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  1. The Truth about the Changes ISO 9001:2008 12th Annual Convention 15 September 2009 IT’S A MOLEHILL NOT A MOUNTAIN! Compiled by:

  2. Joint IAF / ISO Communiqué They have recognized that ISO 9001:2008 introduces no new requirements. ISO 9001:2008 only introduces clarifications to the existing requirements of ISO 9001:2000 based on eight years of experience of implementing the standard world wide with about one million certificates issued in 170 countries to date. It also introduces changes intended to improve consistency with ISO14001:2004 Controlled Disclosure

  3. The Truth about the Changes • 1.1 General a) needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements. Controlled Disclosure

  4. The Truth about the Changes • 4.1 General requirements NOTE 2 An outsourced process is identified as one needed for the organization’s quality management system but chosen to be performed by a party external to the organisation. NOTE 3 Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory and regulatory requirements. Controlled Disclosure

  5. The Truth about the Changes • 4.2 Documentation requirements • 4.2.1 General NOTE 1Where the term ‘documented procedure’ appears within this International Standard, this means that the procedure is established, documented, implemented and maintained. A single document may address the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document. • 4.2.3 Control of documents f) to ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled Controlled Disclosure

  6. The Truth about the Changes • 5.5.2 Management representative Top management shall appoint a member of the organization’s management who, irrespective of other responsibilities, shall have responsibility and authority that includes… Controlled Disclosure

  7. The Truth about the Changes • 6.2.2 Competence, training and awareness The organization shall a) determine the necessary competence for personnel performing work affecting conformity to product requirements, b) where applicable, provide training or take other actions to achieve the necessary competence Controlled Disclosure

  8. The Truth about the Changes • 6.3 Infrastructure • supporting services (such as transport, communication or information systems) • 6.4 Work environment NOTE The term “work environment” relates to those conditions under which work is performed including physical, environmental and other factors (such as noise, temperature, humidity, lighting, or weather) Controlled Disclosure

  9. The Truth about the Changes • 7.2.1 Determination of requirements related to the product NOTE Post-delivery activities include, for example, actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal Controlled Disclosure

  10. The Truth about the Changes • 7.3.1 Design and development planning NOTE Design and development review, verification and validation have distinct purposes. They can be conducted and recorded separately or in any combination, as suitable for the product and the organization • 7.3.3 Design and development outputs NOTE Information for production and service provision can include details for the preservation of product Controlled Disclosure

  11. The Truth about the Changes • 7.6 Control of monitoring and measuring equipment NOTE Confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use Controlled Disclosure

  12. The Truth about the Changes • 8.2.1 Customer satisfaction NOTE Monitoring customer perception can include obtaining input from sources such ascustomer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, warranty claims, dealer reports • 8.2.2 Internal audit Records of the audits and their results shall be maintained Controlled Disclosure

  13. The Truth about the Changes • 8.2.3 Monitoring and measurement of processes NOTE When determining suitable methods, it is advisable that the organisation consider the type and extent of monitoring or measurement appropriate to each of its processes in relation to their impact on the conformity to product requirements and on the effectiveness of the quality management system • 8.2.4 Monitoring and measurement of product Records shall indicate the person(s) authorising release of product for delivery to the customer Controlled Disclosure

  14. The Truth about the Changes - Transition Certification of conformity to ISO 9001:2008 and/or national equivalents shall only be issued after official publication of ISO 9001:2008 (which has now taken place) and after a routine surveillance or recertification audit against ISO 9001:2008. One year after publication of ISO 9001:2008 all accredited certifications issued (new certifications or recertification's) shall be to ISO 9001:2008. Twenty four months after publication by ISO of ISO 9001:2008, any existing certification issued to ISO 9001:2000 shall not be valid. Controlled Disclosure

  15. Implementation issues • What do you, as an organisation, have to do in relation to these changes? • Familiarise yourself with the changes to the standard. • Assess the impact on each function, department, process, area within your organisation’s current Quality Management System. • Where applicable, take appropriate action (implementation) to ensure that your organisation complies with the amendments in ISO 9001:2008. • Monitor and measure your processes and product against policies, objectives and requirements for the product and report the results. • Take further actions to continually improve the performance of the processes. Controlled Disclosure

  16. Contact Details: • Managing Director Operations Manager • Rod Duarte Melanie Biesenbach • Office: +27 12 654 5358 Office: +27 12 654 5358 • E-mail: E-mail: • Mobile: +27 82 800 7237 • Training Coordinator • Marissa Kennedy • Office: +27 12 654 5358 • E-mail: