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?

This was issued on 14th November 2008 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

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

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).

The changes

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 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

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.

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

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 7.5.1 d

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)

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).

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.

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

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

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

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”

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”

What happens next?

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.

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.

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.

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

Thank You. Further information : erisman.soediman@lr.org

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