lloyds register quality assurance indonesia lrqa client gathering 29 january 2009 jw marriott-...

Lloyd’s Register Quality Assurance Indonesia

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

• Time line

• What ISO – IAF was saying?

• Quick Reference

• The changes

• What happens next?


Time Line

This was issued on 14th November 2008


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


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 9001:2008Table B.1 — Changes between ISO 9001:2000 and ISO

9001:2008ISO

9001:2000Clause 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 productNow reads:Where traceability is a requirement, the organisation shall control the unique identification of the product and maintain records



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.


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 textOther 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

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

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”


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 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)

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).


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.

Clarification of approach / application


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


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


implications

7.5.4 Customer property

the Note now states that “Customer property can include intellectual property and personal data”


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.

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 :

[email protected]


Presented By Fefi Mardalena

Commercial Training Manager

Formed in 1760 a Formed in 1760 a non-profit non-profit

distributing distributing society using its society using its

operational operational surplus to surplus to enhance enhance

knowledge and knowledge and promote safety of promote safety of

property and property and peoplepeople

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.

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Post event review visit

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Contact us

T 62 021 5760868F 62 021 5760861E [email protected] W www.id.lrqa.com Key Contacts Fefi Mardalena

Dewi Nur Fitriyati

lloyds register quality assurance indonesia lrqa client gathering 29 january 2009 jw marriott-...

Documents

changes slide

product requirements

changes summary of changes

text slide

changes rewording

iso iaf

records slide

term product