How long does it take to implement ISO 9001?

It depends on you and your company. The very fastest is 2-3 months because most ISO 9001 registrars require at least 2 months ISO 9001 track record before the certification audit.

More realistically: if you have a relatively small company (say, less than 20 employees), if your employees are motivated and if they don’t oppose change, if you have the backing of all senior executives, if you and other managers are ready to put some significant time and efforts into this endeavor, and if you use a really good ISO 9001 quality manual template (a sample ISO 9000 quality manual that you can modify to make it your own ISO 9000 quality manual), then you may be able to get certified in as short as 3-4 months; templates for ISO 9000 forms are an additional time-saver. Some companies are significantly slower, with 6-12 months not being unusual.

However, companies that write their ISO 9001 quality manual and their ISO 9001 quality procedures from scratch, rather than base them on a proven sample ISO 9001 quality manual, often take up to 2 years or longer.

ISO 14001:2004 Document Control System

Documents required by the environmental management system and by this international standard shall be controlled. Records are a special type of document and shall be controlled in accordance with the requirements given in 4.5.4 (Control of Records).

The organization shall establish, implement, and maintain a procedure(s) to

a) approve documents for adequacy prior to issue;

b) review and update as necessary and re-approve documents;

c) ensure that changes and the current revision status of documents are identified;

d) ensure that relevant versions of applicable documents are available at points of use;

e) ensure that documents remain legible and readily identifiable;

f) ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the environmental management system are identified and their distribution controlled; and

g) prevent the unintended use of obsolete documents and apply suitable identification to them if they are retained for any purpose. [ISO 14001, 4.4.5]

Corrective and Preventive Actions In ISO 9001 Standard

Corrective and Preventive actions are used to adjust the manufacturing processes, quality system and product documentation to continuously improve product and service quality. This process never ends. Corrective and preventive actions are usually based on an engineering change request and engineering change order system. In general it is recommended that all feedback from internal and external sources be entered into the engineering change request system. This can include customer survey results, customer complaints, nonconforming material data, field failure data, work-in-process testing results, internal audit results, external audit results and suggestions from personnel. The inputs are then entered into the Engineering Change Request System. This system is used to queue workload for the engineering and quality problem solvers. The engineering manager or quality manager then reviews this bulk of requests for prioritization. The highest priority issues are assigned to personnel who create an engineering change order to correct the problem. Some engineering change requests will be denied and the denial will be justified in the ECR system before the item is closed. Other requests will generate an Engineering Change Order that includes an assignment to a project manager. The engineering change order will include complete details on how to correct the problem and when the change will take effect. This system is a closed loop system that will continuously improve quality. The status of the ECR and ECO systems should be used as input for the management review meetings.

The process of managing this data usually requires a database since priorities change on a daily basis and the amount of input can be very large, even at small companies. A database is also advised since the system can be used to generate automated reports that are used in the management reviews. Without constant supervision, engineering requests and change orders can pile up and start dragging down the company.

Corrective and preventive actions are listed separately in the standard to drive home the point that you can not have successful company that only corrects problems, you must prevent problems.

Corrective and preventive actions also go hand-in-hand with the requirement for continuous improvement. If the company is analyzing their mistakes, anticipating future mistakes and continuously improving, The quality of the product and services at the company will eventually be GREAT. The corrective and preventive actions system is the most critical element for an efficient quality system. Corrective and preventive actions are made using Engineering Change Requests (ECR) and Engineering Change Orders (ECO).

Any quality problem or suggestion should generate an ECR. This is the queue for engineering. If the engineering/quality manager decides that an action is required, then an ECO is created and assigned to someone with the resources to correct and prevent future problems.

ECOs should be generated by negative customer feedback, negative trend in product performance, observed areas for improvement, upgrades to documentation, or any other continuous improvement activities. Engineering change orders are the lifeblood of the organization and they must always be flowing to keep the organization strong and growing.

With this in mind, it is critical that the engineering change order system quick, simple and effective. I highly recommend the use of a database for managing ECRs and ECOs. This will give you a searchable history of changes to your products and is the best tool for continuous improvement.

What is ‘Root Cause Analysis’ In ISO 9001 Standards?

What is ‘Root Cause Analysis’ In ISO 9001 Standards?
Suppose you come across a dandelion weed while in your garden. (If you have as little time in the garden as I do, at times you may find too many!) You pull off the head of the dandelion and all the leaves. There – you can’t see it any more.
The question is: does this fix the problem?
To illustrate, let me share some findings from an audit in a type of courier company. They collect & deliver items for their customers, and have contracts with large customers. If any customer complaints arise, the operations manager must respond in writing.
For audit, I chose a sample of complaints from the last 3 months and looked at what they’d done with them. Most complaints were for late/missed pick-ups or deliveries.
Some sample responses from the manager to the client:
A. This route has too many sites on it, we are looking at changing it.’
B. ‘The entry disappeared from the system. It was re-entered, and the pick-up went ahead the next day.’
C. ‘The driver was new and didn’t know. He has been spoken to.’ (A week later, the same driver missed another pick-up for the same customer.) ‘He no longer works for us.’
D. ‘I can only assume this happened while I was on leave, and the supervisor didn’t know he had to respond to your calls urgently.’

