The secret to success is the use of the right tools:
- no-nonsense, step-by-step instructions and guides;
- easy-to-customize documentation templates and forms;
- convenient online training, and more.
You must implement ISO 9001 in 10 Steps and
with the right Tools
1) Step 1: Decision
The first step is for your company's top management to decide if the company should pursue ISO 9001 certification or not. For that, your company's top management needs to have a good understanding of ISO 9001 from a business point of view.What is Needed?
Concise training program specifically designed for the needs of executives
Our Recommendation:
e-learning course ISO 9001:2008 Management Overview
2) Step 2: ISO 9001 Management Representative
Going forward with the ISO 9001 implementation, one of your company's managers needs to be appointed to be the “ISO 9001 Management Representative”. The ISO 9001 Management Representative is your company's point-person and expert on ISO 9001. Having been appointed, the ISO 9001 Management Representative needs to learn much about ISO 9001 and its various requirements.What is Needed?
Comprehensive training in all ISO 9001:2008 requirements, and in the intent and purpose of the ISO 9001 quality management system (QMS)
(required by ISO 9001:2008 section 6.2.2)
Our Recommendation:
e-learning course ISO 9001:2008 - Benefits and QMS Requirements
What is Needed?
At the time of appointing the ISO 9001 Management Representative you will need:
– a job description, and
– a training plan
(required by ISO 9001:2008 sections 5.5.1, 5.5.2 & 6.2.2)
Our Recommendation:
These materials are only available as part of an Implementation Package.
However, these materials are also relatively easy to create by yourself with the help of our ISO 9001 Documentation Templates (step 5).
At the time of appointing the ISO 9001 Management Representative you will need:
– a job description, and
– a training plan
(required by ISO 9001:2008 sections 5.5.1, 5.5.2 & 6.2.2)
Our Recommendation:
These materials are only available as part of an Implementation Package.
However, these materials are also relatively easy to create by yourself with the help of our ISO 9001 Documentation Templates (step 5).
3) Step 3: ISO 9001 Implementation Plan
In order to properly plan your company's ISO
9001 implementation, you will first perform a gap analysis so that you know
which ISO 9001:2008 requirements your company already meets, and where you will
need to concentrate your ISO 9001 implementation efforts. After performing the
gap analysis, you are able to plan the ISO 9001 implementation project, set
important milestones, estimate time requirements and set a date for the ISO
9001 certification.
What is Needed?
The gap analysis is best performed using a questionnaire.
Our Recommendation:
A gap analysis questionnaire is available separately: The Gap Analysis; it is also included in all Implementation Packages.
What is Needed?
A step-by-step implementation guide that explains each step of the ISO 9001 implementation project in sufficient detail, while at the same time being concise and efficient. A good ISO 9001 implementation guidebook makes the ISO 9001 implementation lean and efficient without wasting time on unnecessary charts and committees.
A step-by-step implementation guide that explains each step of the ISO 9001 implementation project in sufficient detail, while at the same time being concise and efficient. A good ISO 9001 implementation guidebook makes the ISO 9001 implementation lean and efficient without wasting time on unnecessary charts and committees.
Our Recommendation:
An ISO 9001 implementation guide is available separately: The Project Guide; it is also included in all Implementation Packages.
4) Step 4: Employee Introduction
It is important to inform all employees as
early as possible of your company's plan to get ISO 9001 certified. You will
need to explain the concept of ISO 9001 and how it will affect your company's
employees in order to gain buy-in and support. Don't delay this simple step
because once negative rumors and gossip have developed, your ISO 9001
implementation efforts will become more difficult!
What is Needed?
A short and easy-to-understand ISO 9001 introduction course that focuses on how employees are affected and that prevents any misconceptions and fears
(required by ISO 9001:2008 section 6.2.2)
Our Recommendation:
DVD video training ISO 9001:2008 Basics - What Employees Need to Know
DVD video training ISO 9001:2008 Basics - What Employees Need to Know
5) Step 5: ISO 9001 Documentation
ISO 9001:2008 requires extensive documentation
addressing all its requirements. Writing all the required documents is very
difficult and extremely time-consuming if you start from scratch, but it can be
quite easy and fast if you use good pre-written templates with detailed
customization instructions. The selection of templates is very important
because the templates will have a significant impact on both, the time and
efforts you spend for the ISO 9001 implementation, and even more importantly,
on how efficient and business-friendly your company's ISO 9001 quality
management system will be. Please choose wisely.
What is Needed?
Pre-written templates for the entire ISO 9001 documentation including customization instructions. (required by ISO 9001:2008 section s 4.2.1 & 4.2.2)
Our Recommendation:
Extensive ISO 9001 documentation templates are available separately: Quality Manual & Procedures Templates; they are also included in all Implementation Packages.
What is Needed?
The ISO 9001:2008 standard
The ISO 9001:2008 standard
Our Recommendation:
The downloadable PDF version of the ISO 9001:2008 standard is the most convenient version
What is Needed?
An easy-to-understand interpretation of the ISO 9001:2008 standard to clarify the rather abstract requirements
Our Recommendation:
ISO 9001:2008 Explained
6) Step 6: Realization
Put the new business processes contained in
the ISO 9001 documentation into practice throughout the company. In this step,
company management and staff are notified of new or changed work processes as
formalized in the ISO 9001 documentation (step 5). This step also includes the
writing of some detailed and position-specific work instructions; these work
instructions are best written by those employees who perform the work.
What is Needed?
