ISO 9001 · Quality management system

Quality
Management

A management system built on ISO 9001 that is useful for the work, not just for passing the audit.

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Why this programme

The standard they ask you for in order to sell

ISO 9001 is the most demanded in public tenders and in contracts with large companies management system standard in Chile. It is rarely implemented out of conviction: it is implemented because a client asks for it, and with a deadline looming.

That rush produces the result seen in so many certified organisations: a folder of procedures nobody opens, written by an outsider, describing a company that does not exist. The audit is passed, the certificate goes on the wall, and the real work carries on somewhere else.

The risk is not failing to certify: it is certifying something nobody uses

We work the other way round: first we map how the company actually operates, and the documentation is written on top of that. The system stays light and in the language of the house, because what is not understood is not followed, and what is not followed shows up in next year's surveillance audit.

What it builds on

The two principles that order it

Process approach — the company as connected processes, not as departments
Risk-based thinking — anticipating what can go wrong in each one

Methodology we bring

ISO 9000 — vocabulary and principles
ISO 9004 — maturity and sustained improvement
ISO 19011 — management system auditing
ISO 31000 — risk management

It shares its structure with ISO 27001, ISO 27701 and ISO 42001: if you already hold any of them, much of the context, the roles and the internal audit are reused rather than duplicated.

How we work

Seven Phases, Concrete Deliverables

They run through clauses 4 to 10 of the standard. Estimated duration of 4 to 6 months depending on size and number of processes.

Fase 1 of 7 Diagnosis and scope

A gap assessment against ISO 9001 and a defined system scope, with the exclusions justified. Analysis of the context and the interested parties, and an executive report for top management.
Fase 2 of 7 Process map

The company's real processes, their inputs and outputs, who answers for each one and how they connect. It is the phase that saves the most time later: without it, the documentation is written blind.
Fase 3 of 7 Leadership and policy

Quality policy, measurable objectives by process, roles and responsibilities, and top management's commitment documented as the standard requires.
Fase 4 of 7 Risks and opportunities

Risks and opportunities by process with their actions, which is what the current edition requires in place of the preventive action of the older versions.
Fase 5 of 7 Operation

The procedures the operation really needs: control of production or of the service, customer requirements, design where it applies, purchasing and supplier evaluation.
Fase 6 of 7 Measurement and control

Indicators by process, customer satisfaction, control of documented information, management of non-conformities and corrective actions.
Fase 7 of 7 Verification

Internal audit with in-house trained auditors, management review and support through the certification audit.

Your own people run the internal audit

In the final phase we train internal auditors inside the organisation. It is a requirement of the standard, but it is also what decides whether the system survives its second year: if internal audit always depends on an outsider, it happens once and is abandoned.

What you can engage

Scopes of the Programme

The gap assessment can be engaged on its own: it is a useful diagnosis in itself and commits you to nothing. Inside the full programme it comes at a discount.