Why then the REVISION? Health & Safety Health & Safety 8 - - PowerPoint PPT Presentation

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Why then the REVISION? Health & Safety Health & Safety 8 - - PowerPoint PPT Presentation

Jan 04, 2024 309 likes •360 views

Bureau Veritas Bureau Veritas Bureau Veritas One of the most widely recognised certification bodies in the World One of the most widely recognised certification bodies in the World 8 Over 180years of business experience 8 Offices in 140

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SLIDE 1

Recharging your QMS ISO 9001:2008 ISO 9001:2008

For the benefit of business and people

D V Mistry, Bureau Veritas Certification (India) Pvt. Ltd. Mumbai, INDIA

Our Vision Our Vision

8 Over 180years of business experience 8 Turnover over 2 billion euros 8 Over 200 000 customers worldwide 8 Offices in 140 countries 8 550 offices and laboratories 8 Over 33 000 employees

Bureau Veritas

Bureau Veritas

2 6 Feb 2009 Recharging your QMS – ISO 9001:2008 at Quality Conclave – QCI Delhi

Ou s o Ou s o

Become the leader in our industry and a major player in each of our market segments and key geographical markets.

Our Mission Our Mission

Deliver economic value to customers through QHSESA management of their assets, projects, products and systems, resulting in licence to

  • perate, risk reduction and performance improvement.

One of the most widely recognised certification bodies in the World One of the most widely recognised certification bodies in the World

  • 5 000 auditors worldwide in 60 countries
  • 1,00,000+ companies certified
  • World leader for Environmental

Management (ISO 14001)

Bureau Veritas

3 6 Feb 2009 Recharging your QMS – ISO 9001:2008 at Quality Conclave – QCI Delhi

  • World leader (50% Market Share) for

ethical and social certification (SA 8000)

  • Most widely accredited Certification Body

with 35 International Accreditations

  • Global market leader in accredited training
  • Global reach with local expertise
  • Common sense and pragmatic audits

Total Bureau Certification Veritas Offer

Food Safety Food Safety

8 ISO 22000 8 BRC Global Food Standard 8 IFS International Food Standard 8 EurepGAP 8 Ducth HACCP 8 GMP+ and QS and GMO 8 Fami-QS

Quality Quality

8 ISO 9001:2000

Social Accountability Social Accountability

8 SA8000 8 Global Reporting Initiative (GRI) 8 AA1000

Security Security

8 ISO 27001:2005 8 ISO 20000 4 6 Feb 2009 Recharging your QMS – ISO 9001:2008 at Quality Conclave – QCI Delhi 8 AS/EN-9100 8 TL 9000 8 TS 16949:2002

Environmental Environmental

8 ISO 14001/EMAS 8 Compliance Audits 8 Greenhouse Gas – UN CDM / Eu ETS 8 Forestry -PEFC, FSC

Health & Safety Health & Safety

8 OHSAS 18001 8 Industry Standards 8 BS 25999 8 TICK IT 8 TAPA

Others: Others:

8 Clients Own / Bespoke Auditing 8 Integrated Management Systems 8 CE Marking 8 Training

ISO 9001 revised to ISO 9001:2008

(on 15th Nov 2008)

By Subcommittee SC 2 of ISO/TC 176.

NO NEW REQUIREMENTS

The Revision

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The status wise both of present ISO 9001:2000 & ISO 9001:2008 will be treated as equal. Hence ISO 9001:2008 not an UPGRADE.

Why then the REVISION?

ISO reviews standards every 5 years

  • as technological evolution,
  • new methods and materials,
  • new quality
  • safety requirements

The Revision

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  • safety requirements,
  • questions of interpretation and

application.

To confirm, withdraw or revise the documents Guidelines to the SC 2 for Changes:

  • High impact - No changes
  • Medium impact - only if benefit to users
  • Low impact - only if it justifies benefits to users

The Revision

Not to repeat the 9K2K experience

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Low impact only if it justifies benefits to users The Benefits for users of ISO 9001:2008

  • Provides clarity
  • Increases compatibility with ISO 14001.
  • Maintains consistency with ISO 9000 family of stds.
  • Improves translatability.

“The revised ISO 9001 results from a structured process giving weight to the needs of users and to the likely impacts and benefits of the revisions. ISO 9001:2008 is therefore the

  • utcome of a rigorous examination confirming

The Revision

8 6 Feb 2009 Recharging your QMS – ISO 9001:2008 at Quality Conclave – QCI Delhi

  • utcome of a rigorous examination confirming

its fitness for use as the international benchmark for quality management.”

