QMS & EMS AUDIT CHECKLIST

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4.Context of the organisation
4.1 Have external and internal issues been identified?

4. 2 Have the needs of and expectations of interested parties been

determined?

4.3 Has the scope of the management system been determined?

4.4 Has the organisation determined the processes needed for the quality
management system?
5. Leadership and commitment
How does top management demonstrate leadership and commitment?

5.1.2 Customer focus

Are customer and applicable statutory and regulatory requirements
determined, understood and met?
Are risks and opportunities relating to products and services and customer
satisfaction determined and addressed?

How is focus on enhanced customer satisfaction maintained?

5.2 Quality policy

Does the policy provide a framework for setting quality objectives, include a
commitment to continual improvement and satisfy applicable requirements?

How is it communicated within the business environment?

Is it available to relevant interested parties?

5.3 Organisational roles, responsibilities and authorities

How are responsibilities and authorities for relevant roles assigned,
communicated and understood within the organisation?
6 Planning
6.1 Actions to address risks and opportunities
Has the organisation determined risks and opportunities relating to its
external and internal issues and its interested parties?

Give examples

6.2 Quality Objectives and planning to achieve them

Have documented objectives been established?

Are they measurable, communicated and monitored?

Have resources, responsibilities, timescales been determined?

7. Support
7.1 Resources/people
Are resources provided for the establishment, implementation maintenance
and continual improvement of the management system
7.1.3 Infrastructure
Adequate buildings & workspace?

Adequate process equipment for the tasks in hand including hardware and
software?
Adequate support services? e.g. Transport, IT support

7.1.4 Environment
How do they manage the work environment to ensure conformity of the
product/service?
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Are social psychological and physical factors taken into account

7.1.5 Monitoring and measuring resources

Does the organisation have monitoring and measuring equipment that
requires calibration?

Are records / certificates of calibration maintained to evidence traceability?

7.1.6 Organisational Knowledge

How does the organisation ensure its organisational information is up to date
to reflect current practices?
7.2 Competence
Is there an Induction Training Programme?

Is there a competency record for all personnel?

Do they carry out a Competence assessment?

Is the Competency Matrix used?

If not, how do they measure competence?

Are appraisals undertaken?

Are external providers subjected to a competence check (references)?

7.3 Awareness
How is the quality policy communicated?

How are quality objectives communicated?

Are staff aware of the implications of not conforming to the management

system requirements?
7.4 Communication
What are the communication processes within the organisation?

7.5 Documented Information

Are documents referenced?

What format are they held in?

How are they controlled?

8. Operation
8.1 Planning and control
How is the delivery of the product or service planned?

8.2 Requirements for products and services

8.2.1 Customer communication

Is there a process for handling customer communication?

Does it include information re products and services, enquiry handling,

customer feedback, managing customer property if applicable?
Are contract amendments communicated to the customer?

8.2.2 Determination of requirements.

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How are the client requirements determined, including non-stated but
required?

Are statutory/regulatory requirements determined?

Do they review requirements to ensure the organisation can meet them?

8.2.3 Review of requirements

Does the organisation confirm it has the ability to meet its customers’
requirements and is their documentary evidence?

During this process do they consider;

 Requirements for delivery and post delivery activities.

 Requirements not stated by the customer
 Requirements specified by the organisation
 Statutory and regulatory requirements
 Any changes from those previously expressed.

8.3 Design and Development

Does the company undertake design and development on behalf of its
customer?

Is there a clear specification documented?

Is the design planned?

Inputs identified?

Outputs confirmed?

Is there a review process prior to release to customer?

Are changes recorded and approved?

Is the design verified?

Is the design validated?

8.4 Control of externally provided processes, products and

services
Is there a purchasing procedure?

Are suppliers and subcontractors evaluated prior to being used?

Are there clear criteria for selection?

Is there a list of approved suppliers/subcontractors?

Is there a re-evaluation process?

Where necessary do they specify /determine competence of personnel or

subcontractors?
Are orders placed by Purchase Order detailing specification and
requirements?

Verbally?

Upon receipt of goods or service how is compliance confirmed?

8.5.1 Control of Production & Service Provision.

Is there documented information to confirm product/service requirements?
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Is measuring equipment used?

Is the infrastructure/environment suitable?

Are personnel competent with appropriate qualifications if necessary?

Are their specific release, delivery and post-delivery activities?

8.5. Identification & Traceability

Is the product or service identified by part or project no.?

Is the status readily identified through the process?

Is it traceable through the process?

Are details traceable after passed to the customer?

8.5.3 Client Property

Does the company receive any property of the customer (including service
returns) and Intellectual property and personal data?

