ISO 9001 Quality Management System Consultancy

The documents ISO 9001 asks you to have

A standard does not ask for a library. It asks for evidence that you decide things deliberately and can show how. This is what an auditor will look for on a ISO 9001 system — specific to the standard first, then the records every management system needs.

• Quality policy and measurable quality objectives
• Scope of the quality management system, and any clause you exclude with the reason
• Process map showing how the processes feed each other, with owners named
• Procedures for the processes you have decided need them, and work instructions where the job is exacting
• Risks and opportunities register, with what you decided to do about each
• Design and development records, where you design what you sell
• Supplier evaluation and re-evaluation records
• Calibration records for anything used to accept or reject product
• Roles, responsibilities and authorities, written down and known to the people holding them
• Competence and training records for anyone whose work affects the system
• Internal audit programme, audit reports and the findings raised
• Management review minutes, showing what was decided rather than that a meeting happened
• Nonconformity and corrective action records, with root cause and effectiveness checked
• Document and record control — what is current, who approved it, how long it is kept

Length is not compliance. A procedure nobody follows is worse than no procedure, because an auditor will find the gap between the two. Our test is whether the person who has to do the job recognises their own work in it.

How to start

Beginning well is mostly a matter of sequence. Almost everything that goes wrong in a ISO 9001 project can be traced to documentation written before anybody established what the organisation already does.

• Establish what is being asked, and by whom. A customer, a tender, a regulator and a parent company each want something slightly different, and the answer decides the scope.
• Fix the scope in writing — which sites, which activities, which products. Scope drives cost more than any other single decision, and a scope widened after the audit is booked is re-work.
• Have a gap assessment done against ISO 9001, on evidence rather than on a questionnaire. You can score yourself first with the free readiness checklist on this site; the expert assessment is what turns that score into a plan.
• Appoint somebody internally who owns it. Not necessarily full time, but named, and senior enough to get decisions made.
• Document only what the gap assessment showed is missing, in the words the people doing the work already use.
• Train, then run the system long enough to generate real records. Three months of genuine records cannot be produced in a fortnight, and this is the step organisations try hardest to skip.
• Audit yourself, hold a management review that actually decides something, then book the certification audit.

How to choose a certification body

Choosing the body is the one decision in a ISO 9001 project that you cannot delegate to us, and the one where the cheapest answer is most often the wrong one.

Four things decide it. Accreditation: the body should be accredited for your standard and your industry by a recognised accreditation body, and the certificate should carry that mark. Sector competence: an auditor who has audited your industry asks better questions and wastes less of your time. Recognition: ask the customer or tender that triggered this whether they name particular bodies. Cost and diary: audit days are set by your headcount and scope, so quotes should be comparable — and if one is far cheaper, look at the audit days before the price.

Among the bodies most widely recognised, in no particular order: BSI, TÜV, SGS, SIS Certifications, Intertek, DNV, BVQI.

MSCi works with a pool of accredited certification bodies rather than one. That is a commercial advantage to you, and worth being plain about why: bodies differ in audit-day rates, in travel cost to your location, in how quickly they can get an auditor to you, and in which sectors they are accredited for. Having several to approach means we can put your scope in front of the ones that fit it and bring you back comparable quotes, instead of you taking the first number offered.

What it does not change is the audit. We cannot influence a finding and would not try — the body's independence is the entire value of the certificate, and any consultancy offering otherwise is selling you something worthless. We prepare you so that the audit is uneventful, and the body decides.

Note also that whoever builds your management system must not be the body that certifies it. Accreditation rules prohibit it, which is why we prepare and never certify.

What ISO 9001 is usually taken with

Few organisations stop at one standard, and the second costs far less than the first — the clauses that take longest are the ones they share. Where ISO 9001 sits next to something else, this is what carries over.

• ISO 14001 consultancy — runs on the same clause structure, so an integrated system is audited in one visit rather than two.
• ISO 45001 consultancy — shares the same backbone; most organisations add it second because the legal and competence records are already in place.
• ISO 13485 consultancy — is built on the ISO 9001 pattern and then adds what medical devices demand — design files, risk management, traceability.
• ISO/IEC 27001 consultancy — covers the information your quality system runs on, and reuses the same internal audit programme.

Certified to more than one, you hold a single management system with one set of objectives, one internal audit programme and one management review — audited in one visit. Run as separate systems they cost roughly twice as much to keep, which is the usual reason a second certificate feels harder than it was.