JV - Actualizacion Iso 9001 - Lorri Junt

ISO 9001:2015 –
Understanding the Key

Changes
Lorri Hunt
© Copyright Lorri Hunt & Associates Inc. 2014

Disclaimer
 Although the information provided here today

is meant to give an accurate picture of the
revision to ISO 9001, any opinions expressed
by the presenter are not necessarily official
views of ISO/TC176 or of the Working Group
responsible for developing these updates.

Disclaimer
• The information presented today is based on

the Draft International Standard (DIS) of ISO
9001.
• The information presented in this
presentation related to the revision of ISO
9001 is not final and should not be used for
making changes to existing quality
management systems.
• The contents of ISO 9001:2015 are subject to
change and should not be used in any
contractual or legally binding agreements.

ISO 9001:2015 DIS
 More Generic
 Less Prescriptive
 Understanding the “biggest changes” to the standard.
 Structure and Terminology
 Process Approach
 Products and Services
 Context of Organization
 Documented Information
 Externally provided products and services
 Risk Based Thinking
 6.1 Planning
 Applicability
 Organization of Knowledge
 This presentation will focus on those requirements where there is a change
organizations may need to consider.
2014
More Generic

PRODUCTS AND SERVICES

2014
ISO 9001:2015 Proposed
More easily applied to service industries
 ISO 9001:2008 used product to include products,

services, processed materials, and hardware.
 Feedback indicated that the service industry continued to
have difficulty with the application of ISO 9001.
 Not using the word service further complicated the
standard for these users.
 The word “product” has been replaced by “products and
services” when referring to deliverables to the customer.

ISO 9001:2015 DIS
A.2 Products and services
 The term services is to highlight the difference
between products and services in the application of
some requirements.
 In most cases, the terms are used together.
 In some cases, the word product is only used to
specify a certain requirement.

2014
APPLICABILITY

2014
Less Prescriptive
 The revised standard will focus on application and
not exclusions.
 There are no limits to which clauses where
application can be determined.
 Justification will be required as documented
information to ensure that limited application does
not affect the organization’s ability to provide for the
provision of product and services.

ISO 9001:2015 DIS
A.5 Applicability
 The application of requirements may vary.
 Where a requirement can be applied within the
scope of its quality management system, the
organization cannot decide that it is not applicable.
 Where a requirement cannot be applied (for
example where the relevant process is not carried
out) the organization can determine that the
requirement is not applicable. However, this non-
applicability cannot be allowed to result in failure to
achieve conformity of products and services or to
meet the organization’s aim to enhance customer
satisfaction.
2014
Applicability Examples
 A manufacturing organization that does not have any

monitoring and measuring resources could determine
requirements in 7.1.5 do not apply.
 Organizations that build from a customer provided design
could determine requirements for design in 8.3 do not
apply.
 Organizations could not determine that requirements such
as competence are not applicable since this directly
affects the ability to provide product that meets
requirements.

Structure

Structure
 The structure of ISO 9001:2015 will be different than the
current structure of ISO 9001:2008.
 The structure is based on the mandate that Annex SL
from the ISO Directives be applied to management
system standards.

Terminology Changes
ISO 9001:2008 ISO 9001:2015

(Proposed)
Products Products and services
Exclusions Application
Documents, Records Documented Information
Work Environment Environment for the
operation of processes
Purchased Product Externally provided
products and services
Supplier External Provider

ISO 9001:2015 DIS
Annex A.1 Structure and Terminology (Paraphrased)
 The clause structure and some of the terminology in
ISO 9001:2015 is different than ISO 9001:2008 to
improve alignment with other management system
standards.
 The structure is to provide a presentation of
requirements. It is not a model for document for
documenting the organization’s policies, objectives
and processes.
 There is no requirement for the structure of an
organization's quality management system
documentation to mirror that of this International
Standard.
2014
4 Context of the Organization

ISO 9001:2015 DIS
A.3 Context of the organization (Annex)
 Interested parties cannot go beyond the scope of ISO 9001.
 There is no requirement to go beyond interested parties that
are relevant to the quality management system.
 Consider impact on the organization’s ability to consistently
provide products and services that meet customer and
applicable statutory and regulatory requirements or the
organization’s aim to enhance customer satisfaction.
 Organizations can go beyond the minimum requirements to
determine additional needs and expectations for interested
parties that would not be “relevant.”
 Discretion of organization.
 Should be clear in quality management system.

