Quality, ISO, and You

1. MAGGIE DTTO JON KECK KATY FEENY Quality, ISO, and You

2. History of ISO • 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

3. ISO 9000: Overview • 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

4. ISO 9000: Overview • 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

5. ISO 9000: Overview

6. ISO 9000: Overview • 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

7. Certification--us • 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

8. Process for Certification--us

9. Auditing • 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. 2000 • 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?”

10. Pros and Cons of ISO 9000 Pros 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 • 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

11. cGMPvs ISO 9001 • 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

12. Questions? • NCR video • www.youtube.com/watch?v=G8WI2MgyS7w • Quality & ISO video • http://www.youtube.com/watch?v=y4iIO9Db5rk&feature=channel • http://www.youtube.com/watch?v=0YAy79hyJII&feature=channel