ISO9001:2015 Quality Management System · 2017-02-21 · Top management, including our Director / General Manager, are responsible for, and committed to, establishing our Quality

Uncontrolled when printed

Revision: Date:

Alias Business Systems Ltd

Sample 01/01/2017

ISO9001:2015

Quality Management System

Enter QMS Platform

Uncontrolled when printed Page 2 of 33...

Revision: Date:

QMS Home Page

01/01/2017

ISO9001:2015 Quality Management System

Sample


Leadership Context of our Organisation Planning Support Operation Performance

Evaluation Improvement

Using our QMS

Exit QMS Platform

QMS Documented Information Revision Log

Click here to learn how to navigate around the QMS….

4 Uncontrolled when printed Page 3 of 33...

Context of the Organisation:-

Revision: Date: 01/01/2017


Sample


Contents & Structure

Context of our Organisation

The Needs & Expectations of our Interested Parties

Our Organisation & Its Context

The Scope of our Quality Management System

Our Quality Management System & Its Processes

QMS Home Page


Leadership:-



Sample



Quality Policy

Leadership

Organisational Roles, Responsibilities & Authorities Leadership & Commitment

QMS Home Page


Planning:-



Sample



Quality Objectives & Planning to Achieve them

Planning

Actions to Address Risks & Opportunities Planning of Changes

QMS Home Page


Support:-

Revision: Date:


Sample 01/01/2017



Support

Measurement Traceability

Documented Information Communication Awareness Competence Resources

QMS Home Page

Internal & External

People

Infrastructure

Operational Environment

Organisational Knowledge

Monitoring & Measuring Resources

Only these 2 sections are activated in this demo..


Operation:-

Revision: Date:


Sample 01/01/2017



Control of External Processes, Products

& Services

Determination of Requirements for

Products & Services

Review of Requirements for Products & Services

Changes to Requirements for

Products & Services

Property Belonging to Customers or

External Providers

Operation

Operational Planning & Control

Requirements for Products & Processes

Design & Development of Products & Services

Production & Service Provision

Release of Products & Services

Control of Non-Conforming Outputs

QMS Home Page

Control of Production & Service Provision

Identification & Traceability

Preservation

Post Delivery Activities Control of Changes

Only these 3 sections are activated in this demo..


Performance Evaluation:-



Sample



Internal Audit

Performance Evaluation

Management Review Monitoring, Measurement,

Analysis & Evaluation

QMS Home Page


Improvement:-



Sample



Non-conformity & Corrective Action

Improvement

Opportunities for Improvement Continual Improvement

QMS Home Page

4.1 Uncontrolled when printed Page 10 of 33...


The Context of our Organisation

Revision: Date:


01/01/2017Sample

Our Organisation & Its Context


Alias Business Systems Ltd has determined the external & internal issues that may affect our ability to satisfy the intended results from our Quality Management System [QMS], for both our customers and other stakeholders. We have also determined the potential risks & opportunities that may arise from these external & internal issues, and the effect they may have either on the stability of our business processes or the integrity of our QMS.

We have determined that the following internal issues are relevant to our purpose and strategic direction. They also affect

our ability to achieve the intended results of our QMS:

We have determined that the following external issues are relevant to our purpose and strategic direction. They also affect

our ability to achieve the intended results of our QMS:

QMS Home Page ← << Context

Leadership

Company Performance Competence

Values

Culture

Operational Capability

QMS

Customers

Market Forces

Economic Factors

Legal

Regulatory & Statutory

Technology

QMS Review of Internal &

External Issues

Outputs to Management Review




Revision: Date:


Sample 01/01/2017



Other Factors

Internal Interested Parties External Interested Parties

In order to ensure that Alias Business Systems are able to consistently provide our products and services that meet both customer, and where relevant, any applicable statutory requirements, we have determined the "interested Parties" relevant to our QMS. We have also determined the requirements of our Interested Parties, along with a number of other factors, that are relevant to our QMS and the context of our organisation.

