What Changes To Expect In ISO 9001:2008
ISO 9001:2008

Introduction
ISO 9001, like other management system standards is subject to periodic review to determine whether it is still relevant, whether it needs to be updated or whether it’s use be discontinued. The review period is around 5 - 6 years so, since the current version was issued in the year 2000, the standard is now due for revision and re-issue.

The revision process for ISO 9001 is designed so that whenever there are significant changes to be made, the next revision will be less significant.
Since the revisions issued in 2000 were major, it follows that the next one will be minor. Indeed, the proposed changes are more to do with clarifying points already in the standard rather than including new requirements.

ISO 9001 Changes
The following changes have been made to ISO 9001:2000 in the Draft ISO 9001:2008 International Standard (DIS):

Section 01 Para.3
Statement of where and who can use the standard now includes statutory requirements as well as customer and regulatory and clarifies that these requirements are restricted to those applicable to the product.

Section 0.4
A comment has been added that the development of ISO 9001:2008 has made due consideration to ISO 14001:2004.

1.1 & 1.2
Again, statutory requirements have been added (as in 0.1) and Note 1 has been amended to include comments regarding purchased product as well as product from realisation processes. Note 2 has been added explaining that statutory and regulatory requirements may be expressed as legal requirements.

Section 2
The reference to ISO 9000 now states the fact that is at version 2005.

Section 3
The explanation of who the ‘customer,’organisation’ and ’supplier’ are, has been removed

Clause 4.1
a) The word ‘identify’ has been replaced with ‘determine’
The statement regarding outsourced processes has been slightly re-worded but the intent is the same. Note 2 has been added to reflect the fact that outsourced processes may be linked to clause 7.4 (purchasing) and Note 3 expands on the type of control that may be applied to outsourced processes in order to ensure control over them.

4.2.1
The wording has been slightly re-modelled but the intent stays the same.
Note 2 has been added to clarify that a single document may include the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document. e.g. you may combine the documented procedures for corrective and preventive action if you wish.

4.2.3 f
Clarification that the external documents referred to are those needed for use in the QMS.

4.2.4
This clause has been significantly reduced in length but the requirement remains unchanged.

5.1 a
The word statutory has again been added.

5.5.2
The requirement that the management representative needs to be a member of the organisation’s management has been added.

6.2
Change in title but keeps same words (change in their order).
Where the current version mentions ‘….affecting product quality’, it now states’ …affecting conformity to product requirements.’

6.2.2 b) now states that ‘where applicable’ training needs to be provided to achieve the ‘necessary competence’.

6.2.2 c) now requires that the achievement of competence has been ensured rather than checking the effectiveness of training.

6.3c) now includes information systems.

6.4
A note has been added to clarify what work environment includes and gives some examples such as noise, temperature, humidity.

7.1 c
The word measurement has been added.

7.2.1
a) slightly re-worded.
c) the word ‘related’ has changed to ‘applicable’.
d) the statement about additional requirements determined by the organisation becomes ‘considered necessary’ by the organisation.
A note has been added to explain what the phrase post delivery activities’ may include i.e. warranty provisions,etc.

7.3.1
A note has been added to explain that design review, verification and validation are separate activities though they may be performed separately or in any combination e.g. verification and validation may be performed together.

7.3.2
‘These’ inputs becomes ‘the’ inputs (last para).

7.3.3
The word ‘provided’ has been removed and the phrase ’suitable for’ replaces ‘that enables’.
b) the word ‘for’ (service provision) has been removed.
A note has been added regarding the inclusion of ‘preservation of product’.

7.5.3
An added requirement to clarify that inspection and test status must be identified ‘throughout product realisation’.
Slight re-wording of record requirement under traceability.

7.5.4
Re-wording of the requirement to inform the customer if there is a problem and keep records.
The phrase ‘and personal data’ has been added to the note about intellectual property.

7.5.5
Re-wording of ‘conformity of’ to ‘in order to maintain conformity to requirements’.
‘Where appropriate, this’ has changed to ‘as applicable’.

