ISO 9001:2015

Quality Management Systems Awareness Training

The New Version of ISO 9001 Standard

 What is ISO 9001?

A standard that sets out the requirements for a quality

management system.
It helps businesses and organizations to be more efficient and
improve customer satisfaction.
 What benefits will it bring to organization?
Implementing a quality management system will help you:

• Assess the overall context of your organization to define who is affected by your work and
what they expect from you. This will enable you to clearly state your objectives and identify new
business opportunities.

• Put customers first, making sure you consistently meet their needs and enhance their satisfaction.
This can lead to repeat customers, new clients and increased business for your organization.
 Benefits of the ISO 9001 version
• Work in a more efficient way as all your processes will be aligned and understood by everyone in the
business or organization. This increases productivity and efficiency, bringing internal costs down.

• Meet the necessary statutory and regulatory requirements.

• Expand into new markets, as some sectors and clients require ISO 9001 before doing business.

• Identify and address the risks associated with your organization

 Why ISO 9001:2008 was revised?
• All ISO standards are reviewed and revised regularly to make sure they remain relevant to the
marketplace.

• ISO 9001 has been updated to take into account the different challengesthat businesses now face.

• For example, increased globalization has changed the way we do business and organizations often
operate more complex supply chains, and there are increased expectations from customers.

• ISO 9001 needs to reflect these changes in order to remain relevant.

 What are some key improvements?
Structure
ISO 9001:2015 now follows the same overall structure as other ISO management system standards (High-
Level Structure), making it easier for anyone using multiple management systems.

Focus on risk-based thinking

This has always been part of the standard, but the new version gives it increased prominence.
 What are the key changes?
• ISO 9001:2015 will be among the first ISO standards to make use of the standardized
structure represented by “Annex SL”

• Annex SL has also been referred to as the “High Level Outline” or “Annex XL.”

• Annex SL is part of a larger ISO publication called “ISO/IEC Directives Part 1 – Consolidated
ISO Supplement –

• ISO/IEC Directives Part 1 (and Annex SL therein) can be found here

 What is Annex SL?
• Annex SL was first published in 2012 and represented the output of a special committee of the
ISO called the Joint Technical Coordination Group (JTCG.)

• A 10 section “blueprint” for authoring all of the ISO family of standards.

• Annex SL promotes (among other things) utilization of common terms and core definitions.

• Eventual plan calls for full transition of all ISO standards to Annex SL structure by 2016 or
2017.
 What benefits does the new version bring?
The new version of the standard brings number of benefits including:
• Puts greater emphasis on leadership engagement
• Helps address organizational risks and opportunities in a structured manner
• Uses simplified language and a common structure and terms, particularly helpful to organizations using
multiple management systems
• Addresses supply chain management more effectively
• Is more user-friendly for service and knowledge-based organizations
The Process Approach
 What is the process approach?
The systematic management of processes and their interactions to
achieve intended results
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 What is the process approach?
All organizations use processes to:
• set interrelated or interacting activities
• transform inputs into outputs
• build in checks to meet objectives and promote continuous
improvement
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The process approach integrates processes into a complete system to achieve

strategic and operational objectives

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 How will organization do it?
To use the process approach an organization should:
• understand and define the processes needed to meet its objectives

• recognize that the processes are unique to its own context

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• integrate all of the processes and their interactions into a system that
utilizes risk-based thinking

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 The Process approach and PDCA

Plan set objectives and build processes necessary to deliver results

Do implement what was planned

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Check monitor and measure processes and results against the objectives

Act take actions to improve results

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 What are the potential benefits?
• Increases accountability
• Increases ability to focus and link key processes
• Improves internal integration of processes
• Increases awareness of process performance for more consistent results
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• Better use of resources

• Improves customer confidence in the organization
All of these add value to the organization

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 Process approach and Risk-based thinking

• The process approach incorporates risk-based thinking

• Risk-based thinking ensures risk is considered when establishing,
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implementing and maintaining a management system, each process

and each activity

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Risk-based Thinking
 Risk (the scary new requirement)
• The term “risk” is used 18 times in the current Draft standard;

• Identification and management of risk is being viewed as a new system wide strategy in
much the same light that Continual Improvement was when ISO 9001:2000 was published

• A formal/documented Risk Management Process is NOT specifically required.