QMS Home Page ←

Review of Interested Parties &

Other Factors


Market Forces

Customers Suppliers Employees Regulatory &

Statutory Bodies

Legal

Company Performance

Leadership

Operational Capability Culture Competence Values

Economic Factors Technology

As part of our Business Planning, Internal Audit, Management Review and Continual Improvement activities, we monitor and review information about our interested parties, including their requirements and any associated risks & opportunities.

<< Context

The information on this page has been screened with data masking software

The un-masked sample of our QMS Platform is provided completely free of charge and with no-obligation

Click here to request an un-masked sample of our QMS Platform

http://www.businessdocsonline.co.uk/contact-us/�




Revision: Date:


Sample 01/01/2017



Alias Business Systems has determined the boundaries and applicability of our Quality Management System [QMS] in order to establish its scope. As part of this exercise we have also considered the following:

a) the external and internal issues that have been determined within the definition of our organisation and our context b) the needs and expectations of our interested parties c) the products and services that we will provide to our customers

Based on the factors detailed above the scope of our Quality Management System has been determined to be as follows:

Design, Marketing, Sales and Support of Integrated Management Information Systems

The Scope of our QMS will be maintained as documented information.

QMS Home Page ←

______________________________________________________________________________________________________________________________________________________

The following requirements of ISO9001:2015 have been determined as not applicable within the Scope of our Quality Managements System: Monitoring and Measuring Resources Control of Monitoring & Measuring Devices The test equipment used within Alias Business Systems is not used for exact measurement of signals. It is only used to verify the presence of data and therefore the equipment does not need to be calibrated. A documented process & procedure is therefore not included with our QMS. In the event of a Project Acceptance Test requiring exact measurement, a documented process & procedure will be developed and implemented.

<< Context








Core Activities

Revision: Date:


Sample 01/01/2017



QMS Home Page ←

Management Responsibilities, Audit & Review

Resource Management

& Training

Corrective Action, Data Analysis,

Continual Improvement

Document & Data Control

Quality Records

Customer Enquiry

Customer Order

Goods Inwards Verification

Purchasing & Stock Control

Design Activities

Customer Returns & Repairs

Supplier Approval

Non-Conforming Product

Quarantined Awaiting Return

Product Realisation Assembly, Inspection

& Test

Final Despatch Invoice Raised

QMS Planning, Risk & Opportunities

Top Management

Accounts & Admin Resources Operational

Environment

Overview of the interaction between core processes from initiation of contract (including design activities) to final despatch of finished product.

Process Performance

Review


Business Performance Data

(KPI's)

<< Context






Leadership:-

Leadership & Commitment

Revision: Date:


01/01/2017Sample

Leadership & Commitment


Top Management Commitment Alias Business Systems top management team are responsible for ensuing the effectiveness of our QMS. Top management, including our Director / General Manager, are responsible for, and committed to, establishing our Quality Management System [QMS], including our quality policy and subsequent quality objectives. The commitment of our top management is evidenced by their engagement with our Management Review process . The information & data provided during Management Reviews will be used to measure the effectiveness of our QMS.

This information will also be used to help define our quality objectives, and to drive our objectives for continual improvements within our QMS. Alias Business Systems top management team are committed to ensuring that our QMS functions as an integrated part of our wider business processes. Where possible, any information that is provided as part of the Continual Improvement Process within our QMS will be used to drive improvements across other areas of our business. Our top management team are also committed to promoting the use of a process-based approach, combined with risk based thinking within the organisation. This is reinforced at every opportunity through staff inductions, and when relevant, whenever a corrective action has been implemented. Our top management team will use data & information provided at Management Reviews to ensure that the resources needed for the quality management system are available.

