Transcript Wijzigingen ISO 9001:2008 certificering

ISO 9001:2008: Key changes
and transition process
Based on the published ISO 9001:2008
DNV Industry, Global MSC, 2008-11-20
Purpose of the presentation

Highlight the key changes in ISO 9001:2008
(included detailed text in the last slides)

Provide rules for the transition, including:
- Schedule
- Certificate handling and practical arrangements

Explain expectations to certified customers
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07 July 2015
Slide 2
The ISO 9001 revision process

ISO 9001 is by far the most widely used standard for quality management
systems:
- >1.000.000 companies certified in 170 countries
- Annual increase of ~ 15% worldwide

Standards are reviewed and revised periodically because they must be
kept up to date with stakeholder’s expectations. Quality Management is a
dynamic process and evolves over time.

The ISO 9000 “family of documents” is continually reviewed and revised
through the Technical Committee TC 176.
- First Edition – 1987
- Second Edition – 1994
- Third Edition – 2000
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07 July 2015
Slide 3
ISO 9001:2008 - Status

For ISO 9001:2008, a design specification was developed (in 2005) and
balloted. The purpose of the revision was specified to be limited to:
- Enhance the clarity of ISO 9001:2000, without introducing new requirements
- Enhance compatibility with ISO 14001:2004.

ISO 9001:2008 was published November 15th.

Content of the 4th Edition of ISO 9001 (2008):
-
No new requirements introduced
Some useful clarifications to existing requirements
Mainly editorial changes
A few examples of increased compatibility with ISO 14001:2004, but also
these mainly editorial. Most substantial change for 8.5.2/8.5.3, see details.
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07 July 2015
Slide 4
The ISO 900X/ISO 1000X - series

Also the guidance ISO 9004 “Managing for success” is under revision
and scheduled to be published medio 2009. The current draft contains
major and useful changes, and will provide useful guidance for
improvement of quality management in organisations.

The ISO technical committee have also published other guidance
documents related to Quality Management Systems (ISO 1000X-series):
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07 July 2015
Slide 5
Schedule of implementation

ISO and the International Accreditation Forum (IAF) have jointly issued
the following rules for the transition:
- Twenty four months after publication by ISO of ISO 9001:2008 (i.e. Nov. 15th
2010), any existing certification issued to ISO 9001:2000 shall not be valid.
- One year after publication of ISO 9001:2008 (i.e. Nov. 15th 2009), all
accredited certifications issued (new certifications or recertifications) shall be
to ISO 9001:2008.
- Certification of conformity to ISO 9001:2008 and/or national equivalents shall
only be issued after official publication of ISO 9001:2008 (which should take
place before the end of 2008) and after a routine surveillance or recertification
audit against ISO 9001:2008.

Transition can be done during any scheduled re-certification or periodical
audit in the 24 months period, but preferrably during a re-certification
audit to avoid additional costs.
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Slide 6
Transition audit and certificate validity

If transition is performed during a scheduled periodical audit:
-

Certificate validity will be consistent with validity of ISO 9001:2000 certificate
Additional fee for certificate issuance likely to be charged
If transition is performed during a scheduled re-certification audit:
-
Certificate validity will be 3 years from expiry date of ISO 9001:2000
certificate
No additional certificate fee
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07 July 2015
Slide 7
What is required from our certified customers

As there are no new requirements, the transition will not imply major
additional efforts and is expected to be easy.

For the transition DNV will assess that your organisation are aware of the
changes made and have reviewed the quality management system to
ensure it still complies after the clarifications made.

Additional audit time not deemed needed.

Conduct transition during any scheduled audit, but preferrably during a
scheduled re-certification audit (if due within the 24 months) to avoid
additional costs.
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07 July 2015
Slide 8
Key changes
Introduction (0)

Explicitly lists “risks” associated with an “organisation’s environment” as
an influencing factor of the QMS.
Scope (1)

In the standard the term “product” is not solely applicable for product
intended or required by the customer but also any intended output
resulting from the realization process. This broadens the application and
include e.g. purchased products, products from intermediate stages in the
realization process, as well as products from outsourced processes.

