1. LRQA Client Gathering 29 January 2009 JW Marriott- Jakarta
Raj Gungaram – President Director
PT Lloyd’s Register Indonesia

2. Presented by Mr Erisman Soediman Technical Manager LRQA Indonesia

3. Lloyd’s Register Quality Assurance Indonesia
Time line
What ISO – IAF was saying?
Quick Reference
The changes
What happens next?

4. This was issued on 14th November 2008
Lloyd’s Register Quality Assurance Indonesia
Time Line
This was issued on 14th November 2008

5. Lloyd’s Register Quality Assurance Indonesia
In a recent announcement Ref 1152 dated 20 Aug 2008,
a Joint IAF-ISO Communiqué was published:
ISO 9001:2008 does not contain any new requirements

6. Refer to Annex B (informative) Changes between ISO 9001:2000 and
Lloyd’s Register Quality Assurance Indonesia
Quick Reference
Refer to Annex B (informative)
Changes between ISO 9001:2000 and
ISO 9001:2008

7. Changes between ISO 9001:2000 and ISO 9001:2008
Annex B
(Informative)
Changes between ISO 9001:2000 and ISO 9001:2008
Table B.1 — Changes between ISO 9001:2000 and ISO 9001:2008
ISO 9001:2000
Clause No.
Paragraph/
Figure/
Table/
Note
Addition
(A) or
Deletion
(D)
Amended text
(ISO 9001:2008)
4.2.3
Bullet f) A
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, and
4.2.4
Para 1
D + A
Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled. Records shall remain legible, readily identifiable and retrievable.
The organization shall establish a documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.
Records shall remain legible, readily identifiable and retrievable.
4.2.1
Bullet e) D
e) Records required by this International Standard (see 4.2.4).

8. The changes

9. ISO 9001 – 2008 Changes Summary Of Changes
The changes are minimal and mainly comprise:
Rewording of the text with no impact on LRQA/Company
Interpretation
Rewording to provide consistency of terminology between
certification standards
Clarification of approach / application
Subtle changes that may have some implication on LRQA clients

10. ISO 9001 – 2008 Changes Rewording of the text
Example Para Identification and traceability Used to be: Where traceability is a requirement, the organisation shall control and record the unique identification of the product
Now reads: Where traceability is a requirement, the organisation shall control the unique identification of the product and maintain records

11. ISO 9001 – 2008 Changes Rewording of the text
Example 8.3 Para 1st Paragraph, 2nd sentence relating to requirement for a “documented procedure” has been reworded Used to be: The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing with nonconforming productshall be defined in a documented procedure.

12. ISO 9001 – 2008 Changes Rewording of the text
Now reads: The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. A documented procedure shall be established to define the controls and related responsibilities and authorities for dealing with nonconforming product.

13. Rewording of the same text
ISO 9001 – 2008 Changes
Rewording of the same text
Other Examples:
4.1 General requirements
4.2.1 General (Documentation requirements)
7.5.2 Validation of processes for production and service provision
7.5.4 Customer property
7.5.5 Preservation of product
7.6 c identification of calibration status
8.1 a measurement to demonstrate conformity to product requirements
8.2.2 Internal audit
8.2.4 authorising release of product
8.3 Control of nonconforming product

14. To provide consistency in terminology
ISO 9001 – 2008 Changes
To provide consistency in terminology
6.2 Human resources The words “product quality” are not used, replaced by “conformity to product requirements” This now the same as in 6.3 Infrastructure and 6.4 Work environment”
7.6 Control of monitoring and measuring equipment No longer uses the term “devices”, the term now used throughout is “equipment” This also as been reflected in d

15. ISO 9001 – 2008 Changes Clarification of approach / application
Some examples are as follows:
1.1 General (Note 1) - now states what the term “product” means
4.1 General requirements: - section e) clarifies that an organisation monitors and measures processes “where applicable” - Notes 2 & 3 clarify what an outsourced process is and the types of control that may be required
4.2 Documentation requirements – a document might include more than one procedure and a requirement may be covered by more than one procedure (i.e.: Corrective Action)

16. ISO 9001 – 2008 Changes Clarification of approach / application
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
6.4 Work environment – new Note explaining what “work environment” means.
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).

17. Clarification of approach / application
ISO 9001 – 2008 Changes
Clarification of approach / application
7.3.1 Design and development planning –
new Note explaining that the design review, verification and validation have distinct purposes and that they may be conducted and recorded separately or in any combination
8.2.1 Customer Satisfaction (Monitoring and measurement)
new Note has been added to provide some ideas as to how customer satisfaction can be measured, such as opinion surveys, lost business analysis, compliments, warranty claims and dealer report, etc.

18. Subtle changes, but could have some implications
ISO 9001 – 2008 Changes
Subtle changes, but could have some implications
0.1 General now states “the design & implementation of the QMS is influenced by its business environment, changes in that environment, or the risks associated with that environment

19. ISO 9001 – 2008 Changes Subtle changes, but could have some implications
6.3 Infrastructure - section c) now includes “information systems” to supporting services

20. ISO 9001 – 2008 Changes Subtle changes, but could have some implications
7.2.1 Determination of requirements related to product new note added addressing post delivery activities, such as warranty provisions, maintenance services, recycling or final disposition

21. ISO 9001 – 2008 Changes Subtle changes, but could have some implications
7.5.4 Customer property the Note now states that “Customer property can include intellectual property and personal data”

22. ISO 9001 – 2008 Changes Subtle changes, but could have some implications
7.6 Control of monitoring and measuring equipment new Note added stating “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”

23. What happens next?

24. Transition - Strategy
In order to minimise the impact on technical review and administration, we would prefer that where possible clients undertake Transition at their CR visits rather than Surveillances
Or the transition could be done at surveillance assessment.