QMS Home Page << Leadership






Leadership:-

Revision: Date:


Sample 01/01/2017

Quality Policy

Quality Policy


Alias Business Systems top management have established a Quality Policy that defines our Companys commitment to quality, customer satisfaction and continual improvement. It is our Company’s policy to provide products and services that consistently meet, or exceeds, our Customers expectations and enhance their level of customer satisfaction. Our top management have adopted a customer focuses approach and will listen and respond to our Customers requirements. We will actively pursue business excellence with clearly defined quality objectives for our organisation, and we will use our Management Review process to review and revise our quality objectives. The company is committed to satisfying any applicable requirements that are relevant to our business activities. We are also committed to the continual improvement of our Quality Management System. The planning of improvements and changes to our QMS will be undertaken in conjunction with changes to our business activities or the issues that have an impact on our organisation. This Quality Policy, together with our quality objectives, will be reviewed annually for suitability and purpose as part of our Management Review process. This policy is maintained as documented information in the form of an electronic copy located within the QMS section of our company intranet. This policy has been be communicated and understood at appropriate levels within the organisation and is strategically displayed within the business. Where necessary our personnel have been made aware of our quality objectives and have been trained to ensure that they are competent to undertake their roles within the company. This policy will be maintained as documented information and is available on request to all relevant interested parties.

Signed…..........................…………………………......…… Date: 25th December 2016 Director / General Manager.

QMS Home Page << Leadership






Leadership:-

Management Organisation Chart

Revision: Date:


01/01/2017Sample

Organisational Roles, Responsibilities & Authorities


The order of positions above is not necessarily reflective of the levels of responsibility.

QMS Home Page

Director / General Manager

Quality Representative

Design & Development

Purchasing & Stock Records Admin Office

Customer Support Manager

Sales & Customer Order Processing

Manufacture Control & Despatch

Roles, Responsibilities & Authorities

Although we acknowledge that under ISO 9001:2015 there is no explicit requirement for a Management Representative, Alias Business Systems regard this as a key role within our organisation and have therefore elected to retain the role of "Quality Representative" within our management structure.

<< Leadership






Planning:-

Actions to Address Risks and Opportunities

Revision: Date:


Sample 01/01/2017

Actions to Address Risks and Opportunities


The principle of risk based thinking is a corner stone of ISO 9001: 2015. Alias Business Systems has applied this principle throughout the planning & structure of our QMS, and it has also been applied when establishing quality objectives that are aligned with the strategic direction of the business. Our assessment of the relevant risks and opportunities is built on the information that has been used to define the context of our organization. The assessment of our business risks & opportunities is further enhanced by defining the needs and expectations of interested parties - both internal & external - that are relevant to our QMS. These risks and opportunities have been assessed - and action taken - to ensure that their impacts on our purpose and strategic direction, and any affect they may have on our ability to achieve the intended results of our QMS, are either eliminated or reduced to an acceptable level.

QMS Home Page << Planning

Where a business opportunity has been identified it will be assessed by top management during Management Review in order to establish the most effective actions to maximise the desirable effects that the opportunity may provide. Where the elimination of a risk, or the presence of an opportunity, has identified an opportunity to achieve improvement this will be assessed by top management as part of our Management Review.

Review of Actions to Address Risks & Opportunities


The assessment of the risk & opportunities that are relevant to our business are detailed with our Business Risk Assessment. This is a "working Document" that is key to our QMS and the actions from our assessment of risks & opportunities are integrated, and implemented, into our QMS processes & procedures.

Our business risk assessments, including an evaluation of the actions taken, is reviewed by top management as part of our Management Review.






Planning:-

Quality Objectives & Planning to Achieve Them

Revision: Date:


Sample 01/01/2017

Quality Objectives & Planning to Achieve Them


To achieve our goals and objectives for quality, we will review and revises our quality objectives on a yearly basis, as part of our Management Review. All aspects of service and achievements will be continually reviewed and where we identify either business risks or opportunities for improvement we will implement the appropriate corrective actions. We will maintain documented information, and any audit history, relating to our quality objectives.

In addition to the high-level quality objectives contained within our quality policy, Alias Business Systems top management have established quality objectives for the relevant functions & processes that make up our Quality Management System. Enhancing customer satisfaction is one of our principle quality objectives, as is our commitment to satisfying any other applicable requirements that are relevant to our organisation. Our quality objectives also include those needed to ensure conformity of our design services, products and related processes. These objectives are defined within the operating procedures that form part of our QMS and are communicated to all relevant personnel as detailed within our QMS awareness processes. The quality objectives within our operating procedures are monitored, measurable and consistent with the framework provided by our quality policy. Our commitment to delivering continual improvement is underpinned by our SMART objectives for quality.

