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QMS VR’s ISO Certifications: (click each bullet for more detail) - Description: ISO 9001:2008 sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement). It can be used by any organization, large or small, regardless of its field of activity. In fact ISO 9001:2008 is implemented by over one million companies and organizations in over 170 countries. ISO 13485 (Medical Device Quality Management System) - Description: ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices. Quality Management Principles The standard is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement. These principles are explained in more detail in the pdf Quality Management Principles. Using ISO 9001:2008 helps ensure that customers get consistent, good quality products and services, which in turn brings many business benefits. Audits Checking that the system works is a vital part of ISO 9001 and ISO 13485. An organization must perform internal audits to check how its quality management system is working. An organization may decide to invite an independent certification body to verify that it is in conformity to the standard, but there is no requirement for this. Alternatively, it might invite its clients to audit the quality system for themselves. ISO 13485 Abstract 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. All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.
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ISO certifikati Istragrafike: ISO 9001, ISO14001 i ISO 12647-2 Istragrafika ispunjava sve uvjete hrvatske norme HRN EN ISO 9001:2009 koja navodi zahtjeve za sustav upravljanja kvalitetom. Zahtjevi sustava upravljanja kvalitetom određeni ovom normom dopunjuju zahtjeve za proizvode. Normom se mogu koristiti unutrašnje i vanjske strane, uključujući certifikacijska tijela, radi procjene mogućnosti organizacije da zadovolji zahtjeve kupaca, zakonske i propisane zahtjeve primjenjive na proizvode i zahtjevima same organizacije. Prilikom razvoja ove norme u obzir su uzeta načela upravljanja kvalitetom navedena u normama HRN EN ISO 9000 i HRN EN ISO 9004. - Prvo odobrenje: 4. rujna 1998. - Potvrda izdana: 4. srpnja 2010. - Potvrda vrijedi do: 4. srpnja 2013. Još jedna norma čije uvjete ispunjava Istragrafika je HRN EN ISO 14001:2009. ISO 14001 navodi zahtjeve za sustav upravljanja okolišem koji omogućavaju organizaciji razvoj i primjenu politike i ciljeva koji uzimaju u obzir zakonske zahtjeve i druge zahtjeve za koje se ta organizacija opredijelila, kao i podatke o značajnim aspektima okoliša. To se odnosi na one aspekte okoliša koje organizacija može nadzirati, kao i one na koje može utjecati. - Prvo odobrenje: 6. srpnja 2004. - Potvrda izdana: 4. srpnja 2010. - Potvrda vrijedi do: 4. srpnja 2013. Izvor: www.hzn.hr/priopcenja.html ISO 12647-2 (standardizacija šesterobojnog tiska) dokumenti - Certifikat ISO 9001:2008 (.pdf) - veličina 500 KB - Certifikat ISO 14001:2004 (.pdf) - veličina 500 KB