 Risk
Clause 6.1.1 of the ISO 9001 standard states:
• When planning for the quality management system, the organization shall consider the
issues referred to in 4.1and the requirements referred to in 4.2 and determine the risks and
opportunities that need to be addressed to:
a) give assurance that the quality management system can achieve its intended
result(s);
b) prevent, or reduce, undesired effects;
c) achieve continual improvement.
 Risk
Clause 6.1.2 of the ISO 9001 standard states:
• The organization shall plan:
a) Actions to address these risks and opportunities;
b) How to:
1) Integrate and implement the actions into its quality management system
processes(see4.4);
2) Evaluate the effectiveness of these actions.
• Actions taken to address risks and opportunities shall be proportionate to the potential
impact on the conformity of products and services.
 Risk
• Borrows heavily from the concept of Preventive Action (clause 8.5.3 in ISO 9001:2008.)

• Preventive Action isn’t going anywhere!

• Expands the idea of Risk aversion to one that affects all of the various areas of the Quality
Management System.
 What is Risk-based thinking?
• Risk-based thinking is something we all do automatically and often sub-consciously to get the best
result

• The concept of risk has always been implicit in ISO 9001 – this edition makes it more explicit and
builds it into the whole management system
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• Risk-based thinking ensures risk is considered from the beginning and throughout

• Risk-based thinking makes preventive action part of strategic and operational planning

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 Where is risk addressed in
ISO 9001:2015?
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 Risk-based thinking is in:
• Introduction - the concept of risk-based thinking is explained
• Clause 4 - organization is required to determine its QMS processes and address its risks
and opportunities
• Clause 5 – top management is required to
̶ Promote awareness of risk-based thinking
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̶ Determine and address risks and opportunities that can affect product /service
conformity
• Clause 6 - organization is required to identify risks and opportunities related to QMS
performance and take appropriate actions to address them

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 Risk-based thinking is in:
• Clause 7 – organization is required to determine and provide necessary resources

• Clause 8 - organization is required to manage its operational processes

• Clause 9 - organization is required to monitor, measure, analyse and evaluate the

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effectiveness of actions taken to address risks and opportunities

• Clause 10 - organization is required to correct, prevent or reduce undesired effects and

improve the QMS and update risks and opportunities

• Note, risk is implicit whenever suitable or appropriate is mentioned (clause 7 and 8)

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 Why use risk-based thinking?
Successful organizations intuitively apply risk-based thinking because it brings benefits that:

• improve governance

• establish a proactive culture of improvement

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• assist with compliance

• assure consistency of quality of products and services

• improve customer confidence and satisfaction

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 How will organizations do it?
• Identify what your risks are – it depends on context

• Use risk-based thinking to prioritize the way you manage your processes

• ISO 9001:2015 does not require formal risk management

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• ISO 31000 Risk management — Principles and guidelines may be a useful reference for
organizations that want or need a more formal approach to risk (but its use is not
obligatory)

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 How will organizations do it?
• Balance risks and opportunities

• Analyse and prioritize your risks (what is acceptable? what is unacceptable?)

• Plan actions to address the risks (how can I avoid, eliminate or mitigate risks?)
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• Implement the plan; take action

• Check the effectiveness of the action; (does it work?)

• Learn from experience; improve

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 Risk-based thinking
• is not new
• is something you probably do already
• is ongoing
• ensures greater knowledge of risks and improves preparedness
• increases the probability of reaching objectives
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• reduces the probability of negative results

• makes prevention a habit

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Summary of Changes
 Key perspectives
ISO 9001 needs to change, to:
 adapt to a changing world
 reflect the increasingly complex environments in which organizations operate
 provide a consistent foundation for the future
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 reflect the increasingly complex environments in which organizations operate

 ensure the new standard reflects the needs of all relevant interested parties
 Ensure alignment with other management system standards
 Key feature changes
• 10-clause structure and core text for all Management System Standards (MSS)
• More compatible with services and non-manufacturing users
• Clearer understanding of the organization’s context is required “one size doesn’t fit all”
• Process approach strengthened/more explicit
• Concept of preventive action now addressed throughout the standard by risk identification and
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mitigation
• The term documented information replaces the terms document and record
• Control of externally provided products and services replaces purchasing/outsourcing
• Increased emphasis on seeking opportunities for improvement
 Beneficial changes to ISO 9001
• Enhanced leadership involvement in the management system
• Risk-based thinking
• Simplified language, common structure and terms
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• Aligning QMS policy and objectives with the strategy of the

organization
 Potential benefits to the organization
• Focus on achieving planned results
• Flexibility for documented information
• Improved risk control
• Better process control leading to improved results
• Improved customer satisfaction
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• Customer retention and loyalty