QMS Home Page

Review of Quality Objectives


Planning of Quality Objectives Procedure

<< Planning






Planning:-

Planning of Changes

Revision: Date:


Sample 01/01/2017

Planning of Changes


QMS Home Page

Management Review

Inputs to Planning of

Changes

Non-Conformity & Corrective Action

Planning of Changes

Procedure

Operational Planning

Opportunities for Improvement


Impacts of Change

Consequences & Risks Resources

Integrity of Existing QMS

Changes in Responsibilities & Authorities

Outputs to Operational Planning


<< Planning






Support:-

Resources Processes & Procedures

Revision: Date:


Sample

Resources

01/01/2017


QMS Home Page << Support

Infrastructure Operational Environment

Monitoring & Measuring

Resources

Data Back-Up & Restore

People

People Operational Environment



Infrastructure

General

Internal & External Resources

Statement of Non-Applicability

Monitoring & Measuring

Resources












Support:-

Competence

Revision: Date:


01/01/2017Sample

Competence


Training Plan

Determine Competency

Requirements

Competency Skills Chart

Training / Achievement

Record

Induction & Refresher Training

Vocational Training

QMS Home Page

Review Competency Skills Chart

Update Competency Skills

Chart

Evaluate Effectiveness

of Training

Competency Management

Procedure

Review of Training

Requirements


<< Support






Operation:-




Sample



Operational Requirements

Stores & Stock Control

Design Activities

Customer Quotations

QMS Home Page << Operation

Release of Products & Services Purchasing

Inspection & Test Customer Orders

Technical Support & Repairs

Goods In Product Manufacture


Procedure

Projects

Input from Planning of Changes

Input from Opportunities for

Improvement

Output to Non-Conformities

Output to Management Review

Output to Planning of Changes

Product Manufacture (Outsourced)

Input from Operational Risks

Input from Control of Changes





8.2.1 Uncontrolled when printed Page 23 of 33...

Operation:-

Sales Enquiries

Revision: Date:


Requirements for Products & Services

Sample 01/01/2017


QMS Home Page << Operation

Issue Proposal to Customer

Customer Enquiry (Standard Product)

Can Requirements

Be Met?

Yes

No

Prepare Quotation

Proposal Review

Revise Proposal

Supporting Drawings &

Specifications

Proposal Approved

Yes

No Advise Customer

Decline RfP

Commercial & Technical Review

Prepare Project Proposal

Issue Quotation to Customer

Standard Product Price List

Customer Enquiry (Project)

Commercial & Technical Review

Can Requirements

Be Met?

Yes

No

Contract Review Procedure

Supporting Drawings &

Specifications







Monitoring, Measurement, Analysis & Evaluation

Revision: Date:


Sample 01/01/2017

Monitoring & Measuring Customer Satisfaction Analysis & Evaluation of Data

Monitoring, Measurement, Analysis & Evaluation


Evaluation of Customer

Satisfaction

RMA Returns Notes

Internal Audit Reports

Customer Feedback

<< QMS Home Page Performance Evaluation

Monitoring, Measurement, Analysis & Evaluation Procedure

Non-Conformance Register

Customer Satisfaction


QMS Processes & Procedures

Review of Suppliers

Review of Planning, Risks

& Opportunities

Customer Complaints








Internal Audit

Revision: Date:


Sample 01/01/2017

Internal Audit


QMS Audit by Certification Body

No

Yes

Non-Conformity Found

QMS Audit Plan

Internal Audit Report


Internal Audit Procedure

Raise Non-Conformance

Report

QMS Internal Audit

Internal Audit

QMS Home Page

Non-Conformance Report

<< Performance Evaluation




../ISO9001_2015 QMS/QMS Admin Files/Audit Plan.xlsx�




Management Review

Revision: Date:


Sample 01/01/2017

Management Review


Determine Corrective

Action

No

Yes

Actions Required

Management Review Schedule

Management Review Records Management

Review

Management Review

Procedure

Management Review Agenda

Management Review

QMS Home Page

Outputs to Continual Improvement

Outputs to Planning of Changes

<< Performance Evaluation






Improvement:-


Revision: Date:


01/01/2017Sample



QMS Home Page << Improvement

Opportunities for improvement

Outputs to Continual Improvement

Management Review

Product Development

Quality Objectives Internal Audits Analysis of Data



Procedure

Outputs to Planning of Changes Non-Conformity &

Corrective Action







Improvement:-


Revision: Date:


Sample 01/01/2017



QMS Home Page

Undertake Root Cause Analysis


Identify Corrective Action

Raise Non-Conformance

Report

Implement Corrective Action

Review Actions for Effectiveness

Close Non-Conformance on Register

No

Yes Actions Effective

Non-Conformity Identified

Record Actions on Non-Conformance

Register

Non-Conformity & Corrective

Action Procedure



<< Improvement






Improvement:-


Revision: Date:


Sample 01/01/2017



QMS Home Page

Management Review


Quality Objectives Internal Audits Analysis of Data

QMS Continual Improvement


Procedure


External Audit

Inputs to Continual

Improvement



<< Improvement





QmsRevLog Uncontrolled when printed Page 30 of 33...

QMS Front Page Front PageQMS Home Page Home PageContext of the Organisation:- Contents & StructureLeadership:- Contents & StructurePlanning:- Contents & StructureSupport:- Contents & StructureOperation:- Contents & StructurePerformance Evaluation:- Contents & StructureImprovement:- Contents & StructureContext of the Organisation:- Our Organisation & Its ContextContext of the Organisation:- The Needs & Expectations of our Interested PartiesContext of the Organisation:- The Scope of our Quality Management SystemContext of the Organisation:- Our Quality Management System & Its ProcessesLeadership:- Leadership & CommitmentLeadership:- Quality PolicyLeadership:- Organisational Roles, Responsibilities & AuthoritiesPlanning:- Actions to Address Risks and OpportunitiesPlanning:- Quality Objectives & Planning to Achieve ThemPlanning:- Planning of Changes Support:- ResourcesSupport:- Resources Internal & External Resources ProcedureSupport:- Resources People Support:- Resources InfrastructureSupport:- Resources Data Backup & Restore Support:- Resources Operational EnvironmentSupport:- Resources Monitoring & Measuring ResourcesSupport:- Resources Organisational KnowledgeSupport:- CompetenceSupport:- Awareness

Revision: Date:

Sample 01/01/2017Sample 01/01/2017Sample 01/01/2017Sample 01/01/2017Sample 01/01/2017

QMS Documented Information Revision LogQMS Section QMS Document Title

7.1.17.1.27.1.37.1.3

N/A Sample 01/01/2017

01/01/201701/01/201701/01/201701/01/201701/01/2017

Sample 01/01/2017

01/01/201701/01/201701/01/201701/01/2017

01/01/2017

SampleSampleSample

SampleSample

Sample 01/01/20177.1.57.1.4

7.1.6

Sample 01/01/2017

01/01/2017

6.16.26.37.1

7.27.3

SampleSampleSampleSampleSampleSampleSampleSample


4.14.24.34.45.15.25.3

ISO Ref: Date

01/01/2017

Revision

01/01/201701/01/2017

Sample


4 Sample56789

N/A

10

Sample01/01/2017

Sample 01/01/2017Sample 01/01/2017Sample 01/01/2017Sample 01/01/2017Sample 01/01/2017

01/01/2017

QMS Home Page Next Page >

QmsRevLog Uncontrolled when printed Page 31 of 33...



