IMS Audit checklist | Internal IMS Audit checklist | Audit Checklist
Audit Date(s):
Company Name:
Site Address:
Audit Criteria: ISO 9001:2015, 14001:2015 and ISO 45001:2018
(IMS)
Lead Auditor:
Audit Team:
Requirements |
Yes/No |
Evidence |
|
||
4 Context of the
Organisation
|
|
|
|
||
4.1 Understanding the
Organization & Its Context
|
|
|
|
||
Are you able to show the way that your company identifies external and
internal issues that are relevant to your organization’s purpose and your
ability to achieve the intended outcomes of your Quality, Environment &
Occupational Health & Safety management system? |
|
|
|
||
Does your organization monitor and review information about these external
and internal issues? |
|
|
|
||
4.2 Understanding the Needs
& Expectations of Interested Parties
|
|
|
|
||
Has your organization determined: |
|
|
|||
a) The interested parties that are relevant to the IMS? |
|
|
|||
b) The relevant needs and expectations of these interested
parties? |
|
|
|||
c) Which of these needs and expectations it chooses to accept so they
become part of the compliance obligations that your company subscribes to? |
|
|
|||
4.3 Determining the Scope of
the IMS
|
|
|
|||
When determining the scope of your Quality,
Environment & Occupational Health & Safety, were the following issues
considered: |
|
|
|||
a) The boundaries and applicability of the
Quality, Environment & Occupational Health & Safety Management System |
|
|
|||
b) The compliance obligations identified in
response to clause 4.2? |
|
|
|||
c) The relevant external and internal
issues? |
|
|
|||
d) The relevant requirements of interested
parties? |
|
|
|||
e) The products and services provided? |
|
|
|||
Once your scope has been defined, did you
make sure that all activities, products, and services within that scope were
included in your Quality, Environment & Occupational Health & Safety? |
|
|
|||
Can you demonstrate that your organization
has documented the scope and made it available to all interested parties
& throughout the organization? |
|
|
|||
4.4 Quality, Environment & Occupational Health & Safety
Management System
|
|
|
|
||
Does your organization shall establish, implement, maintain and
continually improve the quality & environmental management system,
including the processes to achieve the intended outcomes, including enhancing
its Quality & Environmental performance? |
|
|
|
||
Has your organization got a simple way to describe the interactions
between the processes of your Quality, Environment & Occupational Health
& Safety? |
|
|
|
||
Does your organization retain documentation to give and prove that the
processes are being carried out as planned? |
|
|
|
||
5.
Leadership
|
|
|
|
||
5.1 Leadership & Commitment
|
|
|
|
||
Responsibility can be delegated but Accountability cannot. Does top
management take accountability for the effectiveness of your Quality,
Environment & Occupational Health & Safety? |
|
|
|
||
Were your policy and objectives set by top management and are they
compatible with the strategic direction and context of your organization? |
|
|
|
||
Does top management ensure that you’re Quality, Environment &
Occupational Health & Safety requirements are integrated into your
business processes? |
|
|
|
||
Are the resources needed for your Quality, Environment & Occupational
Health & Safety made available by top management? |
|
|
|
||
Does top management communicate the importance of effective
environmental management and conforming to the Quality, Environment &
Occupational Health & Safety? |
|
|
|
||
Does top management ensure you’re Quality, Environment &
Occupational Health & Safety achieves its intended outcomes? |
|
|
|
||
Are employees encouraged to contribute to the effectiveness of your
Quality, Environment & Occupational Health & Safety? |
|
|
|
||
Is the continual improvement of your Quality, Environment &
Occupational Health & Safety promoted by top management? |
|
|
|
||
Do top management support other management roles related to the
Quality, Environment & Occupational Health & Safety Management
System? |
|
|
|
||
5.2 Policy |
|
|
|||
Can you see how your IMS policy is appropriate to the purpose and
context of your organization, including the nature, scale, and environmental
impacts of your activities, products, and services? |
|
|
|||
Does your policy provide a framework for setting IMS objectives? |
|
|
|||
Does your policy include a commitment to the protection of the
Quality, Environment & Occupational Health & Safety relevant to the
context of your organization? |
|
|
|||
Does your policy include a commitment to fulfill its compliance
obligations? |
|
|
|||
Includes a commitment to eliminate hazards and reduce OH&S risks? |
|
|
|||
Does your policy include a commitment to continual improvement of your
IMS? |
|
|
|||
Includes a commitment to consultation and participation of workers,
and, where they exist workers representative? |
|
|
|||
Does your policy include a commitment to enhancing your IMS
performance? |
|
|
|||
5.3 Organisational Roles, Responsibilities,
and Authorities |
|
|
|
||
Are roles and responsibilities assigned by top management and
communicated within your organization? |
|
|
|
||
Have people been assigned
to report to top management on the IMS performance |
|
|
|
||
Do workers assume responsibility for those aspects of the OH&S
management system for which they have control? |
|
|
|
||
5.4 Consultation of workers |
|
|
|
||
Has your organization established, implemented, and maintained a
process (es) for consultation and participation of workers at all applicable
levels and functions, and where they exist, workers' representatives, in the
development, performance evaluation, and actions for improvement of the
OH&S system? |
|
|
|
||
Does the organization: |
|
|
|
||
a.
Provide mechanisms, time, training, and resources necessary for
consultation and participation. |
|
|
|
||
b.
Provide timely access to clear, understandable, and relevant
information about the OS&H management system. |
|
|
|
||
c.
determine and remove obstacles or barriers to participation and minimize
those that cannot be removed |
|
|
|
||
d.
emphasize the consultation of non-managerial workers on the following:
1.
Determining the needs and expectations of interested parties? 2.
Establishing the OH&S policy? 3.
Assigning organizational roles, responsibilities, and authorities, as
applicable? 4.
Determining how to fulfill legal and other requirements? 5.
Establish and plan to achieve OH&S objectives. 6.
