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SMALL BUSINESS

QMS Self Appraisal ISO 9001:2015


Please complete and return with the signed proposal documents

This questionnaire is designed to help you Guidance Note


judge whether your Quality Management The following questionnaire should be completed in all sections by answering
System (QMS) is ready for assessment by Yes, No or Not Applicable in the appropriate column.
LRQA.
Not Applicable should only be recorded if you do not undertake the process
If you are unsure about any of the described as part of your operational processes. This only applies to section 8.
questions, please do not hesitate to
contact us. Please explain any NO answers in the space given at the end of this
questionnaire. Where there is a specific reference in your system that addresses
Small Business Advisors: this requirement in your quality management system, please record this.
0800 783 2179
A reference MUST be recorded where the ISO 9001:2015 standard indicates a
need for a documented procedure.

This document is numbered in accordance with the ISO 9001:2015 standard.

4 Context of the organisation


4.1 Understanding the organisation and its context

Question: Yes/No: Reference/Link:


Do you know how your organisation determines external and internal issues that are
relevant to its purpose and strategic direction?
Does your organisation determine the external and internal issues that could affect its ability
to achieve the results that your QMS is trying to achieve?
Does your organisation monitor and review information about these external and internal
issues?

4.2 Understanding the needs and expectations of interested parties

Question: Yes/No: Reference/Link:


Can you list the interested parties that are relevant to your organisation’s quality
management system?
Have the requirements of these interested parties been determined and defined?
Is information relating to your organisation’s interested parties and their relevant
requirements monitored and reviewed?

Improving performance,
reducing risk
4.3 Determining the scope of the quality management system

Question: Yes/No: Reference/Link:

When determining the scope of your QMS, were the following issues considered:

a) The boundaries and applicability of the quality management system?

b) The relevant external and internal issues?

c) The relevant requirements of interested parties?

d) The products and services provided?


Is the scope of your management system documented and available throughout the
organisation?
Does your scope clearly state the following:

a) The types of products and services provided?


b) Any requirement of ISO 9001:2015 that your organisation determines is not
applicable to the scope of your QMS?

4.4 Quality management system and its processes

Question: Yes/No: Reference/Link:


Does your organisation’s QMS fully establish, implement, maintain and improved on a
continual basis?
Has your organisation identified the processes required in your QMS?

Have the following requirements for the processes within your QMS been determined:

a) The required inputs and outputs?

b) Their sequence and interaction?


c) The criteria and methods needed to ensure the effective operation and control of
these processes?
d) The resources needed for these processes?

e) Responsibilities and authorities for these processes?

f) The relevant risks and opportunities?

Are the processes measured or monitored and evaluated?


When required are process changes implemented to ensure that they achieve their intended
results?
Does your organisation seek opportunities to improve its processes?
Where required, does your organisation provide documentation to support the operation of
its processes?
Does your organisation retain documentation to give and prove that the processes are being
carried out as planned?
5. Leadership

5.1 Leadership and commitment

Question: Yes/No: Reference/Link:


5.1.1 General

In relation to your QMS, can top management clearly demonstrate their leadership and
commitment with respect to the following:
a) Accountability for the effectiveness of your QMS?
b) Ensuring that your quality policy and objectives are established for your QMS and are
compatible with the context and strategic direction of the organisation?
c) Ensuring the quality policy is communicated, understood and applied?
d) Ensuring the QMS requirements are integrated into the organisation’s business
processes?
e) Promoting the use of the process approach and risk-based thinking?

f) Ensuring that the sufficient resources are provided for the application of your QMS?
g) Communicating the importance of effective quality management and of conforming
to the requirements of your QMS?
h) Ensuring that your QMS achieves its intended results and targets?
i) Engaging, directing and supporting persons to contribute to the effectiveness of your
QMS?
j) Promoting continual improvement?
k) Supporting other relevant management to enable them to demonstrate their
leadership in their areas of responsibility?
5.1.2 Customer focus

Can top management demonstrate their leadership and commitment with respect to
customer focus by ensuring that the following aspects are completed:
a) Customer and applicable statutory and regulatory requirements are determined,
understood and consistently met?
b) Risks and opportunities that can affect conformity of products and services and the
ability to enhance customer satisfaction are determined and addressed?
c) That products and services provided consistently meet the requirements of customers
and applicable statutory and regulatory requirements?
d) The focus on enhancing customer satisfaction is maintained?