2014
4.1 Understanding the Organization and its
context
 Determine external and internal issues for the organization.
 Relevant to its purpose and strategic direction
 Affect the organization’s ability to achieve intended
result(s)
 Monitor and review the information about external and
internal issues.

4.1 Understanding the Organization and its
context
Keys to Understanding
 Strategic Planning
 What could affect the organization
 Competition
 Economic Crisis
 Able to obtain employee resources
 Technology Changes
 Corporate changes
 Management Review requires the monitoring of external and internal

issues.
 Good method for managing this requirement, especially for organizations who do not
have formal strategic planning processes.

4.2 Understanding the needs and
expectations of interested parties
 The organization shall determine
 Relevant interested parties
 Requirements of relevant interested parties
 Relevant interested parties to be considered are those that
potentially could impact the organization’s ability to provide
products and services that meet requirements.
 Monitor and review information related to interested parties
and relevant requirements.

4.2 Understanding the needs and
expectations of interested parties
 Relevant interested parties
 Customers
 Partners
 Persons in the organization
 External providers
 Unions (if impact employee competence)
 Management Review requires the monitoring of relevant interested
parties.
 Good method for managing this requirement, especially for
organizations who do not have formal strategic planning
processes.

4.3 Determining the scope of the quality
management system
 Determine the boundaries of the QMS.
 Consider the internal and external issues determined in 4.1.
 The requirements of relevant interested parties in 4.2.
 Products and services of the organization.
 Requirements that can be applied by the organization shall be
applied.
 Requirements that cannot be applied cannot affect the
organization’s ability to provide product and services that meet
requirements.
 Maintain scope as documented information.
 Products and services covered by the QMS.
 Justification where a requirement cannot be applied.

4.3 Determining the scope of the quality
management system
 While they could be related, this scope should not be
confused with the scope of certification.
 Boundaries could be departments, product / service lines, or
sites.
 Direct relation to clauses 4.1 and 4.2.
 Application not exclusion.
 Information must be maintained.
 No requirement for a quality manual, but existing
methods could be used to maintain this information.

Process Approach

Process Approach
 ISO 9001:2000 and ISO 9001:2008 was based on the

process approach.
 Proposed revision to ISO 9001:2015 is more specific on
requirements.
 4.4.2 Process Approach identifies these requirements.

4.4 Process Approach
 The proposed text includes new requirements

related to the process approach:
 inputs required and the outputs expected
 determining the risks and opportunities
 Determining performance indicators needed to
demonstrate that processes are effective.
 assigning responsibilities and authorities
 Change processes to achieve intended results
Organizations who have taken a minimal approach to this requirement may need to make change.

Process Approach is Still Applicable

ISO 9001:2015 DIS
0.3 Process approach (Introduction)
 The process approach applies systematic
definition and management of processes
and their interactions so as to achieve the
intended results in accordance with the
quality policy and strategic direction of the
organization. Management of the processes
and the system as a whole can be achieved
using a “Plan-Do-Check-Act” (PDCA)
methodology (see 0.4) with an overall focus
on “Risk-based thinking" aimed at preventing
undesirable outcomes (see 0.5).
2014
5 Leadership

5.3 Organization roles, responsibilities
and authorities
 The current draft does not require a management
representative.
 The draft indicates that top management shall be
accountable….
 Top management shall assign the responsibility and
authority for… (actions that were typical to
management representative)
 Ensuring that processes interact

5.3 Organization roles, responsibilities and
authorities
 Organizations may choose to eliminate the role of

management representative.
 It is important to note that the actions required by the
“management representative” are still required.
 There is no mandate that you eliminate the role of
management representative if you feel it is value-added.
 Determine what method will be used to ensure that
leadership is managing the requirements that are typical
of the management representative role.