Determining applicable controls for outsourcing, procurement, and
contractors? 7.
Determining what needs to be monitored, measured, and evaluated? 8.
Planning, establishing, implementing, and maintaining an audit
program? 9.
Ensuring continual improvement? |
|
|
|
||
e.
emphasize the participation of non-managerial workers in the
following: 1.
Determining the mechanisms for their consultation and participation? 2.
Identifying hazards and assessing risks and opportunities? 3.
Determining actions to eliminate hazards and reduce OH&S risks? 4.
Determining competence requirements, training needs, training, and
evaluating training? 5.
Determining what needs to be communicated and how it is to be done? 6.
Determining control measures and their effective implementation and
use? 7.
Investing incidents and nonconformities and determining corrective
action? |
|
|
|
||
6. Planning
|
|
|
|
||
6.1
Actions to Address Risks & Opportunities
|
|
|
|
||
6.1.1
General
|
|
|
|
||
When planning for your Quality, Environment & Occupational Health
& Safety, has your organization considered the following: |
|
|
|
||
a)
External and internal issues that are relevant to its purpose and
strategic direction? |
|
|
|
||
b)
The needs and expectations of interested parties? |
|
|
|
||
c)
The scope of your IMS was determined when you addressed the
requirements of clause 4.3. |
|
|
|
||
d)
Does your organization plan, implement and evaluate actions to deal
with relevant risks and opportunities? |
|
|
|
||
e)
Hazards, compliance obligations, and Legal and other requirements? |
|
|
|
||
f)
The risks and opportunities identified that need to be addressed to
give assurance that your Quality, Environment & Occupational Health &
Safety management system can achieve its intended outcomes? |
|
|
|
||
g)
How to prevent, or reduce, undesired effects, including the potential
for external environmental conditions that may affect your organization? |
|
|
|
||
h)
How to achieve continual improvement? |
|
|
|
||
Within the scope of your IMS, does your organization determine potential
emergencies, including those that may have a Quality, Environment &
Occupational Health & safety impact?
|
|
|
|
||
Does your organization maintain documented information on: |
|
|
|
||
a)
The risks and opportunities that need to be addressed? |
|
|
|
||
b)
The processes needed as a result of considering clauses 6.1.1 to 6.1.4
to the extent necessary to have confidence they are carried out as planned? |
|
|
|
||
Are the actions taken to address risks and opportunities determined
and prioritized based on their potential impact on product and service
conformity? |
|
|
|
||
6.1.2
Environmental Aspects, Hazards identification, and Assessment of Risks and
Opportunities
|
|
|
|
||
6.1.2.1
Environmental Impact |
|
|
|
||
Within the defined scope of your QEMS, does your organization identify
the environmental aspects of its activities, products, and services that it
can control? |
|
|
|
||
Within the defined scope of your EMS, does your organization identify
the environmental aspects of its activities, products, and services that it
can influence? |
|
|
|
||
Do you understand how to take into account the life-cycle perspective
of your activities, products, and services? |
|
|
|
||
When determining environmental aspects, does your organization take
into account: |
|
|
|
||
a) Change, including planned or new developments and new or modified
activities, products, or services? |
|
|
|
||
b) Abnormal conditions and reasonably foreseeable emergencies? |
|
|
|
||
Does your organization use clear criteria for determining those
aspects that can have a significant environmental impact? |
|
|
|
||
Does your organization document its: |
|
|
|
||
Environmental aspects and associated environmental impacts? |
|
|
|
||
The criteria used to determine its significant environmental
aspects? |
|
|
|
||
Significant environmental aspects? |
|
|
|
||
6.1.2.2 Hazards identification and Assessment of Risks and
Opportunities |
|
|
|
||
Has the organization established, implemented, and maintained a
process(s) for hazard identification that is ongoing and proactive? Do the
processes take into account, but not be limited to? |
|
|
|
||
a) How work is organized, social factors (including workload, work
hours, victimization, and harassment and bullying) leadership, and the
culture of the organization? |
|
|
|
||
b) routine and non-routine activities and situations, including
hazards arising from: 1. Infrastructure, equipment, materials, substances, and the physical
conditions of the workplace? 2. Product and service design, research, development, testing,
production, assembly, construction, service delivery, maintenance, and
disposal? 3. Human factors? 4. How work is performed? |
|
|
|
||
c) Past relevant incidents, internal or external to the organization,
including emergencies, and their causes? |
|
|
|
||
d) Potential emergencies? |
|
|
|
||
e) people, including
consideration of: 1. Those with access to the workplace and
their activities, including workers, contractors, visitors, and other
persons? 2. Those in the vicinity of the workplace who
can be affected by the activities of the organization? 3. Workers at a location not under the direct
control of the organization? |
|
|
|
||
f) Other issues, including
consideration of: 1. The design of work areas, processes,
installations, machinery/equipment, operating procedures, and work organization,
including their adaptation to the needs and capabilities of the workers
involved. 2. Situations occurring in the vicinity of the
workplace caused by work-related activities under the control of the organization?
