9001 Council - Information and advice to facilitate your ISO 9001 implementation.

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ISO 9001
implementation and certification

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.

The ISO 9001 implementation is a process that, if done correctly, will unify all employees and managers in improving work processes. Everybody will have a chance to identify processes that are inefficient or otherwise inadequate. Under the umbrella of ISO 9001 implementation, employees and management will be able to improve cross-functional cooperation and fine-tune business processes.


The best time for
ISO 9001 implementation and certification

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.

However, most companies have been long established before they start their ISO 9001 implementation. Since a complete ISO 9001 quality management system brings many benefits to a company, it's always better to start the ISO 9001 implementation sooner rather than later.


How do I start with ISO 9001?

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.

Once you have a working knowledge of ISO 9001 and its implementation, you will need to decide on which approach to take: use a consultant or implement ISO 9001 in-house.


Should we use an ISO 9000 consultant?

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.

If outside help is desired, we recommend using a specialized ISO 9001 instructor (either in-house or in a public class) to teach the ISO 9001 management representative and all of executive management; online ISO 9001 courses or ISO 9001 videos are good and inexpensive alternatives. We further recommend developing the ISO 9001 quality management system in-house as the result is usually more suitable for the individual company. A great help and time-saver can be the use of templates for your ISO 9001 documentation.


ISO 9001 documentation

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.

However, the ISO 9001:2008 standard is very clear that work instructions need only be created where they add business value (for example, a trained painter will not find value in instructions on how to paint; on the other hand, brief instructions - possibly in form of pictures - and displayed right on a machine, explaining how to replace a filter could be a great time-saver). Forms, which must be kept on file after they are filled-in, are also part of any ISO 9001 quality management system. Some of the most typical forms are the Corrective Action Report Form, the Employee Review Form, and the Customer Survey. It is important to note that ISO 9001 does not directly require these forms; however, ISO 9001 calls for recording certain information and a well-designed form not only requires the information but it also guides the user through the process. Since the ISO 9001 documentation is the backbone of your ISO 9001 quality management system, this website has a dedicated section on using Templates for ISO 9001 Documentation.


ISO 9001 certification process

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:

a)

Perform one complete internal ISO 9001 audit. Such an internal audit is performed internally by one or more company employees who verify that their company in fact follows the requirements described in the ISO 9001 documentation.

b)

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.

Certification Audit
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.

TIP:

Evaluate your registrar carefully with the goal of finding a registrar whose auditors are flexible (because there are countless ways of fulfilling the ISO 9001 requirements and some may fit better for an individual business) and whose auditors don't mind sharing their experience (auditors are not allowed to consult but they are allowed to share what they have seen to work for other companies).


How long does the ISO 9001 implementation take?

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.

Some companies are significantly slower, with 6-12 months not being unusual. However, companies that write their quality manual and quality procedures from scratch, rather than base them on a good template, often take as long as 2 years and longer.


Cost of an
ISO 9001 quality management system

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.

While operating a good ISO 9001 quality management system (QMS) typically results in significant cost savings (even after paying the periodic audit fees of about US$1,000 - US$2,000 per auditor day), the ISO 9001 implementation and ISO 9001 certification process can be rather expensive. Large companies often spend in excess of hundred thousand dollars in consultant fees, while small companies can get by with a thousand dollars - if they take the right approach.


The secret

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?

The secret to a quick and inexpensive ISO 9001 certification process is simple: small and mid-size companies best implement the ISO 9001 quality management system internally in-house with the use of a good implementation package that contains all documentation templates, customization instructions and guides. Because such tools can offer enormous benefits and savings, we address them separately in our section on Templates for ISO 9001 Documentation.