Quality systems development: where to start? Such a project has two main objectives:

• obtain an ISO 9001 certificate or
• put the organisation’s processes in order.

The purpose of quality system development affects the consultancy project, so we will cover quality system development projects in two different articles. We will start with the first objective – establishing a quality system for the purposes of ISO 9001 certification.

Quality management system development begins with the first step – understanding

which requirements

we need to consider when implementing a QMS in the organisation.  These requirements include:

• the requirements of ISO 9001 itself. In this part, on the one hand, it is simple, ISO 9001 is publicly available and can be read and studied. On the other hand, the standard without any explanations can be completely incomprehensible (that is why we invite all our customers to take online quality training with OREX Pro);
• the requirements of legislative, regulatory and statutory documents. The absence of legal violations is a prerequisite for certification, so at the start of a consultation project, we identify all the applicable requirements for the organisation’s activities, for issuing permits and licences to it. And while licences and permits are more or less clear, other applicable regulations can raise questions. What are these requirements? A very wide range of legal and regulatory documentation applies here: from the Labour Code, laws and industry standards, standards for products and/or testing.
• customer requirements. Here as well, everything seems logical: the development of quality systems is oriented to the main stakeholder of the organisation – our customers. Targeted deception of requirements and expectations of wishes is not acceptable. Where can the customer’s requirements be found? For example, in contracts, in quality agreements and in market research. This analysis also reveals the expectations of our customers;
• requirements of the parent company, management company, holding company, if the organisation does not operate as a separate entity.

After identification of each and every requirement, we are able to understand the scope of the audit criteria compliance with which we need to demonstrate at the certification audit, and we carry out the next step:

almost a certification audit, usually called a diagnostic audit of the quality system (in our description of services on the website it is named that way) for compliance with

all of the above identified requirements.

Development of quality systems must lead to ISO 9001 certificate, so regardless of complaints statistics; of recent “just the day before” inspections by fire inspectors, Rostechnadzor; of a positive client audit two months ago – we repeat a full, detailed, thorough diagnostic audit. The result of the audit may be the expected one, or it may be the exact opposite of what was expected. In the practice of OREX:

• spoilage of products, uncatalogued products in the warehouse with a positive inventory result from the previous month have been found;
• delivery of products from the warehouse to addresses other than those shown on the consignment note;
• delays in meeting contractual deadlines;
• frequent equipment breakdowns hidden under “unscheduled” maintenance and much more.

Development of quality systems will be completely dependent on the results of this first audit, which will lead to an Action Plan on the way to the goal. It may be unexpected, whatever it may be, but then the audit will be a success, as in our chat in the photo to the post.

To be continued…

Development of quality systems with OREX?

Of course, go ahead and order!

expert@orexpro.com

27.02.22