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Is ISO 9001 A Legal Requirement
Is ISO 9001 A Legal Requirement
Is ISO 9001 A Legal Requirement
ISO 9001 is a quality management system (QMS) that allows businesses to keep a
high level of productivity and quality while delivering products and services to
customers. Quality is not associated with a specific product that is sold, but is
applied to the process that goes into making this product.
All aspects of a supply chain and operation in a business are compared to the ISO
9001 standards to ensure that quality is upheld.
The standards that need to be met in this system are focused on:
Customer driven-outlook
Leadership
Engagement
Improvement
Decision Making
Relationship Management
Process Approach
Details in all of these areas are required to maintain a ISO 9001 certification. In
order make sure these standards are met, companies undergo an audit. This audit
is driven by a third party to ensure objectivity.
The auditors will test all these metrics to ensure a company is following the
standards laid out in the ISO 9001 guidelines. Having this certification can be very
beneficial to a company’s success and reputation.
The ISO 9001 is applicable in both production and service industries. Quality
management can be very useful in manufacturing and customer-based companies.
All companies will benefit from such adherence, but these specific industries should
most definitely be incorporating these policies.
While there are specific steps, the ISO quality management system leaves some
freedom for decisions that make the most sense for your organization.
Choose a strategy
When first deciding to become certified, there are different approaches one can
take in terms of implementation.
You must decide who will be in charge of implementing and executing the
certification. Appointing a specific person will help make sure the company stays on
track.
There should be one person within the company (the Project Manager) responsible
for ISO 9001 monitoring and scheduling management reviews to ensure the
requirements are met.
ISO 9001 is designed to improve and ensure quality throughout all processes in an
organization.
This implementation may result in changes for how your firm is currently operating.
Change can often be threatening or unwelcome by management and employees.
When deciding to implement these standards, it is important to keep your team in
the loop!
Both Top Management and all employees should be aware of the new standards
and well as their impacts.
Keeping people informed early, showing them what changes will be made, and how
they will positively benefit the firm will allow for support. Including everyone in the
process early will result in less push back. Without support, standards will be
difficult to execute.
Documentation
Quality looks different in every firm. Some processes may be successful in some
businesses but not others. Documentation is a key aspect of certification, but it is
specific to an organization.
This is meant to detail the way in which procedures should be conducted in order to
reach maximum quality. Giving clear descriptions of how you wish processes to
work will keep standards consistent.
Being prepared for all processes and how they should be executed will result in
more efficiency across all aspects of the business. It also keeps employees and the
firm accountable! They have something to compare themselves to and push toward
continued improvement.
While each set of documents is specific to a firm, they should all include: a policy
regarding quality, a flowchart of how these plans are executed, instructions for
jobs, goals and objectives, and clear procedures.
The only requirement is that a firm must abide by their documents to maintain
certification. This means that rules and regulations should be meaningful to the
success of the organization and not implemented without a clear and effective
purpose.
Writing these documents is very straightforward with the use of templates such as
our ISO Quality Manual Template.
Implementing
Start simple. Explain to employees how the documents should be adhered to and
the clear benefits
Then begin to teach and show employees what changes must be made to meet
these standards.
This will require a “retooling” of work processes and instructions. It may be helpful
to get input from employees beforehand to see how they best think changes can be
made to add value. Including employees in the process will also enhance support.
Internal Auditing
An audit is used to ensure that the plans created are actually being followed.
Internal audits should be conducted within the company to make sure requirements
are met.
Those performing the audit should be well-versed in ISO 9001 regulations and
auditing. Auditing skills can be acquired easily through good training.
Having multiple auditors is a good idea to provide more input and perspectives in
making sure all standards are met.
Obtaining Certification
The internal audit is a good tool to ensure you are adhering to standards. To
officially obtain ISO 9001 certification, an outside and objective auditor is required.
They will come to a company and randomly observe and check that departments
are adhering to requirements.
You will also need to select a third-party registrar to execute the certification. Make
sure this body is accredited as there are many companies providing this service. If
there are significant issues with the audit, there is an opportunity to fix them and
obtain certification after they are resolved.
You can prepare employees by making sure they are well-versed in their job
functions and procedures. This will allow for a more successful audit.
Maintaining Certification
If your system is designed correctly, it should continually improve upon itself. Your
registrar will perform audits at least once a year to ensure the requirements are still
being met as time passes.
It is quite easy to lose your certification if attention is not continually paid to the
maintenance of quality. A primary purpose of this certification is to continually
improve upon procedures to increase efficiency.
Following each of these steps is important in obtaining certification and keeping it!
Always keep the best interest of your employees and your end user in mind.
Efficiency and quality benefits the firm both internally and externally.
Customers will know they are receiving a product or service that is built upon high
standards! Similarly, companies will be opened up to a larger client base who only
work with ISO 9001-certified firms.