6 Planning for the Quality
Management Sytem

Removal of term “Preventive”
ISO 9001:2008 ISO 9001:2015 Proposed

 8.5.3 Preventive Action  6.1 Actions to address risks and
opportunities

2014
RISK-BASED THINKING

2014
The main objectives of ISO 9001
 to provide confidence in the organization’s ability

to consistently provide customers with
conforming goods and services
 To enhance customer satisfaction
The concept of “risk” in the context of ISO 9001 relates to the

uncertainty in achieving these objectives

What is “risk-based thinking”?
risk-based thinking is something we all do automatically
and often sub-consciously
The concept of risk has always been implicit in ISO 9001 –
this revision makes it more explicit and builds it into the
whole management system
risk-based thinking is already part of the process approach
risk-based thinking makes preventive action part of the
routine
risk is often thought of only in the negative sense. Risk-
based thinking can also help to identify opportunities. This
can be considered to be the positive side of risk

ISO 9001:2015 DIS
0.5 “Risk-based thinking” (Introduction)
 This International Standard makes risk-based
thinking more explicit and incorporates it in
requirements for the establishment,
implementation, maintenance and continual
improvement of the quality management
system.
 Organizations can implement a formal risk
management program such as 31000, but
there is no requirement to do so.

2014
ISO 9001:2015 DIS
A.4 Risk-based approach (Annex)
 Organizations are required to understand the context of
the organization and any external and internal issues
(clause 4.1).
 Risks and opportunities are determined in clause 6.1.
 One of the key purposes of a quality management system
is to act as a preventive tool.
 ISO 9001:2015 does not have a separate clause titled
preventive action.
 The concept of preventive action is controlled through
risk-based thinking and managing risks and opportunities
identified in clause 6.1.

2014
6.1 Actions to address risks and opportunities
 Consider the issues determined in clause 4.1 and

consider the requirements for relevant interested.
 Determine risks and opportunities
 Intended results cannot be achieved
 Prevent or reduced undesired affects
 Continual improvement
 Organization shall plan actions to address risks and
opportunities.
 Appropriate to the potential impact.
 NOTE: No formal risk management program is
required.
6.2 Quality objectives and planning to achieve
them
 This requirement includes requirements in ISO
9001:2008, 5.4.1 Quality Objectives – It also includes
 Relevant to conformity of products and services
 Be monitored
 Take into account applicable requirements
 Be updated as appropriate (Documented Information)
 There is also a requirement that requires more specific
information.
 What will be done
 Required resources
 Who is responsible
 When it will be completed
 How the results will be evaluated
7 Support

7.1.5 Monitoring and Measuring Resources
 Terminology has been changed to be more generic for all

industries.
 Focuses on the monitoring and measuring resources
where traceability is a requirement.
 Manufacturing organizations will see little change.
 Service organizations may need to make adjustments
based on the improved generic nature of the
requirements.

7.1.5 Monitoring and Measuring Resources
 The requirement for monitoring and measuring resources

has been moved to Support.
 Requirements for equipment are addressed in 7.1.3
Infrastructure.
 Clause 7.1.5.1 includes requirements for
 Determining the monitoring and measuring devices
 Determining the risks to the validity of the results from
inaccurate monitoring or measurement
 Determining and implementing the controls.
 The requirement has been modified to be easier to
implement for service organizations.

7.1.6 Knowledge---Future of
Requirement is Uncertain
 The organization shall determine the knowledge
necessary for the operation of the QMS, ensure
conformity of products and services, enhance
customer satisfaction.
 The organization is responsible for maintaining,
protecting and making sure the knowledge is
available (as necessary).
 Knowledge is to be considered when making
changes to the organization.
 How to acquire or access the necessary
additional knowledge.

ISO 9001:2015 DIS
A.7 Organisational knowledge (Annex)
 Considerations in determining the necessary
organization knowledge include
 The size and complexity of the organization
 The risks and opportunities it needs to address
 The need for accessibility of knowledge.
 Consideration can be given to whether competent

employees have this knowledge.

2014
Less Prescriptive
DOCUMENTED INFORMATION

2014
The World of Documents and Records has Evolved
 There were no
significant changes
to documents and
records in the ISO
9001:2008
amendment.
 The way we manage
documents and
records has changed
drastically since
2000.
 Less paper
documents and more
electronic
information.
7.5 Documented Information
 Annex SL does not require documented procedures or a quality
manual.
 The requirements in 7.5 are similar to ISO 9001:2008 – 4.2.3
Control of documents and 4.2.4 Control of Records.
 Most of the language is different.
 7.5.1 General
 7.5.2 Creating and Updating
 7.5.3 Control of documented information
 “As applicable” is used to show that some of the documented
information requirements are not applicable for traditional
documents and records.
 In the context of the standard….
 Maintain means document
 Retain means record
Documented Information
ISO 9001:2008 ISO 9001:2015 Proposed
 4.2.3 Control of  7.5 Documented
Documents Information
 4.2.4 Control of Records
 Documented information replaces the following

terms:
 Documented procedure
 Document
 Record
 Requirements are in clause 7.5 and are consistent
with requirements.
2014
ISO 9001:2015 DIS
A.6 Documented information
 Where ISO 9001:2008 would have referred to
documented procedures (e.g. to define,
control or support a process) this is now
expressed as a requirement to maintain
documented information.
 Where ISO 9001:2008 would have referred to
records this is now expressed as a
requirement to retain documented
information.

