Situational Analysis ISO 9001 2015 | QP0500

ISO Situational Analysis Procedure

The ISO Situational Analysis Procedure identifies how the Company is situated in the marketplace and interacts with the business environment. It evaluate its current situation in order to develop a meaningful quality strategy that leverages the Company’s strengths and minimize its weaknesses in conformance with the company’s QMS and ISO 9001:2015. (14 pages, 2358 words)

ISO Situational Analysis Responsibilities

Top Management is responsible for ensuring the situational analysis is appropriate for developing quality strategies.

The Quality Manager is responsible for ensuring the QMS conforms to requirements, processes are delivering intended results, reporting on QMS performance and improvement, promoting the customer focus, and ensuring the integrity of the QMS throughout planned changes.

The Strategy Team is responsible for gathering information on the Company’s situation, analyzing the information, and preparing and presenting a situational analysis report.

ISO Situational Analysis Definition

Situational analysis – Also known as a “SWOT analysis.”An in-depth process for developing an understanding of the needs of the customer, which involves a combination of data gathering techniques conducted from a variety of internal and external perspectives; a methodology used to aid the organization’s strategic planning process; identifying, evaluating, and planning around the organization’s strengths, weaknesses, opportunities, and threats.

Strengths and Weaknesses are internal and may include topics related to values, culture and performance of the organization.

Opportunities and Threats are external and may include issues related to values, culture and performance of the organization.

ISO Situational Analysis Activities

• Situational Analysis Introduction
• Assessing the Company’s Situation
• SWOT Scoring Attributes
• Analyzing the Data
• Situational Analysis Report
• QMS Components

ISO Situational Analysis References

• ISO 9001:2015, “Quality Management Systems – Requirements”, International Organization for Standardization (ISO), Sept., 2015 http://www.iso.org.
• Statutory and Regulatory Requirements
  • Laws & Regulations: Certain businesses (e.g., food processors, medical, chemical and pharmaceutical manufacturers) are required to identify, evaluate, and manage risks (a) to comply with laws and regulations and (b) because their products or processes have the potential to adversely affect worker or consumer health and safety. These organizations are strongly urged to seek the help of qualified and competent legal counsel, as well as certified and experienced health and safety experts.
• Quality Procedures
  • Risk Opportunities Management ISO 9001 2015

ISO Situational Analysis Forms

• SWOT Analysis Worksheet
• Competitive Analysis Worksheet
• Situational Analysis Report