Quality Management System Context, Requirements and Scope
ISO9001 Toolkit: Version 4 ©CertiKit
QMS Context, Requirements and Scope
Implementation guidance The header page and this section, up to and including Disclaimer, must be removed from the final version of the document. For more details on replacing the logo, yellow highlighted text and certain generic terms, see the Completion Instructions document.
Purpose of this document This document sets out the organizational context of the QMS. It describes what the organization does, how it does it, what factors influence the way it operates and the reasons for the definition of the scope of the QMS.
Areas of the standard addressed This document addresses many of the requirements in section 4 – “Context of the Organization” in the ISO9001 standard. This includes: •
4. Context of the Organization o 4.1 Understanding the organization and its context o 4.2 Understanding the needs and expectations of interested parties o 4.3 Determining the scope of the QMS
General guidance This is a vital document that will need involvement from senior management to put together. In overview, it describes why an effective QMS is needed and what may happen to the organization if one is not in place. The business processes and risk assessments required by later sections of the standard will then define this in more detail. As part of the implementation you may need to meet with the various interested parties to understand their view of the risk areas and consequences of failure. You may also need to obtain legal advice if your industry is subject to significant legal or regulatory requirements. As with most of the documents in the QMS you should ensure that all relevant parties are aware of the contents of this document, particularly as it sets out the need for additional procedures which may involve asking employees to do more work. Understanding the reason for this may reduce resistance to the QMS within the organization. It is worth spending some time getting the scope of the QMS right as the other areas of the standard rely upon this. As with most international standards, it is acceptable to start with a limited scope definition and then to expand it over time as more familiarity and experience is gained by the organization. Version 1
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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.
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”. 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. Press Ctrl A on the keyboard to select all text in the document (or use Select, Select All via the Editing header on the Home tab). 3. Press F9 on the keyboard to update all fields. 4. When prompted, choose the option to just update TOC page numbers. If you wish to permanently convert the fields in this document to text, for instance, so that they are no longer updateable, 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, go to File > Options > Advanced > Show document content > Field shading and set this to “Always”. This can be useful to check you have updated all fields correctly. Further detail on the above procedure can be found in the toolkit Completion Instructions. This document also contains guidance on working with the toolkit documents with an Apple Mac, and in Google Docs/Sheets.
Copyright notice Except for any specifically identified third-party works included, this document has been authored by CertiKit, and is ©CertiKit except as stated below. CertiKit is a company registered in England and Wales with company number 6432088.
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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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Quality Management System Context, Requirements and Scope
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Contents 1
Introduction.............................................................................................................. 8
2
Organizational context .............................................................................................. 9 2.1
Relevant external issues ............................................................................................... 9
2.2
Relevant internal issues ............................................................................................. 11
3
Needs and expectations of interested parties .......................................................... 12
4
Scope of the QMS ................................................................................................... 14 4.1
Organizational units, functions and physical boundaries ............................................. 14
4.2
Activities, products and services ................................................................................. 14
4.3
Exclusions .................................................................................................................. 14
Tables Table 1: Relevant external issues ................................................................................................ 10 Table 2: Relevant internal issues................................................................................................. 11 Table 3: Needs and expectations of Interested Parties, Legal and Regulatory Bodies.................... 12
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1 Introduction [Organization Name] is committed to ensuring the quality of its products and services and to enhancing customer satisfaction and has implemented a Quality Management System (QMS) that is compliant with ISO9001, the international standard for quality management systems. The purpose of this document is to describe the way the business operates, internal and external factors influencing it and to highlight in general terms the direction of the organization. This will allow the scope of the QMS to be appropriately defined and high-level objectives to be set.
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2 Organizational context The organizational context of [Organization Name] is set out in the following sections. Given the fast-moving nature of the business and the markets in which it operates, the context will change over time. This document will be reviewed on an annual basis and any significant changes incorporated. The QMS will also be updated to cater for the implications of such changes. [Organization Name] undertakes a wide range of business activities within its target sectors and is constantly developing new products and services to bring to market. [Give some brief background to the organization, for example: • • • • • • • • • • • • • •
What does the organization do? When was it formed? What is its structure e.g. group of companies? What is its main industrial sector? Who are its main customers? In which geographical regions does it operate? What is its annual turnover? How is it organised into business functions or teams? Where are its main offices? Which products and services create the most revenue and profit? Which products and services are the most high profile? Are any of the products and services subject to external regulation? Do any of the products and services have a health and safety aspect? What supply chains does the organization rely on?]
2.1 Relevant external issues With regard to the external environment in which [Organization Name] operates, there are a number of external issues that create uncertainty and may affect the ability of the QMS to achieve its stated outcomes. These include: [List relevant external issues and explain briefly why they may affect the QMS. These are often grouped under the areas defined by the term PESTLE, for example:] AREA
REF
ISSUE
RELEVANCE
Political
POL1
Government policy changes
More stringent controls may be introduced..
POL2
Government instability
Lack of clear direction on matters affecting quality.
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AREA
Economic
Social
Technology
Legal
Environmental
REF
ISSUE
RELEVANCE
POL3
Unrest in countries in which the organization operates
Employees running the QMS may be in danger.
ECO1
Prevailing economic climate
Revenue levels will affect the resources available for the QMS.
ECO2
Interest and inflation rates
The cost of running the QMS may change.
