Reasons a Company Becomes Certified in ISO 9001 Standards

ISO 9000 certification or registration can be an expensive process. A company must consider the reasons and promised benefits for going through this process. If a company decides to seek certification, they should consider making sure their suppliers are certified or at least compliant to the ISO 9000 standards.

Major reasons
In the early 1990s, companies seemed to be jumping on the certification bandwagon without seriously considering the rationale for doing so. Often they did so because competitors or “everybody else” is getting registered. Today companies seriously look at the reasons and benefits for becoming registered.

The major reasons that company leadership or management decides to seek ISO 9000 certification are to gain continued or increased business and to maintain effective operations.

Improved business
A company can maintain a relationship with customers, as well as get increased business through complying to the ISO 900 standards or becoming certified. This comes from satisfying customer demands, the desire for European business, and to advertise.

Finally, some companies want to become certified, so they can advertise that fact and give the impression of being better than their competitors.

You have seen ads with a logo stating the company is certified at some ISO 9000 level. It apparently gives those companies a leg up on competitors not registered.

Again, this seemed more important in the 1990s, but you don’t see that many companies using ISO 9000 certification as an advertising tool.

ISO 9000 is supposed to make sure your business is run in an orderly manner that will assure continued success.

One would think that a goal such as being run effectively and able to deliver goods consistently and reliably would also be desirable for a company’s own operation. Surprisingly, many companies do not consider that as a goal.

IMPLEMENTATION GUIDANCE FOR ISO 9001:2008

IMPLEMENTATION GUIDANCE FOR ISO 9001:2008

This Implementation Guidance has been developed to assist users in understanding the issues that need to be considered during the co-existence period between ISO 9001:2000 and ISO 9001:2008.

While the changes between ISO 9001:2000 and ISO 9001:2008 are expected to have a limited impact on users, some arrangements regarding implementation are needed.

Note: To reflect the limited scope of the changes the term “implementation” is now being used to make a clear distinction with the former “transition” from ISO 9001:1994 to ISO 9001:2000, when there were significant changes throughout the standard.

A wide diffusion of this implementation guidance is recommended, in particular the comparison table between ISO 9001:2008 and ISO 9001:2000, given in Annex B to ISO 9001:2008.

ISO 9001:2008 has been developed in order to introduce clarifications to the existing requirements of ISO 9001:2000 and to improve compatibility with ISO 14001:2004. ISO 9001:2008 does not introduce additional requirements nor does it change the intent of the ISO 9001:2000 standard.

Certification to ISO 9001:2008 is not an “upgrade”, and organizations that are certified to ISO 9001:2000 should be afforded the same status as those who have already received a new certificate to ISO 9001:2008 No new requirements were introduced in this edition but, in order to benefit from the clarifications of ISO 9001:2008, users of the former version will need to take into consideration whether the clarifications introduced have an impact on their current interpretation of ISO 9001:2000, as changes may be necessary to their QMS In order to assist organizations to have a full understanding of the new ISO 9001:2008, it may be useful to have an insight on the revision process, how this revision reflects the inputs received from users of the standard, and the consideration given to benefits and impacts during its development.

Prior to the commencement of a revision (or amendment) to a management system standard, ISO/Guide 72:2001 Guidelines for the justification and development of management system standards recommends that a “Justification Study” is prepared to present a case for the proposed project and that it outlines details of the data and inputs used to support its arguments. In relation to the development of ISO 9001:2008 user needs were identified from the following:

- the results of a formal “Systematic Review” on ISO 9001:2000 that was performed by the members of ISO/TC 176/SC2 during 2003-2004

- feedback from the ISO/TC 176/Working Group on “Interpretations”

- the results of an extensive worldwide “User Feedback Survey on ISO 9001 and ISO 9004″ by ISO/TC 176/SC 2/WG 18 and similar national surveys.

The Justification Study identified the need for an amendment, provided that the impact on users would be limited and that changes would only be introduced when there were clear benefits to users.

The key focuses of the ISO 9001:2008 amendment were to enhance the clarity of ISO 9001:2000 and to enhance its compatibility with ISO14001:2004.

A tool for assessing the impacts versus benefits for proposed changes was created to assist the drafters of the amendment in deciding which changes should be included, and to assist in the verification of drafts against the identified user needs. The following decision making principles were applied:

1) No changes with high impact would be incorporated into the standard;

2) Changes with medium impact would only be incorporated when they provided a correspondingly medium or high benefit to users of the standard;

3) Even where a change was low impact, it had to be justified by the benefits it delivered to users, before being incorporated.

