QMS Context, Requirements and Scope Questionnaire Guidelines
ISO9001: QMS-DOC-04-1 QMS Context, Requirements and Scope
Purpose
The purpose of this questionnaire is to gather information relating to what the organisation does, how it does it, what factors influence the way it operates and the reasons for the definition of the scope of the QMS.
Scope
The following areas of the ISO9001 standard are addressed:
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4. Context of the Organization
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4.1 Understanding the organization and its context
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4.2 Understanding the needs and expectations of interested parties
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4.3 Determining the scope of the QMS
General guidance
The questionnaire can be partially completed and saved at any stage by clicking the “Save” button at the bottom of a page.
Please ensure that all information is complete and accurate before final submission.
Copyright notice
The questionnaire is copyright of Reflect Quality Limited © Reflect Quality Limited 2023. All rights reserved.
Reflect Quality Limited is a UK Limited company registered in Northern Ireland under company number NI689162.
Disclaimer
The questionnaire is designed as a tool to record information you provide about your organisation.
It is therefore your responsibility to ensure that the information you provide 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.
Reflect Quality Limited makes no claims, promises, or guarantees about the accuracy, completeness or adequacy of the questionnaire; assumes no duty of care to any person with respect to its content and expressly excludes and disclaims liability for any cost, expense, loss or damage suffered or incurred in reliance on the questionnaire meeting your needs, including (without limitation) as a result of misstatements, errors and omissions in its contents.
Risk and Opportunity Management
PESTLE
The following provides some examples of external issues which could be included in the PESTLE analysis.
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Political
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Government policy changes
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Trade restrictions and tariffs
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Economic
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Prevailing economic climate
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Supplier failure
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Social
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Changing demographics
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Social attitudes
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Technology
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Pace of innovation
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Automation and artificial intelligence
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Legal
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Potential legislative changes
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Data protection
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Environmental
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Climate change
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Pollution
SWOT ANALYSIS
SWOT stands for Strengths, Weaknesses, Opportunities and Threats.
Strengths and weaknesses are internal issues.
Examples might include:
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Strengths
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Staff skills and experience
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Unique Selling Point
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Weaknesses
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Are you lacking in any assets?
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Are there any gaps in your staff?
Opportunities and threats, meanwhile, are external issues.
Examples might include:
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Opportunities
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A growing market, or certain trends
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Changes in technology
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Threats
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Your competitors
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Issues with suppliers