LRQA Client Gathering 29 January 2009 JW Marriott- Jakarta Raj Gungaram – President Director PT Lloyd’s Register Indonesia
Presented by Mr Erisman Soediman Technical Manager LRQA Indonesia
Lloyd’s Register Quality Assurance Indonesia • Time line • What ISO – IAF was saying? • Quick Reference • The changes • What happens next?
Lloyd’s Register Quality Assurance Indonesia • Time Line • This was issued on 14th November 2008
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
Lloyd’s Register Quality Assurance Indonesia • Quick Reference • Refer to Annex B (informative) • 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 – 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
ISO 9001 – 2008 Changes Rewording of the text Example 7.5.3 Para 3. - Identification and traceabilityUsed 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
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.
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.
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 ISO 9001 – 2008 Changes Rewording of the same text
6.2 Human resourcesThe 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 equipmentNo longer uses the term “devices”, the term now used throughout is “equipment”This also as been reflected in 7.5.1 d ISO 9001 – 2008 Changes To provide consistency in terminology
ISO 9001 – 2008 ChangesClarification 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)
ISO 9001 – 2008 ChangesClarification 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).
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.
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
ISO 9001 – 2008 ChangesSubtle changes, but could have some implications 6.3 Infrastructure - section c)now includes“information systems” to supporting services
ISO 9001 – 2008 ChangesSubtle changes, but could have some implications 7.2.1 Determination of requirements related to productnew note added addressing post delivery activities, such as warranty provisions, maintenance services, recycling or final disposition
ISO 9001 – 2008 ChangesSubtle 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”
ISO 9001 – 2008 ChangesSubtle 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”
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.
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
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.
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.
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.
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.
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.
Update to ISO 9004? • Likely to be far more radical but not due until 2009 / 2010
Thank You. Further information : firstname.lastname@example.org
Presented By Fefi Mardalena Commercial Training Manager
Formed in 1760 a non-profit distributing society using its operational surplus to enhance knowledge and promote safety of property and people
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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
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
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
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
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 www.lrqa.co.id for information of course venues and dates
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