5.2 Policy

Question: Yes/No: Reference/Link:


5.2.1 Developing the quality policy

Have your top management established, implemented and maintained a quality policy that:
a) Reflects the purpose and context of your organisation and supports its strategic
direction?
b) Provides the basis for setting quality objectives to support the achievement of the
quality policy?
c) Gives a clear commitment to satisfy applicable requirements?

d) Gives a clear commitment to continual improvement of your QMS?


5.2.2 Communicating the quality policy

Is the quality policy:


a) Documented and maintained?

b) Communicated, understood and applied within the organisation?

c) Available to relevant interested parties?

5.3 Organisational roles, responsibilities and authorities

Question: Yes/No: Reference/Link:


Have top management ensured that the responsibilities and authorities for relevant roles
have been assigned, communicated and understood with the organisation?
Have top management assigned the responsibility and authority for the following:

a) That the QMS conforms to the requirements of ISO 9001:2015?

b) That the processes are delivering their required outputs?


c) Reporting to top management and other interested parties on the performance of
your QMS, improvement opportunities and need for change?
d) Promoting customer focus throughout the organisation?
e) That the integrity of your QMS is maintained when changes to your QMS are planned
and implemented?

6. Planning

6.1 Actions to address risks and opportunities

Question: Yes/No: Reference/Link:

When planning for your QMS, has your organisation 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?


When the QMS was planned, did your organisation determine the risks and opportunities
that needed to be addressed to achieve the following:
a) To give assurance that your QMS can achieve its intended result?

b) To prevent, or reduce, undesired effects?

c) To achieve continual improvement?


6.1.2

Does your organisation plan, implement and evaluate actions to deal with relevant risks and
opportunities?
Are the actions taken to address risks and opportunities determined and prioritised based
upon their potential impact on product and service conformity?
6.2 Quality objectives and planning to achieve them

Question: Yes/No: Reference/Link:


Has your organisation established quality objectives at relevant functions, levels and
processes within your QMS?
Are your quality objectives:

a) Consistent with the requirements of your quality policy?

b) Measurable?

c) Address applicable requirements within your QMS?


d) Relevant to conformity of your products and services and the enhancement of
customer satisfaction?
e) Monitored?

f) Communicated?

g) Updated when required?

Are your quality objectives documented?


Were the following factors determined when you were planning the achievement of your
quality 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?

6.3 Planning of changes

Question: Yes/No: Reference/Link:


When changes are required within your QMS, are these changes carried out in a planned
and systematic manner?
When changes are required, does your organisation consider the following:

a) The purpose of the changes and their potential consequences?

b) The integrity of your QMS?

c) The availability of resources?

d) The allocation or reallocation of responsibilities and authorities?

7. Support

7.1 Resources

Question: Yes/No: Reference/Link:


7.1.1 General

Does your organisation determine and provide the resources needed for the establishment,
implementation, maintenance and continual improvement of your QMS?
When resource planning, does your organisation 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 organisation determine and provide persons necessary for the effective
implementation of your QMS and for the operation and control of its processes?
7.1.3 Infrastructure

Does your organisation 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 organisation determine, provide and maintain the environment necessary for the
operation of its processes and the achievement of products and service conformity?
7.1.5 Monitoring and measuring resources

Does your organisation 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 organisation ensure that your resources for monitoring and measurement are
suitable and maintained?
Does your organisation 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 organisation 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 prior to use, against
measurement standards traceable to international or national measurement
standards?
b) If no such standard exists, is the basis for collaboration or verification recorded in a
documented format?
c) Identified in order 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
organisation determine the previous measurement results and take appropriate action as
necessary?
7.1.6 Organisational knowledge

Does your organisation 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?
Is current knowledge and the need for new knowledge considered when addressing
changing needs and trends within your organisation?

