Word Meanings Can Affect Interpretation

An important part of reading and understanding the standards is being clear on the meaning of some key words. You know the difference between Shall as used in ISO 9001 and Should as used in ISO 9004, but how do you interpret words like Can, May, Appropriate, Applicable, Competence, Necessary, Suitable, Determine, Identify, Evaluate, and Review?

Shall is used to indicate a requirement that must be strictly followed to conform to the Standard. For example, clause 6.4 states the organization shall determine and manage the work environment needed to achieve conformity to product requirements.

Should is used to indicate that among several possibilities one is recommended as particularly suitable, without mentioning or excluding others; or that a certain course of action is preferred, but not necessarily required. For example, the Note under clause 4.1 states the processes needed for the quality management system should include processes for management activities, provision of resources, product realization, and measurement.

Can is used for statements of possibility and capability, whether material, physical, or causal. For example, a Note under clause 4.2.1 states the documentation can be in any form or type of medium.

May is used to indicate a course of action permissible within the limits of the standard. For example, the Note under clause 7.1 states the organization may also apply the requirements given in clause 7.3 to the development of product realization processes.

Remember, “may” signifies permission expressed by the standard, whereas “can” refers to the ability of the user of the standard or to a possibility for that person.

Appropriate is used to indicate something is specifically suitable or fitting. For example, clause 5.5.3 states top management shall ensure that appropriate communication processes are established within the organization.

Applicable means capable of being applied; fit or suitable to be applied; having relevance. For example, clause 7.3.2 (b) states design inputs shall include applicable statutory and regulatory requirements.

Competence refers to the ability to perform a task; qualified or capable. For example, clause 6.2.2 (a) states the organization shall determine the necessary competence for personnel performing work affecting product quality.

Necessary is used to indicate that which is required for a given situation. For example, clause 4.2.3 (b) states to review and update as necessary and re-approve documents.

Suitable is used to indicate that which is fit for, or appropriate to, a purpose or occasion. For example, clause 4.2.3 states to apply suitable identification to obsolete documents if they are retained for any purpose.

Determine means to establish or ascertain definitely, as after consideration, investigation, or calculation. For example, clause 7.2.3 states the organization shall determine and implement effective arrangements for communicating with customers.

Identify is used to establish who or what a given person or thing is; recognize. For example, clause 7.5.3 states, where appropriate, the organization shall identify the product by suitable means throughout product realization.

Evaluate is used to ascertain the amount or value of; appraise, assess. For example, clause 8.4 states the organization shall evaluate where continual improvement of the effectiveness of the quality management system can be made.

Review means to determine the suitability, adequacy, and effectiveness of the subject matter to achieve established objectives. For example, clause 7.2.2 states the organization shall review the requirements related to the product.

Keeping these definitions in mind as you read ISO 9001 should help you more clearly interpret the requirements.