7.6
The word ‘devices’ in the title has been changed to ‘equipment’.
The reference to 7.1 has been removed.

c) ‘be identified to enable the’ has been changed to ‘have identification to enable their’.
Note 1 has been amended to remove the reference to ISO 10012-2 and has been replaced by a Note 3 to explain about the verification and configuration management of computer software (where it is used to monitor and measure).

8.2.1
A Note has been added to provide some ideas as to how customer satisfaction can be measured.

8.2.2
The requirement for a documented procedure has been re-worded but remains unchanged. A requirement for records of the audits and their results has been added.
A requirement for management responsiblefor the area audited to ensure that ‘necessary corrections and corrective actions’ has been added.
The Note that makes reference to the fact that ISO 10011 has changed and now refers to ISO 19011.

8.2.3
The phrase ‘to ensure conformity of the product’ has been removed.
A Note has been added to explain that the organisation should consider the type of monitoring and measuring of processes and the extent to which they affect quality and the QMS.

8.2.4
The requirement to ‘maintain evidence of conformity with acceptance criteria’ has moved but is still a requirement.
Clarification of the fact that product release/ service delivery is ‘to the customer’ has been added.

8.3
The requirement for a documented procedure has been re-worded but remains unchanged.
The phrase ‘where applicable’ has been added to the methods for dealing with nonconforming product.
The requirement to deal with nonconforming product discovered after delivery has been moved to be bullet point d) but is unchanged.
The records requirement has moved but is unchanged.

Summary
As can be seen from the above list, these changes, will not have a significant impact on any quality management system and most organizations will have little problem adapting their system to satisfy these changes.

For more information on ISO 9001 and other managements systems, please visit askartsolutions.com

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Getting help with implementing an ISO 9001 Quality Management System (QMS) can be a daunting task. Many Quality Managers try and do it alone and spend many months and even years before they develop, implement and get their QMS certified. Others use a Consultant to help them. If they are lucky and find a good one, they will get results soon and also save money.

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The International Organization For Standardization has produced thousands of standards on a variety of topics and hundreds of new ones are issued every year. Most of these are technical and relate to a specific industry or product/service. The standards that relate to good management practice are known as business management systems. The list here is a lot smaller:
• ISO 9001:2000 - Quality Management
• ISO 14001:2004 - Environmental management
• ISO/TS 16949:2002 - Automotive
• IWA 2:2007 - Education
• ISO/IEC 27001-2005 – Information Security
• ISI 22000-2005 - Food Safety
• IWA 1-2005 – Health Care
• IWA 4:2005 – Local Government
• ISO 13485-2003 – Medical Devices
• ISO 29001- 2003 – Petroleum and Gas
• ISO 30000 – Ship Recycling
• ISO 28000-2007 – Supply Chain Security
In future posts, I will provide details on each one of these standards

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Your internal audit program is one of the key tools, that the ISO 9001 quality management standard requires an organization to use, to determine the effectiveness of its quality management system (QMS). An organization’s QMS effectiveness is measured by its ability to meet its objectives in terms of customer, business and other requirements.
As a process, your Internal Audit program must be controlled no different than other QMS processes. Following the underlying QMS concepts of plan-do-check-act, you must carefully plan, define, implement and control your organization’s internal audit program. Your Internal Audit Program should help you to identify problems, risks, good practices and opportunities to better achieve your goals and enhance customer satisfaction.
So to begin with, senior management must actively support the audit program by providing resources in terms of making personnel available to plan and conduct audits; providing them the requisite training through internal or external means; allowing the workforce the time to respond to audits; communicating to the workforce the importance of this activity; reviewing and taking action on the information provided by internal audit reports.
A number of factors must be considered in planning an effective Internal Audit Program. These include:
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• Audit criteria and scope
• Schedule and frequency
• Auditor training, selection and availability
• Audit strategies and practices
• Audit Plans
• Auditee responsibilities
• Audit reporting
• Audit documents and tools
• Audit sampling
• Communication and interaction
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There are many ways to implement a quality management system ranging from doing it yourself to having a consultant help you. The extent to which you get outside help will depend upon the internal resources you have and the knowledge of the specific management system you wish to install. This website while obviously about consulting services will provide you with guidance on how to go about it the right way. How much you should do yourself and how much and what type of outside help you should get

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