• Improved image and reputation
• Greater credibility
 Key benefits of the common clause structure
A new common format has been developed

• All ISO management systems standards will look the same with the same structure (some
deviations)

• More efficient to address multiple management system requirements

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• Provides the option of integrating management systems

• Standardized core definitions

 Structure of ISO 9001:2015 (1/3)
1 Scope
2 Normative references
3 Terms and definitions
4 Context of the organization
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties
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4.3 Determining the scope of the quality management system

4.4 Quality management system and its processes
5 Leadership
5.1 Leadership and commitment
5.2 Policy
5.3 Organizational roles, responsibilities and authorities
 Structure of ISO 9001:2015 (2/3)
6 Planning
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes

7 Support
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7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
 Structure of ISO 9001:2015 (3/3)
8 Operation
8.1 Operational planning and control
8.2 Requirements for products and services
8.3 Design and development of products and services
8.4 Control of externally provided processes, products and services
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8.5 Production and service provision

8.6 Release of products and services
8.7 Control of nonconforming outputs
 Structure of ISO 9001:2015 (4/4)
9. Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.2 Internal audit
9.3 Management review
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10. Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement
 The common structure and ISO 9001:2015 additions
4 Context of 9 Performance
5 Leadership 6 Planning 7 Support 8 Operation 10 Improvement
organization Evaluation

8.1 9.1 Monitoring,

4.1 5.1 6.1 7.1 measurement, 10.1
Understanding Leadership and Risks and Resources Operational planning
analysis and General
context commitment opportunities and control
evaluation

7.2 10.2
4.2 5.2 6.2 Competence 9.2 Nonconformity
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Interested parties Policy Planning Internal audit and corrective

action
7.3
5.3
4.3 Awareness 9.3 10.3
Organizational
Scope roles, Management Continual
responsibilities review improvement
and authorities 7.4 Communication
4.4
QMS
7.5
Documented
information

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 8 Operation

8.1 Operational planning and

control
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 Plan Do Check Act
4 9
5 6 7 8 10
Context of Performance and
Leadership Planning Support Operation Improvement
organization Evaluation

4.1 6.1 7.1 9.1 10.1

5.1 8.1
Understanding context Actions to address Resources Monitoring, General
Leadership and Operational planning
commitment risks and and control measurement, analysis
opportunities 7.1.2 and evaluation
4.2 People
5.2
Interested parties 10.2 Nonconformity
Policy 6.2 See next slide
9.1.2 and corrective action
7.1.3
Quality objectives and Customer satisfaction
Infrastructure
4.3 planning
Scope 5.3
Organizational roles,
responsibilities and 7.1.4 9.1.3 10.3
6.3 Environment for the
4.4 authorities Analysis and Continual improvement
Planning of changes operation of processes
QMS evaluation

7.1.5 9.2
Monitoring and Internal audit
measuring resources

9.3
7.1.6 Management review
Organizational
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knowledge

7.2
Competence

7.3
Awareness

7.4
Communication

7.5
Documented information

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 4
Context of organization
Clause 4.1
4.1
Determine what the relevant external and internal issues are for your
Understanding context
organization, and that are relevant to its strategic direction
4.2
Interested parties

4.3
Scope

4.4
QMS
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 4 Clause 4.2
Context of organization
Identify the relevant interested parties and their relevant requirements
4.1
Understanding context

4.2
Interested parties

4.3
Scope
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4.4
QMS

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 4 Clause 4.3 and 4.4
Context of organization

The requirement for the scope is now better defined, must be documented
4.1
Understanding context
and consider:
 external and internal issues
4.2
Interested parties
 requirements of relevant interested parties
4.3
Scope  the products and services covered (must also be stated in scope)
4.4
QMS  allowing applicability of specific requirements
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 justification for any case where a requirement cannot be applied

(exclusion)

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 9
4 5 6 7 8 10
Performance and
Context of organization Leadership Planning Support Operation Improvement
Evaluation

