Integrated Management Systems Checklistza
Integrated Management Systems Checklistza
Integrated Management Systems Checklistza
Implementation Checklist
This checklist is intended for use by those organizations who are either looking at implementing an Integrated Management System
(IMS) for the first time or by those who currently have an integrated management system and would like to ensure they are on the
right track during transition to revised ISO standards following Annex SL.
While this checklist is set up by elements of the ISO 9001 and ISO 14001 standards, it should be noted that the standards are
intended to be used – and will be audited by the Certification Body – as a whole. Concepts of planning, management of change, and
risk are woven throughout the standards and are expected to be implemented throughout the business.
Risk planning from the business perspective will differ from risk planning at the operational level – whether it be the design process
for quality (FMEAs) or the aspect analysis – going from “big picture” to detailed analysis.
The audit process will begin and end with top management – defining what the organization is about, where it is, where it wants
to go, how it plans to get there and how it will evaluate its progress and the effectiveness of its efforts. That “line of sight,” starting
from the top, will be applied as a measure throughout the audit; the results will then be delivered to top management to help them
understand if they are on track and if their planning will bring intended results.
ISO 9001:2015 & Meets
Objective Minimum Expectation
ISO 14001:2015 Requirements Expectations
Please use text in the Meets Expectations column to capture procedure numbers, process information,
4. Context of the organization or additions required to ensure all requirements are met and fully integrated.
• Is the scope documented for quality and environmental?
Even in an integrated system, these may differ.
The organization must determine external and internal • Are external and internal issues defined, so they can
issues relevant to its purpose and strategic direction be considered throughout the planning process and the
that may affect its ability to achieve intended outcomes organization can monitor how well they are addressing or
as well as monitor and review information regarding dealing with the issues?
4.1 Understanding the
these issues. Every location has a high-level, conceptual • Can Top Management explain what the concerns of
organization and its context
understanding of the important issues that can affect, the organization are from a quality and environmental
either positively or negatively, the way the organization perspective?
manages its business, from a quality and environmental
• Does Top management understand how the management
perspective – covering all responsibilities.
system is a support and critical part of the overall business
system and a vehicle to help achieve overall strategic goals,
both short and long term.
The organization has determined its important • Has a stakeholder analysis been completed and documented
stakeholders and has defined the Scope of the QMS/ to determine key stakeholders whom have an impact on the
4.2 Understanding the needs and EMS. The location understands who the important requirements of the IMS?
expectations of interested parties internal and external stakeholders are, their expectations
• Have these stakeholders’ expectations been considered for
and which of these are compliance obligations.
incorporation into the IMS?
Note: these are not necessarily legal compliance
requirements, but are QMS/EMS compliance obligations. • Are expectations identified as compliance obligations?
Senior management has defined and communicated • Are the required elements from the quality and
4.4 Quality/Environmental its Quality and Environmental Policy and demonstrates environmental policy readily identifiable (e.g. preventing
management system and its commitment to it. The organization’s quality and pollution or ensuring customer satisfaction)? Even in an
processes environmental policy establishes the framework upon integrated system, the policy for quality may be separate from
which objectives and targets are set. environmental.
ISO 9001:2015 & Meets
Objective Minimum Expectation
ISO 14001:2015 Requirements Expectations
5. Leadership
• Interview management representatives in various levels to
verify how and when they demonstrate their commitment
Senior management demonstrates its commitment to
the QMS/EMS with actions and behaviors and takes • Interview employees and review meeting minutes of strategic
5.1 Leadership and commitment and tactical teams. Is leadership perceived to be visible on the
responsibility for its implementation and continual
improvement. floor on behalf of quality, environmental, health and safety
issues or events, and involved in key decisions and interacts
with groups?
6. Planning
The organization needs to consider the scope, as well as
issues (4.1) and requirements (4.2), when planning for the
• Are customers and other interested parties’ expectations
management system and risks and opportunities should
defined and linked to business issues?
be defined and addressed.
Note: The larger or more complex an organization, the more
While environmental aspects and impacts, and
probable this process will be documented. A formal risk
6.1 Actions to address risks and compliance obligations, may be identified and managed
analysis process is not required to define these issues under
opportunities by the same process used to determine business risks and
4.1
opportunities, they are normally kept separate. Business
risks and opportunities may be identified by management • Are aspects and impacts defined in relation to compliance
discussion and brainstorming, while a formal FMEA-type obligations with a risk assessment methodology for use in
process is applied to aspects and impacts. prioritizing aspects?
