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Quality Manual

ISO9001 Toolkit Version 1 ©CertiKit


Quality Manual

Implementation Guidance (The header page and this section must be removed from final version of the document)

Purpose of this document The Quality Manual is a document which acts as the root definition of the Quality Management System (QMS).

Areas of the standard addressed The following areas of the ISO9001 standard are addressed by this document: 5 Leadership

General Guidance The quality manual should be approved by Top Management (normally defined as the “person or group of people who direct and control the organization at the highest level”) as evidence of their commitment. This manual refers in places to other documents which provide more detail; the exact structure of documentation is not mandated by the ISO9001 standard and so you could choose to add some of the contents of other documents into this manual to reduce the total number of documents in your QMS. We would also recommend that this document is made available via the intranet if you have one or via any other appropriate means.

Review Frequency We would recommend that this document is reviewed as part of an annual exercise which also covers key documents such as the risk assessment and training plan. This exercise should include significant business involvement to ensure that changed requirements are captured and customer feedback obtained.

Toolkit Version Number ISO9001 Toolkit Version 1 ©CertiKit.

Document Fields This document may contain fields which need to be updated with your own information, including a field for Organization Name that is linked to the custom Version 1

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document property “Organization Name”. To update this field (and any others that may exist in this document): 1. Update the custom document property “Organization Name” by clicking File > Info > Properties > Advanced Properties > Custom > Organization Name 2. Replace the text [Organization Name] with the name of your organization and click the Modify button to update it 3. Press Ctrl a on the keyboard (if using a Mac, this is Command a) to select all text in the document (or use Select, Select All on the ribbon) 4. Press F9 on the keyboard to update all fields. If using a Mac, right-click (if enabled) or Control-click, and select Update Field 4. 5. When prompted, choose the option to just update TOC page numbers If you wish to permanently convert the fields in this document to text i.e. so that they are no longer updateable, then you will need to click into each occurrence of the field and press Ctrl Shift F9. If you would like to make all fields in the document visible then go to File > Options > Advanced > Show document content > Field shading and set this to “Always”. This can be useful to check that you have updated all fields correctly. Further detail on the above procedure can be found in the Toolkit Completion Instructions within the Implementation Resources folder.

Copyright notice Except for any third party works included in this document, as identified in this document, this document has been authored by CertiKit, and is © copyright CertiKit except as stated below. CertiKit Limited is a company registered in England and Wales with company number 6432088.

Licence terms This document is licensed on and subject to the standard licence terms of CertiKit, available on request, or by download from our website. All other rights are reserved. Unless you have purchased this product you only have an evaluation licence. If this product was purchased, a full licence is granted to the person identified as the licensee in the relevant purchase order. The standard licence terms include special terms relating to any third party copyright included in this document.

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risk. Document templates are intended to be used as a starting point only from which you will create your own document and to which you will apply all reasonable quality checks before use. Therefore please note that it is your responsibility to ensure that the content of any document you create that is based on our templates is correct and appropriate for your needs and complies with relevant laws in your country. You should take all reasonable and proper legal and other professional advice before using this document. CertiKit makes no claims, promises, or guarantees about the accuracy, completeness, or adequacy of our document templates, assumes no duty of care to any person with respect its document templates or their contents, and expressly excludes and disclaims liability for any cost, expense, loss or damage suffered or incurred in reliance on our document templates, or in expectation of our document templates meeting your needs, including (without limitation) as a result of misstatements, errors and omissions in their contents.

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Revision History Version Date

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Contents 1

INTRODUCTION ....................................................................................................................................... 7

2

QUALITY MANUAL ................................................................................................................................. 8 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9

TOP MANAGEMENT LEADERSHIP AND COMMITMENT ............................................................................... 8 FRAMEWORK FOR SETTING OBJECTIVES ................................................................................................... 8 ROLES AND RESPONSIBILITIES .................................................................................................................. 8 CONTINUAL IMPROVEMENT OF THE QMS ................................................................................................. 9 APPROACH TO MANAGING RISKS AND OPPORTUNITIES ............................................................................ 9 HUMAN RESOURCES ................................................................................................................................. 9 AUDITING AND REVIEW .......................................................................................................................... 10 DOCUMENTATION STRUCTURE AND POLICY ........................................................................................... 10 CONTROL OF RECORDS ........................................................................................................................... 10

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1 Introduction This manual defines how a Quality Management System (QMS) will be set up, managed, measured, reported on and developed within [Organization Name]. Whist it doesn’t give any absolute guarantees of quality, a QMS can contribute significantly towards delivering many of the following benefits to [Organization Name]: • • • • • • • • • •