4.1 7.1 10.1

5.1 6.1 8.1 9.1
Understanding context Resources General
Leadership and commitment Actions to address risks and Operational planning and Monitoring, measurement,
opportunities control analysis and evaluation
7.1.2
4.2 People
5.2
Interested parties 10.2 Nonconformity and
Policy See next slide
6.2 9.1.2 corrective action
7.1.3
Objectives and planning Infrastructure Customer satisfaction
4.3
Scope 5.3
Organizational roles,
responsibilities and 7.1.4 10.3
6.3 Environment for the operation 9.1.3
4.4 authorities Continual improvement
Planning of changes of processes Analysis and evaluation
QMS

7.1.5 9.2
Monitoring and measuring Internal audit
resources

9.3
7.1.6 Management review
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Organizational knowledge

7.2
Competence

7.3
Awareness

7.4
Communication

7.5
Documented information
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 Clause 5.1.1
5
Leadership is required to ensure:
Leadership  take accountability for the effectiveness of the quality management system
 ensure the quality policy and quality objectives are compatible with the
5.1 context and strategic direction of the organization
Leadership and commitment
 ensure the integration of the QMS requirements into the organization’s
5.2 business processes
Policy
 promote the use of the process approach and risk-based thinking
5.3
Organizational roles, responsibilities
 ensure that the QMS achieves its intended results
and authorities
 engage, direct and support persons to contribute to the effectiveness of the
QMS
 supporting relevant management roles
 promotion of improvement
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Clause 5.1.2
Top management needs to ensure customer satisfaction through:
 customer and applicable statutory and regulatory requirements being
determined and met
 risk and opportunities are being addressed
 the focus on products and services meeting customers and other requirements

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 5 Clause 5.2
Leadership
Explicit requirement to apply the policy
5.1
Leadership and commitment

5.2
Policy

5.3
Organizational roles, responsibilities
and authorities
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 5 Clause 5.2
Leadership
 Explicit requirement to apply the policy
5.1
Leadership and commitment

5.2
Clause 5.3
Policy
 Explicit requirement for relevant roles to be assigned,
5.3
Organizational roles, responsibilities communicated and understood
and authorities

 No requirement for a specific management representative and the

responsibility now resides with top management to assign and
manage
 Requirement for defining responsibility and authority for ensuring
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processes are delivering their intended outputs

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 9
4 5 6 7 8 10
Performance and
Context of organization Leadership Planning Support Operation Improvement
Evaluation

4.1 7.1 10.1

5.1 6.1 8.1 9.1
Understanding context Resources General
Leadership and commitment Actions to address risks and Operational planning and Monitoring, measurement,
opportunities control analysis and evaluation
7.1.2
4.2 People
5.2
Interested parties 10.2 Nonconformity and
Policy 6.2 See next slide
9.1.2 corrective action
7.1.3
Quality objectives and Customer satisfaction
Infrastructure
4.3 planning
5.3
Scope
Organizational roles,
responsibilities and 7.1.4 10.3
6.3 Environment for the operation 9.1.3
4.4 authorities Continual improvement
Planning of changes of processes Analysis and evaluation
QMS

7.1.5 9.2
Monitoring and measuring Internal audit
resources

9.3
7.1.6 Management review
Organizational knowledge
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7.2
Competence

7.3
Awareness

7.4
Communication

7.5
Documented information

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 6 Clause 6.1
Planning

 Considering the issues raised and relevant interested parties’

6.1
Actions to address risks and requirements identified (4.1 and 4.2), this clause requires the
opportunities
determination of risks and opportunities which need to be addressed,
6.2 actions to be taken and evaluation of the effectiveness of these actions
Objectives and planning

6.3
Planning of changes
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 6 Clause 6.2
Planning

Objectives should be:

6.1
Actions to address risks and
opportunities  established for processes relevant to the QMS
6.2
Objectives and planning
 in line with customer requirements

