ISO 9001:2008

The Truth about the Changes

Presentation Host: Paul Stock ISO 9001 Product Manager

Question and Answer Host: Peter Crack International Training Manager

Introduction to webinar Systems

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There will be a question and answer session at the end of the presentation. Please utilise the question box to submit a question.

QUESTIONS?

ISO 9001:2008

The Truth about the Changes

Joint IAF / ISO Communique

They have recognized that ISO 9001:2008 introduces no new requirements. ISO 9001:2008 only introduces clarifications to the existing requirements of ISO 9001:2000 based on eight years of experience of implementing the standard world wide with about one million certificates issued in 170 countries to date. It also introduces changes intended to improve consistency with ISO14001:2004

Joint IAF / ISO Communique

They have recognized that ISO 9001:2008 introduces no new requirements. ISO 9001:2008 only introduces clarifications to the existing requirements of ISO 9001:2000 based on eight years of experience of implementing the standard world wide with about one million certificates issued in 170 countries to date. It also introduces changes intended to improve consistency with ISO14001:2004

Joint IAF / ISO Communique

They have recognized that ISO 9001:2008 introduces no new requirements. ISO 9001:2008 only introduces clarifications to the existing requirements of ISO 9001:2000 based on eight years of experience of implementing the standard world wide with about one million certificates issued in 170 countries to date. It also introduces changes intended to improve consistency with

ISO14001:2004.

Joint IAF / ISO Communique

They have recognized that ISO 9001:2008 introduces no new requirements. ISO 9001:2008 only introduces clarifications to the existing requirements of ISO 9001:2000 based on eight years of experience of implementing the standard world wide with about one million certificates issued in 170 countries to date. It also introduces changes intended to improve consistency with

h t u r T e h T

s e g n a h C e h t t u o ab

ISO14001:2004.

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ISO 9001:2008

The Truth about the Changes

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The Truth about the Changes

1.1 General
a) needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.

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The Truth about the Changes

4.1 General requirements

NOTE 2 An outsourced process is identified as one needed for the organizations quality management system but chosen to be performed by a party external to the organisation. NOTE 3 Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory and regulatory requirements.

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The Truth about the Changes

4.2 Documentation requirements
4.2.1 General NOTE 1 Where the term documented procedure appears within this International Standard, this means that the procedure is established, documented, implemented and maintained. A single document may address the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document.

4.2.3 Control of documents 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

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The Truth about the Changes

4.2 Documentation requirements
4.2.1 General NOTE 1 Where the term documented procedure appears within this International Standard, this means that the procedure is established, documented, implemented and maintained. A single document may address the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document.

4.2.3 Control of documents 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

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The Truth about the Changes

5.5.2 Management representative

Top management shall appoint a member of the organizations management who, irrespective of other responsibilities, shall have responsibility and authority that includes

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The Truth about the Changes

6.2.2 Competence, training and awareness

The organization shall a) determine the necessary competence for personnel performing work affecting conformity to product requirements, b) where applicable, provide training or take other actions to achieve the necessary competence

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The Truth about the Changes

6.3 Infrastructure
c) supporting services (such as transport, communication or information systems)

6.4 Work environment

NOTE 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)

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The Truth about the Changes

6.3 Infrastructure
c) supporting services (such as transport, communication or information systems)

6.4 Work environment

NOTE 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)

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The Truth about the Changes

7.2.1 Determination of requirements related to the product

NOTE Post-delivery activities include, for example, actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal

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The Truth about the Changes

7.3.1 Design and development planning

NOTE Design and development review, verification and validation have distinct purposes. They can be conducted and recorded separately or in any combination, as suitable for the product and the organization

7.3.3 Design and development outputs

NOTE Information for production and service provision can include details for the preservation of product

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The Truth about the Changes

7.3.1 Design and development planning

NOTE Design and development review, verification and validation have distinct purposes. They can be conducted and recorded separately or in any combination, as suitable for the product and the organization

7.3.3 Design and development outputs

NOTE Information for production and service provision can include details for the preservation of product

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The Truth about the Changes

7.6 Control of monitoring and measuring equipment

NOTE 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

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The Truth about the Changes

8.2.1 Customer satisfaction

NOTE Monitoring customer perception can include obtaining input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, warranty claims, dealer reports