“Statutory” requirements applicable to the product have been introduced
in addition to the previously used “regulatory” requirements (this is used
consistently throughout the document).
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07 July 2015
Slide 9
Key changes
General requirements (4.1)

Amended text regarding outsourced processes to:
- Clarify what is an outsourced process
- Clarify what factors may influence the extent and type of control to be applied
- Clarify that outsourcing does not absolve the responsibility for the
organisation to meet customer, and applicable statutory and regulatory
requirements for the product
Work environment (6.4)

Text amended to provide examples of influencing conditions of work
environment which may affect product conformity.
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Slide 10
Key changes
Determination of requirements related to the product (7.2.1)

Amended text with examples of possible requirements and contractual
obligations related to post-delivery activities, e.g. warranty provisions,
maintenance services and requirements related to re-cycling and final
disposal post-delivery activities.
Design and development outputs (7.3.3)

Amended text to clarify that the provision of information for production
and service provision also can include information providing details for
the preservation of product
Customer satisfaction (8.2.1)

Amended text to provide examples on relevant input for monitoring of
customer perception.
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07 July 2015
Slide 11
Key changes
Corrective Action/Preventive action (8.5.2f/8.5.3e)

Text amended to include “reviewing the effectiveness of
corrective/preventive action taken” which is also consistent with ISO
14001
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Slide 12
Changes to the Standard

A presentation of all the changes are
contained in Annex B of ISO 9001:2008.

The consecutive slides shows the wording
of the requirement for the clauses containing
the listed key changes. The red text text
shows the revised wording in the new edition.

Remember that information marked “NOTE”
in the ISO 9001 Standard is for guidance in
understanding or clarifying the associated
requirement. The Notes do not constitute
requirements.
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Slide 13
Proposed changes to the Standard

INTRODUCTION
0.1 General
The adoption of a quality management system should be a strategic
decision of an organization. The design and implementation of an
organization's quality management system is influenced by
- its organizational environment, changes in that environment, or risks
associated with that environment,
- its varying needs,
- its particular objectives,
- the products it provides,
- the processes it employs,
- its size and organizational structure.
It is not the intent of this International Standard to imply uniformity in the
structure of quality management systems or uniformity of documentation.
Cont’d..
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Slide 14
Proposed changes to the Standard
Cont’d..
The quality management system requirements specified in this International
Standard are complementary to requirements for products. Information marked
“NOTE” is for guidance in understanding or clarifying the associated
requirement.
This International Standard can be used by internal and external parties,
including certification bodies, to assess the organization's ability to meet
customer, statutory and regulatory requirements applicable to the product, and
the organization's own requirements.
The quality management principles stated in ISO 9000 and ISO 9004 have
been taken into consideration during the development of this International
Standard.
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Slide 15
Proposed changes to the Standard

1. SCOPE
1.1 General
This International Standard specifies requirements for a quality
management system where an organization
- 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.
Cont’d..
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Slide 16
Proposed changes to the Standard
Cont’d..
NOTE 1
In this International Standard, the term “product” only applies to
a) product intended for, or required by, a customer,
b) any intended output resulting from the product realization processes.
NOTE 2
Statutory and regulatory requirements can be expressed as legal requirements.
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07 July 2015
Slide 17
Proposed changes to the Standard

