Presentation on theme: "LRQA Client Gathering 29 January 2009 JW Marriott- Jakarta"— Presentation transcript:
1LRQA Client Gathering 29 January 2009 JW Marriott- Jakarta Raj Gungaram – President DirectorPT Lloyd’s Register Indonesia
2Presented by Mr Erisman Soediman Technical Manager LRQA Indonesia
3Lloyd’s Register Quality Assurance Indonesia Time lineWhat ISO – IAF was saying?Quick ReferenceThe changesWhat happens next?
4This was issued on 14th November 2008 Lloyd’s Register Quality Assurance IndonesiaTime LineThis was issued on 14th November 2008
5Lloyd’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
6Refer to Annex B (informative) Changes between ISO 9001:2000 and Lloyd’s Register Quality Assurance IndonesiaQuick ReferenceRefer to Annex B (informative)Changes between ISO 9001:2000 andISO 9001:2008
7Changes between ISO 9001:2000 and ISO 9001:2008 Annex B(Informative)Changes between ISO 9001:2000 and ISO 9001:2008Table B.1 — Changes between ISO 9001:2000 and ISO 9001:2008ISO 9001:2000Clause No.Paragraph/Figure/Table/NoteAddition(A) orDeletion(D)Amended text(ISO 9001:2008)4.2.3Bullet f)Af) 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, and4.2.4Para 1D + ARecords 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.4.2.1Bullet e)De) Records required by this International Standard (see 4.2.4).
9ISO 9001 – 2008 Changes Summary Of Changes The changes are minimal and mainly comprise:Rewording of the text with no impact on LRQA/CompanyInterpretationRewording to provide consistency of terminology betweencertification standardsClarification of approach / applicationSubtle changes that may have some implication on LRQA clients
10ISO 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 productNow reads: Where traceability is a requirement, the organisation shall control the unique identification of the product and maintain records
11ISO 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.
12ISO 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.
13Rewording of the same text ISO 9001 – 2008 ChangesRewording of the same textOther Examples:4.1 General requirements4.2.1 General (Documentation requirements)7.5.2 Validation of processes for production and service provision7.5.4 Customer property7.5.5 Preservation of product7.6 c identification of calibration status8.1 a measurement to demonstrate conformity to product requirements8.2.2 Internal audit8.2.4 authorising release of product8.3 Control of nonconforming product
14To provide consistency in terminology ISO 9001 – 2008 ChangesTo provide consistency in terminology6.2 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
15ISO 9001 – 2008 Changes Clarification of approach / application Some examples are as follows:1.1 General (Note 1) - now states what the term “product” means4.1 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 required4.2 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)
16ISO 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 includes6.4 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).
17Clarification of approach / application ISO 9001 – 2008 ChangesClarification of approach / application7.3.1 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 combination8.2.1 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.
18Subtle changes, but could have some implications ISO 9001 – 2008 ChangesSubtle changes, but could have some implications0.1 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
19ISO 9001 – 2008 Changes Subtle changes, but could have some implications 6.3 Infrastructure - section c) now includes “information systems” to supporting services
20ISO 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
21ISO 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”
22ISO 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”
24Transition - StrategyIn 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 SurveillancesOr the transition could be done at surveillance assessment.
25TransitionBy 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
26TransitionIt 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.
27Transition - 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.
28Transition - Approved clients Clients are required to carry out a review of theirmanagement system against the requirements of the2008 standard. The results of this review must berecorded and any necessary amendments tothe management system must be made andImplemented.The review and associated actions must be demonstrableto the Assessor.
29Clients will have the choice of being assessed to Transition - Approved clients - Certificate renewal and change to approval visitsClients will have the choice of being assessed toeither version up to 01 July 2009.After this date, all certificate renewal andchange to approval visits will be againstthe 2008 standard.There will be no additional charge for includingthe transition assessment at these visits.
30Transition - 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.
31Likely 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
33Commercial Training Manager Presented ByFefi MardalenaCommercial Training Manager
34Formed in 1760 a non-profit distributing society using its operational surplus to enhance knowledge and promote safety of property and people
35The organization employs over 6,200 people in its 250 offices in over 100 countries across the world, managed from its City of London headquarters.
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42LRQA Training Tailored or Bespoke? Tailored All our in-company events include the following:-A pre-event visit to discuss your specific training needsThe appointed trainer will contact you prior to the event to discuss the objectives of the course and to gather information on your organisationTailored in Delivery referencing your own policies and proceduresAllocated time prior to the event for the trainer to familiarise themselves with your organisation
43LRQA Training Tailored or Bespoke Bespoke Technical visit arranged prior to the event by the appointed trainerMaterials to be customised and/or designed specific to your organisationPresentations customisedCase Studies DesignedYour own processes and procedures used during the deliverLive audits can be scheduled into the event
44LRQA Training The next step A formal proposal will be forwarded to you within 48 hours of your visitAn advisor will contact you to discuss timescales and venuesUpon confirmation of event our customer services team will contact you to discuss arrangementsCourse notes will be despatched directly to you prior to the event taking placeDelegates will receive their own certificate (for appropriate courses) after the eventPost event review visit
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