ISO9001 Toolkit Version 2 Â©CertiKit
Implementation Guidance (The header page and this section must be removed from final version of the document)
Purpose of this document The quality policy acts as the root “Quality Manual” of the Quality Management System (QMS) and must be approved by Top Management (defined as the “person or group of people who direct and control the organisation at the highest level”) as evidence of their commitment.
Areas of the standard addressed Section 5.2 of the standard sets out some of what the policy must contain, and these areas are covered by the template document. We would therefore recommend that no section headings are removed.
General Guidance Prior to the certification audit you must ensure that the policy has been communicated to relevant staff, that they have understood it and that these facts are evidenced e.g. via meeting minutes. The inviting and answering of questions during such a meeting is likely to show evidence of understanding. We would also recommend that the document is made available via the intranet if you have one or any other appropriate means.
Review Frequency We would recommend that this document is reviewed as part of an annual exercise which should include significant business involvement to ensure that changed requirements are captured and feedback obtained.
Toolkit Version Number ISO9001 Toolkit Version 2 ©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 document property “Organization Name”.
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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.
Disclaimer Please Note: Your use of and reliance on this document template is at your sole risk. Document templates are intended to be used as a starting point only from
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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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[Replace with your logo]
Document Ref. Version: Dated: Document Author: Document Owner:
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QMS-DOC-05-1 1 [Insert date]
Revision History Version Date
Summary of Changes
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INTRODUCTION ....................................................................................................................................... 8
QUALITY POLICY ................................................................................................................................... 9 2.1 2.2 2.3 2.4 2.5
SETTING OBJECTIVES ................................................................................................................................ 9 COMMITMENT TO SATISFYING APPLICABLE REQUIREMENTS .................................................................... 9 CONTINUAL IMPROVEMENT OF THE QMS ............................................................................................... 10 APPROACH TO MANAGING RISKS AND OPPORTUNITIES .......................................................................... 11 CONTROL OF DOCUMENTS AND RECORDS............................................................................................... 12
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1 Introduction As a modern, forward-looking business, [Organization Name] recognises at senior levels the need to ensure that its business operates smoothly and that its products and services satisfy requirements for the benefit of its customers, shareholders and other stakeholders. In order to provide such assurance, [Organization Name] has implemented a Quality Management System (QMS) in line with the international standard for quality management systems, ISO9001. The operation of this QMS has many benefits for the business, including: • • • •
Protection of revenue streams and company profitability Ensuring goods and services meet customer requirements Maintenance and enhancement of shareholder value Compliance with legal and regulatory requirements
It is important to understand which areas of the business are currently within the umbrella of the QMS and which are excluded. The boundaries of the QMS as implemented within [Organization Name] are defined within the document entitled QMS Context, Requirements and Scope. It is recommended that this document should be reviewed in conjunction with this policy. The purpose of this document is to define an overall policy with regard to quality management that is appropriate to the purpose of [Organization Name], and includes: • • •
A framework for setting objectives A commitment to satisfying applicable requirements A commitment to continual improvement of the QMS
This QMS Policy is available in both paper and electronic form and will be communicated within the organisation and to all relevant stakeholders and interested third parties.
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2 Quality Policy 2.1
The high-level objectives for quality management within [Organization Name] are defined within the document QMS Context, Requirements and Scope. These are fundamental to the nature of the business and are not be subject to frequent change. These overall objectives will be used as guidance in the setting of lower level, more short-term objectives for quality planning within an annual cycle timed to coincide with organisational budget planning. This will ensure that adequate funding is obtained for the improvement activities identified. These objectives will be based upon a clear understanding of the overall business requirements and how they may change during the year. Quality objectives will be documented in the Quality Management Plan for the relevant financial year, together with details of a plan for how they will be achieved. Once approved, this plan will be reviewed on a quarterly basis as part of the management review process, at which time the objectives will also be reviewed to ensure that they remain valid. If amendments are required, these will be managed through the organisational change management process.