The changes incorporated in this ISO 9001:2008 edition were classified in terms of impact into the following categories:

- No changes or minimum changes on user documents, including records

- No changes or minimum changes to existing processes of the organization

- No additional training required or minimal training required

- No effects on current certifications

The benefits identified for the ISO 9001:2008 edition fall into the following categories:

- Provides clarity

- Increases compatibility with ISO 14001.

- Maintains consistency with ISO 9000 family of standards.

- Improves translatability.

Demonstrating conformity with ISO 9001:2008

Demonstrating conformity with ISO 9001:2008

For organizations wishing to demonstrate conformity with the requirements of ISO 9001:2008, for the purposes of certification/registration, contractual, or other reasons, it is important to remember the need to provide evidence of the effective implementation of the QMS.

Organizations may be able to demonstrate conformity without the need for extensive documentation.

To claim conformity with ISO 9001:2008, the organization has to be able to provide objective evidence of the effectiveness of its processes and its quality management system. Clause 3.8.1 of ISO 9000:2005 defines “objective

evidence” as “data supporting the existence or variety of something” and notes that “objective evidence may be obtained through observation, measurement, test, or other means.”

Objective evidence does not necessarily depend on the existence of documented procedures, records or other documents, except where specifically mentioned in ISO 9001:2008. In some cases, (for example, in clause 7.1(d)

Planning of product realization, and clause 8.2.4 Monitoring and measurement of product), it is up to the organization to determine what records are necessary in order to provide this objective evidence.

Where the organization has no specific internal procedure for a particular activity, and this is not required by the standard, (for example, clause 5.6 Management Review), it is acceptable for this activity to be conducted using as a basis the relevant clause of ISO 9001:2008. In these situations, both internal and external audits may use the text of ISO 9001:2008 for conformity assessment purposes.

ISO 9001 Standards New Blogs

Some of the new blogs on ISO 9001 Standards & ISO 14001 standards was found as below:

http://iso14000standards.blogspot.com/

http://iso-9001-standards.blogspot.com/

http://iso14001environmentmanagementsystem.blogspot.com/

http://iso9001qualitymanagementsystem.blogspot.com/

http://iso9001qualitymanual.blogspot.com/

http://iso9000standards.blogspot.com/

http://iso9001-standards.blogspot.com/

http://iso14001standards.blogspot.com/

Update on ISO 9001:2008

Update on ISO 9001:2008

Following a recent meeting of ISO’s Technical Committee TC176 in Helsinki, Finland, from June

11 – 15t, 2007, publication of the new version of ISO 9001 has been brought forward from 2009

and is now scheduled to be published in October 2008. Experts representing over 70 ISO member

bodies, met to discuss the comments received during circulation of the Committee Draft (”CD”) of

the new standard, and concluded that in view of the very limited changes being proposed, the draft

is now sufficiently mature to progress directly to the DIS (Draft International Standard).

The main changes being introduced into the new standard are as follows:

Clause 0.2 (Process approach)

Text added to emphasize the importance of processes being capable of achieving desired outputs

Clause 1.1 (Scope)

Clarification that “product” also includes intermediate product

Explanation regarding statutory, regulatory and legal requirements

Clause 4.1 (General requirements)

Notes added to explain more about outsourcing

Types of control that may be applied to outsourced processes

Relationship to clause 7.4 (Purchasing)

Clarification that outsourced processes are still responsibility of the organization and must be

included in the quality management system

Clause 4.2.1 (Documentation)

Clarification that QMS documentation also includes records

Documents required by the standard may be combined

ISO 9001 requirements may be covered by more than one documented procedure

Clause 4.2.3 (Document control)

Clarification that only external documents relevant to the QMS need to be controlled

Clause 4.2.4 (Records control)

Editorial changes only (better alignment with ISO 14001)

Clause 5.5.2 (Management rep)

Clarifies that this must be a member of the organization’s own management

Clause 6.2.1 (Human resources)

Clarification that competence requirements are relevant for any personnel who are involved in the

operation of the quality management system

Clause 6.3 (Infrastructure)

Includes information systems as example

Clause 6.4 (Work environment)

Clarifies that this includes conditions under which work is performed and includes, for example

physical, environmental and other factors such as noise, temperature, humidity, lighting, or weather

Clause 7.2.1 (Customer related processes)

