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Quality System Handbook Amendments to 4th Edition

Anyone detecting an error or an omission should contact the author David Hoyle indicating the nature of the problem found by clicking  here Handbook Amendment and when appropriate, amendments will be posted on this page of the web site.

2003 Reprint

The following errors were corrected with the 2003 reprint

Chapter 2 
Page 22  2nd paragraph - 'fitness for use' should be 'fit for use'
Page 36 4th paragraph - 'People naturally concentrate on what they are measured.' should be 'People naturally concentrate on what they are measured against.'
Page 63  2nd paragraph - 'quality management' should be 'quality management system'
Page 64  3rd paragraph - 'the inherent characteristics are limited to products. should be the inherent characteristics are not limited to products'
Page 69  1st paragraph - 'not carried our...' should be 'not carried out...'
Page 78  item 23 'should be exist' should'  read 'should exist'

Chapter 3
Page 91 Figure 3.1 'Biq Q to little q' should read 'Little q to big Q'

Page 129  2nd paragraph - 'In order to determining..' should read 'In order to determine...'

Chapter 5
Page  263  last paragraph - 'inventory required meeting the..' should read 'inventory required for meeting the...'

Chapter 6
Page 304 and page 307 Headings - (6.2.1) should be (6.1)

Chapter 7
Page 394 2nd paragraph - 'communication production information.' should read 'communicating product information'
Page 468 2nd paragraph - '...obligation to accept product...' should read '...obligation to provide product...'
Page 468 4th paragraph - '...in three ways:' should read '...in four ways:'

Chapter 8 
Page 598 'clause 4.14.3' should be clause 8.5.3'
Page 614 Table 8.1 item 21 '..steps 1 to 14' should read '..steps 1 to 20'
Page 638 Clause 8.5.3d '...requirements for recoding..' should read '...requirements for recording.

Appendix A
Page 652 'Plan  Provisions made to achieve and objective' should be Provisions made to achieve an objective'

The following omissions remain

Chapter 4 
Outsourcing
Omission of requirement. Clause 4.1 paragraph 4. This is addressed briefly on page 160 and refers to this requirement as a note, which is what it was in the final draft of ISO 9001:2000 but became a requirement in the final version.
The standard requires the organization to ensure control of any outsourced processes that affects product conformity with requirements and to identify such control within the quality management system.
What does it mean
In purchasing products and services to the supplier's own specification, the organization is not outsourcing processes or subcontracting. It is simply buying products and services. An outsourced process is one that is managed by another organization on behalf of the parent organization. The most common outsourced processes are manufacturing processes such as fabrication, assembly, finishing processes. But organizations also outsource information technology, human resources, cleaning, maintenance and accounting services. Often it is the activities that are outsourced not the process in its entirety. For a process to be outsourced, the supplier should be given an objective and given freedom to determine how that objective will be met. If the supplier merely performs activities dictated by the organization to the organization's specification it is not a process that has been outsourced. 
Why is this necessary
At one time, an organization would develop all the processes it required and keep them in-house because it was believed it had better control over them. As trade became more competitive, organizations found that their none-core processes were absorbing a heavy overhead and required significant investment just to keep pace with advances in technology. They realized that if they were to make this investment they would diminish the resources given to their core business and not make the advances they needed to either maintain or grow the business. A more cost effective solution was to put the management of these non-core processes in the hands of organizations for which they were the core processes.  However, the organization needs to have control over all the processes required for it to achieve its objectives otherwise it is not in a position to predict performance or provide confidence to its customers that it will satisfy customer requirements. 
How is this implemented
When managing an outsourced process, the organization is not simply placing orders for products and checking that the products received comply with the requirements but establishing process objectives and verifying that the supplier has developed a process that is capable of achieving those objectives. The processes should have a capability that enables the organization to avoid checking the outputs. All the rigor applied to the internal processes should be applied to the outsourced process. Data on the performance of these processes, their efficiency and effectiveness should be analysed by the organization and measures put in place to cause improvement action should the outcomes of the process not satisfy the organization's objectives.

Chapter 8 
Correction of processes
Omission of requirement. Clause 8.2.3
The standard requires correction and corrective action to be taken to ensure conformity of product when planned results are not achieved.
What does it mean
When the performance of a process fails to meet the process objectives, (i.e. the planned results) action should be taken. The requirement can be interpreted in two ways. Action on the product or action on the process that produced the product. Correction of the product is addressed by clause 8.3 on Control of Nonconforming product (see pages 584 to 595). Corrective action is addressed by clause 8.5.2 (see pages 612 to 627) and can result in changes to the process as well as the product in order to prevent recurrence of the problem. Correction of the process is a corrective action relative to the batch of product being produced but possibly not for future product i.e adjusting a process so that all current product conforms will prevent further nonconformity of the current batch but when the process is run again, the same problems may emerge unless corrective action is taken on the process.
Why is this necessary
This requirement responds to the process approach principle.
Unless adjustments to the process are taken to bring a process under control, it may never produce the desirable output. Such adjustment are process corrections and are necessary until such time as the process is capable - i.e all special cause variation has been removed (see page 49). .
How is this implemented
When a process is under statistical control variation is random and may need to be reduced in order to increase process yield. When the process is under statistical control process correction is undesirable as it may induce instability. If you happen to detect the one in a million products that is defective, don't change the process   Action on the product will not prevent further failures unless the root cause of the problem is detected and eliminated. In order to implement this requirement an understanding of quality control is required and this is addressed in Chapter 2 (see page 47 to 51). Process monitoring and measurement is also addressed in Chapter 4  on pages 167 to 170.

Control of nonconforming product (8.3)
In the 4th Edition I did not clarify what is meant by product in the context of nonconforming product.  In ISO 9000 clause 3.4.2 it defines a product as a result of a process but when applying ISO 9001, it is not intended that the product of any process be treated as conforming product or nonconforming product - it is only the product that is required by or intended for a customer. Therefore whilst a business plan is a product of the business management process, it is not intended that an inadequate business plan be controlled in accordance with clause 8.3 as though it was nonconforming product.