Why you need to Understand the organisation and its context for your ISO Management System (MS) using a SWOT Analysis

Clause 4.1 of the ISO 9001:2015 Quality Management standard requires you to understand the organisation and its context.

Understanding the organisation's context requires you to monitor and review both internal and external issues that could have a positive or negative impact on your QMS and Strategic Objectives. Internal context considers topics such as values, culture, knowledge and performance of the organisation. External context considers legal, technological, competitive, market, cultural, social, and economic issues.

Title Strengths & Weaknesses

The Strengths and Weaknesses columns identify the internal issues within the context of the organisation and MS. For example, this could include:

• Core values that support your vision
• Reputation for quality
• Employee skills and knowledge
• Resources and scalability
• Cashflow and financial status
• Service levels and performance
• Systems and consistency of process outputs

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Opportunities

This column identifies the external Opportunities within the context of the organisation and MS. For example, this could include:

• ISO standards
• New markets
• Strategic plans

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Threats

This column identifies the external issues within the context of the organisation and MS. For example, this could include:

• Political – Considers government rules, policies, frameworks, etc.
• Economical – Considers economic growth, inflation, minimum wage, etc.
• Social – Considers cultural expectations, career attitudes, population growth, etc.
• Technological – Considers latest innovations, robotics, cloud computing, etc.
• Environmental – Considers climate change, sustainability
• Legal - Considers legislation and contractual issues
  

It would be best if you addressed any significant threats and opportunities in your Risks and Opportunities register.

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Controlling the issues identified by the context of the organisation

This column lookups to the Controls list enabling you to easily select all the controls in place that ensure you address the issues identified by the organisation's context in your MS. For example, maintaining employee skills and knowledge could include:

• Induction Process
• Training Programme
• Documented Operational Procedures
• Record of Roles & Responsibilities
• Internal Audits

Having determined roles, responsibilities, and authorities for your ISO MS, you can now move to the next step:

Step Implementation Guides:

1: Roles & Responsibilities

2: Aims and objectives

3: Controls

4: SWOT Analysis

5: Interested Parties

6: Legal Register

7: Processes & Procedures

8: Key Performance Indicators

9: Risks & Opportunities

10: Audit Programme