Radio Quality Assurance Scheme - Quality System Guide (Part B) Issue 2: May 1999

Interpretation of BS EN 9000 for Application to Civil Radio Services.

B.1 REFERENCES

In the National Forward to BS EN IS0 9004-1 there are cross-references to a range of International standards and the corresponding British standards which may be of relevance to your Quality Management system.

Legal and Safety Regulations

Firms should be aware of and comply with all relevant and current UK and EU Statutory requirements.

Particular attention is drawn to the following legal and/or safety requirements:

Specific Intrinsically Safe Specifications.
Electricity at Work Regulations.
IKE Wiring Regulations.
COSHH Regulations.
Health and Safety at Work Act.
Planning Regulations.
Road Traffic Act.
Consumer Protection Act
Product Liability laws

Note: this is not an exhaustive list.

Technical References and Type Approvals

Most radio equipment is subject to type approval specifications drawn up by the Radiocommunications Agency, or the equivalent ETSI specifications. In addition the RA produce codes of practice and specifications applicable to radio activities. The RA publishes lists of specifications for radio services as well as a list of all general information sheets. Copies are available from the RA Library at the address on the front of this document. Further details about specifications, codes of practice and other documents relevant to the activities covered by the RQAS are listed in the Specific Guidance Notes.

Firms should also be aware of the following documents where relevant:-

BABT Type Approvals;

BASEEFA Specifications;

BEAB Approvals;

British Standards for Safety and any other relevant British Standards;

Manufacturer's Instruction Manuals;

any relevant International Agreements.

B.2 GENERAL DEFINITIONS

In addition to the definitions in ISO 8402, for the purpose of this guide, the following definitions apply:

Customer
The organisation which is receiving a product, or service, from the supplier.

Product
The result of activities or processes. Note: a product may include service, hardware, processed material, software of a combination thereof. A product can be tangible (e.g. assemblies or processed materials) or intangible (e.g. knowledge or concepts) or a combination thereof. For the purpose of The Standard, the term "product" applies to the intended product offering only and not unintended "by-products" affecting the environment. This differs from the definition given in ISO 8402.

Quality Assurance
All those planned and systematic actions necessary to provide adequate confidence that a product or service will satisfy given requirements for quality.

Quality Management
That aspect of overall management function that determines and implements the quality policy.

Sub Contractor
An organisation, or individual, providing service(s) or material(s) to the supplier.

Supplier
The organisation which provides the product by a process which satisfies the requirements of the quality management system (i.e. the organisation seeking registration).

Other specific service definitions appear in the Specific Guidance Notes at Part C.

B.3 GENERAL GUIDANCE TO QUALITY SYSTEM REQUIREMENTS

This part of The Guide gives general guidance on the application of BS EN ISO 9000 to civil radio services - i.e. the guidance is thought to apply to all activities covered by the RQAS. Reference should be made to the general guidance on the application of quality management systems contained in ISO 9000-2: Generic guidelines for the application of ISO 9001, ISO 9002 and ISO 9003. Specific guidance for businesses with less than approximately 30 employees is available in the "Small Business Guide: Quality Systems in the Small Firm" published by the Institute of Quality Assurance, PO Box 712, 61 Southwark Street, London SE1 1SB.

For particular radio activities the general guidance should be read in conjunction with the appropriate Specific Guidance Note at Part C.

The sub-paragraph numbering follows that of BS EN ISO 9000 for ease of reference.

3.1 Management responsibility (Clause 4. 1)

No generic radio-related guidance is considered necessary, refer to Specific Guidance Notes in Part C of this document for specific activity guidance, where appropriate.

3.2 Quality system (Clause 4.2)

The auditor will check that there is an adequate procedure for documenting and controlling the quality activities in accordance with:

Wireless Telegraphy Acts 1949 and 1967

The Telecommunications Act 1984

Any Licence or Approval granted or having effect as if granted under these Acts

NB This legislation or any relevant Statutory Instruments takes precedence over contractual agreements.

