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What is a Quality Management System?
A Quality Manual will describe briefly how your quality
system meets the requirements of the standard.
There will
be procedures for required areas of the standard and procedures
you determine are needed.
Work Instructions will describe
how specific tasks are done. You decide what work instructions you
need to provide a consistent product or service and to serve as
training tools. Work instructions can be detailed or outline or
checklists.
Records will be kept demonstrating that documented
procedures and work instructions were followed. All required records
must be maintained.
Procedures, and work instructions, and
job descriptions or other responsibility documents will clearly
describe employee responsibilities.
An internal audit program
will continually evaluate the quality system and highlight areas
for improvement.
Corrective and preventive action processes
will allow problems to be fixed and verified for effectiveness.
Information from corrective actions, internal audits, process
measurements and product measurement will be reviewed by management
on a regular basis. Management will be informed on the quality system
performance and will take action for continual improvement.
Registration and surveillance audits by the registrar will confirm
your system is working effectively.
What are the benefits of ISO 9001:2008
Quality
Management System?
Increased Quality
Awareness and Internal Advantages
There are many
reasons to implement an ISO 9000 based quality management system.
Often the market or client is the driving factor. Once an ISO quality
system is in place, companies realize that there are internal benefits
which are as important as the external ones.
Benefits
during implementation:
- Process Improvements
As you implement
the system; you have the opportunity to improve your processes.
You will outline the current process, and the requirements of
the standard, and then optimize the process with input from
the process users.
- As the system is implemented, quality awareness
will increase because all staff must be trained on ISO 9000
and the processes as they are implemented. Staff will have "ownership"
of processes they are involved in developing and improving.
Benefits after implementation:
- Market Advantages
Surveys of registered
companies show more than 40% were asked by a client to obtain
registration. Using a registered supplier reduces the amount
of vendor audits a company must perform.
When a client
requests a vendor to seek ISO registration, it can take anything
from 6 to 18 months or more to comply. Therefore, the vendor
who is already registered has an advantage. This can be used
as a strong marketing tool.
ISO is becoming a requirement
to do business in many markets. Registered companies currently
have an advantage over their competition. As registration becomes
more common, this will shift and the unregistered companies
will be at a disadvantage.
- Once registered, companies often find the
greatest payoffs are internal, as processes experience continual
improvement.
A survey of 100 registered firms reported
the average improvement in their operating margin was at 5%
of sales. Firms also report improvements in order turnaround
time, scrap and overtime.
The quality system has built-in
systems to report on key quality indicators: Corrective and
Preventive Action, Internal Audits and Management Review. Management
is required to take action based on this information.
These built-in systems also contribute to continual improvement
by significantly reducing the reoccurrence of problems. Corrective
actions issued must be addressed, the root cause determined,
and action taken to prevent reoccurrence. Follow-up will make
sure the action was effective.
Internal audits will evaluate
the effectiveness of the system, and identify opportunities
for improvements. Nonconformities must be addressed. Internal
auditors are also able to make observations and suggestions.
Management review is a chance for management to evaluate
the performance of the quality system. Information is provided
from corrective actions, internal audits, purchasing information
and client complaints.
The operation will run more smoothly,
with fewer crises and "fires". The quality system promotes consistency
in how work is done and recorded. It helps employees learn more
easily and quickly what should be done. It reduces misunderstandings
with customers.
When a problem occurs, it is corrected
at the root cause. It does not have to be "fixed" again and
again by someone else, meanwhile productivity is lost.
There is a strong quality culture. Internal audits, corrective
action and training result in "top of mind" awareness of the
system. Increased confidence in workmanship results in a more
confident staff. Systems in place allow staff to address problems.
Staff recognises problems as systems or process issues. Problems
are solved, not blamed on anyone.
What is Process Approach?
The process approach is an activity that uses resources
to transform inputs to outputs, for an organisation to function
effectively, they need to identify and manage a numerous interrelated
and interacting processes. The ISO 9001:2008
Standard is designed
to manage and improve those processes.
- 1. Input to a process are generally output to another process
(e.g.: the output, becomes an Input to a process)
- 2. Processes in an Organisation are generally planned and
carried out under controlled conditions to add value to your
business.