3. Situations not controlled by the organization
and occurring in the vicinity of the workplace that can cause injury and ill
health to persons in the workplace? |
|
|
|
||
g) Actual or proposed changes in organization, operations, processes,
activities, and the OH&S management system? |
|
|
|
||
h) Changes in knowledge of, and information about, hazards? |
|
|
|
||
6.1.2.3 Assessment of OH&S & Other Risks & Opportunities
to OH&S Management system |
|
|
|
||
Has the organization established implemented and maintained a process
to: |
|
|
|
||
a) Assess OH&S risks & opportunities from the identified
hazards, while taking into account the effectiveness of existing controls? |
|
|
|
||
b) Determine and assess the other risks & opportunities related to
the establishment, implementation, operation, and maintenance of the OH&S
management system? |
|
|
|
||
c) Opportunities to adapt work, work for the organization and work
environment to workers? Opportunities to eliminate hazards and reduce OH&S risks? |
|
|
|
||
Has the organization’s methodologies and criteria for the assessment
of OH&S risks been defined concerning the scope, nature, and timing to
ensure they are proactive rather than reactive and are used systematically? |
|
|
|
||
Does the organization maintain and retain documented information on
the methodologies and criteria? |
|
|
|
||
6.1.3 Determination of Legal Requirements and Other Requirements &
Compliance Obligations |
|
|
|
||
Does your organization: |
|
|
|
||
Determine and have access to the compliance obligations, Legal
Requirements, and Other Requirements & related to its Quality,
environmental aspects & Occupational Health & Safety Management. |
|
|
|
||
Determine how compliance obligations & legal & other legal
requirements are applicable to your organization. |
|
|
|
||
Take these compliance obligations into account when establishing,
implementing, maintaining, and continually improving your IMS. |
|
|
|
||
Does your organization keep its compliance obligations & legal
& other legal requirements in documented form? |
|
|
|
||
6.1.4
Planning Action |
|
|
|
||
Does your organization plan to take action to address its: |
|
|
|
||
a) Significant environmental aspects? |
|
|
|
||
b) Actions to address these risks and opportunities, address
compliance obligations, legal and other requirements and prepare for and
respond to emergencies? |
|
|
|
||
Does your organization plan how to |
|
|
|
||
a) Integrate and implement the actions into your IMS processes or
other business processes? |
|
|
|
||
b) Evaluate the effectiveness of these actions? |
|
|
|
||
When planning these actions, does your organization consider its
technological options and its financial, operational, and business
requirements? |
|
|
|
||
6.2 Quality, Environment & Occupational
Health & Safety Objectives and Planning to Achieve Them |
|
|
|||
Has your organization established IMS objectives at relevant
functions, and levels that are needed to maintain and continually improve the
IMS management system |
|
|
|||
Are your IMS objectives: |
|
|
|||
a) Consistent with the requirements of your policy? |
|
|
|||
b) Measurable? |
|
|
|||
c) Address applicable requirements within your IMS? |
|
|
|||
d) Relevant to the conformity of your products and services and the
enhancement of customer satisfaction? |
|
|
|||
e) Monitored? |
|
|
|||
f) Communicated? |
|
|
|||
g) Updated when required? |
|
|
|||
Are your IMS objectives
documented? |
|
|
|||
Were the following factors determined when you were planning the
achievement of your Quality, Environment & Occupational Health &
Safety objectives: |
|
|
|||
a) What needs to be done? |
|
|
|||
b) What resources will be required? |
|
|
|||
c) Who will be responsible? |
|
|
|||
d) When it will be completed? |
|
|
|||
e) How the results will be evaluated? |
|
|
|||
Do you maintain and retain documented information on the OH&S
plans? |
|
|
|||
How the actions to achieve IMS objectives will be integrated into the
organization's business processes? |
|
|
|||
6.3 Planning of Changes |
|
|
|||
When changes are required within your IMS, are these changes carried out
in a planned and systematic manner? |
|
|
|||
When changes are required, does your organization consider the
following: |
|
|
|||
a) The purpose of the changes and their
potential consequences? |
|
|
|||
b) The integrity of your IMS? |
|
|
|||
c) The availability of resources? |
|
|
|||
d) The allocation or reallocation of
responsibilities and authorities? |
|
|
|||
7.
Support
|
|
|
|
||
7.1
Resources
|
|
|
|
||
7.1.1 General
|
|
|
|
||
Does your organization determine and provide the resources needed for
the establishment, implementation, maintenance, and continual improvement of
your QEMS? |
|
|
|
||
When resource planning, does your organization consider the following: |
|
|
|
||
a) The capabilities of, and constraints on,
existing internal resources? |
|
|
|
||
b) What needs to be obtained from external
providers? |
|
|
|
||
7.1.2 people |
|
|
|
||
Does the organization determine and provide persons necessary for the
effective implementation of your QEMS and the operation and control of its
processes? |
|
|
|
||
7.1.3 Infrastructure |
|
|
|
||
Does your organization
determine, provide and maintain the infrastructure necessary for the
implementation of its processes and the achievement of product and service
conformity, i.e., buildings and associated utilities, equipment, including
hardware and software, transportation resources, information and communication
technology, etc.? |
|
|
|
||
7.1.4 Environment for the Operation
Processes |
|
|
|
||
Does your organization
determine, provide and maintain the environment necessary for the operation
of its processes and the achievement of product and service conformity? |
|
|
|
||
7.1.5 Monitoring and Measuring Resources |
|
|
|
||
Does your organization determine and provide the resources needed to
ensure valid and reliable results when monitoring or measuring is used to
verify the conformity of products and services to requirements? |
|
|
|
||
Does your organization ensure that your resources for monitoring and
measurement are suitable and maintained? |
|
|
|
||
Does your organization retain appropriate documentation to prove the
fitness for purpose of the monitoring and measurement resources? |
|
|
|
||
When measurement traceability is a requirement or is considered by
your organization to be an essential part of providing confidence in the
validity of measurement results, is your measuring equipment: |
|
|
|
||
a) Calibrated
or verified, or both, at specified intervals, or before use, against
measurement standards traceable to international or national measurement
standards? |
|
|
|
||
b) If no such
standard exists, is the basis for calibration or verification recorded in a
documented format? |
|
|
|
||
c) Identified
to determine their status? |
|
|
|
||
d)
Safeguarded from adjustments, damage, or deterioration that would invalidate
the calibration status and subsequent measurement results? |
|
|
|
||
When measuring equipment is found to be unfit for its intended
purpose, does your organization determine the previous measurement results
and take appropriate action as necessary? |
|
|
|
||
7.1.6 Organisational Knowledge |
|
|
|
||
Does your organization determine, maintain and ensure the availability