Forms and checklists – they will make the ISO 9001 implementation and compliance with ISO 9001 requirements significantly easier.
Our Recommendation:
Forms and checklists are available separately:Forms & Checklists; however, they are also included in all Implementation Packages.
What is Needed?
Brief and easy-to-understand employee newsletters are one possible option to inform staff about new and changed work processes.
(required by ISO 9001:2008 section 6.2.2)
Brief and easy-to-understand employee newsletters are one possible option to inform staff about new and changed work processes.
(required by ISO 9001:2008 section 6.2.2)
Our Recommendation:
Employee newsletters are only available as part of an Implementation Package.
However, these materials are also relatively easy to create by yourself based on your company's new ISO 9001 quality procedures.
What is Needed?
Work instructions are written by those employees who perform the work. (required by ISO 9001:2008 sections 7.5.1 & 7.5.2)
Work instructions are written by those employees who perform the work. (required by ISO 9001:2008 sections 7.5.1 & 7.5.2)
Our Recommendation:
Work instructions don't require a particular format and can be written “free style”. However, guidelines and templates are included in the Implementation Packages.
7) Step 7: Internal ISO 9001 Audits
ISO 9001 requires that your company
periodically self-evaluates its ISO 9001 quality management system through
internal ISO 9001 audits. These internal audits will also be of help during the
ISO 9001 implementation phase; a complete and successful internal ISO 9001
audit is required before you can get ISO 9001 certified. Therefore, one or more
employees will need to be appointed to serve as internal ISO 9001 auditors;
they will require training and then perform at least one complete internal
audit.
What is Needed?
Comprehensive training in both
(a) the ISO 9001:2008 requirements, and
(b) in auditing techniques.
(required by ISO 9001:2008 section 6.2.2)
Our Recommendation:
The combination of these two courses is ideal:
(a) e-learning course ISO 9001:2008 Internal Auditor
(b) DVD video training Internal Auditing Basics - An Introduction to Auditing for Employees
What is Needed?
Audit tools that include forms, a complete audit checklist and an audit report form. (required by ISO 9001:2008 section 8.2.2)
Our Recommendation:
Audit tools are available separately: The Audit Package; however, they are also included in all Implementation Packages.
Audit tools that include forms, a complete audit checklist and an audit report form. (required by ISO 9001:2008 section 8.2.2)
Our Recommendation:
Audit tools are available separately: The Audit Package; however, they are also included in all Implementation Packages.
8) Step 8: ISO 9001 Registration
Before your company can get ISO 9001
certified, you need to select and appoint an ISO 9001 registrar. The ISO 9001
registrar is an independent organization that is officially accredited to issue
ISO 9001 certifications in your country. The ISO 9001 registrar will audit your
company's ISO 9001 quality management system (QMS) and – if the audit is
successful – issue the ISO 9001 certificate. It is important to select an ISO
9001 registrar that is appropriate for your company's individual circumstances.
What is Needed?
You need to carefully select an ISO 9001 registrar from among the many local and international ISO 9001 registrars available in your area. (required by ISO 9001:2008 section 7.4.1)
Our Recommendation:
ISO 9001 registrar selection materials are only available as part of an Implementation Package.
9) Step 9: ISO 9001 Certification
The most important step is to pass the ISO
9001 certification audit and get ISO 9001 certified. Steps 1 through 8 were
designed to implement an ISO 9001 quality management system so that you can
achieve ISO 9001 certification. However, since your company's employees are
likely not familiar with undergoing external audits, it is strongly recommended
to prepare them for the audit and how to interact with the external ISO 9001
auditor. Don't let an uninformed or nervous employee spoil your company's ISO
9001 certification!
What is Needed?
Good employee preparation for the ISO 9001 certification audit, including instructions on how to interact with the auditor, expected auditor questions, and areas that the audit will likely focus on.
Our Recommendation:
Some of the Implementation Packages contain useful materials to prepare for the ISO 9001 certification audit. However, our DVD video training course may prove most effective and easily worth its cost: How to Deal with External Auditors - A Basic Guide for Employees.
10) Step 10: Maintaining ISO 9001 Certification
It is a common misconception to think that the
ISO 9001 certification is the last step. In order to maintain the ISO 9001 certification,
your company needs to keep the ISO 9001 quality management system alive, use it
in daily operations and continually improve upon it. In order to reap the
marketing benefits of ISO 9001, your company needs to properly publicize its
ISO 9001 certification. In addition, your company will only reap the many
internal benefits of ISO 9001 by really utilizing the ISO 9001 quality
management system in day to day business. Therefore, once your company reached
ISO 9001 accreditation, you should properly leverage the certificate for
marketing, use the ISO 9001 quality management system (QMS) in daily business,
and continually improve the ISO 9001 QMS in order to maintain your
certification.
What is Needed?
An ISO 9001 marketing guide – to get ideas on how to best leverage the ISO 9001 certificate in marketing.
Our Recommendation:
ISO 9001 marketing guides are only available as part of an Implementation Package
What is Needed?
Using the ISO 9001 quality management system in daily operations and continually improving it. (required by ISO 9001:2008 section 8.5.1)
Using the ISO 9001 quality management system in daily operations and continually improving it. (required by ISO 9001:2008 section 8.5.1)
Our Recommendation:
If your company is serious about using ISO 9001 in daily operations, meeting this requirement will not be a problem. However, there is also another interesting alternative: implementing a streamlined and efficient 2nd generation ISO 9001 documentation after 1-2 years: Streamlining Manual
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