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Scope
1. To demonstrate that they have ability to consistently meet customer and applicable legal
requirements
Generic Standard
This clause also clarifies that this standard is a generic standard and is applicable to any type
of business, industry or the size of the organization.
1. In this International Standard, the terms "product" or "service" only apply to products and
services
intended for, or required by, a customer.
2 Normative References
ISO 9001:2015 lists the following standard as normative reference.
It is a reference standard which is indispensable (or vital, very important or essential) to the
application of ISO 9001:2015.
In simple and plain words, ISO 9000 provides definitions of key words mentioned in ISO
9001.
So if you come across the term "Risk and Opportunity" in ISO 9001:2015 clause 6.1 then you
should look at the definitions of these in ISO 9000.
Which issues?
The issues which are
The organization would need to monitor and review the information about these issues.
4.2 Understanding the Needs and Expectations of Interested Parties
Due to their effect, or potential effect, on the organization's ability to consistently provide
products and services that meet customer and applicable legal requirements, determine:
Monitor and review information about these interested parties and their relevant
requirements.
Who are interested parties?
Typically these would include:
Shareholders
Owners
Management
Employees
Trade unions
Suppliers
Partners
Client
Government agencies
Media
Society
any other person or organization interested in the organization
No. Once you have identified the interested parties the next step you can take is to analyze
these interested parties on two parameters (the standard does not require this but this
might help you in understanding your interested parties better).
Power
Interest
Depending upon these two factors you can choose the appropriate approach. Stakeholder
analysis is typically used in the project management.
However in this version the scope has to be determined considering the following facts:
a) external and internal issues (see 4.1 )
b) requirements of relevant interested parties (see 4.2 )
c) the products and services of the organization
Unlike previously the organization can not exclude any requirement from the quality
management system. They can only exclude a requirement, if that is not applicable and
does not affect the product quality (conformity to requirements and customer satisfaction).
The organization is required to determine the processes needed for the QMS and their
application in the organization.
Determine:
Retain documented information to the extent necessary to have confidence that the
processes are being carried out as planned. (Records)
5 Leadership
The term business here includes public, private, for profit and not for profit organizations.
5.1.2 Customer focus
Top management to demonstrate leadership and commitment with respect to customer
focus by ensuring that:
customer requirements and applicable legal requirements are determined, understood and
met;
risks and opportunities that can affect conformity of products and services and the ability
to enhance customer satisfaction are determined and addressed;
focus on enhancing customer satisfaction is maintained.
5.2 Policy
5.2.1 Developing the quality policy
Top management must establish, implement, and maintain a quality policy that:
is appropriate to the purpose and context of the organization and supports its strategic
directions
provides a framework for setting quality objectives
includes a commitment to satisfy applicable requirements
includes a commitment to continual improvement of the QMS
6 Planning
6.1 Actions to Address Risks and Opportunities
ISO 9001:2015 Requirement
6.1.1
When planning for the quality management system, the organization need to consider
issues referenced in clause 4.1 , and the requirements referenced in clause 4.2 and
determine the risks and opportunities that need to be addressed to:
give assurance that the quality management system can achieve its intended results
enhance desired effects
prevent, or reduce, undesired effects;
achieve improvement
6.1.2
Plan:
Organization to take actions to address risks and opportunities that are proportionate to the
potential impact on the conformity of products and services.
monitored
communicated
updated as appropriate
6.2.2