of the knowledge necessary for the operation of its processes and to achieve
conformity of your products and services? |
|
|
|
||
Are current knowledge and the need for new knowledge considered when
addressing changing needs and trends within your organization? |
|
|
|
||
7.2 Competence |
|
|
|
||
In respect of competence, does your organization complete the
following: |
|
|
|
||
a) Determine
the necessary competence of persons doing work that affects the performance
and effectiveness of your IMS? |
|
|
|
||
b) Ensure
that these persons are competent ((including the ability to identify hazards)
based on appropriate education, training or experience? |
|
|
|
||
c) Determine
training needs associated with your organization’s IMS? |
|
|
|
||
d) Where
applicable, take actions to acquire the necessary competence and evaluate the
effectiveness of the actions taken. |
|
|
|
||
e) Retain
appropriate records as evidence of competence? |
|
|
|
||
7.3 Awareness |
|
|
|||
Does your organization ensure that persons doing work under your
organization’s control are aware of the following: |
|
|
|||
a) The Quality & Environmental policy? |
|
|
|||
b) The significant environmental aspects
and related actual or potential environmental impacts associated with their
work? |
|
|
|||
c) Relevant Quality & Environment &
OHS objectives? |
|
|
|||
d) Their contribution to the effectiveness
of your IMS, including the benefits of improved performance? |
|
|
|||
e) The implications of not conforming to the
requirements of the IMS? |
|
|
|||
f) the ability to remove themselves from
work situations that they consider presenting an imminent and serious danger
to their life or health, as well as the arrangements for protecting them from
undue consequences for doing so? |
|
|
|||
7.4 Communication |
|
|
|||
Does your organization determine the internal and external
communications relevant to your IMS, including the following: |
|
|
|||
a) On what it will communicate? |
|
|
|||
b) When to communicate? |
|
|
|||
c) With whom to communicate? |
|
|
|||
d) How to communicate? |
|
|
|||
7.4.2 Internal Communications |
|
|
|||
Does your organization: |
|
|
|||
a) Internally communicate information
relevant to your IMS among the various levels and functions of your organization,
including changes to the IMS. |
|
|
|||
b) Ensure its communication processes
enables persons doing work under your organization’s control to contribute to
continual improvement. |
|
|
|||
7.4.3 External Communication |
|
|
|||
Does your organization externally
communicate information relevant to your IMS, as established by your organization’s
communication processes and as required by its compliance obligations? |
|
|
|||
7.5 Documented Information |
|
|
|||
7.5.1 General |
|
|
|||
Does your organization’s
IMS include: |
|
|
|||
a) The Documentation required by QMS, EMS
& OHSMS? |
|
|
|||
b) The Documentation determined by your
organization as being necessary for the effectiveness of your IMS? |
|
|
|||
7.5.2 Creating and Updating |
|
|
|||
When creating and updating documentation, does your organization
ensure appropriately: |
|
|
|||
a) Identified and described? |
|
|
|||
b) Formatted? |
|
|
|||
c) Reviewed and approved for suitability
and adequacy? |
|
|
|||
7.5.3 Control of Documented Information |
|
|
|||
Is documented information required by QMS & EMS controlled to
ensure: |
|
|
|||
a) That it is available and suitable for
use, where and when it is needed? |
|
|
|||
b) That it is adequately protected? |
|
|
|||
In respect of documentation, does your organization address and
control the following practices: |
|
|
|||
a) Distribution, access, retrieval and use? |
|
|
|||
b) Storage and preservation, including
preservation of legibility? |
|
|
|||
c) Control of changes? |
|
|
|||
d) Retention and disposition? |
|
|
|||
Do you have methods in place to ensure that documentation of external
origin determined by your organization necessary for the planning operation
of your IMS is identified as appropriate, and is controlled? |
|
|
|||
Does your organization retain documentation as evidence of conformity
and is it protected from unintended alterations? |
|
|
|||
8
Operation
|
|
|
|||
8.1 Operational Planning and Control
|
|
|
|||
8.1.1 General |
|
|
|||
Does your organization plan, implement and control the processes
needed to meet the requirements for the provision of products and services,
and to implement the actions determined when planning and completing the
following: |
|
|
|||
a) Determining the IMS requirements for the
products and services? |
|
|
|||
b) Establishing criteria for the processes
and the acceptance or products and services? |
|
|
|||
c) Determining the resources needed to
achieve product and service conformity? |
|
|
|||
d) Implementing control of the processes following
the criteria? |
|
|
|||
e) Determining and keeping documentation to
the extent necessary to give confidence that processes have been completed as
planned and to demonstrate products and services? |
|
|
|||
Is the output of operational planning suitable for your organization’s
operations? |
|
|
|||
Does your organization control planned changes and review the
consequences of unintended changes and when required take action to mitigate
any adverse effects? |
|
|
|||
Does your organization ensure that the outsourced processes are
controlled? |
|
|
|||
How does your organization coordinate the relevant parts of the IMS
management system with other organizations in multi-employer situations? |
|
|
|||
8.1.2 Eliminating Hazards and Reducing OH&S Risks |
|
|
|||
Has the organization established, implemented, and maintained
processes for the elimination of hazards and reduction of OH&S risks
using the following hierarchy of controls: |
|
|
|||
a) Eliminate the hazard? |
|
|
|||
b) Substitute with the less hazardous process, operations, materials
or equipment? |
|
|
|||
c) use engineering controls and reorganization of work? |
|
|
|||
d) Use administration controls, including training? |
|
|
|||
e) Use adequate personal protective equipment? |
|
|
|||
8.1.3 Management of Change |
|
|
|||
Has the organization established processes for the implementation and
control of planned temporary and permanent changes that impact performance
including: |
|
|
|
||
a) new products, services, and processes, or changes to existing
products, services, and processes, including: ·
Workplace locations and surroundings? ·
Working organization? ·
Working conditions? ·
Equipment? ·
Workforce? |
|
|
|
||
b) Changes to legal requirements and other requirements? |
|
|
|
||
c) Changes to knowledge or information about hazards and OH&S
risks? |
|
|
|
||
d) Developments in Knowledge and technology? |
|
|
|
||
Does the organization review the consequences of unintended changes,
taking action to mitigate any adverse effects, as necessary? |
|
|
|
||
8.1.4 Procurement |
|
|
|
||
Has the organization established, implemented, and maintained
processes to control the procurement of products and services to ensure their
conformity to its IMS management system? |
|
|
|
||
Does the organization coordinate its procurement processes with its
contractors, to identify hazards and assess and control the OH&S risks
arising from: |
|
|
|
||
a) The contractors’ activities and operations that impact the organization?