4.1 General requirements
The organization shall establish, document, implement and maintain a quality
management system and continually improve its effectiveness in accordance
with the requirements of this International Standard.
The organization shall
- a) determine the processes needed for the quality management system
and their application throughout the organization (see 1.2),
- b) determine the sequence and interaction of these processes,
- c) determine criteria and methods needed to ensure that both the
operation and control of these processes are effective,
- d) ensure the availability of resources and information necessary to
support the operation and monitoring of these processes,
- e) monitor, measure (where applicable), and analyze these processes, and
- f) implement actions necessary to achieve planned results and continual
improvement of these processes.
These processes shall be managed by the organization in accordance with the
requirements of this International Standard.
Cont’d..
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07 July 2015
Slide 18
Proposed changes to the Standard
Cont’d…
Where an organization chooses to outsource any process that affects product
conformity to requirements, the organization shall ensure control over such
processes. The type and extent of control to be applied to these outsourced
processes shall be defined within the quality management system.
NOTE 1
Processes needed for the quality management system referred to above include
processes for management activities, provision of resources, product realization
and measurement, analysis and improvement.
NOTE 2
An outsourced process is identified as one needed for the organization's quality
management system but chosen to be performed by a party external to the
organization.
Cont’d…
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07 July 2015
Slide 19
Proposed changes to the Standard
Cont’d…
NOTE 3
Ensuring control over outsourced processes does not absolve the organization of
the responsibility of conformity to all customer, statutory and regulatory
requirements. The type and extent of control to be applied to the outsourced
process can be influenced by factors such as
- a) the potential impact of the outsourced process on the organization's
capability to provide product that conforms to requirements,
- b) the degree to which the control for the process is shared,
- c) the capability of achieving the necessary control through the application of
7.4.
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07 July 2015
Slide 20
Proposed changes to the Standard

6.4 Work environment
The organization shall determine and manage the work environment needed to
achieve conformity to product requirements.
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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07 July 2015
Slide 21
Proposed changes to the Standard

7.2.1 Determination of requirements related to the product
The organization shall determine
- a) requirements specified by the customer, including the requirements for
delivery and post-delivery activities,
- b) requirements not stated by the customer but necessary for specified or
intended use, where known,
- c) statutory and regulatory requirements applicable to the product, and
- d) any additional requirements considered necessary by the organization.
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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Slide 22
Proposed changes to the Standard

7.3.3 Design and development outputs
The outputs of design and development shall be in a form suitable for verification
against the design and development input and shall be approved prior to release.
Design and development outputs shall
- a) meet the input requirements for design and development,
- b) provide appropriate information for purchasing, production and service
provision,
- c) contain or reference product acceptance criteria, and
- d) specify the characteristics of the product that are essential for its safe
and proper use.
NOTE
Information for production and service provision can include details for the
preservation of product.
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07 July 2015
Slide 23
Proposed changes to the Standard

8.2.1 Customer satisfaction
As one of the measurements of the performance of the quality management
system, the organization shall monitor information relating to customer perception
as to whether the organization has met customer requirements. The methods for
obtaining and using this information shall be determined.
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 and dealer
reports.
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07 July 2015
Slide 24
Proposed changes to the Standard

8.5.2 Corrective action
The organization shall take action to eliminate the causes of nonconformities in
order to prevent recurrence. Corrective actions shall be appropriate to the effects
of the nonconformities encountered.
A documented procedure shall be established to define requirements for
- a) reviewing nonconformities (including customer complaints),
- b) determining the causes of nonconformities,
- c) evaluating the need for action to ensure that nonconformities
do not recur,
- d) determining and implementing action needed,
- e) records of the results of action taken (see 4.2.4), and
- f) reviewing the effectiveness of the corrective action taken.
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Slide 25
Proposed changes to the Standard

8.5.3 Preventive action
The organization shall determine action to eliminate the causes of potential
nonconformities in order to prevent their occurrence. Preventive actions shall be
appropriate to the effects of the potential problems.
A documented procedure shall be established to define requirements for
- a) determining potential nonconformities and their causes,
- b) evaluating the need for action to prevent occurrence of nonconformities,
- c) determining and implementing action needed,
- d) records of results of action taken (see 4.2.4), and
- e) reviewing the effectiveness of the preventive action taken.
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07 July 2015
Slide 26
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Slide 27