See Annex A6.1.1 for more information.
• Are objectives set based on data collected and analyzed in
relation to customers’ needs and satisfaction, market changes,
The organization needs to establish objectives at relevant environmental performance, best practices, changes in
functions, levels and processes needed for the integrated regulations, etc.?
6.2 Quality/Environmental
management system and plan actions to achieve • Are objectives meaningful, realistic, achievable and
objectives and planning to
these objectives. This includes considering risks and measurable, and most importantly, do they have a positive
achieve them
opportunities associated with environmental aspects and impact on the business?
impacts as well as associated compliance obligations.
• Are objectives dynamic and easy to change/update to
keep current to the organization needs and ever-changing
environment the organization operate in?
• How is the management of change defined, managed and
measured for success and can you ensure lessons learned are
incorporated into future actions?
Any changes needed from the management system
should be planned with consideration given to availability • Do processes defined identify and plan for changes related
6.3 Planning of changes to customers, products, new equipment, new processes, new
of resources as well as the potential consequences and
integrity of the integrated management system. materials, changed equipment, amended processes, new uses
applied to current materials, new compliance obligations,
changes in personnel responsible, etc. that can impact quality
or environmental?
ISO 9001:2015 & Meets
Objective Minimum Expectation
ISO 14001:2015 Requirements Expectations
7. Support
• Are key roles within the management system defined and
duties assigned?
The organization must determine and provide resources
needed for the establishment, implementation, • Is required training identified by position?
maintenance and continual improvement of the • Are succession plans identified for key resources/positions?
7.1 Resources integrated management system. This includes determining
• Are calibration needs for both quality and environmental
and providing the necessary people, infrastructure,
purposes must be identified and defined? Criteria may not
environment, monitoring/measurement resources, and
be the same, but will take into account industry-standard
organizational knowledge required for operations.
calibration processes, ISO standard requirements, regulatory
requirements, and customer requirements as applicable.
• Can you define what is needed from persons working for the
People working for the organization need to be aware of organization?
the policy and objectives as well as their contribution to • Have you determined potential for impacting quality or the
7.3 Awareness
the effectiveness of the integrated management system environment.?
and the implications of not conforming to requirements.
• Have you determined what needs to be communicated in
order to avoid negative impacts?
Relevant internal and external communications need to be • Is the process defined and responsibility for communication
established, implemented and maintained, including what assigned?
7.4 Communication
will be communicated as well as timing, audience, method • Does the process define documented evidence of
and who will deliver the message. communications required, where appropriate?
8. Operation
• Have you defined critical control points in operations from
both a quality and environmental perspective?
Necessary processes need to be established,
• Is control criteria established?
implemented, controlled and maintained to meet system
8.1 Operational planning and
requirements. Actions identified in 6.1 and 6.2 need to • After implementation of the control process, use monitoring
control
be implemented by establishing operational criteria and or the audit process to ensure it is maintained, and is
implementing control of processes. adequate and effective in achieving customer satisfaction
and preventing of pollution/consumption of nonrenewable
resources
• Implement and plan the criteria for products and services to
8.2 Requirements for products 8.2 Requirements for products and services lends itself to meet standard and customer requirements.
and services (ISO 9001:2015) integration. • Analyze the established criteria to determine in which areas
8.2 Emergency preparedness 8.2 Emergency preparedness and response will remain risk of material use and disposal could lead to environmental
and response (ISO 14001:2015) separate due to legal implications. impacts that must be controlled, and add these controls to the
process, in support of 8.1.
• Establish the design criteria per the ISO 9001:2015 standard,
determine the process required, ensuring all standard and
customer requirements are met.
• If environmental criteria within the design were not set by the
Gather all the information needed to ensure products client, determine the environmental controls your organization
8.3 Design and development of wishes to establish for the design criteria and process and
and services are understood and properly planned,
products and services establish them within the quality process.
including communication with the client to ensure their
(ISO 9001:2015)
expectations are met. • Establish a process to ensure the quality and environmental
criteria will be considered in each product or process change
going forward, if such criteria has been established.
