Management
systems.

ISO 9001, 14001 and 45001 certification

Three standards built on the same frame: context, interested parties, risks and opportunities, processes, measurement, improvement. What changes is the subject — quality, the environment, safety — not the method.

The work begins with a gap analysis between what the company already does and what the standard asks for. The distance is almost always smaller than feared: firms that work well already have their processes under control, they simply have not written them down. From there the system is designed — policy, context analysis, process map, indicators, procedures and forms — while avoiding the classic trap: a manual describing an ideal company, different from the one the auditor will find on the shop floor.

I then follow the whole cycle: training the people involved, internal audits, management review, handling non-conformities and corrective actions. And I stand with you through the certification body's audit, managing findings until closure.

I carry out the internal audits personally, holding Lead Auditor qualification for all four standards I work with, and likewise the second-party audits on suppliers, when it is the company that must assess who supplies it. An internal audit done properly is, more than anything else, what lets you reach the certification audit calmly: findings surface while there is still time to close them.

Where it is needed, the system extends to product and process standards — for instance ISO 3834 on quality in welding and EN 1090 for steel structures, which for a steel fabricator are not an extra but the condition for trading at all.

• ISO 9001 — quality management system
• ISO 14001 — environmental management system, with analysis of aspects and impacts
• ISO 45001 — occupational health and safety, integrated with the statutory risk assessment and with worker participation
• Integrated systems, with a single set of documents instead of three parallel ones
• Maintenance over time: annual surveillance audits and certificate renewal

EMAS and environmental performance

EMAS asks for one step beyond ISO 14001: making your environmental data public and having it validated by an accredited verifier.

The path set out in Regulation (EC) 1221/2009 starts from the initial environmental review of the site — consumption, emissions, waste, discharges, substances, emergency situations — and from a point-by-point check of legal compliance, which under EMAS must be demonstrated, not declared. Then comes the management system itself and the environmental statement, the public document in which the organisation sets out its objectives and results with indicators comparable over time.

I handle the review, the drafting of the statement and the preparation for the verifier's visit, as well as the annual updates the registration requires in order to stay valid. It is a path I have followed from the beginning through to registration obtained, and that I am currently following at a second site.

ISO 13485 and quality in the medical field

For a manufacturer of medical devices or in vitro diagnostics, a quality system is not a commercial choice: it is an obligation under the European Regulations, and ISO 13485 is the ordinary way of meeting it.

Compared with ISO 9001 the emphasis shifts: what counts here is design control, risk management to ISO 14971, traceability of every batch, control of special processes and rigorous document management, where every revision of a document has a history that can be reconstructed.

I handle the building and the upkeep of the system: procedures and work instructions, production and quality control records, supplier qualification, complaint and non-conformity handling, post-market surveillance and vigilance.

I am a qualified ISO 13485 Lead Auditor and an MDSAP programme auditor — the scheme that lets a manufacturer satisfy the requirements of several non-European regulatory authorities with a single audit. For the client that qualification translates into internal audits run by the same yardstick they will be measured against.