clause 4; Context of the organisation

Clause 4 is primarily for Senior leadership. It highlights the business goals and any variables that may affect the
business. This section helps a company to identify their stakeholders and any procedures related to policy.

How have all inputs and outputs been determined?

How have SLT applied criteria and methods, such

as monitoring, measuring and KPIs?

How have suitable resources for effective running

of the site been determined?

Can the organisation show that all staff have

clearly defined responsibilities

Have risks and opportunities been addressed?

the organisation must evaluate the processes for
effectiveness;

* has the 'Plan - Do - Check - Act' model been

integrated into the site/company procedures?

How does the organisation maintain and retain

documented information to support the processes
and prove the effectiveness of the systems?
clause 5; leadership
Clause 5 is about leadership responsibility. SLT must demonstrate leadership and commitment, establish and communicate a qu
policy, and ensure responsibilities are assigned.

Demonstrate leadership Are there enough resources available for

the effective operation of the site?

How is continual improvement being

promoted?

Customer focus How have all customer requirements been

met?

Show how all risks and opportunities have

met/been identified?

How is statisfaction maintained/ analysed?

Policy Does the organisation have a company
policy in place?

How is the policy communicated to all

staff?

Roles and responsibilities Have top management ensured that roles

and responsibilities have been assigned?

How are they being reported to on the

performance of the QMS?
 This key is for guidance; there may be some clauses that are the
responsibility of both site and SLT.
clause 6; planning
ment, establish and communicate a quality Clause 6 is planning for the quality management system. What needs to be in place for the effect
organisational risks, opportunities, changes that may affect the system and organisation objective

Addressing risks and opportunities How have risks and opportunities been
addressed?

Planning of changes Have objectives been established?

Are they consistent, measurable, monitored,

communicated and documented etc?
Have we determined how to achieve the
objectives?

How does the organisation consider;

 site responsibility

senior management (SLT) responsibility

combination of site and SLT responsibility

clause 7; Support
o be in place for the effective operation of the system. This section should identify Clause 7 is mainly a combination of SLT an
and organisation objectives. to have an effective QMS.

Do they meet the needs and expectations of Resources

interested parties?

Do they identify the internal and external

issues that may affect the management
systems?

Monitoring and measuring

resources
* What is the objective,

* what is needed to achieve the objective,

* who will do it,

* when and how?

* the purpose of changes, Knowledge

* effect on the integrity of the QMS,

* resources,
* responsibilities Competence

Awareness
Communication

Documented information
rt
nly a combination of SLT and site management, working together to identify what documentaion and resources are needed
tive QMS.

How do you demonstrate that there are

there enough resources to meet the needs
of the site?

Can you demonstrate that there are

enough staff to fulfill the needs of the
site?

is the infrastructure satisfactory to meet

business and staff needs?

is the environment suitable for the staff

and able to fulfill business needs to a
level where quality isn't affected?

are monitoring and measuring resources

effective?
How are they maintained?

is documentation of maintenance kept?

are measurements traceable and verifiable

through calibration?

is there a procedure for verification if

faulty equipment may have affected
quality?

Can you demonstrate that the current

knowledge level is sufficient to ensure
conformity?

How is knowledge maintained and

available to all necessary personnel?

is current knowledge always being

reviewed for changing trends and new
information?
How have team competencies been
determined?

How can you show the staff are

competent to carry out their tasks?

How does the site evaluate employee

competencies?

Is training documentation retained as

evidence of competence?

How do you ensure that all staff are aware * the company policy?
of;

* the company objectives?

* the importance of their

contribution and the benefits of
continual improvement?

* the implications to themselves

and the organisation of non-
conformance?
How and how often does the organisation
communicate with staff?

What is communicated to staff?

Documentation should be put in place that

has been determined as 'necessary' for the
effectiveness of the IMS on this site.

How often is it reviewed for suitability?

How do you ensure it is available to those

that need it and how is it protected from
loss of confidentiality, improper use or
loss of integrity?

How is documentation controlled in its; - distribution, access, retrieval and

use?

- storage and preservation?

- version history?
 - retention and disposition?

How do we ensure that external

documentation is controlled?

How is information retained as evidence

of conformity?

How is it protected from alterations?

clause 8; Operation
Clause 8 covers the plan and control processes that are needed to meet the requirements for our products and services. This incl
and development, external service providers, production and service provision, release of products and services, and non-confo
outputs.

Operational planning and How has the organisation planned,

control implemented and controlled the
processes that are needed to meet
quality and customer requirements?

What controls are in place to prevent

any unplanned changes?

Requirement for products and How do you determine if there is

services sufficient and satisfactory
communication with customers?

Have the organisation determined the

requirements for products - (e.g.
statutory and customer requirements)?

How often are these requirements

reviewed to ensure the site can still
supply these requirements?

Frequency of review?
 How are changes documented and
relevant persons notified if changes are
required?

Design and development How is product design and development

planned?

