| ISO9001 has been around now since 2000 and it is | | | | disposal |
| normal practise for Standards to be reviewed and | | | | Clause 7.3.1 (Design & development planning) |
| updated every five years or so. This update is now | | | | - Clarifies that design and development review, |
| overdue. | | | | verification and validation have distinct purposes |
| The PDCA model has been retained and one member | | | | - These may be conducted and recorded separately |
| of then committee said it should stand for 'Please don't | | | | or in any combination as suitable for the product and |
| change anything' rather than PLAN-DO-CHECK-ACT. | | | | the organization |
| The ISO Committee has proposed that only minor | | | | Clause 7.3.3(Design & development outputs) |
| changes should be incorporated into the 2008 update: | | | | - Clarifies that information needed for production and |
| Clause 0.2 (Process approach) | | | | service provision includes preservation of the product |
| - Text added to emphasize the importance of | | | | Clause 7.5.4 (Customer property) |
| processes being capable of achieving desired outputs | | | | - Explains that both intellectual property and personal |
| Clause 4.2.3 (Document control) | | | | data should be considered as customer property |
| - Clarification that only external documents relevant to | | | | Clause 7.6 (Now retitled Control of Monitoring and |
| the QMS need to be controlled | | | | Measuring equipment) |
| Clause 4.2.4 (Records control) | | | | - Explanatory notes added regarding the use of |
| - Editorial changes only (better alignment with ISO | | | | computer software: |
| 14001) | | | | "Confirmation of the ability of computer software to |
| Clause 5.5.2 (Management rep) | | | | satisfy the intended application would typically include |
| - Clarifies that this must be a member of the | | | | its verification and configuration management to |
| organization's own management | | | | maintain its suitability for use." |
| Clause 6.2.1 (Human resources) | | | | Clause 8.2.1 (Customer satisfaction) |
| - Clarification that competence requirements are | | | | - Note added to explain that monitoring of customer |
| relevant for any personnel who are involved in the | | | | perception may include input from sources such as |
| operation of the quality management system | | | | customer satisfaction surveys, customer data on |
| Clause 6.3 (Infrastructure | | | | delivered product quality, user opinion surveys, lost |
| - Includes information systems as example | | | | business analysis, compliments, and dealer reports |
| Clause 6.4 (Work environment) | | | | Clause 8.2.3 (Monitoring / Measurement of process) |
| - Clarifies that this includes conditions under which | | | | - Note added to clarify that when deciding on |
| work is performed and includes, for example physical, | | | | appropriate methods, the organization should consider |
| environmental and other factors such as noise, | | | | impact on the conformity to product requirements and |
| temperature, humidity, lighting, or weather | | | | on the effectiveness of the quality management |
| Clause 7.2.1 (Customer related processes) | | | | system. |
| - Clarifies that post-delivery activities may include: | | | | I must emphasise that these are proposed changes |
| - Actions under warranty provisions | | | | and not 'set in stone'. |
| - Contractual obligations such as maintenance services | | | | The 2008 Standard is expected to be published in |
| - Supplementary services such as recycling or final | | | | November 2008. |