Tip #1 – Shrink the bureaucracy
How many signatures do you require to authorize your controlled documents? A number of organizations we work with have created extra work with little or no added value when they require more than 1 approval to authorize changes to a controlled document. Some regulatory bodies have requirements for certain levels of management to authorize certain levels of documents and naturally those will be met.
ISO 9001, 14001 and 45001, however, do not have any specific requirements for maintaining documented information other than knowing who authorized the information and what the revision level is. The 2015 and newer versions of the QMS, EMS and OHS standards also removed the old requirement to identify the changes in a revised document. Great news! Same point here, though, there are some Regulatory bodies that require us to be able to demonstrate what version of a document was in circulation on any particular day. This can be helpful in a court case. ISO 13485:2016 still requires that revisions be identified (clause 4.2.4 c). It also has more prescriptive requirements for record retention.
By reducing the number of approvals required, we can shorten the time it takes from a requested change until the document is accessible for use. This typically results in more changes being requested and creates a more vibrant, relevant management system. When improvements happen, profitability increases if the improvement is controlled and tested for effectiveness.
Know Quality, Know Profit – No Quality, No profit
To find out if your ISO life can be simpler…
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