The two most common items missing from a QMS

The path to achieving ISO 9001 certification for a Quality Management System is significant for any organisation. While many elements of a QMS may be in place, two common items often hold up an organisation’s progress towards getting certified.

Any organisation developing a Quality Management System to achieve certification will know it will take time. Defining and documenting processes, creating policies, and building feedback channels in your business take time. Not to mention, all this must be done well to develop an effective system for continuous improvement.

But the reality is many organisations need certification to win contracts or tenders for different types of work to grow. This can often create time pressures within a business to ensure the Quality Management System is ready to be certified as soon as possible.

While you don’t need your system wholly finalised to commence a Stage 1 audit, an auditor must see steps to meet the ISO standard’s requirements. These need to be addressed before starting the Stage 2 audit. Here are the two most common items our auditors find are missing with clients trying to achieve certification.

1. Documented management review meetings

Management review meetings are a pivotal aspect of an effective QMS. These meetings serve as a platform for top-level management to review the performance of the QMS. They assist in making critical decisions and provide direction to ensure continuous improvement.

Documented management review meetings provide accountability by attributing specific decisions or actions to responsible individuals and identifying trends and recurring issues. They also ensure crucial information is consistently conveyed to relevant stakeholders. Without documented management review meetings, employees may not be aware of essential updates. This can lead to misunderstandings and, ultimately, a lack of alignment within the organisation.

This requirement includes creating meeting agendas, capturing minutes, and defining action items with clear responsibilities and deadlines. At least one management review meeting should be held and documented before seeking certification. This assists in ensuring it meets the standard’s requirements.

2. Internal audits

Internal audits are systematic and objective assessments of a company’s QMS. These audits are conducted by internal auditors independent of the processes being audited. They play a vital role in evaluating the QMS’s effectiveness, identifying non-conformances, and verifying compliance with ISO 9001 requirements.

While internal resources can often be difficult to source due to lack of time or training, investing in training internal auditors can benefit an organisation in the long term. Another option is seeking external audit assistance to carry out internal audits.

Whatever path you choose, at least one internal audit needs to be completed before seeking certification, and an audit schedule or plan for the next 12 months should be in place, with internal audits scheduled at regular intervals.

The Stage 1 audit checks that these things are in place. You don’t have to have everything in place for Stage 1. But any gaps that are identified need to be addressed prior to Stage 2.

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Is your QMS ready for ISO 9001 certification?

This handy guide outlines 16 things you need to have in place to get your Quality Management System ready for certification.