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TRAINING NOTES

1. What is ISO?
ISO (International Organization for Standardization) is the worlds largest developer of
voluntary International Standards. International Standards give state of the art
specifications for products, services and good practice, helping to make industry more
efficient and effective. Developed through global consensus, they help to break down
barriers to international trade.
2. ISO9000 vs ISO9001
ISO9000
ISO 9000 is a family of standards focused
on quality management, put together
through input from a wide spectrum of
organisations and experts both in the
public and private sectors. The ISO 9000
suite is intended to help organisations, no
matter what size or industry, to become
better managed, more efficient and more
customer-focused.
ISO 9000 is based around eight Quality
Management Principles:
Customer focus
Leadership
Involvement of people
Process approach
System approach to management
Continual improvement
Factual approach to decision making
Mutually beneficial supplier relationships
There are multiple standards within the
ISO 9000 family including ISO 9000 itself,
which sets the tone by providing the
fundamentals and vocabulary. The other
standards cover specific points such as
performance
improvements,
documentation and training. There is also
ISO 9001, which determines the
requirements of a Quality Management
System (QMS). If you are unsure on
anything related to this standard, we offer
ISO 9000 training to get you up to speed.

ISO9001
ISO 9001 is the only standard within the
ISO 9000 family that an organisation can
become certified against, because it is
the
standard
that
defines
the
requirements of having a Quality
Management System.
In its latest guise, ISO 9001's full title is
ISO 9001:2008, representing its last
revision date. The standard provides a
framework for a systematic approach to
managing an organisation's processes so
that their service is consistent and meets
client expectation. It also ensures the
organisation meets applicable laws and
regulations.

3. What is ISO9001?
ISO 9001 is the internationally recognised standard for the quality management of
businesses. It applies to the processes that create and control the products and
services an organisation supplies, and prescribes systematic control of activities to
ensure that the needs and expectations of customers are met. ISO 9001 is designed
and intended to apply to virtually any product or service, made by any process
anywhere in the world.
4. Who should apply?
The ISO 9001 certificate is suitable for all sizes of organisation and is well established
around the world as an invaluable quality management system. It is suitable for
organisations in all industry sectors and will help your organisation to improve
management processes to compete locally and/or globally.
5. Why is it important?
Objective: Its objective is to provide quality management systems that will be of real
benefit to your organisation to help manage your business effectively and put in place
best practice methodology.
6. What are the benefits?
Some of the benefits to your organisation:

Provides senior management with an efficient management process


Sets out areas of responsibility across the organisation
Mandatory if you want to tender for some public sector work
Communicates a positive message to staff and customers
Identifies and encourages more efficient and time saving processes
Highlights deficiencies
Reduces your costs
Provides continuous assessment and improvement
Marketing opportunities

Some of the benefits to your customers:

Improved quality and service


Delivery on time
Right first time attitude
Fewer returned products and complaints
Independent audit demonstrates commitment to quality

7. Process? How do you start to implement ISO 9001? What is involved?

Identify the requirements of ISO 9001 and how they apply to the business involved.
Establish quality objectives and how they fit in to the operation of the business.
Produce a documented quality policy indicating how these requirements are satisfied.
Communicate them throughout the organisation.
Evaluate the quality policy, its stated objectives and then prioritise requirements to
ensure they are met.
Identify the boundaries of the management system and produce documented
procedures as required.
Ensure these procedures are suitable and adhered to.
Once developed, internal audits are needed to ensure the system carries on working.

8. Scope of ISO9001
As an ISO 9001 certified organisation you will have implemented quality management
system requirements for all areas of the business including:

Facilities
People
Training
Services
Equipment

9. My company is very small. Can I get certified?


Absolutely. We've worked with companies of one or two people who decided to get
certified. The processes that you'll put in place would have the same intent as a much
larger company; it's just that the implementation will be simpler. We work with
organizations to assist them in balancing the appropriate level of documentation with
what's necessary to meet requirements.
10. Do I need a consultant?
Many companies choose to attain ISO certification on their own, so having a consultant
is not a mandatory but highly advisable. We do believe that having access to a
consultant's knowledge and expertise can be very helpful as you try to sort out how to
apply ISO in your business. And if you have an urgent need to attain certification and
limited resources, using consultant is often the most practical approach. We provide
several flexible options to meet most needs.
11. How many procedures are we required to write?

The standard specifically requires six procedures:


Control of Documents
Control of Records
Internal Audits

Control of Nonconforming Product


Corrective Action and
Preventive Action

That may not be enough: the standard also asks that you prepare any other documents
you need to for planning, operation and control of your processes. The standard also
asks that you have available the work instructions you feel are necessary. The answer
to how many procedures or work instructions are required: you must decide this.
12. What records are required by the standard?

The standard specifically requires records for the following items:


Management reviews
Education, training, skills and experience
Evidence that processes and product or service meet requirements
Review of customer requirements and any related actions
Design and development including: inputs, reviews, verification, validation and
changes
Results of supplier evaluations
Traceability where it is an industry requirement
Notification to customer of damaged or lost property
Calibration
Internal audit
Product testing results
Corrective action
Preventive action
Records you need to provide evidence of following your processes.

13. How often should we have management review meetings?


There is no specific requirement for frequency of management review meetings. We
recommend quarterly meetings. This allows you to stay on top of upcoming issues and
yet collect data between meetings that is meaningful. We have found annual meetings
are not acceptable to all registrars. With annual meetings you may not be able to
prevent issues or resolves issues in a timely manner. Management Review