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ISO 9001 2015 Quality Manual

Quality Manual

ISO 9000:2015

FMB Oxford Limited

Units 1-4 Ferry Mills,

Osney Mead,

Oxford, OX2 0ES,

United Kingdom.

Quality Manual

ISO 9001 2015 Quality Manual of 11

Contents 1 Scope 3 2 Applicable Standard 3 3 Terms and Definitions 3 4 Context of the Organisation 4

4.1 Establishing Organisational Context 4

4.2 Needs and Expectations of Interested Parties 4

4.3 Scope of the QMS 4

4.4 System and Processes 4

5 Leadership 5 5.1 Management Commitment 5

5.2 Customer Focus 5

5.3 Policy 5

5.4 Responsibilities 6

6 Planning 6 6.1 Risks and Opportunities 6

6.2 Quality Objectives 6

6.3 Planning 6

7 Support 6 7.1 Resources 6

7.2 Competence 6

7.3 Awareness 7

7.4 Communication 7

7.5 Information 7

8 Operation 7 8.1 Planning and Control 7

8.2 Requirements for Products and Services 7

8.3 Design and Development of Products and Services 8

8.4 Externally Provided Processes, Products and Resources 8

8.5 Production and Service Provision 9

8.6 Release of Products and Services 9

9 Performance Evaluation 10 9.1 Monitoring, Measurement, Analysis and Evaluation 10

9.2 Internal Audit 10

9.3 Management Review 10

10 Improvement 10 10.1 Opportunities for Improvement 10

10.2 Nonconformity and Corrective Action 11

10.3 Continual Improvement 11

Quality Manual


1 Scope

In support of its business activities FMB Oxford has implemented a quality management system (QMS). The

QMS takes account of the needs of interested parties, aims to minimise business risk and provides

processes and procedures that promote consistency of operation.

All FMB Oxford employees have access to the QMS and its associated documents via the FMB Intranet.

This manual provides an overview of the QMS. It is specifically aimed at customers and other stakeholders

who do not have access to the full QMS.

2 Applicable Standard

The FMB Oxford QMS meets the requirements of ISO 9000:2015 and is independently validated and

accredited by BSI.

3 Terms and Definitions

The structure of this manual and the terminology used is consistent with that used in ISO 9000:2015.

Quality Manual


4 Context of the Organisation

4.1 Establishing Organisational Context

FMB Oxford has established its organisational context by:

1. Publishing a business strategy and making this available to all employees via the QMS

2. Identifying all interested parties and understanding the business relationship with each, including the

needs and expectations of those parties

3. Determining the scope of the products and services offered to customers

4.2 Needs and Expectations of Interested Parties

FMB Oxford has identified and mapped all interested parties relevant to its business operations. For each

interested party the company has defined the relationship in terms of the benefits, services and information

received by the interested party and also the benefits, services and information provided to FMB Oxford.

4.3 Scope of the QMS

The scope of the QMS includes the design, development, delivery and deployment of products and services

relevant to our chosen market and associated customers. The scope includes the supply of information and

expertise as well as the delivery, commissioning and support of equipment.

4.4 System and Processes

The FMB Oxford QMS comprises of 7 key processes:

Sales

Design & Development

Procurement

Manufacture

Shipping & Installation

Customer Support

Performance evaluation

The scope of each process is defined by the context of the organisation and is in turn supported by

appropriate operating procedures, work instructions, people systems and infrastructure.

Quality Manual


5 Leadership

5.1 Management Commitment

The QMS is driven top down with active participation of top management. The management team hold

regular management reviews in line with the requirements of ISO 9000:2015. Managers also have functional

responsibility for the key processes detailed in this manual.

5.2 Customer Focus

Customer focus is embedded into all of the 7 key processes listed in section 4.4 of this Quality Manual.

Customer satisfaction is monitored and reported on using a variety of measures including:

Customer compliments and complaints

Performance KPIs –

o On time delivery

o In-field failures

o Customer service response times

Risks and opportunities are evaluated at various stages in the overall customer delivery process. Any

identified risks are communicated to customers via formal reviews, monthly reports and other project specific

documents.

5.3 Policy

The Managing Director has issued the following Quality Policy. The policy is reviewed annually and

establishes a basis for the organisation’s Quality Objectives.

Quality Manual


5.4 Responsibilities

In support of the QMS the Managing Director has appointed a Quality Manager who is also a member of the

senior management team. The day to day operation of the QMS is under the control of the Quality

Coordinator who reports directly to the Quality Manager.

6 Planning

6.1 Risks and Opportunities

FMB Oxford has compiled a risks and opportunities register. The register is reviewed and updated by the

Quality Manager, with input from other departments. This activity is monitored during the quality

management meetings, see section 5.1

6.2 Quality Objectives

FMB Oxford sets and reviews annual Quality Objectives. These include:

Customer focus

Quality system performance

Non-conformance

Key supplier performance

Improvement projects covering specific areas such as:

o Communications

o People

o Products & Services

o Suppliers

o Processes

6.3 Planning

Management, project and departmental reviews monitor resource needs and determine priorities and

actions. Supporting information is derived from market and business intelligence as well as data provided by

business systems including MRP.

7 Support

7.1 Resources

The 7 key business processes listed in section 4.4 are underpinned by the support process shown above.

This process focusses on resources, including people, infrastructure and knowledge.