- 3. A process where the conformity of the resulting product,
cannot be readily or economically verified is frequently referred
to as a "special process".
- 4. The ISO standard requires that you identify your processes
and determine the sequence and interaction of the processes.
This is most easily accomplished by preparing flow charts of
your product realization processes.
How many procedures are
required by the standards?
The standard specifically requires a Quality Manual,
Quality Policy and six procedures:
- Control of Documents
- Control of Records
- Internal Audits
- Control of Nonconforming Prod cut
- 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, this is
decided by your organisation during the developing of the Quality
Management Systems.
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
meets the requirement
- 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
- Nonconforming product and actions taken
- Corrective action
- Preventive action
- Records you need to provide evidence of following
your processes.
How often should we have management
review meetings?
There is no specific requirement
for frequency of management review meetings. We recommend quarterly
meetings at lower management level and six monthly at senior management
level. This allows you to stay on top of upcoming issues and collect
data between meetings that are meaningful to the organisation. We
have found annual meetings are not acceptable to all registrars.
With annual meetings you may not be able to prevent issues or resolves
problems in a timely manner.
Management Review
Are Job descriptions
required?
In the ISO standards do not specifically mentions
that a job description is required. The standard requires that the
organisation:
- define responsibility and authority, and
- define competency in terms of education, experience, skills
and training.
Normally Job descriptions are one way of accomplishing this, there
are also other ways by, including preparing organizational, job
responsibility lists, and competency matrices.
Who in the organisation
should be involved?
Everyone needs to be involved, either in the planning,
implementation or maintenance of the Quality Management Systems.
Management involvement is critical. Management must support
the project by providing resources, removing roadblocks, and watching
the timeline. Employees should be involved in evaluating and documenting
the processes in which they are involved.
Employee involvement
is critical to getting buy-in and support from people throughout
the facility. Their support will help successfully implement the
new processes. Employee involvement also gives employees a chance
to give input into changes and modifications for process improvements.
For more suggestions on which employees need to be involved, read
our planning page..
Should we use outside
help - Consultant?
A consultant can help you use your time and resources
effectively. Consider using a consultant:
- To help plan your project
An efficient
implementation begins with a solid plan, taking into account
those things you need to work on, leaving out those things which
are already in place, and developing an accurate estimate of
how long each implementation phase should take.
- To help keep your project on time and
on budget
Everyone is stretched thin on their jobs these
days. Staff working on the implementation internally is often
pulled to help fights fires or assist with production. With
external assistance it is easier to keep the focus on the plan
without interfering with day-to-day operations.
- To help interpret the standard
A consultant
who understands the standard's requirements can prevent wasted
time doing things the standard does not require, or that otherwise
might be spent on unnecessary or noncompliant work. QCG Quality
Consulting Group experienced staff is very familiar with ISO
standards and requirements.
- To allow you to benefit from experience
Using a consultant
allows you to begin work right away without having to learn
things on your own, and without having to learn by your mistakes.
What is process auditing?
Recently we have been receiving questions regarding
process auditing and what it means. If you are auditing your quality
management system by area or department and then auditing all the
applicable ISO elements while in that department, you are doing
process auditing. If you are auditing your quality system by ISO
elements throughout the organization you are not set up currently
for process auditing.
Process Auditing
How
often should we audit each department or process?
The ISO standard requires that all processes are
audited within the certification scope. The audit schedule should
be based on the level of importance and on the results from the
previous audits and customer complaints. In a new developed system,
you will need to audit frequently, perhaps monthly, to make sure
that all processes are implemented and working. For established
systems, normal recommended practice is every three months to one
year with options to increase the audits if nonconformity is identified
(Internally or by the customer).
How long
will it take to implement ISO 9001:2008?
-
An implementation
project will typically take about 12 months, but ranges from
6-18 months. You will need a minimum of three months of records
to show your registrar. Plan your registration audit no less
than three months after finilising you ISO QMS.
Factors that affect the timeline include:
- Size and complexity of the organization
- How much existing documentation is available
- Amount of resources available for the
project
- Amount of ISO expertise available
Recommendation : Start with a gap analysis,
this should help you determining the correct timeline for implementation
a QMS and obtain a consultant to assist your organisation.