How are all potential inputs for design

and development considered during the
design process?

Have all possible controls measures,

validation technicques and verification
methods been considered?

Do the resultant outputs meet the stated

requirements?

Is documentation kept of the changes in

the design and development stages?

Control of externally provided Do externally provided services etc.

products, processes and conform to the stated requirements?
services
Control of externally provided
products, processes and
services

If they are integrated into our systems,

how are they controlled by us?

If not, how are they controlled and will

loss of control affect the outputs
(product)?

If they may affect the customer, are they

controlled by us?

If a part of our process is provided by an

external provider, how is that controlled
by us?

How are these services/ actions

monitored, evaluated and documented?

How has the impact of external services

on our organisation and products/
service been considered?

How has the effectiveness of the

providers been verified and validated?

Production and service How do we manage control of * using monitoring and

provision production: measuring,

Can we demonstrate:
Can we demonstrate:

* defined activities,

* outcomes,

* competencies,

* verficiation and validation

How is identification and traceability

monitored?

What measures are in place to ensure

providers' and customers' property is
cared for and protected?

How are outputs preserved from error? * identification,

* handling,
 * contamination control,

* packaging

Are there any post-delivery activities we * customer feedback,

are obliged to perform;

How is this managed?

* customer requirements,

* statutory and regulatory

requirements for follow up

Release of products and How does the site ensure that product
services and service requirements have been
met?

Is there documented evidence of

confomity with acceptance criteria and
traceability to the person authorising
release?

Control of non-conforming How does the organisation ensure that

outputs non-confomances are identified and
prevented from release?

What does the organisation have in

place for non-conforming products that
have already been released?
Is documentation retained that describes
what was done to correct the NC, what
happened, why, actions taken etc?
 This key is for guidance; there may be some clauses that are the
and SLT.
clause 9; performance evaluation
r products and services. This includes; design Clause 9 requires us to monitor, measure, analyse and evaluate our systems. This includes are
ucts and services, and non-conforming conformance, and supplier performance.

Monitoring, measurement, How have we determined;

analysis and evaluation

How do we evaluate the performance and

effectiveness of the management system?
Customer satisfaction How do we measure customer satisfaction?

Analysis and evaluation How do we analyse data taken from our

monitoring and measuring activities?

Do we include all aspects of the management

system, covering;
Internal audit How are internal audits conducted to ensure the
management system conforms to it's own
requirements and the requirements of the
standard?

How do we make sure it's effectively

implemented and maintained?

Is there an audit plan in place that considers

frequency, methods, responsibilities, planning,
changes to the organisation and the results of
previous audit?

Does the plan;

Management review Do SLT conduct a management review?

Does the manegement review consider;

Do decisions arising from the management review
include opportunities for improvement, potential
changes to the management system, resources?

Is the management review documented?

 site responsibi

senior management (SLT

some clauses that are the responsibility of both site combination of site and SL
and SLT.
clause 10; improvement
systems. This includes areas such as customer satisfaction, product quality, non- Clause 10 is based on continual improvement and in
improve the systems (proactive rather than reactive)

* what should be monitored and General

measured

* the methods

* the frequency

* analysis of monitoring and measuring Non-conformity and

corrective action
conformity of products and services

customer satisfaction

performance and effectiveness of the Continual

management system improvement

effective planning implementation

effectiveness of actions to address risks

and opportunities
external provider performance

continual improvement

* define the audit criteria and scope for

each audit,

* select impartial and objective

auditors,

* ensure results of audits are reported,

* ensure that corrective actions are
addressed without undue delay,

* retain documented information as

evidence of the implementation of the
audit plan and results

actions from previous reviews?

changes in internal and eternal issues?

the perfomance and effectiveness of the

management systems?

the adequacy of resources?

risks and opportunities?

opportunities for improvement?
 site responsibility

senior management (SLT) responsibility

combination of site and SLT responsibility

mprovement
s based on continual improvement and includes actions taken to address nonconformities, RCA and ways to further
systems (proactive rather than reactive).

How does the organisation by improving products and

determine and select opportunities services?
for improvement and implement
any actions needed to meet
requirements;

Correcting or preventing
undesired effects?

re

Is there a procedure for non-

conforming product?

How does the organisation * by reviewing the NC and

evaluate whether the non- performing RCA?
conformity can arise elsewhere?
conformity can arise elsewhere?

* implementing any actions,

* updating risks and

opportunities ?

* making changes to the

management system if
necessary?

Documented evidence of the NC

and any corrective action shall be
retained

The organisation shall continually

improve the suitability, adequacy,
effectiveness of the management
system.

How is this achieved?

The organisation should consider

the results of analysis and
evaluation to determine if there are
needs or opportunities to be
addressed as part of continual
improvement.

How is this achieved?

The organisation should consider
the results of analysis and
evaluation to determine if there are
needs or opportunities to be
addressed as part of continual
improvement.

How is this achieved?