Radio industry Codes of Practice and relevant MPT/ETSI specifications (see Specific Guidance Notes for documents specific to radio industry activities).

3.3 Contract review (Clause 4.3)

Every order or request from a customer to perform work (i.e. supply goods or services) should be regarded as a contract, whether written or verbal. The contract with the customer should adequately define and document the service that the radio firm (the supplier) is being asked to provide. The contract should be reviewed with respect to technical capability and how it meets the customers commercial requirement and form the basis of the confirmation to the customer. Any requirements differing from those requested should be resolved with the customer. These are especially important where licence infringements or safety issues are concerned. Any subsequent amendments to the contract must similarly be reviewed and communicated to those responsible for execution of the contract.

The auditor will check that service contracts are subject to contract review, that the review period is reasonable (ideally, the review period should be part of the contract - and should relate to the length of time of the service contract) and that records of these reviews are kept. The auditor will check that service contracts clearly define:

the types and levels of service provided;

any service options (e.g. to cover any interruptions to the service);

(where a firm has a range of service options), a clear description of the options and the circumstances under which they are provided;

warranty terms which are made available to customers.

The auditor will check that firms offering service can demonstrate an ability to control and measure response and repair times.

The auditor will check that firms offering service can demonstrate that provision is made to ensure that adequate levels of resource are maintained and controlled to support the customer to the level of service offered.

3.4 Design control (Clause 4.4 of BS EN ISO 9001 only)

No generic radio-related guidance is considered necessary, refer to Specific Guidance Notes in Part C of this document for specific activity guidance, where appropriate.

3.5 Document and data control (Clause A 5)

3.5.1 Document approval and issue
No generic radio-related guidance is considered necessary, refer to Specific Guidance Notes in Part C of this document for specific activity guidance, where appropriate.

3.5.2 Document changes/modifications
The auditor will check that an effective procedure exists to identify what documents are held (and/or needed) and to maintain the issue status of all documents used or referred to in the quality system, including:

relevant legislation;

licences issued under the legislation;

Codes of Practice;

MPTs and/or ETSI documents (European equivalent of MPT);

manufacturers technical documentation.

3.6 Purchasing (Clause A 6)

3.6.1 General
Where appropriate all radio equipment must be type-approved to a valid specification, as determined from time to time by the RA. Equipment should be programmed for use in the permitted band in accordance with the conditions of the user's licence.

The auditor should check that the supplier has evidence of adequate support from subcontractors covering the products they supply. This may include the supply of spare parts, training, technical support and documentation.

3.6.2 Assessment of sub-contractors
Sub-contractors should be evaluated and selected to ensure that purchased products and services conform to the requirements of the RQAS.

Any secondary level sub-contracting should not be undertaken without the prior agreement of the prime contractor.

The sub-contracting of any element(s) of the service does not absolve the supplier of any responsibility for ensuring the quality of the product or service.

The sub-contracting of all elements of the service is not allowed under the terms of this scheme.

3.6.3 Purchasing data
No generic radio-related guidance is considered necessary, refer to Specific Guidance Notes in Part C of this document for specific activity guidance, where appropriate.

3.6.4 Verification of purchased products or services
This clause relates to the customer's right, when specified in the contract, to verify on yours or your sub-contractor's premises that the product conforms to the specified requirements. When this right is specified in the contract with your customer you will need to incorporate the same requirement in your contracts with your sub-contractors.

3.7 Control of customer-supplied products (Clause 4.7)

Customer-supplied products include any goods, services, data, information or any other materiel which is the property of your customer and is to be incorporated into or affects the performance of the delivered product.

Procedures should be in place to identify customer-owned products while in your care. The requirements of the Data Protection Act should be observed where relevant.

The auditor will check that customer-supplied products are the subject of reviews, where appropriate; and that a procedure exists to inform the customer of any deficiencies before any service activity is commenced. Examples of customer-supplied products are:

equipment returned for repair;

customer vehicles or premises, into which equipment is to be installed or maintained.

3.8 Product identification and traceability (Clause 4.8)

The degree of identification and traceability may well be subject to special contract conditions, for example intrinsically safe equipment.