7.2 Competence

Question: Yes/No: Reference/Link:

In respect of competence, does your organisation complete the following:


a) Determine the necessary competence of persons doing work that affects the
performance and effectiveness of you QMS?
b) Ensure that these persons are competent on the basis of appropriate education,
training or experience?
c) Where applicable, take actions to acquire the necessary competence and evaluate the
effectiveness of the actions taken?
d) Retain appropriate records as evidence of competence?
7.3 Awareness

Question: Yes/No: Reference/Link:


Does your organisation ensure that persons doing work under your organisation’s control
are aware of the following:
a) The quality policy?

b) Relevant quality objectives?


c) Their contribution to the effectiveness of your QMS, including benefits of improved
performance?
d) The implications of not conforming the requirements of the QMS?

7.4 Communication

Question: Yes/No: Reference/Link:


Does your organisation determine the internal and external communications relevant to
your QMS, including the following:
a) On what it will communicate?

b) When to communicate?

c) With whom to communicate?

d) How to communicate?

7.5 Documented information

Question: Yes/No: Reference/Link:


7.5.1 General

Does your organisation’s QMS include:


a) The Documentation required by ISO 9001:2015?
b) The Documentation determined by your organisation as being necessary for the
effectiveness of your QMS?
7.5.2 Creating and updating

When creating and updating documentation, does your organisation 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 your QMS and by ISO 9001:2015 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 organisation 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 organisation necessary for the planning operation of your QMS is identified as
appropriate, and is controlled?
Does your organisation retain documentation as evidence of conformity and is it protected
from unintended alterations?

8 Operation

8.1 Operational planning and control

Question: Yes/No: Reference/Link:


Does your organisation 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 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 in accordance with the criteria?


e) Determining and keeping documentation to the extent necessary to give confidence
that processes have been completed out as planned and to demonstrate products
and services?
Is the output of operational planning suitable for your organisation’s operations?
Does your organisation control planned changes and review the consequences of
unintended changes and when required take action to mitigate any adverse effects?
Does your organisation ensure that the outsourced processes are controlled?

8.2 Requirements for products and services

Question: Yes/No: Reference/Link:


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 enquiries, 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 organisation 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 organisation ensure that it has the ability to meet the requirements for products
and services that are offered to customers?
Does your organisation conduct a review before committing to supply products and services
to customers that includes:
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 organisation?

d) Statutory and regulatory requirements applicable to the products and services?

e) Contract or order requirements differing from those previously expressed?


Does your organisation ensure that contract or order requirements differ from those
previously defined, are resolved?
Are your customer requirement’s confirmed by your organisation before acceptance, when
the customer does not provide documented statement of their requirements?
Does your organisation retain documented information on:

a) the results of the review?

b) any new requirements of the products and services?


8.2.4 Changes to requirements for products and services

Does your organisation 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

Question: Yes/No: Reference/Link:


8.3.1 General

Does your organisation establish, implement and maintain 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 organisation
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 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 organisation determine the requirements essential for the specific types of
products and services to be designed and developed?
Does your organisation 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 organisation has committed to implement?

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 organisation resolve your conflicting design and development issues?

Does your organisation retain documented information on design and development inputs?
8.3.4 Design and development controls

Does your organisation 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 are taken on problems determined during the reviews, or
verification and validation activities?
f) Documented information of these activities is retained?
8.3.5 Design and development outputs

Does your organisation 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 organisation retain documented information on design and development
outputs?
8.3.6 Design and development changes

Does your organisation identify, review and control changes made during, or subsequent to,
the design and development of products and services, to the extent necessary to ensure that
there are no adverse impact on the conformity to requirements?
Does your organisation retain documented information on:

a) Design and development changes?

b) The results of reviews?

c) The authorisation of the changes?

d) The actions taken to prevent adverse impacts?