6.3  in line with products and services conformity

Planning of changes

 monitored, communicated & updated

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 6 Clause 6.3
Planning
Changes to the QMS should be carried out in a planned manner
6.1 The standard has evolved to enable organizations to adapt to changing
Actions to address risk and opportunity
environments or circumstances
6.2
Objectives and planning
Note: It is important to know that change is addressed in the following
clauses:
6.3
Planning of changes
 Clause 6.3 - Planning/implementing changes to the QMS
 Clause 7.1.6 - Organizational knowledge - for addressing
changing needs and trends, with respect to knowledge
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 Clause 8.1 - Controlling operational changes, planned and

unintentional
 Clause 8.5.6 - Addressing changes affecting products & services

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4 5 6 7 8 10
Performance and
Context of organization Leadership Planning Support Operation Improvement
Evaluation

4.1 7.1 10.1

5.1 6.1 8.1 9.1
Understanding context Resources General
Leadership and commitment Actions to address risks and Operational planning and Monitoring, measurement,
opportunities control analysis and evaluation
7.1.2
4.2 People
5.2
Interested parties 10.2 Nonconformity and
Policy See next slide
6.2 9.1.2 corrective action
7.1.3
Objectives and planning Infrastructure Customer satisfaction
4.3
5.3
Scope
Organizational roles,
responsibilities and 7.1.4 10.3
6.3 Environment for the operation 9.1.3
4.4 authorities Continual improvement
Planning of changes of processes Analysis and evaluation
QMS

7.1.5 9.2
Monitoring and measuring Internal audit
resources

9.3
7.1.6 Management review
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Organizational knowledge

7.2
Competence

7.3
Awareness

7.4
Communication

7.5
Documented information

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 7
Support Clause 7.1
7.1
Resources
There should be adequate resources to ensure effectiveness of the QMS.
7.1.2
Resource considerations now include:
People

7.1.3
 internal resources
Infrastructure

 external providers
7.1.4
Environment for the operation of
processes  people
7.1.5  monitoring and measuring resources
Monitoring and measuring resources

 organizational knowledge required to ensure the processes provide

7.1.6
conforming products and services
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Organizational knowledge

7.2
Competence
 external communication
7.3
Awareness

7.4
Communication

7.5
Documented information

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 7
Support Clause 7.3 and 7.4
7.1 Relevant persons doing work under the organization’s control need to have
Resources
awareness and communication (internal and external) of the QMS and benefits of
7.1.2
People improving performance
7.1.3
Infrastructure

7.1.4
Environment for the operation of
processes

7.1.5
Monitoring and measuring resources

7.1.6
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Organizational knowledge

7.2
Competence

7.3
Awareness

7.4
Communication

7.5
Documented information

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 7
Support Clause 7.5.1
7.1
Resources
Requirements that used to be required for a quality manual have been enhanced
and made more flexible to allow for the use of documented information needed
7.1.2
People for the quality management system
7.1.3
Infrastructure

7.1.4 Clause 7.5.2

Environment for operation of processes

Enhanced requirement for the creation and updating of documented information,

7.1.5 e.g. description, format & suitability
Monitoring and measuring resources

7.1.6
Clause 7.5.3
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Organizational knowledge

7.2
Competence Control of documented information – now explicitly includes confidentiality,
7.3
Awareness
integrity and access
7.4
Communication

7.5
Documented information

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4 5 6 7 8 10
Performance and
Context of organization Leadership Planning Support Operation Improvement
Evaluation

4.1 7.1 10.1

5.1 6.1 8.1 9.1
Understanding context Resources General
Leadership and commitment Actions to address risks and Operational planning and Monitoring, measurement,
opportunities control analysis and evaluation
7.1.2
4.2 People
5.2
Interested parties 10.2 Nonconformity and
Policy See next slide
6.2 9.1.2 corrective action
7.1.3
Objectives and planning Infrastructure Customer satisfaction
4.3
5.3
Scope
Organizational roles,
responsibilities and 7.1.4 10.3
6.3 Environment for operation of 9.1.3
4.4 authorities Continual improvement
Planning of changes processes Analysis and evaluation
QMS

7.1.5 9.2
Monitoring and measuring Internal audit
resources

9.3
7.1.6 Management review
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Organizational knowledge

7.2
Competence

7.3
Awareness

7.4
Communication

7.5
Documented information

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 4 5 6 7 8 9 10
Context of organization Leadership Planning Support Operation Performance and Evaluation Improvement

8.1 Operational planning and control 8.3 Design and development of 8.4 Control of externally provided 8.6 Release of products and services
processes, products and services 8.5 Production and service provision
products and services