And my favourite E: ‘The driver was late because there were delays during the day.’
These responses are typical of just looking at symptoms: pulling off the dandelion leaves. That approach leaves the root of the problem still intact. Like the dandelion, you can pretty much bank on the fact that it’s going to come up again. And again. And again. Until you do something to find the real cause (or causes). That’s effective root cause analysis, because you get to the root: the real underlying cause.
For example: Why does a route have ‘too many sites’ on it? What does ‘looking at changing it’ mean? Has it been done? If it was changed, did the changes work? If not, when will it be done? How did that route get ‘too many sites’ on it? And what would stop that happening again, or on another route?
Consider the ‘new’ driver: Why didn’t he know what to do? Had he received the information he needed such as induction and training? If not, why not? Why is ’speaking to’ a driver adequate to prevent recurrence? (it’s not) Has the company reviewed how it selects its drivers? Because the recurrence a week is a strong sign of inadequate cause analysis and ineffective corrective action.
Why Find the Root Cause?
Most organisations are busy and somewhat chaotic. Immediacy often rules. So there’s often a tendency to go for the quick fix – treat the symptom rather than the real, underlying cause. The driver is ’spoken to’, the order ‘re-entered into the system’. But this almost guarantees the same or very similar situation will recur, and have to be dealt with again. And again.
When problems come up in your organisation – which they will – you can choose how to respond. You can look for someone to blame and stop at the symptom (’the driver was new… the supervisor didn’t know… it disappeared from the system’). Quite apart from the damage it causes to personnel relations, this approach isn’t effective.
An organisation with an intelligent approach to quality knows the value of a systematic approach to problems, including root cause analysis. The best question is: What can we learn from this situation? And then: How can we apply that learning to improve?
When Should You Use Root Cause Analysis?
If you have or aspire to ISO 9001, you must have a systematic approach to problems: nonconformance, corrective and preventive action. Without it, you’ll find it hard to pick problems for root cause analysis, because they’re often distributed over time (so you don’t realize they recur), or happen to different people (so you don’t realise they recur in your organisation).
Good candidates for root cause analysis are the situations that recur most often, and use the most resources to rectify or those that cause the most damage when they do.
Remove the Root Cause or Not?
After you’ve identified the root cause/s, you have to decide if it’s worth removing the root cause or whether you continue to treat the symptoms. This isn’t always an easy decision.
It’s often relatively easy to estimate the cost of removing the root cause, but less easy to assess the cost of not doing so. Suppose, for example, a truck breakdown turns out to have been caused by ineffective maintenance by a supplier. And suppose that supplier costs $10,000 less per year than the other. Superficially, the cost vs savings looks good.
But suppose that also means a truck off the road for at least an extra 5 days a year – and your largest customer got so angry about one too many crucial but failed pick-ups that they don’t renew your contract. And tell everyone what an unreliable company you are.

The Most Common Mistakes Made with ISO 9001

The Most Common Mistakes Made with ISO 9001
Some very common mistakes often happen when companies try for ISO 9001. Usually they:
Don’t really know what they want from their system
Don’t make the system work for them
Don’t keep it simple
Don’t understand the Standard, let alone how to apply it to what they do
Don’t know or use a ’systems approach’
Don’t get the documentation right (the dreaded ‘quality manual’)
Don’t get their people involved
Don’t actually know what they mean by ‘quality’.
Then there’s the biggest one of all.
They don’t follow their own system. Is it any wonder?
Perhaps you’ve already looked into getting ISO 9001. If you’ve read it, you’ll probably agree it doesn’t make great reading. But it does talk about a ‘quality manual’, so presumably you have to write lots of documents.

Assessment to ISO 9001 Standards

ISO 14001 Standards Certification

ISO 14001 Standards Certification

ISO 14001 sets out a system that can be audited and certified. In many cases, it is the issue of certification that is critical or controversial and is at the heart of the discussion about the trade implications.

The standard allows for “self-certification,” a declaration by an enterprise that it conforms toISO 14001. There is considerable skepticism as to whether this approach would be widely accepted, especially when certification has legal or commercial consequences. At the same time, obtaining certification can entail significant costs, and there are issues relating to the international acceptance of national certification that may make it particularly difficult for companies in some countries to achieve credible certification at a reasonable cost. For firms concerned about having certification that carries real credibility, the costs of bringing in international auditors are typically quite high, partly because the number of internationally recognized firms of certifiers is limited at present.

The issue of accreditation of certifiers is becoming increasingly important as the demand increases.

The ISO has outlined procedures for accreditation and certification (Guides 61 and 62), and a formal body, QSAR, has been established to operationalize the process. At the same time, a number of established national accreditation bodies heavily involved in ISO have set up the informal International Accreditation Forum (IAF) to examine mechanisms for achieving international reciprocity through multilateral agreements (MLAs). However, these systems are in the early stages, and many enterprises continue to use the established international certifiers, even at additional cost, because of lack of confidence in the acceptability of local certifiers.

Given the variability in the design of individual EMS and the substantial costs of the ISO 14000 certification process, there is a growing tendency for large companies that are implementing EMS approaches to pause before taking this last step. After implementing an EMS and confirming that the enterprise is broadly in conformance with ISO 14001, it is becoming routine to carry out a “gap analysis” to determine exactly what further actions would be required to achieve certification and to examine the benefits and costs of bringing in third-party certifiers.

Certification means that a qualified body (an “accredited certifier”) has inspected the EMS system that has been put in place and has made a formal declaration that the system is consistent with the requirements of ISO 14001.Countries that have adopted ISO 14001 as a national standard can accredit qualified companies as certifiers, and this will satisfy national legal or contractual requirements. However, the fundamental purpose of ISO is to achieve consistency internationally. If certificates from certain countries or agencies are not fully accepted or are regarded as “second class,” the goal will not have been achieved. It is probable that the international marketplace will eventually put a real commercial value on high-quality certificates, but this level of sophistication and discrimination has not yet been achieved. It is essential to the ultimate success of the whole system that there be a mechanism to ensure that certification in any one country has credibility and acceptability elsewhere.