7.2 Competence

To ensure the business has trained and competent people performing key roles FMB Oxford takes care that:

All jobs have an associated role profile

Managers and team leaders carry out regular development reviews with staff

Staff have access to continuing professional development (CPD)

Candidate qualifications, experience and behaviours are matched with recruitment needs

Quality Manual


7.3 Awareness

Awareness of the QMS forms part of the standard FMB Oxford induction for new staff.

7.4 Communication

Key issues relating to quality and customer satisfaction are routinely communicated at regular monthly staff

meetings. All staff are encouraged to raise quality issues and propose improvement projects.

7.5 Information

FMB Oxford provides access to the QMS via the company Intranet. Work instruction and records are also

displayed at the place of work where appropriate.

Critical documents, data and records are protected by a system of user permissions that prevent

unauthorised alteration.

8 Operation

8.1 Planning and Control

Sales fulfilment is satisfied by the Sales (Customer Requirements) process shown in section 8.2.

Responsibilities for the planning and control of each stage are detailed in supporting procedures and role

profiles.

8.2 Requirements for Products and Services

The above process and supporting procedures ensure that customer requirements are documented,

authorised and communicated across the organisation. Functional Specifications and Project Plans are

generally agreed with the customer and are two of the key documents that define the requirements of each

major contract.

Quality Manual


8.3 Design and Development of Products and Services

The design and development process uses a series of stage gates to control progress from one stage to the

next. At key stages in the process there are document approvals and review meetings which validate

customer requirements and identify and mitigate product or schedule risk.

8.4 Externally Provided Processes, Products and Resources

FMB Oxford uses subcontractors and specialist to supply a variety of goods and services. Wherever possible

these are ISO 9000:2015 approved organisations. New suppliers are subject to an assessment and approval

process and supplier performance data is routinely collected and evaluated.

General supplier information is held in the Sage 200 system. A recommended supplier list is also maintained

for critical categories of supply and includes supplier risk assessments.

Quality Manual


8.5 Production and Service Provision

Product and service provision information is provided in various forms:

System generated information, mainly provided by the Sage 200 MRP system

Design information, mainly provided by the Solid Edge CAD system and DDM document

management system

Standard documentation and information forming part of the QMS

Project specific documentation and information provided by the project manager

Records relating to parts and labour usage are held within the Sage 200 system. Information relating to test

and inspection information is stored in the project and manufacturing folders within the IT network.

8.6 Release of Products and Services

Authority for the release of products and services lies with the relevant project manager. For project and

service delivery there are usually agreed criteria for acceptance by the customer.

8.7 Control of Nonconforming Outputs

The manufacturing process, see section 8.5 above, controls the identification, segregation and determination

of nonconforming outputs. Documented procedures and instructions support this process. The performance

evaluation process, see section 9 of this manual, provides further oversight on the effectiveness of the

control of nonconforming outputs.

Quality Manual


9 Performance Evaluation

9.1 Monitoring, Measurement, Analysis and Evaluation

FMB Oxford monitors:

The performance of its processes via internal review meetings, change requests, corrective actions,

internal audits (first party audits) and external audits (third party audits)

The performance of its suppliers via key performance indicators (KPIs) and supplier audits (second

party audits)

Conformance to product specifications via internal testing and customer feedback

Customer satisfaction through a combination of direct feedback (compliments and complaints) and

internal KPIs

9.2 Internal Audit

FMB Oxford operates an internal audit programme. The programme of audits is carried out in line with an

annual schedule set by the Quality Manager and Quality Coordinator. This also takes account of the

schedule of BSI surveillance audits.

Internal auditors are trained in line with ISO 19011:2011; Guidelines for Auditing Management Systems.

9.3 Management Review

The senior management team hold regular quality management meetings to discuss the effectiveness of the

QMS. The structure of the meetings are in line with ISO 2000:2015 and agenda items include:

Set and review quality policy and objectives

Agree changes to the QMS, where appropriate

Assess new risks and opportunities

Monitor customer satisfaction and put in place corrective actions where appropriate

Review the outcomes of internal and external audits and associated corrective actions

Review key supplier performance and put in place corrective actions where appropriate

Identify and track improvement projects

10 Improvement

10.1 Opportunities for Improvement

In additional to identifying a number of strategic opportunities FMB Oxford also engages with staff and other

stakeholders to identify opportunities for improvement in products, services and internal processes. Where

opportunities are identified top management assign responsibility and resources.

Progress on improvement projects is monitored and reviewed at management meetings and communicated

to staff via departmental or company meetings.

Quality Manual


10.2 Nonconformity and Corrective Action

FMB Oxford monitors all business processes for nonconformity. Examples include:

Monitoring the quality of supplied parts and services

Monitoring products and services against the requirements of test and functional specifications

Monitoring the QMS to check adequacy of controls and conformity to procedures and work

instruction

Where a nonconformity is identified it is documented and reviewed and a corrective action put in place.

Corrective actions are monitored as part of the QMS management review and only closed out on the

authority of the Quality Manager

10.3 Continual Improvement

FMB Oxford continually strives to improve and develop its products, services, partnerships, processes

infrastructure and people. It achieves this goal by:

Identifying and responding to risks and opportunities

Measuring satisfaction levels both internally and externally

Evaluating the performance of supplied products and services

Acting on feedback from other interested parties

Monitoring the efficiency and effectiveness of business processes and looking for improvement

opportunities

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