Significantly reduced risk of reputational damage, legal penalties or business revenue due to quality issues Peace of mind assurance to our customers, staff, board members, suppliers and other interested parties that our products and services are of defined quality An ability to bid for and respond to tenders for business where ISO9001 certification is a requirement A public demonstration that [Organization Name] takes quality management seriously Internal and external recognition of the quality controls in place Year-on-year improvement in the quality of our products and services as a result of the continuous improvement aspects of the standard A strong move away from reactive fire-fighting towards proactive quality management Better alignment of quality management with the needs of the business and our customers through regular review meetings with interested parties Better perception and awareness of quality issues within the business, our customers and other stakeholders An improved ability to manage quality issues if they do occur, so reducing reputational damage and limiting business impact to us and our customers

The International Standard for Quality Management Systems, ISO9001:2015 (referred to in this document as ISO9001), is a development of the earlier British Standard, BS 5750 and was first published in 1987. This standard defines the requirements for a QMS based on internationally-recognized best practice. [Organization Name] has decided to pursue full certification to ISO9001 in order that the effective adoption of quality management best practice may be validated by an independent third party, a Registered Certification Body (RCB).

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2 Quality Manual 2.1

Top Management Leadership and Commitment

Commitment to quality management extends to senior levels of the organization and will be demonstrated through this Quality Manual and the provision of appropriate resources to provide and develop the QMS and associated procedures and controls. Top management will also ensure that a systematic review of performance of the programme is conducted on a regular basis to ensure that quality objectives are being met and relevant issues are identified through the audit programme and management processes. Management review can take several forms including departmental and other management meetings. The [Quality Manager] shall have overall authority and responsibility for the implementation and management of the Quality Management System, specifically: • • • • •

2.2

The identification, documentation and fulfilment of quality requirements Implementation, management and improvement of risk and opportunity management processes Integration of operational processes, procedures and controls Compliance with statutory, regulatory and contractual requirements Reporting to top management on performance and improvement

Framework for Setting Objectives

A regular cycle will be used for the setting of objectives for quality, to coincide with the budget planning cycle. This framework is documented in the Quality Policy.

2.3

Roles and Responsibilities

Within the field of quality management, there are a number of roles that correspond to the areas defined within the scope set out above. In a larger organization, these roles will often be filled by an individual in each area. In a smaller organization these roles and responsibilities must be allocated between the members of the team. Full details of the responsibilities associated with each of the roles and how they are allocated within [Organization Name] are given in a separate document QMS Roles, Responsibilities and Authorities. It is the responsibility of the [Quality Manager] to ensure that employees and contractors understand the roles they are fulfilling and that they have appropriate skills and competence to do so.

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2.4

Continual Improvement of the QMS

[Organization Name] policy with regard to continual improvement of the QMS is described in the Quality Policy.

2.5

Approach to Managing Risks and Opportunities

Risk and opportunity management will take place at several levels within the QMS, including: • • • •

Management planning – risks to the achievement of quality objectives will be assessed and reviewed on a regular basis Organization-wide risk and opportunity assessments Assessment of the risk of changes via the change management process As part of major projects to achieve business change e.g. new computer systems and services

High level risk and opportunity assessments will be reviewed on an annual basis or upon significant change to the business or service provision. A risk and opportunity assessment process will be used which is line with the requirements and recommendations of ISO9001, the International Standard for Quality Management Systems. This is documented in Risk and Opportunity Assessment Process. From this analysis, a risk and opportunity assessment report will be generated followed by a plan in which appropriate actions will be identified to address these risks and opportunities.

2.6

Human Resources

[Organization Name] will ensure that all staff involved in quality management are competent on the basis of appropriate education, training, skills and experience. The skills required will be determined and reviewed on a regular basis together with an assessment of existing skill levels within [Organization Name]. Training needs will be identified and a plan maintained to ensure that the necessary competencies are in place. Training, education and other relevant records will be kept by the HR Department to document individual skill levels attained.

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2.7

Auditing and Review

Once in place, it is vital that regular reviews take place of how well quality management processes and procedures are being adhered to. This will happen at three levels: 1. Structured regular management review of conformity to policies and procedures 2. Internal audit reviews against the ISO9001 standard (and accompanying codes of practice) by the [Organization Name] Internal Audit Team 3. External audit against the standard by a Registered Certification Body (RCB) in order to gain and maintain certification Details of how internal audits will be carried out can be found in Procedure for Internal Audits.

2.8

Documentation Structure and Policy

All quality management policies and plans must be documented. Details of documentation conventions and standards are given in the Procedure for the Control of Documented Information. A number of core documents will be maintained as part of the QMS. They are uniquely numbered and the current versions are tracked in the QMS Documentation Log.

2.9

Control of Records

The keeping of records is a fundamental part of the QMS. Records are key information resources and represent evidence that processes are being carried out effectively. The controls in place to manage records are defined in the document Procedure for the Control of Documented Information.

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QMS-DOC-05-2 Quality Manual  
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