|
|
|
|
||
b) The organization’s activities and operations that impact the
contractor’s workers? |
|
|
|
||
c) The contractors’ activities and operations that impact other
interested parties in the workplace? |
|
|
|
||
How does the organization ensure that the requirements of its Quality
Environment & OH&S management system are met by contractors and their
workers? |
|
|
|
||
Does the organization`s procurement processes define and apply
occupational health and safety criteria for the selection of contractors? |
|
|
|
||
How does the organization ensure outsourced functions and processes
are controlled? |
|
|
|
||
Does the organization ensure that its outsourcing arrangements are
consistent with legal requirements and other requirements and with achieving
the intended outcomes of the Integrated management system? |
|
|
|
||
8.2 Requirements for Products and Services |
|
|
|
||
8.2.1 Customer Communication |
|
|
|
||
Do you have suitable processes in place to communicate with customers
in respect of the following: |
|
|
|
||
a) Provision of information relating to
products and services? |
|
|
|
||
b) Handling of inquiries, contracts, or
orders, including changes? |
|
|
|
||
c) Obtaining customer feedback relating to
products and services, including customer complaints? |
|
|
|
||
d) Handling or controlling customer
property? |
|
|
|
||
e) Establishing specific requirements for
contingency actions, when relevant? |
|
|
|
||
8.2.2 Determining the requirements related
to products and services |
|
|
|
||
When selecting the products and services to be offered to customers,
do you ensure that: |
|
|
|
||
a) Requirements for the products and
services are defined, including those considered necessary by your organization
and any applicable statutory and regulatory requirements. |
|
|
|
||
b) Your organisation can meet the claims
for the products and services it offers? |
|
|
|
||
8.2.3 Review of requirements related to
products and services |
|
|
|
||
Does your organization ensure that it can meet the requirements for
products and services that are offered to customers? |
|
|
|
||
Does your organization
conduct a review before committing to supply products and services to
customers that include: |
|
|
|
||
a)
Requirements specified by the customer, including the requirements for
delivery and post-delivery activities? |
|
|
|
||
b)
Requirements not stated by the customer, but necessary for the specified or
intended use, when known? |
|
|
|
||
c) Requirements specified by the organization? |
|
|
|
||
d) Statutory and regulatory requirements
applicable to the products and services? |
|
|
|
||
e) Contract or order requirements differing
from those previously expressed? |
|
|
|
||
Does your organization ensure that contract or order requirements that
differ from those previously defined, are resolved? |
|
|
|
||
Are your customer requirements confirmed by your organization before
acceptance, when the customer does not provide a documented statement of
their requirements? |
|
|
|
||
Does your organization retain documented information on: |
|
|
|
||
a) The results of the review? |
|
|
|
||
b) Any new requirements for the products
and services? |
|
|
|
||
8.2.4 Changes to Requirements for Products
and Services |
|
|
|
||
Does your organization ensure that relevant documented information is
amended and that relevant persons are made aware of the changed requirements
when the requirements for products and services are changed? |
|
|
|
||
8.3 Design and Development of Products and
Services |
|
|
|
||
8.3.1 General |
|
|
|
||
Does your organization establish, implement and maintain a design and
development process that is appropriate to ensure the subsequent provision of
products and services? |
|
|
|
||
8.3.2 Design and Development Planning |
|
|
|
||
In determining the stages and controls for design and development,
does your organization consider: |
|
|
|
||
a) The nature, duration, and complexity of the design and development
activities? |
|
|
|
||
b) The required process stages, including
applicable design and development reviews? |
|
|
|
||
c) The required design and development verification and validation
activities? |
|
|
|
||
d) The responsibilities and authorities involved in the design and
development process? |
|
|
|
||
e) The internal and external resource needs for the design and
development of products and services? |
|
|
|
||
f) The need to control interfaces between persons involved in the
design and development process? |
|
|
|
||
g) The need for involvement of customers and users in the design
development process? |
|
|
|
||
h) The requirements for the subsequent provision of products and
services? |
|
|
|
||
i) The level of control expected for the design and development
process by customers and other relevant interested parties? |
|
|
|
||
j) The documented information needed to demonstrate that design and
development requirements have been met? |
|
|
|
||
8.3.3 Design and Development Inputs |
|
|
|
||
Does your organization determine the requirements essential for the
specific types of products and services to be designed and developed? |
|
|
|
||
Does your organization consider: |
|
|
|
||
a) Functional and performance requirements? |
|
|
|
||
b) Information derived from previous similar design and development
activities? |
|
|
|
||
c) Statutory and regulatory requirements? |
|
|
|
||
d) Standards or codes of practice that the
organization has committed to implementing? |
|
|
|
||
e) Potential consequences
of failure due to the nature of the products and services? |
|
|
|
||
Are your organisation’s inputs adequate for design and development
purposes and are they complete and unambiguous? |
|
|
|
||
Does your organization resolve your conflicting design and development
issues? |
|
|
|
||
Does your organization retain documented information on design and
development inputs? |
|
|
|
||
8.3.4 Design and Development Controls |
|
|
|
||
Does your organization apply controls to
the design and development process to ensure that: |
|
|
|
||
a) The results to be achieved are defined? |
|
|
|
||
b) Reviews
are conducted to evaluate the ability of the results of design and
development to meet requirements. |
|
|
|
||
c) Verification activities are conducted to
ensure that the design and development outputs meet the input requirements? |
|
|
|
||
d) Validation
activities are conducted to ensure the resulting products and services meet