3.9 Process control (Clause 4.9)

3.9.1 General
The operation of all radio equipment must comply with the conditions and requirements of any licence issued by the RA on behalf of the Secretary of State.

The auditor will check that procedures and work instructions control activities in accordance with radio Codes of Practice and MPT/ETSI specifications where appropriate.

3.9.2 Special processes
Procedures for handling intrinsically safe equipment and electrostatically sensitive devices must be considered a special process. Special attention should also be given to processes where their quality cannot necessarily be determined by a final inspection, for example:

soldering;

crimping.

3.10 Inspection and testing (Clause 4.10)

No generic radio-related guidance is considered necessary, refer to Specific Guidance Notes in Part C of this document for specific activity guidance, where appropriate.

3.11 Control of inspection, measuring and test equipment (Clause 4.11)

No generic radio-related guidance is considered necessary, refer to Specific Guidance Notes in Part C of this document for specific activity guidance, where appropriate.

3.12 Inspection and test status (Clause 4.12)

No generic radio-related guidance is considered necessary, refer to Specific Guidance Notes in Part C of this document for specific activity guidance, where appropriate.

3.13 Control of non-conforming product (Clause 4.13)

No generic radio-related guidance is considered necessary, refer to Specific Guidance Notes in Part C of this document for specific activity guidance, where appropriate.

3.14 Corrective and preventive action (Clause 4.14)

The auditor will check that firms providing a service have clearly defined and documented procedures for raising problems with other suppliers in the chain.

3.15 Handling, storage, packaging, preservation and delivery (Clause 4.15)

Procedures should exist for the handling, storage, packaging, preservation and delivery of electrostatic sensitive devices at all stages within the organisation. These procedures should comply with the requirements of BS EN 100015-1:1992 and be in accordance with manufacturers recommendations.

Procedures should exist for the handling and disposal of components which contain hazardous materials, for example beryllium oxide.

3.16 Control of quality records (Clause 4.16)

The auditor will check that records are kept for sufficient time to enable an effective audit trail of the services delivered.

The procedures relating to record keeping should specify responsibility for creating and keeping the record and the period of retention. The method of retention should specify the location and environmental conditions, including the use of back-up copies for records on magnetic tape, or other electronic media. A hard copy of any electronic records should be made available on request to anyone entitled to see such records.

3.17 Internal quality audits (Clause A 17)

No generic radio-related guidance is considered necessary, refer to Specific Guidance Notes in Part C of this document for specific activity guidance, where appropriate.

3.18 Training (Clause A 18)

All staff should be competent in the administration and/or technical skills required to carry out the tasks assigned to them in the course of performing their duties. In the absence of formal qualifications, or assessment under the relevant National Vocational Qualifications (NVQ) where these are available, on the job training by suitably qualified staff may be appropriate.

The auditor will check that staff have been trained in the use of specific tools and test equipment and the techniques and methodologies they are expected to use in a given task to which they have been assigned.

Records of training and related experience should be maintained so that procedures for the assignment of staff to specific tasks take such training and experience into account.

3.19 Servicing (Clause 4. 19)

No generic radio-related guidance is considered necessary, refer to Specific Guidance Notes in Part C of this document for specific activity guidance, where appropriate.

3.20 Statistical techniques (Clause 4.20)

No generic radio-related guidance is considered necessary, refer to Specific Guidance Notes in Part C of this document for specific activity guidance, where appropriate.

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Enquiries about the RQAS should be addressed to:

The Secretary
Radiocommunications Agency
c/o Radiocommunications Agency
Wyndham House
189 Marsh Wall
London
E14 9SX

Tel: 020-7211 0193
Fax: 020-7211 0118

Copies of all RA publications can be obtained from:

website: www.radio.gov.uk

This guide may be freely reproduced as a complete document except for sale or advertising purposes.

Published on behalf of the Radiocommunications Quality Council by the Radiocommunications Agency, an Executive Agency of the Department of Trade and Industry

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