8.2 Requirements for products and 8.5.1 Control of production and

8.3.1 General 8.4.1 General 8.7 Control of nonconforming process outputs
services service provision

8.3.2 Design and development

8.2.1 Customer communication 8.4.2 Type and extent of control 8.5.2 Identification and traceability
planning

8.2.2 Determination of requirements 8.5.3 Property belonging to customers

8.3.3 Design and development Inputs 8.4.3 Information for external providers
related to products and services or external providers
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8.2.3 Review of requirements related to 8.3.4 Design and development controls 8.5.4 Preservation
products and services

8.2.4 Changes to requirements for 8.5.5 Post-delivery activities

8.3.5 Design and development outputs
products and services

8.5.6 Control of changes

8.3.6 Design and development
changes

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 8 Operation
Clause 8.1.b
 explicit requirement for establishing criteria for processes

8.1 Operational planning and control

Clause 8.2.1
 explicit considerations are now linked to: customer communications;
8.2 Requirements for products and
services customer property, and contingency actions

8.2.1 Customer communication

Clause 8.2.2
 Determination of requirements; this requires a process and is explicit with
8.2.2 Determination of requirements
related to products and services regard to substantiating claims for products and services being offered
8.2.3 Review of requirements related to
products and services
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8.2.4 Changes to requirements for

products and services

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 8 Operation
Clause 8.3
This section on design and development of products and services has
substantively changed and simplified:
8.3 Design and development of
products and services
Clause 8.3.2
8.3.1 General
 Design and development has been restructured to allow for a more process
8.3.2 Design and development
orientated approach
planning
 Involvement of customers and users as part of design planning to be
8.3.3 Design and development inputs considered
Clause 8.3.3
8.3.4 Design and development controls

 Design and development inputs – explicit requirements for internal and

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8.3.5 Design and development outputs external resource needs, potential consequences of failure, level of control
expected by customers
8.3.6 Design and development
changes
Clause 8.3.4
 Design and development controls – new clause combining Reviews,
Verification & Validation
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 8 Operation
8.4 Control of externally provided
processes products and services
8.4.1 General
8.4.2 Type and extent of control
8.4.3 Information for external
providers
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Clause 8.4
 The terms which previously referred to purchasing and ‘outsourcing’ is now
‘Control of externally provided processes, products and services’
Clause 8.4.1
 Conditions are applied when controls are required for externally provided
processes, products and service
 Terminology has changed from ‘supplier’ to ‘external provider’
Clause 8.4.2
 Type and extent of control of external provision previous notes in 4.1 (ISO
9001:2008) now turned into requirements
Clause 8.4.3
 Information for external providers are now more detailed and explicit
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 8 Operation
Clause 8.5.1
This clause specifically considers:

8.5 Production and service provision

 monitoring and measurement activities will ensure the control of processes
and output (clauses 8.2.3 and 8.2.4 of ISO 9001:2008 have been moved to
8.5.1 Control of production and 8.5.1)
service provision

 acceptance criteria for products and services are met

8.5.2 Identification and traceability
 the use, and control of suitable infrastructure and process environment
8.5.3 Property belonging to customers
or external providers  suitable monitoring and measuring resources
8.5.4 Preservation
 Requires competent persons
ISO/TC 176/SC 2/ N1282

8.5.5 Post-delivery activities

8.5.6 Control of changes

63
 Clause 8.5.2
8 Operation
 The identification and traceability now focus on ‘outputs’ rather than on
‘product’ (includes intermediate products and services) rather than on
‘product’
8.5 Production and service provision

Clause 8.5.3
8.5.1 Control of production and
service provision
 Customer property has been expanded to include external providers’
property
8.5.2 Identification and traceability

Clause 8.5.4
8.5.3 Property belonging to customers
or external providers
 Preservation of product has been changed to preservation of the output
8.5.4 Preservation Clause 8.5.5
ISO/TC 176/SC 2/ N1282

8.5.5 Post-delivery activities  Post-delivery activities is a new clause

8.5.6 Control of changes

Clause 8.5.6
 A new requirement for the control of changes is addressed in the slide
introducing the concept of change

64
 8 Operation
Clause 8.6
 The release of products and services is now part of the operational
requirements
8.6 Release of products and services
Clause 8.7
8.7 Control of nonconforming outputs
 The control of nonconforming output is more explicit; it now considers the
options to apply correction and corrective action
 Nonconforming product changed to nonconforming output
ISO/TC 176/SC 2/ N1282