the requirements for the specified application or intended use. |
|
|
|
||
e) Any necessary actions taken on problems
determined during the reviews, or verification and validation activities? |
|
|
|
||
f) Documented information on these activities is retained? |
|
|
|
||
8.3.5 Design and Development Outputs |
|
|
|
||
Does your organization ensure that design and development outputs: |
|
|
|
||
a) Meet the input requirements? |
|
|
|
||
b) Are adequate for the
subsequent processes for the provision of products and services? |
|
|
|
||
c) Include or reference monitoring and measuring requirements, as
appropriate and acceptance criteria? |
|
|
|
||
d) Specify the characteristics of the products and services that are
essential for their intended purpose and their safe and proper provision? |
|
|
|
||
Does your organization retain documented information on design and
development outputs? |
|
|
|
||
8.3.6 Design and Development Changes |
|
|
|
||
Does your organization identify, review and control changes made
during, or after, the design and development of products and services, to the
extent necessary to ensure that there is no adverse impact on the conformity
to requirements? |
|
|
|
||
Does your organization retain documented information on: |
|
|
|
||
a) Design and development changes? |
|
|
|
||
b) The results of reviews? |
|
|
|
||
c) The authorization of the changes? |
|
|
|
||
d) The actions are taken to prevent adverse impacts? |
|
|
|
||
8.4 Control of Externally Provided
Processes, Products & Services |
|
|
|
||
8.4.1 General |
|
|
|
||
Does your organization ensure that externally provided processes,
products and services conform to requirements? |
|
|
|
||
Does your organization determine the controls to be applied to
externally provided processes, products and services when: |
|
|
|
||
a) Products and services from external providers intended for
incorporation into your organization’s products and services? |
|
|
|
||
b) Products and services are provided directly to the customer by
external providers on behalf of your organization? |
|
|
|
||
c) A process, or part of a process, is provided by an external
provider as a result of a decision by your organization? |
|
|
|
||
Does your organization determine and apply criteria for the
evaluation, selection, monitoring of performance, and re-evaluation of
external providers, based on their ability to provide processes or products
and services following requirements? |
|
|
|
||
Does your organization retain documented information on these
activities and any necessary actions arising from the evaluations? |
|
|
|
||
8.4.2 Type and Extent of Control |
|
|
|
||
Does your organization ensure that externally provided processes,
products, and services do not adversely affect the organization’s ability to
consistently deliver conforming products and services to its customers? |
|
|
|
||
Does your organization: |
|
|
|
||
a) Ensure that externally
provided processes remain within the control of your QEMS? |
|
|
|
||
b) Define both the controls that it intends to apply to an external
provider and those it intends to apply to the resulting output? |
|
|
|
||
c) Take into consideration: |
|
|
|
||
1) The potential impact of the externally
provided processes, products, and services on your organization’s ability to
consistently meet customer and applicable statutory and regulatory
requirements? |
|
|
|
||
2) The effectiveness of the controls
applied by the external provider? |
|
|
|
||
d) Determine the verification, or other activities, necessary to
ensure that the externally provided processes, products, and services meet
requirements? |
|
|
|
||
8.4.3 Information for external providers |
|
|
|
||
Does your organization ensure the adequacy of requirements before
their communication to the external provider? |
|
|
|
||
Does your organization communicate to external providers its
requirements for: |
|
|
|
||
a) The processes, products, and services to
be provided? |
|
|
|
||
b) The approval of: |
|
|
|
||
1) Products and services? |
|
|
|
||
2) Methods, processes, and equipment? |
|
|
|
||
3) The release of products and services? |
|
|
|
||
c) Competence, including any required
qualification of persons? |
|
|
|
||
d) The external providers’ interactions
with your organization? |
|
|
|
||
e) Control
and monitoring of the external providers’ performance to be applied by the
organization? |
|
|
|
||
f)
Verification or validation activities that the organization, opt its
customers, intends to perform at the external providers’ premises? |
|
|
|
||
8.5 Production and Service Provision |
|
|
|
||
8.5.1 Control of Production and Service
Provision |
|
|
|
||
Does your organization implement production and service provision
under controlled conditions? |
|
|
|
||
Does your organization’s controlled conditions include: |
|
|
|
||
a) The availability of documented
information that defines: |
|
|
|
||
1) The
characteristics of the products to be produced, the services to be provided,
or the activities to be performed? |
|
|
|
||
2) The results are to be
achieved? |
|
|
|
||
b) The availability and use of suitable
monitoring and measuring resources? |
|
|
|
||
c) The
implementation of monitoring and measurement activities at appropriate stages
to verify that criteria for control of processes or outputs, and acceptance
criteria for products and services, have been met? |
|
|
|
||
d) The use of suitable infrastructure and environment for the
operation of processes? |
|
|
|
||
e) The
appointment of competent persons, including any required qualification? |
|
|
|
||
f) The
validation, and periodic revalidation, of the ability to achieve planned
results of the processes for production and service provision, where the
resulting output cannot be verified by subsequent monitoring or measurements? |
|
|
|
||
g) The
implementation of actions to prevent human error? |
|
|
|
||
h) The
implementation of release, delivery, and post-delivery activities? |
|
|
|
||
8.5.2 Identification and traceability |
|
|
|
||
Does your organization use suitable means to identify outputs when it
is necessary to ensure the conformity of products and services? |
|
|
|
||
Does your organization identify the status of outputs concerning
monitoring and measurement requirements throughout production and service
provision? |
|
|
|
||