ECO3
Supplier failure
Availability of key resources may be affected.
SOC1
Changing demographics
Aging population and increasing income may have an impact on QMS targets.
SOC2
Population growth changes
Increasing urbanization may affect requirements at some of our locations.
SOC3
Social attitudes
Increasing concern regarding our products may affect the outcomes our QMS must achieve.
TEC1
Pace of innovation
The QMS will need to cope with new technologies.
TEC2
Supporting technologies and infrastructure
We are reliant on the existing infrastructure working.
TEC3
Automation and artificial intelligence
Removal of human oversight may affect the QMS.
LEG1
Potential legislative changes
The targets we must meet may change.
LEG2
Regulatory changes
The regulator may change their approach to enforcement.
LEG3
Contractual changes
Stricter requirements may be introduced as part of new contracts.
ENV1
Climate change
Increasing effects of climate change must be catered for within the QMS.
ENV2
Fire, flood, earthquake etc
Natural events are likely to affect the operation of the QMS.
ENV3
Pollution
Pollution by third parties may affect the outcomes of the QMS.
Table 1: Relevant external issues
These external issues will be considered in more detail as part of the risk and opportunity assessment process.
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2.2 Relevant internal issues With regard to the business operations of [Organization Name], there are a number of internal issues that create uncertainty and may affect the ability of the QMS to achieve its stated outcomes. These include: [List relevant internal issues and explain briefly why they may affect the QMS, for example:] REF
ISSUE
RELEVANCE
INT1
The strategic direction of the organization
The direction of the business will have implications which will need to be managed by the QMS.
INT2
The nature of the organization’s products and services
New products and services will result in changed requirements.
INT3
Internal environmental conditions
Some of our control systems are due for replacement and may become unreliable.
INT4
Uncertainties in employee relations
At some sites there is a history of employee dissatisfaction which could affect the performance of the QMS.
INT5
Significant organizational changes
Changes to the organizational structure will have implications for training and roles within the QMS.
INT6
Location moves
The closing down of locations will affect the operation of the QMS.
INT7
Company financial performance
Good financial results will allow more investment in the QMS.
INT8
Perceptions, values and culture
At some locations there is a perceived lack of focus on quality management which could affect the success of the QMS.
INT9
Available capabilities and knowledge
In some countries in which we operate the required skills are hard to recruit to.
INT10
Available resourcing levels
The QMS will need significant resources in order to achieve its outcomes.
Table 2: Relevant internal issues
[You could choose to group internal issues using a SWOT analysis – Strengths, Weaknesses, Opportunities and Threats] These internal issues will be considered in more detail as part of the risk and opportunity assessment process.
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3 Needs and expectations of interested parties This section of the document sets out the interested parties that are relevant to the QMS and which of their requirements are relevant. It also summarises the applicable legal and regulatory requirements to which the organization subscribes. An interested party is defined as “a person or organization that can affect, be affected by, or perceive itself to be affected by a decision or activity”. The following table shows the interested parties that are relevant to the QMS: INTERESTED PARTY, LEGAL OR REGULATORY BODY
REF
NEEDS AND EXPECTATIONS
RELEVANT TO THE QMS
Shareholders
R1
Value of share price should be maintained
No
Board of Directors
R2
Legal obligations must be met
Yes
R3
Organizational reputation must be protected
Yes
R4
Revenue stream must be maintained
No
R5
Payment schedule must be kept to
No
R6
Facility for receiving shipments must be available
Yes
R7
Consideration of quality factors in our products and services
Yes
Suppliers
Customers Regulatory bodies
Etc
Customer user groups Employees of the organization Contractors providing services to the organization National or local government organizations Emergency services Trade associations and industry bodies Trade unions Environmental Groups Health and Safety legislation
Table 3: Needs and expectations of Interested Parties, Legal and Regulatory Bodies
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Applicable legal and regulatory requirements arise from the following: • • • • • • • •
Sarbanes-Oxley Act 2002 (USA) European Union General Data Protection Regulation Health and Safety legislation Payment Card Industry – Data Security Standard compliance Financial Services legislation National and international standards e.g. ISO9001 Consumer protection legislation [Specify laws and regulation relevant to your organization]
For details of how applicable statutory and regulatory requirements are identified, accessed and assessed see the document Statutory and Regulatory Requirements Procedure.
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4 Scope of the QMS The defined scope of [Organization Name]’s QMS takes into account the relevant internal and external issues referred to in this document. It also reflects the needs and expectations of interested parties and the legal and regulatory requirements that are applicable to the organization. The scope is defined below in terms of the parts of the organization, products and services and related activities.
4.1 Organizational units, functions and physical boundaries The QMS includes the following parts of the [Organization Name] organization: [Specify the parts of the organization included in terms of business function, geographical location or other organizational boundary e.g. individual companies within a group structure]
4.2 Activities, products and services The following activities, products and services are within the scope of the QMS: [List the activities, products and services at an appropriate level of detail. This is more likely to be in the form of product and service types rather than specifics which are likely to change rapidly over time. The activities, products and services selected must be consistent with the organizational split given in the previous section]
4.3 Exclusions The following areas are specifically excluded from the scope of the QMS: [Detail what is excluded and why, in terms of organizational parts, products / services and activities. This must remain consistent with the overall approach and not compromise the ability of the QMS to produce the desired results and meet its objectives.]
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