ISO 9001 Consultants | Cheshire | North Wales | Manchester

8. Operation

8.1 Operational planning and control

Plan and implement the processes necessary to ensure that your products and services are what your customers require.

Do this by

a) Determining the requirements for the products and / or services.

b) Establishing criteria for the processes and customer acceptance.

c) Determining the resources needed to achieve conformity.

d) Controlling processes as required by you and your customers.

e) Maintaining documented information as appropriate to support your organisation.

f) Ensuring that outsourced processes are sensibly controlled.

8.2 Requirements for products and services

8.2.1 Customer communication

Communication to customers shall be completed through a variety of methods.

This shall include

a) Information relating to your products and services.

b) The handling of queries and enquiries.

c) The obtaining of feedback relating to your products and services, including complaints.

d) The handling or controlling of customer property and information.

e) Emergency information and contingency plans if necessary.

8.2.2 Determining the requirements for products and services

When determining your products and services consider your own requirements, as well as that of your customers.

Do this by

a) Determining requirements of your product or service which will include consideration of compliance, safety and operability requirements.

b) Ensuring that other considerations and obligations are satisfied.

c) Ensuring that your products and services do what we say they do.

d) Ensuring that you have the right staff to do the job.

8.2.3 Review of the requirements for products and services When reviewing your products and services, ensure that they will do what you and your customers want them to do and ensure that customer satisfaction is upheld.

Do this by

a) Ensuring that you fulfil requirements specified by the customer, including delivery and post-delivery requirements.

b) Ensuring that you fulfil your obligations necessary for the intended use and use industry guidance where applicable.

c) Ensuring that the product or service has been appropriately examined and fulfil your own requirements by following best practice methods.

d) Ensuring that known compliance requirements are met.

e) Ensuring that other order requirements are met.

f) Provide a verbal or documented order acknowledgement where necessary, if the customer does not provide a documented statement of their requirements. Retain documented information of product and services review at management  review when appropriate.

a) If, you review your products and services.

b) If, new requirements of products and services are required.

8.2.4 Changes to requirements for products and services

Any changes required to products and services will be discussed.

Do this by

a) Internal discussion.

b) Discussion with clients if appropriate.

c) Discussions with external providers.

d) Documenting any changes, if required. You may not always document your changes. This will be decided by management.

e) Checking if documented information is required to be modified. If so, the relevant people will be communicated with and agreement shall be reached on the necessary requirements.

8.3 Design and development of products and services (A potential exclusion for those who do not design products).

8.3.1 General

Design and development processes are in place to support your product.

8.3.2 Design and development planning

When you design, you shall take into consideration your experience of the product.

We shall plan by

a) Taking into consideration the nature, duration and complexity of the potential requirement.

b) Considering the required stages of process, including review activities.

c) Considering the responsibilities and authorities involved.

d) Considering the internal and external staffing and resource requirements and forecasts.

e) Considering the need to control communications as part of the development.

f) Involving customers and external providers where appropriate.

g) Ensuring that you can provide what you propose.

h) Discussing the expectations of interested parties to a reasonable degree.

i) Providing documented information where 'designs' are required or requested.

8.3.3 Design and development inputs

When developing products, it is necessary to decide on the inputs.

Do this by

a) Considering functional and performance requirements.

b) Considering Information derived from previous designs and experience of staff.

c) Considering Statutory and Regulatory compliance.

d) Considering National, International or Best Practice Standards or codes of practice that you have committed to using.

e) Considering potential consequences of failure and success.

8.3.4 Design and development controls

Apply controls to your development process.

Do this by

a) Defining that you understand what results are to be achieved.

b) Reviewing the results of design and development, modify as necessary.

c) Verifying that the design and development should meet planned expectation.

d) Use validation techniques to ensure that the intended use can be met.

e) Resolving problems and addressing causes promptly.

f) Documenting where appropriate.

8.3.5 Design and development outputs

Design and development outputs shall be monitored as appropriate.

Do this by

a) Meeting the input requirements, if not, having reasons to modify.

b) Ensuring adequacy of product.

c) Deciding on the acceptance criteria.

d) Ensuring that the specification of the design and development requirement and any modification requirements are met, and that the design and development can be used for its intended purpose and is safe to use.

e) Keeping documented information as appropriate.

8.3.6 Design and development changes

Ensure that any changes to the design and development are controlled.

