The ISO 9001 implementation and the ISO 9001 certification process will not only result in the desired ISO 9001 registration but prove to be one of the most valuable "exercises" you can do to improve virtually all aspects of your company.
Most people seem to be primarily interested in how to get ISO 9001 certification - the quicker the better. Before we explain how small and mid-size companies can achieve ISO 9001 certification easily and inexpensively, we would like to point out that the ISO 9001 implementation and certification process itself will provide numerous valuable benefits.
Ideally you should begin your ISO 9001 implementation when you first start up your company.
If you are in the position of starting up a new company, you should be setting up your business processes according to ISO 9001:2008 requirements and start implementing ISO 9001 before hiring your employees. This is the most efficient approach as your company not only immediately reaps the benefits of ISO 9001 but you also don't have to overcome resistance to change when adjusting work processes later to meet the requirements of the ISO 9001:2008 standard.
As a first step, you should make yourself familiar with the ISO 9001:2008 standard and its requirements.
It is important that you get a good understanding of the ISO 9001 requirements, how they will affect your company, and how much is involved in the ISO 9001 certification process before you make the final decision on starting the ISO 9001 implementation. You can find some important information on ISO 9001:2008 and links to organizations selling the standard and ISO 9001 training courses in our Reviews section.
We found that ISO 9000 consultants can be of great help, and they can also cause great damage, depending on the ISO 9000 consultant and depending on how you use them.
Good ISO 9000 consultants can add value as trainers. It may be beneficial if an expert in ISO 9001 requirements is used to train the ISO 9001 Management Representative, or to “sell” the benefits of ISO 9001 certification to top management. However, since most consultants try to sell their consulting services, pure ISO 9001 instructors are generally a better choice. We have heard of countless cases in which ISO 9000 consultants purposely made the ISO 9001 requirements appear overly complicated and restrictive only in order to justify the high price of their consulting services.
The most common and also most severe problems that we routinely encounter are inefficient and bureaucratic ISO 9001 quality management systems. These are typically the result of an ISO 9000 consultant writing an overly complicated and convoluted ISO 9001 quality manual and quality procedures.
Developing the ISO 9001 documentation is a significant part of any ISO 9001 implementation process. The ISO 9001 standard contains specific requirements on the nature and content of several documents.
The required documents are: a quality manual, quality procedures, a quality policy and quality objectives; in addition, ISO 9001 requires work instructions that provide detailed guidelines to employees on how to perform their work.
The ISO 9001 certificate is issued by an independent registrar after successful verification that you company has implemented an ISO 9001 quality management system and follows all its requirements in daily operations.
Once the company has completed all ISO 9001 documentation (including the all-important quality manual and quality procedures), the company may apply for ISO 9001 certification. The certification is issued by an independent and accredited ISO 9001 registrar. There are many such ISO 9001 registrars, so you can choose the one that fits your company's circumstances the best. We recommend that you choose your ISO 9001 registrar early during the ISO 9001 implementation process as some registrars offer free support materials that help you implement ISO 9001.
Steps to ISO 9001 Certification
In order to achieve ISO 9001 certification, your company needs to have the entire ISO 9001 quality management system implemented; this includes having written the entire ISO 9001 documentation and following all the requirements stipulated in your documentation. Before the certification audit can be performed and the ISO 9001 certification be issued, your company needs to meet two conditions:
Secondly, your company needs to have a track record of operating according to ISO 9001 requirements; most registrars require about 2 months of track record.
Once the above requirements are fulfilled, an accredited ISO 9001 registrar will have an auditor (or a team of auditors) perform two audits:
A documentation audit, in which the ISO 9001 registrar verifies that the company's quality manual and quality procedures meet the requirements of ISO 9001:2008. This audit can be passed easily if you based your ISO 9001 documentation on good templates.
An onsite audit at the company, in which the ISO 9001 registrar verifies that the organization operates according to its ISO 9001 documentation and to ISO 9001:2008 requirements. As part of this audit (often also referred to as "external audit" as opposed to the internal audit), the auditor will randomly check records, interview management and staff and observe employees perform their work. The goal is to establish evidence that the company meets all ISO 9001:2008 requirements. In case the auditor identifies problems, or so-called non-conformities, the company will have the opportunity to correct the non-conformities.
ISO 9001 Certificate
If no significant gaps to the ISO 9001:2008 requirements are discovered (or if any discovered gaps have been corrected), the ISO 9001 registrar issues the prestigious ISO 9001 certification. The ISO 9001 certificate is typically valid for three years and can then be easily renewed. A condition for continued validity of the ISO 9001 certification is that periodic so-called surveillance audits are conducted by the ISO 9001 registrar, and that those surveillance audits show continued ISO 9001 compliance (again, the company has an opportunity to correct any non-conformities). Surveillance audits are usually conducted every 6 - 12 months; they are much smaller in scope, time and cost than the initial certification audit.
How to find an ISO 9001 Registrar?
Finding an accredited ISO 9001 registrar is not difficult. A Google search will reveal several international registrars as well as some local registrars. You may also check our Reviews for recommendations.
The time to implement ISO 9001 and reach certification depends very much on you and your company. The fastest is 2-3 months because most ISO 9001 registrars require at least 2 months ISO 9001 track record before the certification audit.
A more realistic estimate may be this - but there are many “if's”:
if you have a relatively small company (say, less than 20 employees),
if your employees are motivated and if they don't oppose change (employee buy-in is crucial, and employees must be involved from the beginning; consider an ISO 9001 introduction video presentation),
if you have the backing of all senior executives (which you will likely only get if they understand ISO 9001 and its benefits to the company; consider a training course),
if you and other managers are ready to put significant time and efforts into the ISO 9001 implementation endeavor, and
if you use a really good pre-written template for your ISO 9001 quality manual and quality procedures, as well as good pre-written forms and checklists,
then you may be able to get your organization certified in as short as 3-4 months.
The cost of ISO 9001 implementation and achieving ISO 9001 certification varies significantly depending on the size of your company and the implementation approach you take.
Most people at the beginning of their ISO 9001 implementation seem to ask the same question: how to get ISO 9001 certification as quickly and inexpensively as possible?