofadditional QMS standards exists that are adapted to specific sectorsand industries. ISO 13485, as an example, addresses regulatoryrequirements for medical devices.2your organization’schances of obtainingcertification whilereducing hassle andpersonnel costs.
What is ISO 55001?ISO 55001 is the international standard forasset management, which lays the frameworkto help organizations manage the life cycle oftheir physical assets more effectively, mitigateand manage risk, and improve their financialperformance. Physical assets are made ofassemblies of individual components working as a system. For toolmanufacturers, these include asset molds, equipment, tools, andspare parts. ISO 550011 divides asset management systems intosix elements: Context of ce evaluationContinuous improvementAdopting the ISO 55001 standard may standardize assetmanagement process and lead to better outcomes, but it does notguarantee excellence. To achieve a world-class enterprise assetmanagement system, a computerized maintenance managementsystem (CMMS) is often the solution.3
Documentation is keyObtaining ISO certification requires many steps; however, gooddocumentation of maintenance activities and work processeswill provide clear evidence that you are acting in accordance withISO standards. Auditors look at everything from manufacturingprocesses, training records, and equipment repair to productfunctionality, packaging, and labeling.“We often“We often meet with companies who produce high quality,repeatable products but lack a way to effectively demonstrateinspections, relevant work orders, and preventive maintenancetasks,” said John Headrick, executive vice president of engineeringat COAST Systems, a leadingCMMS software provider andindustry solutions leader. “OurCMMS package helps theseorganizations centralize allof their relevant data acrossmultiple locations with reportsthat can be convenientlyaccessed at any time. Thiscapability reduces thecomplexity of an audit whilefreeing up personnel.”lack a way to effectivelyImplementing a quality CMMS solution will provide: One central database for assets and procedures, preventing thepossibility of accessing outdated information Transparency of accurate asset data, including usage, availability,repair history, and life cycle A high level of organizational and process control, with datareadily available for retrieving and reporting Proof that maintenance, training, and safety activities areplanned and implemented appropriately Identification of ISO-critical equipment and assets Enhanced efficiency due to reduced downtime Sound empirical data that can be analyzed for evidence-baseddecision making Operations, maintenance, and asset risk management, withinspections and manufacturing information retained in the CMMSorganizations centralize4meet withcompanies whoproduce high quality,repeatable products butdemonstrate inspections,relevant work orders, andpreventive maintenancetasks,” said John Headrick,executive vice presidentof engineering at COASTSystems, a leadingCMMS software providerand industry solutionsleader. “Our CMMSpackage helps theseall of their relevant dataacross multiple locationswith reports that can beconveniently accessed atany time. This capabilityreduces the complexity ofan audit while freeing uppersonnel.”
Choosing a CMMS platform toachieve certificationNo CMMS provider can guarantee ISO 9001 or ISO55001 certification as a result of using their platform.The reality is that it takes great preparation, research,and planning to fully understand all the technicalrequirements and required documentation neededfor compliance.With deep experience in the manufacturingindustry, and a specialist in plastic molding,including engineering and production, COASTSystems is uniquely positioned to help companiesimprove their manufacturing processes,maintenance management, asset management,and documentation activities. COAST combines itsmaintenance management system technology withstrategic consulting to deliver compliance solutionsthat work. Make sure the CMMS solution you decideon features: Powerful and secure cloud-hosted dataStringent documentation and recordkeeping capabilityFlexible and configurable interfaceFast setup and deploymentScalability for growthAttractive pricing modelsCompliance with GDPR, HIPPA, and FDA Title 21 CRFISO 9001 and ISO 55001 certifications are both complexprocesses that require a traceable history of maintenanceactivities as well as documented work processes. Implementinga CMMS solution can help your company comply with strictISO documentation and recordkeeping requirements, whilesimultaneously helping to improve efficiency, reduce downtime,extend asset life, and increase profitability.For more informationon how COAST canhelp modernizeyour maintenancemanagement processmaking you betterprepared to achieveISO 9001 or ISO 55001certification, contactus at (877) 262-7801.Contributing author: Jerry Sherman, President, COAST Systems 2019 COAST 8/195Corporate Headquarters161 East Jefferson Street, Suite ABrooksville, Florida 34601 U.S.A. 1 com
What is ISO 9001? The ISO 9000 series of standards specifi cally address various aspects of a quality management system (QMS). Within the 9000 family, ISO 9001 is the only standard that requires certifi cation. Depending on the industry, ISO 9001 certifi cation is a legal or contractual requirement. The most current