65
 4 5 6 7 8 9 10
Context of organization Leadership Planning Support Operation Performance evaluation Improvement

4.1 7.1 10.1

5.1 6.1 8.1 9.1
Understanding context Resources General
Leadership and commitment Actions to address risks and Operational planning and Monitoring, measurement,
opportunities control analysis and evaluation
7.1.2
4.2 People
5.2
Interested parties 10.2 Nonconformity and
Policy 6.2 See next slide
9.1.2 corrective action
7.1.3
Quality objectives and Customer satisfaction
Infrastructure
4.3 planning
5.3
Scope
Organizational roles,
responsibilities and 7.1.4 10.3
6.3 Environment for the operation 9.1.3
4.4 authorities Continual improvement
Planning of changes of processes Analysis and evaluation
QMS

7.1.5 9.2
Monitoring and measuring Internal audit
resources

9.3
ISO/TC 176/SC 2/ N1282

7.1.6 Management review

Organizational knowledge

7.2
Competence

7.3
Awareness

7.4
Communication

7.5
Documented information 66
 9 Clause 9.1.1
Performance evaluation
 In 8.1 ISO 9001:2008 (clause 8.1) there was a requirement for planning. This is
9.1 replaced with identifying what needs monitoring and measuring, and the
Monitoring, measurement, analysis and
evaluation methods to be used
Clause 9.1.3
9.1.1
General
 There are specific requirements for analysis and evaluation when using
9.1.2
results as inputs to management review
Customer satisfaction
 Effective implementation of planning and actions to address risks and
9.1.3
opportunities are new requirements in this clause
Analysis and evaluation
ISO/TC 176/SC 2/ N1282

9.2
Internal audit

9.3
Management review

67
 9 Clause 9.2
Performance Evaluation
 Internal audit program now has explicit considerations for: quality objectives,
customer feedback and changes impacting the organization; management
9.1
Monitoring, measurement, analysis and responsibility for action is now implicit whereas previously this was explicit
evaluation
 An auditor is now required to be impartial versus in the previous version they could
9.1.2
not audit their own work
Customer satisfaction
Clause 9.3
9.1.3
 There are now additional requirements for management review. These include:
Analysis and evaluation
 changes in external and internal issues (such as strategic direction)
9.2  performance concerning external providers
Internal audit
 adequacy of resources for effective QMS and effectiveness of actions taken
9.3 addressing risks & opportunities
ISO/TC 176/SC 2/ N1282

Management review
Clause 9.3.1
9.3.1
General
 Management reviews should be aligned to the strategic direction of the organization
Clause 9.3.3
9.3 .2
Management review input  Management review outputs have been enhanced to include many of the new areas of
focus
9.3.3
Management review output

68
 4 5 6 7 8 9 10
Context of organization Leadership Planning Support Operation Performance Evaluation Improvement

4.1 7.1
5.1 6.1 8.1 9.1
Understanding context Resources 10.1 General
Leadership and commitment Actions to address risks and Operational planning and Monitoring, measurement,
opportunities control analysis and evaluation
7.1.2
4.2 People
5.2
Interested parties
Policy See next slide 10.2 Nonconformity and
6.2 7.1.3 9.1.2
corrective action
Objectives and planning Infrastructure Customer satisfaction
4.3
5.3
Scope
Organizational roles,
responsibilities and 7.1.4
6.3 Environment for the operation 9.1.3 10.3
4.4 authorities
Planning of changes of processes Analysis and evaluation Continual improvement
QMS

7.1.5 9.2
Monitoring and measuring Internal audit
resources

9.3
ISO/TC 176/SC 2/ N1282

7.1.6 Management review

Organizational knowledge

7.2
Competence

7.3
Awareness

7.4
Communication

7.5
Documented information 69
 10 Clause 10.1
Improvement  This clause is new, it addresses more comprehensive opportunities for improvement;
not only continual improvement
10.1
General
 Addresses improvement of products and services and future needs and expectations
 Emphasis is now on improving processes to prevent nonconformities and improving
10.2 Nonconformity and corrective
products and services
action Clause 10.2
 The nonconformity referred to in this clause concerns the entire QMS and not
10.3 specifically the products or services which are addressed under clause 8.7
Continual improvement
Clause 10.2.1
 New emphasis is placed on nonconformity and corrective action
 Consequences are now included thus actions taken now recognize the potential
occurrence of a similar nonconformity elsewhere
 Risks and opportunities now need to be updated when required following a
ISO/TC 176/SC 2/ N1282

nonconformity
Clause 10.2.2
 Documented information is now required on the nature of the nonconformity and
subsequent actions taken
Clause 10.3
 Opportunities shall be addressed as part of continual improvement