Are they held in a secure and safe environment?

Readily identifiable?

If customer property is lost or damaged do they advise the customer?

8.5.4 Preservation of Product

How is the product managed and safeguarded throughout the delivery
process?
8.5.5 Post-delivery activities
Is the organisation committed to providing post –delivery services e.g.
warranty, contractual obligations, maintenance services, recycling or final
disposal?
8.5.6 Control of changes
If there are changes to service provision are they documented?

8.6 Release of products/services

How is the release or of product/service managed and is there documented
information available to confirm this

8.7 Control of non conforming product

Are non conformances identified and recorded?

Is corrective action undertaken?

Is trend analysis undertaken?

Is there a quarantine area for non conforming product?

is there a concessions process for product not quite matching specification

and if applied is this documented?
9.1 Monitoring, measurement, analysis and evaluation
Has the company determined the process for performance evaluation??

Is there documented information to evidence this?

9.1.2 Customer satisfaction

How does the company evaluate customer perception?
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Is there documented information available to confirm this?

9.1.3 Analysis and evaluation

Are performance trends analysed with regards particularly to the following;

 Conformity of products and services?
 Degree of customer satisfaction?
 Performance and effectiveness of the management system
 Effective planning
 Effectiveness of actions to address risks and opportunities
 External; provider performance
 Ned for improvements

9.2 Internal audit

Does the company carry out internal audits?

Is there a planned audit programme?

Is there documented evidence available to confirm the implementation of the

audit programme and audit results?

9.3 Management review

Are management reviews held?

Are they planned?

Is the agenda followed?

Is there documented information available to evidence the results of

management reviews?
10 Improvement/non conformity/corrective
action/continual improvement
What is the complaints process and is there evidence this
leads to improvement?
What other activities are undertaken to address (continual)
improvement?

ADDITIONAL REQUIREMENTS FOR ISO 14001

Compliant COMMENTS/
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5.2 Environmental policy
Does the policy include commitments to:

1. Continual improvement?
2. Prevention of pollution?
3. Compliance

How is the Policy communicated to all persons working for

or on behalf of the Organisation?
Is the Policy available to interested parties?
6.1.2 Environmental aspects
Have significant aspects and those having legal and/or
regulatory reporting, monitoring or operational requirements
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been identified and documented?
Are the following Environmental Aspects considered in
sufficient detail?
1. Air emission?
2. Wastewater effluent?
3. Waste management?
4. Soil pollution?
5. Raw material and natural resource usage?
6. Hazardous and toxic material?
7. Impact on well-being (e.g. noise, smell, heat, landscape,
protection)?
8. Utility, energy and resource?
9. Other environmental specific issues on site such as
housekeeping, storage areas, air conditioning?
Are the following Operational Aspects considered?
1. Normal operating conditions?
2. Abnormal operating conditions/emergencies (e.g. start up
and shut down conditions, maintenance, incidents)?
3. Development of new or modified processes, products or
services?
6.1.3 Compliance obligations
Has the organisation determined its compliance obligations
related to its aspects?
Are they documented?
Are current copies of all applicable regulatory and other
requirements accessible to personnel as necessary?
Where applicable, are the following licenses, permits and
approvals available to demonstrate full legal compliance?
1. Licenses of waste collectors, including Waste Transfer
and/or Consignment Notes?
2. Air emission permits?
3. Wastewater discharge permits?
4. Permits and licenses related to dangerous goods?
5. Environmental fees, e.g. wastewater discharge fee?
6. Registration at authorities (e.g. wastewater discharge, air
emission inspection)?
8 Operational Control
Have processes been established, implemented and
maintained for operations associated with significant
environmental aspects, policy and objectives?
Is there documented information available to confirm that
these processes have been carried out as planned?
Are outsourced processes controlled or influenced and how?
Life cycle perspective;
 Are environmental requirements addressed within
the design and development process?
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 Are the environmental requirements for the
procurement of products and services determined?
 Are environmental communicated to external
providers including contractors?
 Information provided about potential significant
environmental impacts associated within
transportation, delivery, use, end of life treatment
and final disposal?
Is there documented information available to confirm that
operational processes have been carried out as planned?
8.2 Emergency Preparedness and Response
Have procedures been implemented to identify the potential
for and response to accidents and emergencies?
Are emergency plans available to ensure that Environmental
Impacts or accidents and emergency situations are .
mitigated?
Are emergency procedures tested where practicable?
Evidence?
How often are emergency procedures reviewed? Are they
reviewed after accidents or emergency situations?
Is there documented information available to confirm that
operational processes have been carried out as planned?