Does your organization control the unique identification of the
outputs when traceability is a requirement and does your organisation retain
the documented information necessary to enable traceability? |
|
|
|
||
8.5.3 Property Belonging to Customers or
External Providers |
|
|
|
||
Does your organization exercise care with property belonging to
customers or external providers while it is under your organization’s control
or being used by your organization? |
|
|
|
||
Does your organization identify, verify, protect, and safeguard
customers’ or external providers’ property provided for use or incorporated
into the products or services? |
|
|
|
||
When the property of a customer or external provider is lost, damaged,
or otherwise found to be unsuitable for use, does your organization report
this to your customer or external provider and retain documented information
on what has occurred? |
|
|
|
||
8.5.4 Preservation |
|
|
|
||
Does your organization preserve the outputs during production and
service provision, to the extent necessary to ensure conformity to
requirements? |
|
|
|
||
8.5.5 Post-Delivery Activities |
|
|
|
||
Does your organization meet requirements for post-delivery activities
associated with the products and services? |
|
|
|
||
In determining the extent of post-delivery activities that are
required, do you 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? |
|
|
|
||
8.5.6 Control of Changes |
|
|
|
||
Does your organization review and control changes for production or
service provision, to the extent necessary to ensure continuing conformity
with requirements? |
|
|
|
||
8.6 Release of Products and Services |
|
|
|
||
Does your organization implement planned arrangements, at appropriate
stages to verify that the product and service requirements have been met? |
|
|
|
||
Does your organization make sure the release of products and services
to the customer does not proceed until the planned arrangements have been
satisfactorily completed, unless otherwise approved by a relevant authority
and, as applicable, by the customer? |
|
|
|
||
Does your organization retain documented information on the release of
products and services? |
|
|
|
||
Does your organization's documented
information include: |
|
|
|
||
a) Evidence
of conformity with the acceptance criteria? |
|
|
|
||
b) Traceability
to the person(s) authorising the release? |
|
|
|
||
8.7 Control of Non-Conforming Outputs |
|
|
|
||
8.7.1 Does your organization ensure that outputs that do not conform to
their requirements are identified and controlled to prevent their unintended
use or delivery? |
|
|
|
||
Does your organization take appropriate action based on the nature of
the nonconformity and its effect on the conformity of products and services?
Does this also apply to nonconforming products and services detected after
delivery of products, during or after the provision of services? |
|
|
|
||
Does your organization deal with nonconforming outputs in one or more
of the following ways: |
|
|
|
||
a) Correction? |
|
|
|
||
b) Segregation, containment, return, or
suspension of the provision of products and services? |
|
|
|
||
c) Informing the customer? |
|
|
|
||
d) Obtaining authorization? |
|
|
|
||
Does your organization
ensure conformity to the requirements is verified when nonconforming outputs
are corrected? |
|
|
|
||
8.7.2 Does your organization retain documented
information that: |
|
|
|
||
a) Describes the nonconformity? |
|
|
|
||
b) Describes the actions taken? |
|
|
|
||
c) Describes any concessions obtained. |
|
|
|
||
d) Identifies the authority deciding the
action in respect of the nonconformity? |
|
|
|
||
8.8 Emergency Preparedness and Response |
|
|
|
||
Have you established, implemented, and
maintained a procedure(s): a) To identify the potential for emergencies? b) To respond to such emergency systems? |
|
|
|
||
Does your organization respond to actual
emergencies and prevent or mitigate adverse associated Quality, Environmental
impact & QHS consequences? |
|
|
|
||
When you are planning your emergency
response, do you take account of the needs of the relevant interested
parties, e.g. emergency services and neighbors? |
|
|
|
||
Do you periodically test your procedure(s)
to respond to emergencies and where practicable, do you involve relevant
interested parties as appropriate? |
|
|
|
||
Do you review and where necessary, revise
your emergency preparedness and response procedure(s), in particular, after
periodical testing and after the occurrence of emergencies? |
|
|
|
||
Has the organization maintained documented
information on the process and on the plans for responding to potential
emergencies? |
|
|
|
||
9
Performance Evaluation
|
|
|
|
||
9.1 Monitoring, Measurement, Analysis, and
Evaluation
|
|
|
|
||
9.1.1 General |
|
|
|
||
Does your organization
determine: |
|
|
|
||
a)
What needs to be monitored and measured? |
|
|
|
||
b)
The methods for monitoring, measurement, analysis and evaluation are needed
to ensure valid results? |
|
|
|
||
c)
When the monitoring and measuring shall be performed? |
|
|
|
||
d)
When the results from monitoring and measurement are analyzed and
evaluated? |
|
|
|
||
Does your organization evaluate the performance and effectiveness of
your IMS? |
|
|
|
||
Does your organization retain appropriate documented information as evidence
of the results? |
|
|
|
||
9.1.2 Customer Satisfaction |
|
|
|
||
Does your organization monitor customers’ perceptions of the degree to
which their needs and expectations have been fulfilled? |
|
|
|
||
Does your organization determine the methods for obtaining, monitoring,
and reviewing this information? |
|
|
|
||
9.1.3 Analysis and Evaluation |
|
|
|
||
Does your organization analyze and evaluate appropriate data and
information arising from monitoring and measurement? |
|
|
|
||
Are the results of your
analysis used to evaluate: |
|
|
|
||
a) Conformity of products and services? |
|
|
|
||
b) The degree of customer satisfaction? |
|
|
|
||
c) The performance and effectiveness of
your IMS? |
|
|
|
||
d) If planning had been implemented
effectively? |
|
|
|
||
e) The effectiveness of actions taken to
address risks and opportunities? |
|
|
|
||
f) The performance of external providers? |
|
|
|
||
g) The need for improvements to your IMS? |
|
|
|
||
9.1.2 Evaluation of Compliance |
|
|
|
||
Does your organization establish, implement and maintain the processes