Commitment to Satisfying Applicable Requirements
Commitment to the delivery of quality management extends to senior levels of the organisation and will be demonstrated through this Quality Policy and the provision of appropriate resources to establish and develop the Quality Management System. 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 quality issues are identified through the audit programme and management processes. Management Review can take several forms including departmental and other management meetings. Within the field of Quality Management, there are a number of key roles that need to be undertaken to ensure the success of the QMS and protect the business from risk. The [Quality Manager] shall have overall authority and responsibility for the implementation and management of the Quality Management System, specifically: • • • •
The identification, documentation and fulfilment of applicable requirements Assigning authorities and responsibilities for the implementation, management and improvement of quality management processes Integration of business processes with the QMS Compliance with statutory, regulatory and contractual requirements in the management of assets used to deliver products and services
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Reporting to top management on performance and improvement of the QMS
It is also the responsibility of the [Quality Manager] to ensure that employees understand the roles they are required to fulfil and that they have appropriate skills and competence to do so. [Organization Name] will ensure that all employees involved in quality management are competent on the basis of appropriate education, training, skills and experience. The skills required to ensure business quality 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. Full details of the responsibilities associated with each of the required roles and how they are allocated within [Organization Name] are given in a separate document entitled QMS Roles, Responsibilities and Authorities. [Organization Name] makes use of various third parties, both internal and external, in the delivery of products and services to its customers. Where this involves the operation of a business process, or a part of the process on behalf of [Organization Name], that falls within the defined scope of the QMS, this is identified in the Quality Management Plan. In all cases, [Organization Name] will retain governance of the relevant quality management processes by demonstrating: • • • •
Accountability for the process Control of the definition of and interface to the process Performance and compliance monitoring Control over process improvements
This will be evidenced by documents and records such as contracts, meeting minutes and performance reports.
Continual Improvement of the QMS
[Organization Name]’s policy with regard to Continual Improvement of the QMS is to: ➢ Continually improve the effectiveness of the Quality Management System across all areas within scope ➢ Enhance current processes to bring them into line with good practice as defined within ISO9001 ➢ Achieve ISO9001 certification and maintain it on an on-going basis
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➢ Increase the level of proactivity (and the business perception of proactivity) with regard to the on-going management of quality ➢ Achieve an enhanced understanding of, and relationship with, the business units to which the QMS applies ➢ Review relevant metrics on an annual basis to assess whether it is appropriate to change them, based on collected historical data and feedback from relevant sources ➢ Obtain ideas for improvement via regular review meetings with stakeholders and document them ➢ Review ideas for continual improvement at regular management meetings in order to prioritise them and assess timescales and benefits Ideas for improvements may be obtained from any source including customers, suppliers, employees, risk assessments and audits. Once identified they will be documented and evaluated by the staff member responsible for continual improvement. As part of the evaluation of proposed improvements, the following criteria will be used: • • • • •
Cost Business Benefit Risk Implementation timescale Resource requirement
If accepted, the improvement proposal will be prioritised in order to allow more effective planning.
Approach to Managing Risks and Opportunities
Risk and opportunity management will take place at several levels within the Quality Management System, including: • • • •
Quality planning – risks to the achievement of quality objectives Organization-wide risk and opportunity management As part of the business change management process As part of individual business projects
High level risk and opportunity assessments will be reviewed on an annual basis, or upon significant change to the business environment. For more detail on the approach to risk assessment please review the document Risk and Opportunity Assessment Process. 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:
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1. Structured regular management review of conformity to policies and procedures within [Organization Name] 2. Internal audit reviews against the ISO9001 standard by the [Organization Name] Quality Team 3. External audit against the standard in order to gain and maintain certification to ISO9001 Details of how internal audits will be carried out can be found in the Procedure for Internal Audits.
Control of Documents and Records
All quality management policies and plans that form part of the QMS must be documented. The way in which these documents are created and managed through their lifecycle is set out in Procedure for the Control of Documented Information. All documents in the QMS are uniquely numbered and the current versions are tracked â€“ see document QMS Documentation Log. The keeping of records is a fundamental part of the Quality Management System. Records are key information resources and represent evidence that processes are being carried out effectively. The controls in place to manage records are also defined in the document Procedure for the Control of Documented Information.
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