8.4 Control of externally provided processes, products and services

Question: Yes/No: Reference/Link:


8.4.1 General

Does your organisation ensure that externally provided processes, products and services
conform to requirements?
Does your organisation determine the controls to be applied to externally provided
processes, products and services when:
a) Products and services from external providers are intended for incorporation into
your organisation’s own products and services?
b) Products and services are provided directly to the customer by external providers on
behalf of your organisation?
c) A process, or part of a process, is provided by an external provider as a result of a
decision by your organisation?
Does your organisation 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 in accordance with requirements?
Does your organisation retain documented information of these activities and any necessary
actions arising from the evaluations?
8.4.2 Type and extent of control

Does your organisation ensure that externally provided processes, products and services do
not adversely affect the organisation’s ability to consistently deliver conforming products
and service to its customers?
Does your organisation:

a) Ensure that externally provided processes remain within the control of your QMS?
b) Define both the controls that it intends to apply to an external provider and those it
intends to apply to resulting output?
c) Take into consideration:
1) The potential impact of the externally provided processes, products and services
on your organisation’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 organisation ensure the adequacy of requirements prior to their communication
to the external provider?
Does your organisation 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 organisation?


e) Control and monitoring of the external providers’ performance to be applied by the
organisation?
f) Verification or validation activities that the organisation, opt its customers, intends to
perform at the external providers’ premises?
8.5 Production and service provision

Question: Yes/No: Reference/Link:


8.5.1 Control of production and service provision

Does your organisation implement production and service provision under controlled
conditions?
Does your organisation’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 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 organisation use suitable means to identify outputs when it is necessary to ensure
the conformity of products and services?
Does your organisation identify the status of outputs with respect to monitoring and
measurement requirements throughout production and service provision?
Does your organisation 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 organisation exercise care with property belonging to customers or external
providers while it is under your organisation’s control or being used by your organisation?
Does your organisation 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 you organisation report this to your customer or external
provider and retain documented information on what has occurred?
8.5.4 Preservation

Does your organisation 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 organisation meet requirements for post-delivery activities associated with the
products and services?
In determining the extent of post-delivery activities that are required, does 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 organisation review and control changes for production or service provision, to
the extent necessary to ensure continuing conformity with requirements?
Does your organisation implement planned arrangements, at appropriate stages to verify
that the product and service requirements have been met?
Does your organisation make sure the release of products and services to the customer are
not proceeded until the planned arrangements have been satisfactorily completed, unless
otherwise approved by a relevant authority and, as applicable, by the customer?
Does your organisation retain documented information on the release of products and
services?
Does your organisations documented information include:

a) Evidence of conformity with the acceptance criteria?

b) Traceability to the person(s) authorising the release?

8.7 Control of nonconforming outputs

Question: Yes/No: Reference/Link:


8.7.1

Does your organisation ensure that outputs that do not conform to their requirements are
identified and controlled to prevent their unintended use or delivery?
Does your organisation 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 organisation deal with nonconforming outputs in one or more of the following
ways:
a) Correction?

b) Segregation, containment, return or suspension of provision of products and services?

c) Informing the customer?

d) Obtaining authorisation?
Does your organisation ensure conformity to the requirements are verified when
nonconforming outputs are corrected?
8.7.2

Does your organisation 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?


9 Performance evaluation

9.1 Monitoring, measurement, analysis and evaluation

Question: Yes/No: Reference/Link:


9.1.1 General

Does your organisation determine:


a) What needs to be monitored and measured?
b) The methods for monitoring, measurement, analysis and evaluation needed to ensure
valid results?
c) When the monitoring and measuring shall be performed?

d) When the results from monitoring and measurement are analysed and evaluated?

Does your organisation evaluate the performance and the effectiveness of your QMS?
Does your organisation retain appropriate documented information as evidence of the
results?
9.1.2 Customer satisfaction

Does your organisation monitor customers’ perceptions of the degree to which their needs
and expectations have been fulfilled?
Does your organisation determine the methods for obtaining, monitoring and reviewing this
information?
9.1.3 Analysis and evaluation

Does your organisation analyse 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 QMS?

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 QMS?

9.2 Internal audit

Question: Yes/No: Reference/Link:


9.2.1

Does your organisation conduct internal audits at planned intervals to provide information
on whether your QMS:
a) conforms to:

1) your organisation’s own requirements for your QMS?

2) the requirements of ISO 9001:2015?

b) is effectively implemented and maintained?


