ISO-9001:2015 & 14001:2015

Where we have been and where we are going

9001 PDCA
14001 PDCA
Agenda
• Context of the Organization
• Process Approach and Risk Based Thinking
• Organizational Knowledge
• Post-delivery Activities
• Release of Products & Services
• Changes to the Quality Management System
• Environmental Aspect and Impact - Life cycle
• Compliance Obligations (Legal & Other requirements)
Context of the Organization
Context of the Organization
Understanding the organization and its context
• The new requirement reads: “The organization shall determine external and
internal issues that are relevant to its purpose and its strategic direction and that
affect its ability to achieve the intended result(s) of its quality management
system.”
Issues can include positive and negative factors or conditions for
consideration.
• Understanding the external context can be facilitated by considering issues
arising from legal, technological, competitive, market, cultural, social and
economic environments, whether international, national, regional or local.
• Understanding the internal context can be facilitated by considering issues
related to values, culture, knowledge and performance of the organization.
Context of the Organization
Understanding the needs and expectations of interested parties
The organization shall determine:
• the interested parties that are relevant to the quality management system;
• the requirements of these interested parties that are relevant to the quality
management system.
Govt. / Legal Stake Holders
Customers Employee(s)
Authorities (Owners)

Suppliers/ Certification
TPI Services External Internal
Subcontractors Bodies

Bank(s) Visitor(s) Neighbour(s)

Decision making and ISO-9001:2015
• The first is a quality principle quoted from ISO 9000:2015, namely “evidence-
based decision making.” It is not hard to understand that better decisions are
made when they are based on evidence rather than by conjecture.
• The second is found in Clause 0.1, “Addressing risks and opportunities
associated with its context and objectives.” Addressing risks means proactively
managing uncertainties. The simple meaning of “managing uncertainties” is that
decisions should be made with consideration of the possible positive and
negative consequences that the uncertain future may bring.
• Finally, in Clause 5.1, entitled Leadership and Commitment, there is a
requirement for top management: “Ensuring that the quality policy and quality
objectives are established for the quality management system and are
compatible with the context and strategic direction of the organization.” Top
management’s most basic role is strategic decision-making for the organization.
Decisions are to be made based
on evidence. Evidence is found
in the CONTEXT of the
organization.
Examples
• Customer pressures and complaints can force organizations to change policies such as
product returns and customer and technical support .
• Technological changes can provide new and more effective ways to handle
communications, operations, shipping and logistics.
• Governments regulatory and trade policies can play a significant role in determining how
businesses operate, especially in regard to international trade, taxation, and regulations
• The media, including social media, can have a huge impact on a company’s image and
public relations. A bad news video or news report can go viral pretty fast, and if your
organization doesn’t provide an acceptable response, the negative publicity and effects
can last a long time.
• Sociological forces often drive what, where and how consumers buy product and
services. There is an increasing trend in the number of consumers purchasing products
online and reading reviews before making a purchase.
• The multinational and multicultural trend in workforce composition can cause significant
changes in hiring and retention of competent human resources.
Risk Based Thinking
Examples and Ideas

• Purchasing
• Design and Development
• Process
Purchasing
Supplier Approval and Re-Evaluation

• Do all raw materials create the same risk for our

final product?
• Do all suppliers bring the same risk to our
business?

Does your current QMS account for these differences?

Design and Development
Design FMEA – for actual design
Risk Registers – for project risks
The Process Approach and Risk
Based Thinking
• Assign a Process Owner
• Define the process
• Identify the inputs and outputs
• Define measures of effectiveness and efficiency
• Identify risks and opportunities
• Report on the status of each process
 Manpower
Materials Measures
(Training/Skills)
RISK!

Suppliers Customer
(By whom)
Inputs PROCESS Outputs
(For Whom)

Methods Machine Environment

(How) (With what) (Conditions)
Quarterly Business Reviews
(Management Representative and Process Owners)
• Review of identified risk within each key process
• Has the risk changed?
• Have high risk issues been addressed?
• Does performance to objectives reflect risk mitigation?
Quality Risk Assessment
The organization shall consider the issues referred to in
understanding the organization and its context and the
requirements referred to in understanding the needs and
expectations of interested parties and determine the risks
and opportunities.

Actions taken to address risks and opportunities shall be

proportionate to the potential impact on the conformity of
products and services.
Organizational Knowledge
• The organization shall determine the knowledge necessary for the
operation of its processes and to achieve conformity of products and
services.
• Organizational knowledge can be based on:
a) internal sources (e.g. intellectual property; knowledge gained
from experience; lessons learned from failures and successful
projects; capturing and sharing undocumented knowledge and
experience; the results of improvements in processes, products and
services);
b) external sources (e.g. standards; academia; conferences;
gathering knowledge from customers or external providers).
Post-delivery Activities
• The organization shall meet requirements for post‐delivery activities
associated with the products and services.
• In determining the extent of post‐delivery activities that are required,
the organization shall consider:
a) statutory and regulatory requirements;
b) the potential undesired consequences associated with its products and
services;
c) the nature, use and intended lifetime of its products and services;
d) customer requirements;
e) customer feedback.
Release of Products & Services
• The organization shall implement planned arrangements, at
appropriate stages, to verify that the product and service
requirements have been met.
• The organization shall retain documented information on the release
of products and services. The documented information shall include:
a) evidence of conformity with the acceptance criteria;
b) traceability to the person(s) authorizing the release.
Changes to the QMS & EMS
• When the organization determines the need for changes to the
quality management system, the changes shall be carried out in a
planned manner.
• The organization shall consider:
a) the purpose of the changes and their potential consequences;
b) the integrity of the quality management system;
c) the availability of resources;
d) the allocation or reallocation of responsibilities and authorities.
Environmental Aspects & Impacts –
Lifecycle perspective
• The organization shall determine the environmental aspects of its
activities, products & services that it can control and those that it can
influence, and their associated environmental impacts, considering a
life cycle perspective.
• When determining environmental aspects, the organization shall take
into account:
a)change, including planned or new development and new or modified
activities, products & services;
b)abnormal conditions and reasonably foreseeable emergency
situations.
• Significant Environmental Aspects can result in risk & opportunities
associated with either adverse environmental impacts (threats) or
beneficial environmental impacts (opportunities).
Compliance Obligations
• Compliance Obligations (Legal &
Other requirements) related to
Environmental aspects.
- it can arise from mandatory
requirements, such as applicable
laws and regulations, or voluntary
commitments, such as organizational
and industry standards, contractual
relationships, codes of practice and
agreement with community groups
or non-governmental organizations.