needed to evaluate the fulfillment of its compliance obligations & Legal
& other requirements? |
|
|
|
||
Does your organization: |
|
|
|
||
a) Determine the frequency that compliance will be evaluated? |
|
|
|
||
b) Evaluate compliance and take action if needed? |
|
|
|
||
c) Maintain knowledge and understanding of its compliance status? |
|
|
|
||
Does your organization retain documented
information as evidence of the compliance evaluation results? |
|
|
|
||
9.2 Internal Audit |
|
|
|
||
9.2.1 Does your organization conduct internal audits at planned intervals to
provide information on whether your IMS: |
|
|
|
||
a) conforms to: |
|
|
|
||
1) Your organization’s requirements for
your IMS? |
|
|
|
||
2) The requirements of the standard? |
|
|
|
||
B) is effectively implemented and
maintained? |
|
|
|
||
9.2.2 Internal Audit Programme |
|
|
|
||
Does your organization: |
|
|
|
||
a) Plan,
establish, implement and maintain an audit program including the frequency,
methods, responsibilities, planning requirements, and reporting, which take
into consideration the importance of the processes concerned, changes
affecting the organization, and the results of previous audits. |
|
|
|
||
b) Define the audit
criteria and scope for each audit? |
|
|
|
||
c) Select
auditors and conduct an audit to ensure objectivity and impartiality of the
audit process? |
|
|
|
||
d) Ensure
that the results of the audits are reported to relevant management? |
|
|
|
||
e) Take
appropriate correction and corrective actions without undue delay? |
|
|
|
||
f) Retain
documented information as evidence of the implementation of the audit program
and the audit results? |
|
|
|
||
9.3 Management review |
|
|
|||
9.3.1 General |
|
|
|||
Do top management review your organization’s IMS, at planned
intervals, to ensure its continuing suitability, adequacy, effectiveness, and
alignment with the strategic direction of the organization? |
|
|
|||
9.3.2 Management Review Inputs |
|
|
|||
Is the management review planned and carried out taking into
consideration: |
|
|
|||
a) The status of actions from previous
management reviews? |
|
|
|||
b) Changes in external and internal issues
that are relevant to your IMS? |
|
|
|||
c) Changes in the needs and expectations of
interested parties, including compliance obligations? |
|
|
|||
d) Changes in its significant environmental
aspects? |
|
|
|||
e) Changes in the risks and opportunities |
|
|
|||
f) Information on the performance and effectiveness
of your IMS, including trends in: |
|
|
|||
1) Customer satisfaction and feedback from
relevant interested parties? |
|
|
|||
2) The extent to which Quality &
Environmental objectives have been met? |
|
|
|||
3) Process performance and conformity of
products and services? |
|
|
|||
4) Nonconformities and corrective actions? |
|
|
|||
5) Monitoring and measurement results? |
|
|
|||
6) Audit results? |
|
|
|||
7) The performance of external providers? |
|
|
|||
g)
The adequacy of resources? |
|
|
|||
h)
The effectiveness of actions taken to address risks and opportunities? |
|
|
|||
i)
Opportunities for improvement? |
|
|
|||
9.3.3 Management Review Outputs |
|
|
|||
Do the outputs of your management review include decisions and actions
related to: |
|
|
|||
a) Conclusions on the continuing suitability, adequacy, and
effectiveness of your EMS? |
|
|
|||
b) Decisions related to continual improvement opportunities? |
|
|
|||
c) Decisions related to any need for changes to your EMS, including
resources? |
|
|
|||
d) Actions, if needed, when environmental objectives have not been
achieved? |
|
|
|||
e) Opportunities to improve integration of your EMS with other business
processes if needed? |
|
|
|||
f) Any implications for the strategic direction of the organization |
|
|
|||
Does your organization retain documented information as evidence of
the results of your management reviews? |
|
|
|||
10
Improvement
|
|
|
|
||
10.1 General |
|
|
|
||
Does your organization determine and select opportunities for
improvement and implement any necessary actions to meet customer requirements
and enhance customer satisfaction? |
|
|
|
||
Do these include: |
|
|
|
||
a) Improving
products and services to meet requirements as well as to address future needs
and expectations? |
|
|
|
||
b) Correcting, preventing, or reducing undesired effects? |
|
|
|
||
c) Improving the performance and effectiveness of your IMS? |
|
|
|
||
10.2 Incident, Non-Conformity, and
Corrective Action |
|
|
|||
10.2.1 When a nonconformity occurs, including any
arising from complaints, does your organization: |
|
|
|||
a) React to the nonconformity and, as
applicable: |
|
|
|||
1) Take action to control and correct it? |
|
|
|||
2) Deal with the consequences |
|
|
|||
b) Evaluate
the need for action to eliminate the cause of the nonconformity, so that it
does not recur or occur elsewhere, by: |
|
|
|||
1) Investigate the incident by reviewing
and analyzing the nonconformity? |
|
|
|||
2) Determining the causes of the incident
& or nonconformity? |
|
|
|||
3) Determining if a similar incident
occurs, nonconformities exist, or could potentially occur. |
|
|
|||
c) Implement any action needed? |
|
|
|||
d) Review the effectiveness of any
corrective action taken? |
|
|
|||
e) Assess OH&S risks &
opportunities and that relate to new or changed hazards, before taking action.
if necessary? |
|
|
|||
f) Make changes to the Quality, Environment
& Occupational Health & Safety management system, if necessary? |
|
|
|||
Do you ensure corrective actions are appropriate to the effects of the
nonconformities encountered? |
|
|
|||
Does your organization retain documented information evidence of: |
|
|
|||
a) The nature of the incidents or nonconformities and any subsequent
actions that were taken? |
|
|
|||
b) The results of any action and corrective action including their
effectiveness? |
|
|
|||
How is this information communicated to relevant workers, and, where
applicable, workers' representatives, and other interested parties? |
|
|
|||
10.3 Continual Improvement |
|
|
|
||
Does your organization continually improve the suitability, adequacy,
and effectiveness of your IMS? |
|
|
|
||
Does your organization consider the results of your analysis and
evaluation, and the outputs from management review, to determine if some
needs or opportunities are addressed as part of continual improvement? |
|
|
|
0 Comments