25. Transition
By 14 November 2009, (one year after publication of ISO 9001:2008) all accredited new certificates issued shall be to ISO 9001:2008.
By 14 November 2010 (twenty four months after publication of ISO 9001:2008) any existing certificates issued to ISO 9001:2000 will no longer be valid

26. Transition
It is anticipated that the majority of clients will not require additional time for us to carry out a transition assessment.
Transition cannot be completed if any major non-conformances are open.
Any minor non-conformances will need to have potential corrective action identified before transition can be achieved.

27. Transition - Stage 1 and Stage 2 visits
For contracts already issued, clients have the choice of being assessed to either the 2000 or 2008 versions.
All new contracts will be issued for assessment to the 2008 standard.

28. Transition - Approved clients
Clients are required to carry out a review of their
management system against the requirements of the
2008 standard. The results of this review must be
recorded and any necessary amendments to
the management system must be made and
Implemented.
The review and associated actions must be demonstrable
to the Assessor.

29. Clients will have the choice of being assessed to
Transition - Approved clients - Certificate renewal and change to approval visits
Clients will have the choice of being assessed to
either version up to 01 July 2009.
After this date, all certificate renewal and
change to approval visits will be against
the 2008 standard.
There will be no additional charge for including
the transition assessment at these visits.

30. Transition - Approved clients - Surveillance visits
Clients who want to be assessed to the 2008 standard must make the Assessor aware of this during the courtesy call before the surveillance visit. The assessor will confirm whether or not there are any potential obstacles to undertaking the transition assessment as part of the surveillance visit, for example, time constraints or non-conformances outstanding.
Any client who has not been approved to the 2008 version by the time of their surveillance visit immediately before 14 November 2010 will be assessed against the 2008 version.

31. Likely to be far more radical but not due until 2009 / 2010
Update to ISO 9004?
Likely to be far more radical but not due until 2009 / 2010

32. Thank You.
Further information :

33. Commercial Training Manager
Presented By
Fefi Mardalena
Commercial Training Manager

34. Formed in 1760 a non-profit distributing society using its operational surplus to enhance knowledge and promote safety of property and people

35. The organization employs over 6,200 people in its 250 offices in over 100 countries across the world, managed from its City of London headquarters.

36. LRQA Indonesia Training Services
LRQA is pleased to announce a new service offering
Training Services – for your most valuable asset
Fully accredited range of training courses to meet your business objectives
Full details in the brochure

37. “Investment for your
most valuable asset”

38. LRQA Training
Accreditations

39. LRQA Indonesia Training Services
Internal Audit ( IRCA Registered)
- QMS
- EMS
- OHSAS
Lead Auditor
Integrated Management System
Food Training ( ISO & HACCP)

40. LRQA Training Our Commitment to you Our Trainers
Professional training that can improve your business by giving your people the knowledge and skills to come up with innovative solutions.
Our Trainers
All practicing assessors with in depth knowledge of the challengers and issues you face daily.
Use the latest thinking, real experiences and practical models to ensure all you learn can be transferred back to the workplace.
Focused on the objectives of the training

41. LRQA Training In-Company
Cost effective for those organisations wanting more than 4 delegates trained
Delivered at a time and venue of your choice
All delegates already have an understanding of the organisations processes and procedures that can be used in the delivery of the event
Your Management system is unique – choosing in-company training is a unique solution to your training needs

42. LRQA Training Tailored or Bespoke? Tailored
All our in-company events include the following:-
A pre-event visit to discuss your specific training needs
The appointed trainer will contact you prior to the event to discuss the objectives of the course and to gather information on your organisation
Tailored in Delivery referencing your own policies and procedures
Allocated time prior to the event for the trainer to familiarise themselves with your organisation

43. LRQA Training Tailored or Bespoke Bespoke
Technical visit arranged prior to the event by the appointed trainer
Materials to be customised and/or designed specific to your organisation
Presentations customised
Case Studies Designed
Your own processes and procedures used during the deliver
Live audits can be scheduled into the event

44. LRQA Training The next step
A formal proposal will be forwarded to you within 48 hours of your visit
An advisor will contact you to discuss timescales and venues
Upon confirmation of event our customer services team will contact you to discuss arrangements
Course notes will be despatched directly to you prior to the event taking place
Delegates will receive their own certificate (for appropriate courses) after the event
Post event review visit

45. LRQA Training Public courses
Venues across Indonesia that are visited and inspected prior to use
Suitable should you only need 1 or 2 delegates trained
Delegates benefit from the interaction with other organisations
Visit for information of course venues and dates

47. LRQA Training Contact us T 62 021 5760868 F 62 021 5760861E W
Key Contacts Fefi Mardalena
Dewi Nur Fitriyati