ISO 9001:2015 Articles
is the ISO 9001 standard all about?
The ISO 9001 standard incorporates internationally recognized management concepts, principles and practices
into a set of standardized requirements for a quality
management system (QMS). These standardized requirements define controls that focus on improving an organization’s ability to
deliver products or services to:
Consistently meet customer’s quality requirements
Meet applicable regulatory requirements
Enhance customer satisfaction
Improve its performance in pursuit of these objectives.
Context of the organization
Let’s start by paraphrasing the requirements and notes from
various parts of the new standard:
1. As part of its strategic planning, the organization must
determine, understand and consider its external and internal contextual issues in determining its risks and
opportunities as a basis for planning its QMS and achieve improvement.
2. These issues must:
a. Be relevant to the organization’s purpose and its strategic
b. Affect its ability to achieve the intended result(s) of its quality
3. We must monitor and review information about these external and internal
4. The issues we consider can include positive and negative
factors and conditions
5. To help understand:
a. The external context, we can
consider issues arising from legal, technological, competitive, market, cultural, social and economic
environments, whether international, national, regional or local.
b. The internal context, we can
consider issues related to values, culture, knowledge and performance of the
Understanding the needs and expectations of interested
What are ISO 9001:2015 requirements for “Understanding the needs
and expectations of interested parties”?
Let’s start with paraphrasing what the revised standard says and
An organization’s ability - to consistently provide products and services may be affected by
relevant interested parties.
We need to ascertain and identify each interested party and in
what way, shape or form they affect this ability.
We need to find out their specific requirements that impact
We need to track, collect and review information
about relevant interested parties and their requirements (Copyright
material askartsolutions 2015)
When determining the scope of the
QMS, the organization must take
into account the requirements of relevant interested
There is no requirement to widen the QMS scope to include
meeting the requirements of relevant parties, other than customers and applicable statutory and
In ISO 9000:2015, “Quality
management systems—Fundamentals and vocabulary,” risk is defined as the “effect of uncertainty.” Notes in
the definition further describe risk as a “deviation from the expected,” either positive or negative. The term
“uncertainty” is defined as a lack of information or knowledge about a potential event that can be expressed
as a result of the likelihood and consequence of such an event. A positive deviation arising from a
risk can provide an opportunity, but not all positive effects of risk result in opportunities. Actions to
address opportunities can also include consideration of associated risks
ISO 9001:2015, requires that when planning its
QMS, the top management must implement and promote a culture of risk-based thinking throughout the
organization to determine and address the risks and opportunities associated with providing assurance that the
QMS can achieve its intended result(s); provide conforming products and services, enhance customer
satisfaction; promote desirable effects and improvement; prevent, or mitigate, undesired