SWOT Analysis

After understanding the business environment in which the organization is active and the factors that
influence this environment, the organization must evaluate itself. SWOT analysis (or SWOT model) was
originally developed as a corporate planning tool. The analysis uses comparative data that enables the
organization to evaluate itself and to help develop and shape a strategy—in our case, the QMS. SWOT
evaluates the internal business environment of an organization through four axes: Strengths, Weaknesses,
Opportunities, and Threats. Most of us know or use SWOT as part of our marketing strategy. But in fact
the conclusions of this analysis may assist organizations in identifying the relevant quality elements that
affect the
Context of the Organization 13
QMS: products and/or services, processes, and resources. The principle of SWOT analysis is easy to
understand:
• What is good in the present and in the past is a strength
• What is bad in the present and in the past is a weakness
• What is good in the future is an opportunity
• What is bad in the future is a threat
The Strengths, Weaknesses, Opportunities, and Threats are axes of the analysis. Each of these axes will
be analyzed according to the next index:
• Product (what are we realizing?)
• Process (how do we realize the product?)
• Customer (to whom are we delivering it?)
• Administration (and how do we manage these activities?)
What is the difference between PEST and SWOT analysis? PEST analysis measures the market and
external business environment that a business unit is active in. SWOT analysis measures the internal
factors of the business unit. The factors of PEST analysis cannot be influenced; the factors of SWOT can.
The most effective (and easy) way to perform a SWOT analysis is to begin with answering question
regarding each of the parameters mentioned earlier.
Strengths
The strengths are the internal attributes and resources that support the realization of the product and the
establishment, implementation, maintenance, and improvement of the QMS. In other words, the
advantages the organization has to realize the product or service. The appropriate questions in this case
will be
• What are the reasons that on their behalf we achieve our objectives (process,
administration)?
• Which resources in the organization are at our advantage and support the realization of the product (product,
process)?
• Which knowledge in our organization is at our advantage (product, process)?
• Which processes do we perform better than others (process)?
• Which customer expectations and requirements do we meet the best (customer)?
• What are the reasons our customers are satisfied (customer)?
Weaknesses
Weaknesses are internal attributes that may interrupt the realization of the product and may produce a
nonconformity in the QMS. When analyzing the weaknesses it is highly recommended to consider it from
an external (as well as internal) point of view. With external point of view I mean—do other parties
perceive a weakness that you are unaware of? Another external point of view is seeing the strengths of
your competitors as your weaknesses. The appropriate questions in this case will be
• What are the reasons we do not achieve our objectives (process, administration)?
• Which resources in our organization we need to improve or supplement (process,
administration)?
14 ISO 9001:2015—A Complete Guide to Quality Management Systems
• What knowledge are we lacking in order to achieve our objectives (process, product)?
• Which processes we need to improve (process)?
• Which customer expectations do we fail to understand or answer (product,
customer)?
• What are the reasons our customers are not satisfied (product, customer)?
Opportunities
Opportunities are factors the organization can draw advantages from in the future. These are the chances
for improvements that the ISO 9001 is so fond of. A lot is written on this topic in this standard—many of
the standard’s clauses refer directly to the opportunities. In fact the standard requires an assessment of
external as well as internal issues that may serve as opportunities that may assure that the QMS can
achieve its objectives.
The outputs of the analysis of opportunities may serve as inputs to some of the standard’s clauses (e.g.,
6.1—Actions to address risks and opportunities, 6.3—Planning of changes). In these clauses, you will
need to demonstrate methods and manners for identifying opportunities (aside from SWOT analysis). So
the advantage of performing a clear and accurate analysis of opportunities will serve you with other
standard requirements. The appropriate questions in this case will be
• Which product features, customer expectations, or trends can we develop or
improve (product, customer)?
• Which processes can we do better (product, customer, admin)?
• Which outputs of PEST analysis can we view as opportunities for chances improvement (product, process,
customer, administration)?
Threats
Threats may be considered as the risks that the organization faces while managing the QMS and realizing
the products or services. Threats are the risks that may cause nonconformities in the QMS or in the
realization processes, which the organization must address and eliminate. In fact the standard requires that
the organization address risks that may affect the ability of the organization to provide a product
according to the expectations of the interested parties. While conducting SWOT analysis, you need to
assess the factors that may influence this ability. The appropriate questions in this case will be
• Which regulatory issues or standard specifications may affect the realization
processes or the products (process, product)?
• Which technological issues may affect the product, its realization, or its distribution
(process, product)?
• Which economic issues may affect the product, its realization, or its distribution
(process, product)?
• Which processes, product characteristics, and/or customer satisfaction factors may
be affected by upcoming changes or events (process, product, and customer)?
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Determining and Documenting the Internal and External Issues and the Context of the Organization
After completing the analyses discussed earlier, gathering all the information and identifying the issues
that may influence the organizational context and affect the QMS, you are in a position to define what
internal and external issues are relevant to the organization and its QMS. We reviewed the business
environment through PEST analysis. We analyzed our SWOT. Now we should have enough inputs and
should know which issues are affecting our activities and what the extent of each one is.
I highly recommend documenting this analysis for the following reasons:
• In clause 4.1 (Understanding the organization and its context) there is no explicit
requirement for documented information, but in clause 4.3 (Determining the
scope of the quality management system) it is required to maintain as documented
information the scope of the organization’s QMS. The analyses and its conclusion
are a great part of the scope.
• In clause 4.2 (Understanding the needs and expectations of interested parties), the
organization is required to monitor and review information about the interested
parties and their relevant requirements. This review is done through update of the
analysis mentioned in this clause.
• Audit—During an audit you will probably be asked to explain and demonstrate how
you reached the conclusion of your analysis. When the day comes and the question
will pop “please enlighten me how you came to all these conclusions?” you then will
refer to the quality manual (if you decide to maintain one) or any other document
and will have all the answers at hand.
In case you decide to still maintain your quality manual, you may include the conclusions there; just add
chapters bearing the information and conclusions you came to during your analyses.