2014
7.5 Documented Information
 Don’t let the wording change lead you to

think change is needed.
 There is no requirement to change.
 If it isn’t broke, don’t fix it!
 Determine if improvements can be made to
your quality management system

Less Prescriptive – No Required
Quality Manual
 The current draft of ISO 9001 does not require a quality
manual.
 There are many references to similar type of
requirements being included as documented information
from clauses 4.1 through 4.3.
 External and Internal Issues
 Needs and expectations of interested parties that
are relevant to the quality management system
due to their impact or potential impact on the
organization’s ability to provide products and
services that meet customer and regulatory
requirements.
 Justification for when a requirement of the
standard is not applied.
8 Operation

8.2 Determination of Customer
Requirements
 These requirements are in line with ISO 9001:2008,

Clause 7.2 Determination of Customer Requirements.
 There is ongoing work on this clause to “modernize” this
clause to be more in line with how organizations obtain
requirements.
 Requirements are established for products and
services
 Customers place orders based on these orders
 Less negotiation and documented information related
to orders

Change to Design Structure
ISO 9001:2008 ISO 9001:2015 Proposed

 7.3.1 Design and development  8.3.2 Design and Development
planning Planning
inputs Inputs
 7.3.3 Design and Development  8.3.4 Design and Development
outputs controls
review Outputs
verification Changes (may be incorporated
into controls)
 7.3.6 Design and development
validation
 7.3.7 Control of design and
development changes
2014
8.3 Design and Development of products and
Services
 ISO 9001:2008 – 7.3 Design and Development
 Some new text in requirements to make the text
more flexible.
 Nature, duration and complexity of the design and
development activities (8.3.1)
 The determined risks associated with the design and
development activities (8.3.2)

EXTERNALLY PROVIDED
PRODUCTS AND SERVICES

2014
 ISO 9001:2008  ISO 9001:2015 Proposed
 4.1 – “Outsourcing”  8.6 Control of external provision

of products and services
 7.4 Purchasing
 Supplier and Outsourcing have been replaced by external

provider.
 Purchasing from suppliers
 Arrangement with an associate/sister company.
 Outsourcing of processes and functions.
 Controls based on associated risks
ISO 9001:2015 DIS
Purchased products has been replaced

with externally provided products and
services.

2014
ISO 9001:2015 DIS
A.8 Control of externally provided products
and services (Annex)
 Clause 8.4 Control of externally provided
products and services addresses all forms
of external provision, whether it is by
purchasing from a supplier, through an
arrangement with an associate company,
through the outsourcing of processes and
functions of the organization or by any other
means.

2014
8.4 Control of External Provision of products and
Services
 ISO 9001:2008 – 4.1 (Outsourcing) and 7.4
Purchasing
 The terms supplier and outsourcing are no longer
used.
 The determined risks and the potential effects on the
organization. (8.4.2)
 Controls applied by the external provider and their
effectiveness. (8.4.2)
 The control and monitoring of the external provider’s
performance to be applied by the organization.
(8.4.3)

8.4 Control of externally provided
products and Services
 8.4.1 General
 The requirements are similar to clause 7.4 with the
exception that the term supplier has been replaced
with external provider
 8.4.2 Type and Extent of control of external provision
 Consider potential impact of the externally provided
processes, products and services
 Perceived effectiveness of the control
 Processes or functions outsourced to an external
provider must also be controlled.

8.5.6 Control of changes
 This is a new requirement, but still not firm.

 The actual requirement is similar to making sure the
conformity of products and services is not affected when
changes are made.
 Focus is on unplanned changes.
 Requirement based on the need to address control when
an organization conducts design.

9 Performance Evaluation

9 Performance Evaluation
 The requirements in Clause 9 are consistent with

requirements that existing in ISO 9001:2008.
 Most requirements are easily implemented.

10 Improvement

10 Improvement
 The requirements in Clause 10 are consistent with

requirements that existing in ISO 9001:2008.
 Most requirements are easily implemented.