8.2.2 Internal audit

Records of the audits and their results shall be maintained

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The Truth about the Changes

8.2.1 Customer satisfaction

NOTE Monitoring customer perception can include obtaining input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, warranty claims, dealer reports

8.2.2 Internal audit

Records of the audits and their results shall be maintained

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The Truth about the Changes

8.2.3 Monitoring and measurement of processes

NOTE When determining suitable methods, it is advisable that the organisation consider the type and extent of monitoring or measurement appropriate to each of its processes in relation to their impact on the conformity to product requirements and on the effectiveness of the quality management system

8.2.4 Monitoring and measurement of product

Records shall indicate the person(s) authorising release of product for delivery to the customer

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The Truth about the Changes

8.2.3 Monitoring and measurement of processes

NOTE When determining suitable methods, it is advisable that the organisation consider the type and extent of monitoring or measurement appropriate to each of its processes in relation to their impact on the conformity to product requirements and on the effectiveness of the quality management system

8.2.4 Monitoring and measurement of product

Records shall indicate the person(s) authorising release of product for delivery to the customer

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ISO 9001:2008

The Truth about the Changes

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The Truth about the Changes - Transition

Certification of conformity to ISO 9001:2008 and/or national equivalents shall only be issued after official publication of ISO 9001:2008 (which has now taken place) and after a routine surveillance or recertification audit against ISO 9001:2008.

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The Truth about the Changes - Transition

Validity of certifications to ISO 9001:2000 One year after publication of ISO 9001:2008 all accredited certifications issued (new certifications or recertifications) shall be to ISO 9001:2008. Twenty four months after publication by ISO of ISO 9001:2008, any existing certification issued to ISO 9001:2000 shall not be valid.

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The Truth about the Changes - Transition

Validity of certifications to ISO 9001:2000 One year after publication of ISO 9001:2008 all accredited certifications issued (new certifications or recertifications) shall be to ISO 9001:2008. Twenty four months after publication by ISO of ISO 9001:2008, any existing certification issued to ISO 9001:2000 shall not be valid.

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ISO 9001:2008

The Truth about the Changes

End of presentation - thank you for your participation

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There will now be a question and answer session. Please utilise the question box to submit any questions.

QUESTIONS?

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Implementation issues
What do you, as an organisation, have to do in relation to these changes?

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Implementation issues
What do you, as an organisation, have to do in relation to these changes? Familiarise yourself with the changes to the standard.

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Implementation issues
What do you, as an organisation, have to do in relation to these changes? Familiarise yourself with the changes to the standard. Assess the impact on each function, department, process, area within your organisations current Quality Management System.

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Implementation issues
What do you, as an organisation, have to do in relation to these changes? Familiarise yourself with the changes to the standard. Assess the impact on each function, department, process, area within your organisations current Quality Management System. Where applicable, take appropriate action (implementation) to ensure that your organisation complies with the amendments in ISO 9001:2008.

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Implementation issues
What do you, as an organisation, have to do in relation to these changes? Familiarise yourself with the changes to the standard. Assess the impact on each function, department, process, area within your organisations current Quality Management System. Where applicable, take appropriate action (implementation) to ensure that your organisation complies with the amendments in ISO 9001:2008. Monitor and measure your processes and product against policies, objectives and requirements for the product and report the results.

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Implementation issues
What do you, as an organisation, have to do in relation to these changes? Familiarise yourself with the changes to the standard. Assess the impact on each function, department, process, area within your organisations current Quality Management System. Where applicable, take appropriate action (implementation) to ensure that your organisation complies with the amendments in ISO 9001:2008. Monitor and measure your processes and product against policies, objectives and requirements for the product and report the results. Take further actions to continually improve the performance of the processes.

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Implementation issues

DO PLAN

CHECK ACT

We cannot stand still or slip backwards. We must go forward now together.

Gerald R. Ford
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Any further questions or request for information can be obtained by contacting:

SGS United Kingdom Ltd Systems & Services Certification SGS House 217/221 London Road Camberley Surrey GU15 3EY United Kingdom Tel: +44(0) 1276 697999 Fax: +44(0) 1276 697696 Email: ukenquiries@sgs.com
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