• Note: Look at 8.1 of 14001 for life cycle perspective and the
impact of design on that life cycle.
8.4 Control of externally Should this be a consideration, selection of contracted services
provided processes, products This may be excluded from the integration process. may include environmental considerations, or contractor’s
and services (ISO 9001:2015) environmental performance, as a criteria.
Ensure defined process to control quality and environmental
8.5 Production and service These requirements may be integrated with environmental
criteria is considered in each product design or process
provision (ISO 9001:2015) criteria, if the provisions of 8.3 have been integrated.
change going forward, if such criteria has been established.
ISO 9001:2015 & Meets
Objective Minimum Expectation
ISO 14001:2015 Requirements Expectations
8. Operation (continued)
Ensure defined process to control quality and environmental
These requirements may be integrated with environmental
8.6 Release of products and criteria is considered in each product design, design change,
criteria, such as packaging, if the provisions of 8.3 have
services (ISO 9001:2015) or process change going forward, if such criteria has been
been integrated.
established.
8.7 Control of nonconforming
See 8.6 See 8.6
outputs (ISO 9001:2015)
9. Performance evaluation
• Are critical control points determined in operation, regulatory
requirements for monitoring, weaknesses identified through
customer feedback, and system requirements for monitoring
The organization must determine what needs to be
in both quality and environmental?
monitored and measured as well as the criteria, method
9.1 Monitoring, measurement, and timing for analysis. This includes monitoring • Establish acceptable criteria parameters, where applicable.
analysis and evaluation customer satisfaction as well as evaluating performance, • Are monitoring requirements defined in relation to method
effectiveness and compliance of the integrated and timing?
management system.
• Analyze and ensure sufficient information is captured and
provided for Management Review to determine adequacy,
suitability and effectiveness of the system.
• Is risk considered when determining the audit plan frequency
and content/processes for both quality and environmental?
Internal audits need to be planned regularly to provide • While there is an expectation that individuals will not
9.2 Internal audit information on the integrated management system’s audit work for which they are responsible, individuals with
conformance and effectiveness. specialized skill can be utilized as “consultants” in areas for
which they are responsible to ensure the competency of the
auditors is sufficient to provide depth and breadth of audit.
• Is management provided with sufficient data to ensure
decisions made in review are satisfactory? They must
The integrated management system needs to be reviewed
understand results of customer satisfaction measurements,
at planned intervals and, if needed, action should be
progress on objectives, trends in internal audit findings,
9.3 Management review taken to ensure its continuing suitability, adequacy,
and current regulatory compliance status for quality and
effectiveness and alignment with the strategic direction of
environmental before they can make decisions on suitability,
the organization.
adequacy and effectiveness of the management system, and
whether the organization is performing as expected.
ISO 9001:2015 & Meets
Objective Minimum Expectation
ISO 14001:2015 Requirements Expectations
10. Improvement
Opportunities for improvement need to be identified
•What are the processes for gathering information on
and necessary actions should be implemented to
10.1 General opportunities? These are critical to ensure good input – for
meet customer requirements and enhance customer
quality and environmental management.
satisfaction.
• Is containment of any condition of nonconformity handled
immediately?
• Without cause analysis, you cannot determine the issue or
Any nonconformity should be dealt with by taking action issues that led to the nonconforming condition.
to correct and control it and evaluated to determine • Once determined and implemented, is corrective action
10.2 Nonconformity and
and eliminate root cause. This will ensure that the verified to ensure it not only eliminated the nonconforming
corrective action
nonconformity does not recur or occur elsewhere in the condition, but that it didn’t cause another issue?
system.
• Are customer complaints, agency notices of violation, process
conditions that cause work stoppages, incidents, etc. all
conditions of nonconformity, and require analysis, correction
and corrective action?
• Is continual improvement expected throughout the
The organization needs to consider the evaluation and organization’s process – from product improvements to capitol
management review to determine any actions needed improvements – for quality and environmental?
10.3 Continual improvement
to continually improve the suitability, adequacy and • Note: data analyzed for continual improvement can be
effectiveness of the integrated management system. quantitative or qualitative, but must demonstrate targets have
been met.