MAGGIE DTTO JON KECK KATY FEENY

 ISO stands for International Organization for Standardization  Pre ISO 9000  BS 5750 ▪ Required factories to document manufacturing practices ▪ Covered how to manage manufacturing processes, not what to make ▪ In 1987, the ISO was persuaded to adopt BS 5750, which became ISO 9000

 ISO 9000 encompasses a family of standards for quality management systems  Must be certified to be able to state “ISO 9000 Certified/Registered”  Versions of ISO 9000  AS: Aerospace Basic Quality System Standard  PS: Pharmaceutical Packaging Materials  QS: Automotive Manufacturers  ISO 13485: 2003 is medical industry equivalent ▪ Requires only that quality system is implemented and maintained  In 2000, ISO 9001, 9002 & 9003 were combined to make ISO 9001  Placed process management front and center

 ISO 9001:2008 (Requirements)  Same requirements as ISO 9001:2000  Intended for organizations which design, manufacture, install and/or service any product or provides any form of service  Provides requirements to achieve customer satisfaction and expectations  Includes a requirement for the continual improvement of the Quality Managements (QM) system  The only standard which auditors may grant certification

ISO 9001 Elements Management ResponsibilitiesInspection and Testing Quality SystemNonconforming Product Contract ReviewCorrective and Preventative Action (CAPA) Design ControlHandling, Storage, and Packaging Document ControlControl of Quality Records PurchasingInternal Audits Control of Customer Supplied ProductTraining Product Identification and TraceabilityServicing Process ControlStatistical Techniques

 ISO 9004: 2000 (Guidelines for performance improvements)  Covers continual improvement and advises how to enhance a mature system  ISO 9000:2005 (Fundamentals and vocabulary)  Covers basics of QM systems and contain the language of the ISO 9000 family

 The ISO does not certify companies itself  Must be certified by authorized body via auditing  Both accreditation and certification bodies charge fees for this service  An ISO certification must be reviewed regularly (3 years)  Certification does not guarantee compliance and therefore end product quality  Certification attests that consistent business processes are being applied

Applying organization is reviewed based on appraisal of its sites, functions, products, services, and processes A list of problems is made known to the management ISO 9001 certification is awarded If problems are minor, a resolution plan must be set in place pre certification

 Purpose: Continual process of review and assessment  Types Required  External (certification body)  Internal (staff trained in ISO certification) ▪ Must audit outside their usual management lines so judgment is not biased  1994 vs  1994 asks “Are you doing what the manual says you should be doing?”  2000 asks “Will this process help you achieve your stated objectives or is there a better way?”

PROS  A more efficient, effective operation  Increased customer satisfaction and retention  Enhanced marketing  Improved employee motivation, awareness, and morale  Promoted international trade  Increased profit  Reduced waste and increased productivity CONS  Timely and costly  Prone to failure when a company is interested in certification before quality  Customer contractual requirements force certifications rather than a desire to improve quality  Certification by an independent auditor is often a problem  ISO actually advises ISO 9001 implementation without certification, simply for the quality benefits that can be achieved

 Medical device manufacturers must comply with quality requirements in cGMP  cGMP governs methods, facilities, and controls used in the design, manufacture, packaging, labeling, storage, installation, and servicing of medical devices  cGMP is similar to ISO 9001 but not exact

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