ISO 9001-2008 and Advanced Systems Assurance — Already Certified
Help and Support for Organisations With ISO 9001 Certification
Touchstone Renard can provide friendly, professional and flexible support to organisations that have already achieved ISO 9001 certification to help manage and maintain their Quality Management Systems. The ISO 9001:2000 standard was amended in 2008 and is now known as ISO 9001-2008. Further details about the amendments are set out below.
If your external audit is due or you need any help or advice, please call or e-mail us and we will be there to support you and take care of your System! Our experienced people can provide the following services to businesses of all types and sizes:
- The support of a part-time Quality Manager to work with you in whatever way suits you best, on a regular or ad hoc basis, enabling changes to your System to be planned and implemented effectively.
- The services of a trained Internal Auditor with up-to-date skills and knowledge, who have completed the ISO Lead Auditor’s course, to check your Quality Management System, advise you on any gaps in your processes.
- A two day training programme for one or more of your staff to develop their skills and allow them to act as your Internal Auditor.
- The facilitation of Management Reviews by trained experts who will be independent and able to communicate effectively with your management team.
- Presentations and introductory workshops delivered by our friendly experts for your employees about ISO 9001 and (if required) other ISO Standards to engage their enthusiasm.
- The preparation of your organisation’s documentation for new policies and procedures to provide you with time to focus on other important business tasks.
- An objective review of your organisation’s policies and procedures.
- The facilitation of visits by an External Assessor to support your organisation in maintaining ISO 9001 certification (we always recommend that you use an independent assessment body that has been accredited by UKAS to ensure that your customers retain confidence in your business).
- Integration of systems where feasible between ISO 9001 and other Standards, such as ISO 14001 (the Environmental Management Standard) and ISO 27001 (Information Security) and BS 25999 (Business Continuity).
Changes to ISO 9001:2000 in 2008
The ISO 9001 standard is regularly reviewed and amended or sometimes updated more comprehensively. ISO 9001:2000 was amended in November 2008 and is now known as ISO 9001-2008. Most of the changes are intended to clarify the existing position and to make ISO 9001 more compatible with the Environmental Management Standard ISO14001 (for example, by using similar terminology), rather than to impose new requirements.
To find out more about the changes in detail, please see below. The impact of the changes on any organisation already certified to ISO 9001:2000 will be minimal. By the end of 2009, all new certifications or re-certifications will be to ISO 9001-2008 and, by the end of 2010, ISO 9000:2010 will have been phased out. If you are concerned about whether the amendments might affect your organisation or you would like any other help or advice with regard to your quality management system, please contact us at Touchstone Renard.
Please contact: Phil Austin, Touchstone Renard Limited, 11-15 Betterton Street, Covent Garden, London WC2H 9BP, United Kingdom.
- Tel: +44 (0)20 7866 8123.
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The Key Changes to ISO 9001:2000 Published in 2008
ISO 9001:2008 has now been published but the main changes are briefly set out below. You will probably need to have your copy of the ISO 9001:2000 Standard to hand in order to make comparison.
Introductory Clauses
There are changes and updates to various words, titles and expressions, with some wording removed.
4 — Quality Management System
4.1 — General Requirements
Rather than having to ‘identify’ processes needed in your quality management system (QMS), organisations are required to ‘determine’ them. This means that you still need to know what the processes are but you won’t have to specify them.
The statement relating to outsourced processes has been changed slightly so that organisations have to define the outsourced controls in the QMS, rather than the processes.
4.2.1 — Document Requirements — General
The words have changed but the meaning is the same! A note has been added to state that one or more procedures may be included in a single document and a documented procedure may be covered by one or more documents.
4.2.3 — Control of Documents
It has been clarified that ‘external documents’ means the external documents needed for the QMS.
4.2.4 — Control of Records
Despite the changed wording about control of records, the meaning remains the same!
5 — Management Responsibility
There are two small changes: the word ‘regulatory’ has been supplemented by ‘statutory and regulatory’ and ‘the management’ now says ‘the organisation’s management’.
6.2.1 — Resource Management — Human resources — General
The words ‘product quality’ have been changed to ‘conformity to product requirements’.
6.2.2 — Human Resources — Competence, Awareness and Training
Again, ‘product quality’ is changed, as mentioned above to remain consistent.
Training to achieve the necessary competence only has to be provided ‘where applicable’.
6.3 (c) — Infrastructure
The infrastructure of the organisation now includes ‘information systems’.
6.4 — Work Environment
This contains a clarification in the notes of what is included in ‘work environment’.
7.1 — Product Realisation — Planning
These contain small changes, including the addition of ‘measurement in 7.1 (c).
7.2 — Customer-Related Processes
The word ‘related’ changes to ‘applicable’ in 7.2.1 (d); and the word ‘determined’ changes to ‘considered necessary’ in7.2.1 (d).
7.3.1 — Design and Development Planning
A new note explains that review, verification and validation are separate processes although they can be carried out together.
7.3.3 — Design and Development Outputs
Some minor changes have been made to some words and there is a new note, including preservation of product in production and Service provision.
7.5.1 — Production and Service Provision — Control
There are minor changes to some words, for example, ‘devices’ has become ‘equipment’.
7.5.2 — Validation of Processes for Production and Service Provision
The wording has been changes slightly and the words ‘This includes any processes where…’ have been removed.
7.5.3 — Identification and Traceability
This adds to the requirement that inspection and test status must be identified throughout the production process (’product realisation’).
7.5.4 — Customer Property
The wording about the requirement to inform a customer if there is a problem has been changed but the requirement remains the same.
7.6 — Control of Monitoring and Measuring Devices
‘Measuring Devices’ has been changed to ‘Measuring Equipment’ and other words have changed but the requirements are the same.
Notes have been added to provide further clarifications.
8.2.1 — Monitoring and Measurement — Customer Satisfaction
A note has been added regarding the measurement of customer satisfaction.
8.2.2 — Internal Audit
Wording relating to auditors has changed slightly and the requirements in respect of a documented system have been re-worded.
8.2.3 — Monitoring and Measurement of Processes
There is a new note, stating that an organisation should give thought to the type of measuring and monitoring processes used and the extent to which they affect the QMS.
8.2.4 — Monitoring and Measurement of Product
Wording relating to ‘evidence of conformity’ has been moved.
8.3 — Control of Nonconforming Product
The requirement related to a documented procedure is the same, although the wording has changed. The words ‘where applicable’ have been applied to the ways of dealing with non-conforming products.
8.4 — Analysis of Data
There is a new requirement to review the effectiveness of Corrective Action, although many organisations have probably been doing this in any event.
The Annexes
The annexes to ISO 9001-2008 have also been changed to reflect various updates and, in particular, Annexe B clarifies the latest amendments.