Support:- CommunicationSupport:- Documented InformationSupport:- QMS Documented InformationSupport:- Operational Documented InformationOperation:- Operational Planning & ControlOperation:- Requirements for Products & Services Sales EnquiriesOperation:- Requirements for Products & Services Sales Order ProcessingOperation:- Design & Development of Products & ServicesOperation:- Control of Externally Provided Processes, Products & ServicesOperation:- Production & Service Provision Control of ProjectsOperation:- Production & Service Provision In-Process, Final Inspection & TestOperation:- Production & Service Provision Property belonging to Customers or External ProvidersOperation:- Production & Service Provision Goods Inward, Stores & Materials ControlOperation:- Production & Service Provision Technical Support & RepairsOperation:- Production & Service Provision Control of ChangesOperation:- Release of Product & ServicesOperation:- Control of Non-Conforming OutputsPerformance Evaluation:- Monitoring, Measurement, Analysis & EvaluationPerformance Evaluation:- Internal AuditPerformance Evaluation:- Management ReviewImprovement:- Opportunities for ImprovementImprovement:- Non-Conformity & Corrective Action Improvement:- Continual ImprovementUsing our QMS How to use this QMS, and what lives where in ISO9001:2015…

Revision: Date:

7.57.5

7.47.5

QMS Documented Information Revision Log

ISO Ref: Revision DateQMS Document TitleQMS Section

8.1

SampleSample 01/01/2017

01/01/2017Sample

Sample 01/01/2017Sample 01/01/2017

SampleSample

01/01/2017

01/01/201701/01/2017

Sample 01/01/201710.3 01/01/2017

8.5.6

SampleSample

01/01/2017

Sample

Sample

SampleSample

8.5.5

01/01/201701/01/201701/01/201701/01/2017

01/01/2017

01/01/201701/01/2017

Sample

SampleSampleSampleSampleSampleSample

Sample

SampleSample

01/01/2017Sample

8.2.18.2.38.38.4

8.5.18.5.28.5.38.5.4

01/01/201701/01/201701/01/201701/01/201701/01/201701/01/2017

8.68.79.19.29.3

10.110.2

01/01/2017

QMS Home Page < Previous Page

Uncontrolled when printed Page 32 of 33

Revision: Date:


01/01/2017Sample

How to use this QMS, and what lives where in ISO9001:2015…


The main sections of the QMS can be accessed by clicking on the relevant button: ---------------- The "QMS Home Page" is accessed by clicking on the green button: ----------------------------------- Navigation within each section is done using the blue buttons at the foot of each page: ---------

ISO9001:2015 is an internationally recognised standard that provides organisations with a framework for the management of quality related business activities. The adoption of a quality management system is a strategic decision for an organization that can help to improve its overall performance and provide a sound basis for sustainable development initiatives. The potential benefits to an organisation of implementing a quality management system based on this International Standard are significant and should be viewed as an investment that will underpin the continued effectiveness of the organisation.

Next Page >

This Quality Management System has been developed to provide the user with a simplified method of navigating their way around its various sections, processes & procedures. Each page contains a number of "buttons" with hyperlinks that are configured to connect directly to the various parts of the system.

Resources

QMS Home Page

Next Page >

Uncontrolled when printed Page 33 of 33



Revision: Date: 01/01/2017Sample

ISO9001:2015 had been revised and its structure is based on the Plan, Do, Check, Act cycle (PDCA). This PDCA approach is reflected in the structure of this QMS. The table above shows where the quality process &

procedures for the various aspects of the organisation are located.

Act


Corrective Action


Check

Business Performance

Analysis

Non-conformities

Management Reviews

Do

Sales & Marketing Design

Purchasing Materials Control

Manufacturing Inspection & Test

Projects Despatch

Service & Support

Plan

Leadership Context of our Organisation Planning Support Operation Performance

Evaluation Improvement

Our Context

Who we are What we do

Who we work for Who we work with How we do things Scope of our QMS

Planning

Risks & Opportunities And how we

plan for them

Leadership

Management Roles, Responsibilities & Authorities Quality Policy

Quality Objectives

Support

People Offices

Equipment Training

Communication Documentation

QMS Home Page < Previous Page

Documents

ISO9001:2015 Quality Management System · 2017-02-21 · Top management, including our Director / General Manager, are responsible for, and committed to, establishing our Quality