Clarifies that post-delivery activities may include:

- Actions under warranty provisions

- Contractual obligations such as maintenance services

- Supplementary services such as recycling or final disposal

Clause 7.3.1 (Design & development planning)

Clarifies that design and development review, verification and validation have distinct purposes

These may be conducted and recorded separately or in any combination as suitable for the product

and the organization

Clause 7.3.3(Design & development outputs)

Clarifies that information needed for production and service provision includes preservation of the product

Clause 7.5.4 (Customer property)

Explains that both intellectual property and personal data should be considered as customer property

Clause 7.6 (Now retitled Control of Monitoring and Measuring equipment)

Explanatory notes added regarding the use of computer software: “Confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.”

Clause 8.2.1 (Customer satisfaction)

Note added to explain that monitoring of customer perception may include input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, and dealer reports

Clause 8.2.3 (Monitoring / Measurement of process)

Note added to clarify that when deciding on appropriate methods, the organization should consider impact on the conformity to product requirements and on the effectiveness of the quality management system.

ISO 9001:2008 Requirements – Documentation Requirements

ISO 9001:2008 Requirements – Documentation Requirements

Include in the quality management system documentation:
? Documented statements of a quality policy and quality objectives
? A quality manual
? Documented procedures and records required by ISO 9001
? Documents and records determined by the organization to be necessary for the effective planning, operation, and control of its processes
NOTE 1: Where “documented procedure” appears within the Standard, this means that the procedure is established, documented, implemented, and maintained. A single document may address the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document.
NOTE 2: The extent of the quality management system documentation can differ from one organization to another due to:
? Size of the organization and type of activities
? Complexity of processes and their interactions
? Competence of personnel
NOTE 3: The documentation can be in any form or type of medium.
4.2.2 Quality Manual
Establish and maintain a quality manual with:
? Scope of the quality management system
? Details and justification for any exclusions
? Procedures or references to the procedures
? Description of interaction between processes
4.2.3 Control of Documents
Control the documents required by the quality management system. Records are a special type of document and must be controlled as required by clause 4.2.4.

Establish a documented procedure to:
? Approve documents for adequacy prior to issue
? Review, update as necessary, and re-approve documents
? Identify the changes and current document revision status
? Make relevant documents available at points of use
? Ensure the documents remain legible and readily identifiable
? Identify external documents and control their distribution
? Prevent obsolete documents from unintended use
? Apply suitable identification if obsolete documents are retained
4.2.4 Control of Records
Establish and control records as evidence of conformity to requirements and to demonstrate the effective operation of the quality management system.
Establish a documented procedure to define the controls needed for record:
? Identification
? Storage
? Protection
? Retrieval
? Retention
? Disposition
Keep records legible, readily identifiable, and retrievable.

How long does it take to register to ISO 9000?

The time it takes to get ISO 9001 registered are varies. But it is talking
months here, not weeks. For one thing, you have to keep running your
business. You cannot simply shut down while getting registered.
The entire process can be broken down into the following general
phases:
a. Implementing the ISO 9000 system.
b. Operating it for the minimum time. (A minimum of three, and
preferably six, months before registration audit.)
c. Selecting a registrar. This can be done during the registration
process, to save time.
d. Interval between application and registration audit. This depends
on the registrar’s backlog.

The time it takes to implement the ISO 9000 system depends in large
part on where you are when you start. If you already have any of the
following, implementation time should be relatively short:
a. A documented quality system of any kind that is active, meaningful,
but not necessarily compliant with any particular standard.
b. Resources temporarily dedicated solely to implementing the system.
c. The guidance of a good consultant

If you are starting from square one, implementation can take a long
time. (Unless you can shut down operations while implementing—but
who can do that?) Here are some other factors that can extend the
time it takes:
a. Multiple locations.
b. Head count.
c. Whether or not you are design responsible.
d. Corporate turmoil.
e. Lack of ongoing, consistent, persistent top management commitment.
This exhibits itself in a host of symptoms, including lack of
sufficient resources, other issues taking priority, vacillation, failure
to pay attention, failure to learn and understand, and failure
to lead.
All that being said, experience has shown the following:
a. On average, the shortest interval for the entire process—from
launch through registration audit—seems to be around 6 to 9
months.
b. At the other extreme, it’s been known to take 18 to 24 to 36
months, even with significant resources and full management
commitment.
On average, for the typical organization (whatever that is), you are
looking at 10 to 18 months to get the job done.