Determining Adequate 2015 Documentation

Wednesday, 29 July 2015
Rand Winters
3.5/5 rating (2 votes)
New Compliance RulesRevision writers left it up to organizations determine how many and what procedures and work instructions to document. This vague approach to documentation opens the door for each organization to develop a system that reflects what works best for them.

Final voting on the 2015 revisions concludes in September and there may be some slight language changes.

Two types of documented information (ISO 9001:2015 4.4.2) are required. Organizations will have to maintain documented information (procedures and work instructions) and they will have to retain documented (records) information.

Maintaining documented information is NOT defined in the standard but left to an organization to determine the number of procedures that may be necessary. Retained documented information is clearly defined and is nearly identical to what is written in the 2008 version of ISO 9001.

Management is now charged with determining if the QMS is adequately documented based on the following sub-clauses of Clause 9 Performance Evaluation:

9.1.1 - organization shall evaluate performance and effectiveness of the QMS.

9.2 - organization shall determine of QMS is effectively implemented by internal auditing

9.3.2 – a review by management of the system's performance and effectiveness including trends

If management is to determine that there is sufficient documented information to support an effectively implemented QMS, their review will include information that is being maintained as well as retained. In other words, whether or not there is a procedure, management will need to review specific records to determine if a process is effective.

An example is the purchasing process – management would review retained
documented (records) information. They will look for consistency in the purchasing process whether or not it is documented in a procedure. In order to make a determination, management will look at a potential list of retained information:

Metrics – supplier on time delivery, supplier quality, nonconforming material

Criteria – selecting and monitoring of external suppliers, records of supplier performance

Purchase Orders – customer specific requirements

Verification – determination of methods to ensure providers meet requirements

If the review indicates that requirements and performance are being met, then it suggests the system is effectively implemented and the documented information is probably adequate. Adequate information is a judgment call by the organization as well as external auditors. One size doesn't fit all.

Just because revision writers left documentation vague doesn't mean organizations should feel pushed to tear up their existing system and start again. Most firms will take this opportunity to update their systems with the new requirements such as risk based thinking and adjust what documentation works/doesn't work.

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