9.2.2

Does your organisation:


a) plan, establish, implement and maintain an audit programme including the
frequency, methods, responsibilities, planning requirements and reporting, which
take into consideration the importance of the processes concerned, changes affecting
the organisation and the results of previous audits?
b) Define the audit criteria and scope for each audit?
c) Select auditors and conduct audits to ensure objectivity and the 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
programme and the audit results?

9.3 Management review

Question: Yes/No: Reference/Link:


9.3.1 General

Do top management review your organisation’s QMS, at planned intervals, to ensure its
continuing suitability, adequacy, effectiveness and alignment with the strategic direction of
the organisation?
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 QMS?

c) Information on the performance and effectiveness of your QMS, including trends in:

1) Customer satisfaction and feedback from relevant interested parties?

2) The extent to which quality 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?

d) The adequacy of resources?

e) The effectiveness of actions taken to address risks and opportunities?

f) Opportunities for improvement?


9.3.3 Management review outputs

Do the outputs of your management review include decisions and actions related to:
a) Opportunities for improvement?

b) Any need for changes to your QMS?

c) Resource needs?
Does your organisation retain documented information as evidence of the results of your
management reviews?
10 Improvement

10.1 General

Question: Yes/No: Reference/Link:


Does your organisation 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 QMS?

10.2 Nonconformity and corrective action

Question: Yes/No: Reference/Link:


10.2.1

When a nonconformity occurs, including any arising from complaints, does your
organisation:
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) reviewing and analysing the nonconformity?

2) determining the causes of the nonconformity?

3) determining if similar nonconformities exist, or could potentially occur?

c) implement any action needed?

d) review the effectiveness of any corrective action taken?

e) update risks and opportunities determined during planning, if necessary?

f) make changes to the quality management system, if necessary?


Do you ensure corrective actions are appropriate to the effects of the nonconformities
encountered?
10.2.2

Does your organisation retain documented information as evidence of:


a) the nature of the nonconformities and any subsequent actions taken?

b) the results of any corrective action?

10.3 Continual improvement

Question: Yes/No: Reference/Link:


Does your organisation continually improve the suitability, adequacy and effectiveness of
your QMS?
Does your organisation consider the results of your analysis and evaluation, and the outputs
from management review, to determine if there are needs or opportunities that are
addressed as part of continual improvement?
Do you believe you are now ready for assessment? Yes or No (as applicable)

If No, please advise when you feel that you will be ready months please complete

Please advise how long your system has been issued and in use months please complete

If you are ready for assessment or believe you will be ready within the next six months, then you should complete and return this
questionnaire to us as soon as possible, either by post to ‘LRQA Small Business Advisors’ (see address at the bottom of this page)
or by e-mail to your LRQA contact or enquiries@lrqa.co.uk

Our technical staff will then review it and, if we need to clarify any points, we will contact you before we visit.

If you have any questions at all, please call our dedicated Small Business Advisors on 0800 783 2179.

Finally, please also complete the following section about your organisation:

Mr, Mrs, Ms, Dr…?

First name:

Last name:

Job title:

Organisation:

Post Code:

E-mail:

Telephone (Mobile:)

Telephone (Office):

Signature:

Date:

LRQA Sales and Marketing LRQA Training


1 Trinity Park, T 0330 414 1342 T 0330 414 1340
Bickenhill Lane, E enquiries@lrqa.co.uk E lrqatraining@lrqa.com
Birmingham,
West Midlands, B37 7ES, UK

Improving performance,
reducing risk
Care is taken to ensure that all information provided is accurate and up to date. However, LRQA accepts no responsibility for inaccuracies in, or
changes to, information. Lloyd’s Register and variants of it are trading names of Lloyd’s Register Group Limited, its subsidiaries and affiliates.
© Lloyd’s Register Quality Assurance Limited 2016. A member of the Lloyd’s Register group. Rev. April 2016
For LRQA office use only:

Office review Client Support

Technical

1) Has client confirmed their readiness for assessment? Yes or No (as applicable)

2) Have ‘No’ responses been qualified? Yes or No (as applicable)

3) Has the questionnaire been reviewed and deemed satisfactory? Yes or No (as applicable)

Client Support

Name:

Signature:

Date:

Technical

Name:

Signature:

Date:

Improving performance,
reducing risk

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