70
 Key Changes in Terminology (1/2)
• “Procedures”, “Records”, and “Documents” have all been eliminated in favor of
“Documented Information”

• The standard is trying to be more inclusive in accepting alternative approaches to these

areas.

• All references to “Product” will now read “Products and Services.”

• This has long been the case already, as clause 3 of ISO 9001:2008 stated
“Wherever the term “Product” “Wherever the term “Product” appears
• The standard is further pushing the idea of ISO 9001 as with and those without a
tangible product.)
 Key Changes in Terminology (2/2)
• “ “Management Responsibility” has become “Leadership
• Pushes further the concept that Management must lead by example and
involvement, rather than simply directing that activities are performed.

• “Continual Improvement” has evolved into a larger section called “Improvement”

• Promotes the concept that Continual Improvement is not the only aspect of
improvement strived for in a quality system (improvement can also be
characterized by breakthroughs, reactive changes, and reorganizations.)

• Suppliers are now referred to as “External Providers”

• This is intended to better accommodate service organizations.
 Elimination of Required Content
 ISO 9001:2015 will not specifically require any of the following:
• Quality Manual
• Procedures Manual
• Work Instructions
 Elimination of Management Representative
• The title of “Management Representative” does not appear within the ISO
9001:2015 standard.

• The implication is not that this responsibility has been eliminated, but rather that
many of this party’s key functions should now fall to top management itself.

• This reflects the current “in practice” arrangement for many of the companies
already certified.
 Elimination of Permissible Exclusions
• ISO 9001:2015 has removed all verbiage related to “Permissible Exclusions.”

• Organizations can still claim certain items under a “Non-Applicable” designation.

• This means that the validity of such designations will continue to be verified at each audit.

• In practice – not terribly different from current approach.

 Summary (1/2)
 Determining the organizational context enables a more effective implementation of the
quality management system

 Greater emphasis on processes being managed to achieve planned results

ISO/TC 176 SC 2/N1290

 Alignment with strategic direction

 Integration of the QMS into organization’s business processes

 Summary (2/2)
 Determining risks and opportunities increase the effectiveness of the organization’s QMS

 Change management has been expanded to add emphasis that the QMS should be carried
out in a planned manner
ISO/TC 176 SC 2/N1290

 The concept of organizational knowledge introduced to ensure the organization acquires

and maintains the necessary knowledge

 Communication expanded to include external

 ISO 9001:2015 Certification
Transition Timeline
2015 2016 2017 2018
ISO/TC 176 SC 2/N1290

September 2015
Published International Standard

September 2015 start of 3 years transition period to September 2018

Certifications to ISO 9001:2008 will no longer be valid after September 2018
 ISO 9001: 2015 By the Numbers

7
ISO 9001:2015 WAS MORE THAN THE AUDITABLE REQUIREMENT
TRANSITION WILL BE ALLOWED

1.1
PUBLSHED OF ISO 9001:2015
FROM 2015 TO 2018

9
WILL BE FOUND IN

3
SEVEN SECTIONS OF Y
E
MILLION THE NEW STANDARD, A
CLAUSES 4-10
ON SEPTEMBER TWENTY- NUMBER OF ORGANIZATIONS CERTIFIED TO ISO R
THIRD 2015 9001 S

NUMBER OF
ISO 9001:2015

60
WILL BE DIVIDED INTO “SHALL”
STATEMENTS
TEN SECTIONS IN ISO
ISO/TC 176 SC 2/N1290

FOLLOWED THE ANNEX SL MODEL

9001:2015
NUMBER OF
+
_ 138
10 TIMES THE TERM
“DOCUMENTED INFORMATION”
IS USED IN ISO 9001:2015 SOMEONE’S BOUND TO ASK
Questions?

Thank You
Thank you.