Transition from ISO
9001:2008
Proceed with Caution

Transition
 There will be a three-year transition time after the
publication of ISO 9001:2015.
 Estimated September 2015 – September 2018
 Details for how this transition will work will be
available from the International Accreditation
Forum and specific certification bodies.
 Organizations can start integrating change with the
understanding that the revision is not complete and
additional changes may be required.
 Proceed with caution.

Questions

¡GRACIAS!

2014

JV - Actualizacion Iso 9001 - Lorri Junt

Загружено:

Сведения о документе

Оригинальное название

Авторское право

Доступные форматы

Поделиться этим документом

Поделиться или встроить документ

Параметры публикации

Этот документ был вам полезен?

Это неприемлемый материал?

Авторское право:

Доступные форматы

JV - Actualizacion Iso 9001 - Lorri Junt

Загружено:

Авторское право:

Доступные форматы

ISO 9001:2015 –

Understanding the Key

© Copyright Lorri Hunt & Associates Inc. 2014

 Although the information provided here today

© Copyright Lorri Hunt & Associates Inc. 2014

• The information presented today is based on

© Copyright Lorri Hunt & Associates Inc. 2014

© Copyright Lorri Hunt & Associates Inc. 2014

© Copyright Lorri Hunt & Associates Inc. 201

 ISO 9001:2008 used product to include products,

© Copyright Lorri Hunt & Associates Inc. 2014

© Copyright Lorri Hunt & Associates Inc. 201

© Copyright Lorri Hunt & Associates Inc. 201

© Copyright Lorri Hunt & Associates Inc. 2014

 A manufacturing organization that does not have any

© Copyright Lorri Hunt & Associates Inc. 2014

© Copyright Lorri Hunt & Associates Inc. 2014

© Copyright Lorri Hunt & Associates Inc. 2014

ISO 9001:2008 ISO 9001:2015

© Copyright Lorri Hunt & Associates Inc. 2014

© Copyright Lorri Hunt & Associates Inc. 2014

© Copyright Lorri Hunt & Associates Inc. 201

© Copyright Lorri Hunt & Associates Inc. 2014

 Management Review requires the monitoring of external and internal

© Copyright Lorri Hunt & Associates Inc. 2014

© Copyright Lorri Hunt & Associates Inc. 2014

© Copyright Lorri Hunt & Associates Inc. 2014

© Copyright Lorri Hunt & Associates Inc. 2014

© Copyright Lorri Hunt & Associates Inc. 2014

© Copyright Lorri Hunt & Associates Inc. 2014

 ISO 9001:2000 and ISO 9001:2008 was based on the

© Copyright Lorri Hunt & Associates Inc. 2014

 The proposed text includes new requirements

© Copyright Lorri Hunt & Associates Inc. 2014

© Copyright Lorri Hunt & Associates Inc. 2014

© Copyright Lorri Hunt & Associates Inc. 2014

© Copyright Lorri Hunt & Associates Inc. 2014

 Organizations may choose to eliminate the role of

© Copyright Lorri Hunt & Associates Inc. 2014

© Copyright Lorri Hunt & Associates Inc. 2014

ISO 9001:2008 ISO 9001:2015 Proposed

© Copyright Lorri Hunt & Associates Inc. 201

© Copyright Lorri Hunt & Associates Inc. 201

 to provide confidence in the organization’s ability

 To enhance customer satisfaction

The concept of “risk” in the context of ISO 9001 relates to the

© Copyright Lorri Hunt & Associates Inc. 2014

© Copyright Lorri Hunt & Associates Inc. 2014

© Copyright Lorri Hunt & Associates Inc. 201

© Copyright Lorri Hunt & Associates Inc. 201

 Consider the issues determined in clause 4.1 and

© Copyright Lorri Hunt & Associates Inc. 2014

 Terminology has been changed to be more generic for all

© Copyright Lorri Hunt & Associates Inc. 2014

 The requirement for monitoring and measuring resources

© Copyright Lorri Hunt & Associates Inc. 2014

© Copyright Lorri Hunt & Associates Inc. 2014

 Consideration can be given to whether competent

© Copyright Lorri Hunt & Associates Inc. 201

© Copyright Lorri Hunt & Associates Inc. 201

 Documented information replaces the following

© Copyright Lorri Hunt & Associates Inc. 201

 Don’t let the wording change lead you to