Do this by

a) Ensuring that changes do not have an adverse impact on the specification.

b) Reviewing changes with experienced staff.

c) Authorising those changes, with customers where considered proper or necessary.

d) Ensuring that operation changes do not have an adverse impact on the safety or conformity of the development.

e) Plan the scheduling.

8.4 Control of externally provided processes, products and services (suppliers)

8.4.1 General

Externally provided processes, products and services (sources of supply) are used to maintain the quality of your product and service.


a) The products and services that you require intended for incorporation into our product.

b) Decide if these products and services shall be directly provided: as in not always seen by you, direct to the customer.

c) If a process or a part of a process is to be provided by an external provider. (Critical supplier).

d) We shall apply criteria as required for the evaluation and selection of external providers to determine if they meet specified requirements.

8.4.2 Type and extent of control

Ensure that externally provided processes, products and services (sources of supply) are able to deliver consistent value and do not adversely affect your product or service.

Do this by

a) Ensuring that relevant monitoring activities remain in the control of the organisation.

b) Taking into consideration the impact of the external provider. Just how important is the process they are undertaking?

c) Defining criteria that you intend to place on an external provider if required.

d) Determining if you require verification of the source of supply, including potential visits or requests of information if necessary, to meet your requirements.

8.4.3 Information for external providers

You must ensure that external providers are given the correct information.

Do this by taking into consideration

a) That the provider understands what it is you require from them.

b) That if they are what you deem a process important / critical external provider that they understand your approval process of their products and services.

c) Competency requirements.

d) Communication and interaction methods.

e) Their ongoing performance and review.

f) Verification of the external provider's products and services at locations other than your own organisation's location.

8.5 Production and service provision (What you manufacture or deliver)

8.5.1 Control of Production and service provision

Aim to control your production and service provision in a manner suitable with your products and services.

Take into consideration

a) The availability of documented information that defines the characteristics of the product or service, or the activities being performed.

b) The results to be achieved.

c) The availability and use of monitoring resources.

d) The use of a suitable environment and infrastructure.

e) The appointment of experienced staff or suitable persons deemed competent. Support with education and training where necessary.

f) Validating and reviewing planned results where the resulting output cannot be verified by subsequent monitoring and measurement. I.e. tested by the customer or at point of use.

g) Actions to prevent human error.

h) Release and post release activities.

8.5.2 Identification and traceability

Use suitable means to identify customers, products, suppliers, parts and documented information throughout your organisation.

Endeavour to control traceability and unique identification in a sensible and organisational manner that suits you.

8.5.3 Property belonging to customers or external providers

Any property belonging to anyone other than yourselves shall be taken care of.

Do this by safeguarding, protecting and controlling other people's or another organisation's property. If any damage or improper use shall occur whilst in your custody, an investigation may be undertaken and the owner contacted.

8.5.4 Preservation

You shall preserve our products and services where appropriate.

Take into consideration

  • Identification.

  • Handling.

  • Contamination control.

  • Packaging.

  • Storage conditions.

  • Transportation requirements.

  • Protection.

8.5.5 Post delivery activities

Ensure that post-delivery activities comply with your client's requirements or planned arrangements.

Do this by

a) Determining any compliance requirements.

b) Considering undesirable consequences.

c) Understanding the nature of your products and services.

d) Understanding your customer requirements, i.e. instructions on usage.

e) Communicating with your customers.

8.5.6 Control of changes

If you or your customer require any changes to your products or services, take into consideration the extent of the changes, what has already been completed and the effect the change has on the conformity of what you have provided. Document only what is necessary by agreement with our customer.

8.6 Release of products and services

To ensure that products and services meet customer requirement, verify that suitability of what is being provided is checked before release. If arrangements are to be made, you shall arrange this with your customer or any interested party / authority as deemed necessary.

If required you should

a) Provide evidence of conformity and acceptance criteria.

b) Provide traceability to the person authorising the release.

8.7 Control of nonconforming outputs

8.7.1 Outputs that do not conform to requirements shall be identified if possible and controlled to  prevent their unintended use or delivery.

Deal with items deemed nonconforming by consideration of the following points

a) Identifying the root cause.

b) Segregation and containment (if possible).

c) Return or suspension of provision.

d) Inform the customer or external provider.

e) Obtain authorisation for acceptance under an agreed concession.

f) Conformity is re-established after correction.

8.7.2 Retain documented information where appropriate.

You may do this by

a) Describing the nonconformity and its root cause.

b) Describing the actions to be taken.

c) Describe any concessions obtained.

d) Identify the authority with regards to the action in respect of the nonconformity.

I hope this helps