  • --- ISO Secretary-General Alan Bryden

Evolution

ISO 9001:2000 ISO 9001:2008 ISO 9001:2012 Mutual standard 9001/14001/ 18001/SA8000

Focus Focus Focus

Evolution

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19841987 1997 2000 2003 2008 2012

ISO 9001:1987 ISO 9001:1994 Correspondence to customers needs Quality Policy Fulfil Objectives Customer focus Continuing Improvement Management Review Fulfil Req. in Regulations Process Identification Make Service Objectives public Risk Management Doc.comply with Legislation Stabilise processes Global Markets

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SLIDE 2

8In 2000, major changes were put in place and

continue to remain important and valid. 8 The current changes are more a clarification of points already in the standard rather than the

ISO 9001:2008 – The Changes

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points already in the standard rather than the inclusion of new requirements. 8 Changes have also been made to be consistent with the current ISO 14001:2004 in order to make the combination easier and more efficient. Clause New/Deleted/Revised

4.1 New (2 notes added) 4.2.1 Revised 6.2.1 New 6.4 New 7.2.1 New

NOTE: Changes due to 2008 revision

NOTES

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7.2.1 New 7.3.1 New 7.3.3 New 7.5.4 Revised 7.6 Deleted 2000 note & added New note 8.2.1 New 8.2.2 Revised 8.2.3 New

NOTES

ISO 9001:2008 main changes

8Main changes ; they must be checked for organisation already certified to 9001:2000

  • Reinforcement of Control over outsourced processes that affect product conformity

to requirements

  • Management representative has to be a member of the organisation’s management

and not an external individual

  • Competence of all personnel affecting conformity to product requirement must be

12 6 Feb 2009 Recharging your QMS – ISO 9001:2008 at Quality Conclave – QCI Delhi

Competence of all personnel affecting conformity to product requirement must be controlled by the organisation

  • Additional guidance to explain the different methods on measuring and monitoring

customer satisfaction

  • For internal audits, the management of the audited unit must ensure that necessary

corrections and corrective actions are taken

  • Clarification that information systems are included as part of the company

infrastructure, and therefore the management system

  • New requirement to review the effectiveness of corrective and preventive actions
  • 1. No wholesome changes
  • 2. Many changes are ‘subtle’. They may escape
  • ne’s eye.
  • 3. Modification to improve interpretation

How it it done?

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  • 4. For standardisation & better understanding,

some clauses are restructured.

  • 5. Improving compatibility with ISO 14001
  • 6. Uses NOTEs to give better understanding

IAF and ISO policy for transition

8IAF and ISO have approved a transition policy

8 Certification to new revision granted only after a surveillance or a recertification audit against ISO 9001:2008. 8 No ISO 9001:2000 certificates issued after Nov 15 2009 8 All ISO 9001:2000 to be transitioned and withdrawn before Nov 15 2010

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Decide: Your Organisation’s QMS is:

  • Mature - might be no changes needed
  • Not exactly mature – has interpretation worries
  • Just existing - lack of understanding
  • Lackadaisical - lots of issues of understanding and

implementations

Opportunities to recharge

15 6 Feb 2009 Recharging your QMS – ISO 9001:2008 at Quality Conclave – QCI Delhi

implementations

An opportunity: To review QMS and reinforce

the values as per above

Key: Find the balance between

  • potentially over interpreting the standard and
  • making no change.
  • Adds “organizational environment”, “change”, and

“risk” to the list of factors that influence the design and implementation of a quality management system.

  • Clarifies "regulatory" to "statutory and regulatory”

and clarifies that the customer, statutory, and regulatory

Points to Review and Act if required

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f y g y requirements are those applicable to the product.

  • Defines the term “product” also applies to any intended
  • utput resulting from the product realization processes.
  • Clarifies that specific controls are to be defined and

applied, not just identified for out sourced processes.

i

  • Provides an explanation of what is considered an
  • utsourced process. ( 2 Notes added for this)
  • Clarifies that to appoint a Management Representative

that is a member of their own management team

  • Changes “ product quality” to conformity to product

Points to Review and Act if required

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Changes product quality to conformity to product requirements.(Both - directly & indirectly which affect CPR).

  • For competency - “satisfy these needs” changed to

achieve the necessary competence.

  • Adds "information systems" as an example of a

supporting service

  • Clarifies ‘post-delivery activities’ by the new Note.
  • Note revised to include "personal data" as an example
  • f customer property, broadening its applicability to

more organizations, especially service organizations.

Points to Review and Act if required

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  • Deletes in 7.6, how to confirm that software used for

monitoring and measurement has the ability to satisfy the intended application & a note added in its place.

  • Clarifies that Monitoring & measuring processes need

to include both QMS processes & those which impact conformity to product requirement.

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SLIDE 3
  • Expanding from "actions" to "any necessary

corrections and corrective actions" for Internal Audit nonconformities..

  • Clarifies in Corrective Action & Preventive actions

“reviewing” means determining actions effectiveness

Points to Review and Act if required

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g g ff instead of ‘checking an action was taken’.

Please Review the process approach: Points to Review and Act if required

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The process approach introduces horizontal management, crossing the barriers between different functional units and unifying their focus to the main goals of the organization.

  • Processes for the management of an
  • rganization.

(strategic planning, establishing policies, setting objectives, ensuring communication, ensuring availability of resources and management reviews)

Points to Review and Act if required

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resources and management reviews).

  • Processes for managing resources.
  • Realization processes.
  • Measurement, analysis and improvement

processes.

Decide: Your Organisation’s QMS is:

  • Mature - might be no changes needed
  • Not exactly mature – has interpretation worries
  • Just existing - lack of understanding
  • Lackadaisical - lots of issues of understanding and

implementations

Opportunities to recharge

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implementations

An opportunity: To review QMS and reinforce

the values as per above

Key: Find the balance between

  • potentially over interpreting the standard and
  • making no change.

Organisation should do – WHAT?

Review

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Decide ACT!

You need to carry this message back to your Organisation.

Thank You!

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Any Questions please?

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