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this pageHow to get ISO-9000 certification for your organization
This article may be useful for a Quality Assurance person to champion the efforts in getting his/her organization ISO-9000 certified. It does not assume the reader to have any previous knowledge regarding ISO standards. As such any aspiring professional who wants to excel in the field of Quality Assurance may benefit by reading this.We
had used "Smartworks"
as a vehicle to speed up our process of getting an ISO-9000 certification
for our organization. However one can use any other similar tool to
achieve the same objective.
What is ISO-9000 ?
The standards are issued by the International Organization of Standardization (ISO),which is an international agency, founded in 1946 in Geneva, Switzerland. ISO was formed to promote the development of international standards and facilitate the exchange of goods and services worldwide.ISO-9000 is an International standard for quality system. A model for Design, Development Production, Installation and Servicing. It Emphasizes documented QMS (Quality management system), Compliance and documented evidence of compliance.
The three models of ISO 9000 series are
- ISO 9001 :- Quality Systems - Model for Quality Assurance in Design/Development, Production, Installation and Servicing.
- ISO 9002 :- Quality Systems - Model for Quality Assurance in Production and Installation
- ISO 9003 :- Quality Systems - Model for Quality Assurance in Final Inspection and Test.
Why ISO-9000 ?
There
are several reasons for a company to go in for a certification such
as ISO-9000. In my opinion following would be the principal driving
factors for an organization to go in for a certification process :
Ripple effect - Customers
specify as a part of contractual requirement.
Increases Marketability of
the Company.
Improved product quality.
Financial benefits (Cost
savings).
Competitive edge
Increased employee morale
due to reduced “gray areas”.
What is the Essence of ISO-9000 ?
The essence
of ISO-9000 is simple. It expects the following from an organization
Plan & Document what you do.
Do what you document & Record What you did.
Check the results
Act on the difference
Do this periodically
The twenty
elements of ISO-9001 Quality System are
Management responsibility
Quality System
Contract Review
Design control
Document & Data Control
Purchasing
Control of Customer Supplied Product
Product ID & Traceability
Process Control
Inspection & Testing
Control of Inspection, Measuring & Test Equipment
Inspection & Test Status
Control of Non-conforming product
Corrective & Preventive Action
Handling, Storage, Packaging & delivery
Control of Quality Records
Internal Quality Audits
Training
Servicing
Statistical Techniques
How to get ISO-9000 ?
The two
phases of ISO-9000 certification are
1. Documentation
Documentation
The documentation involves
procedures, standards and forms, which can be done in house (or by the
help of a consultant).
An
Organization needs to develop a documented quality system, which satisfies
the requirements of the chosen ISO model. The organization needs to
implement this quality system. Audit of the implementation needs to
be done regularly and in a timely fashion. Preventive and corrective
actions need to be identified and taken.
Define the quality
policy and ensure the quality management systems are effective. The
quality policy needs to be imbibed by everyone in the organization.
Hence define your quality policy in simple terms and try to cover all
the aspects of your business as quality permeates every aspect of your
business.
In order to start, you can use your favorite internet search engine
to get sample quality policies of organizations similar to yours. Remember,
it is only for a start. Unless the top level management believes every
word written in the quality policy, it would be difficult for the rest
of the organization to buy it.
I reproduce
our organization's quality policy for your reference
We believe that the customer satisfaction and
trust are fundamental to our success. We shall strive to achieve this
b delivering high quality products and services to our customers, both
external and internal, in accordance with agreed upon requirements and
budget.
We commit to achieve quality by creating a
work environment that encourages our employees and suppliers to focus
on defect prevention rather than detection.
Once you have drafted a quality policy for your organization, you
may do the following;
Define the quality objectives for the company
State the mission of the company by defining the Scope within which
it is operated.
Define
the life cycle of the product / project, derive the standards and procedures
needed to achieve and maintain quality.
Plan for the activity, involving every member of the organization
Implement the quality management systems, the three levels of documents
are
1.Quality Manual
Identify the key process areas for your company and
prepare the procedures and standards to maintain the quality system.
Monitor
the quality management system and ensure it is effective in maintaining
the quality policy, take necessary corrective and preventive actions
if required.
ISO-900 Certification:-
The certification
is done by an agency accredited in this regard.
Some
tips for Selecting a Certification Agency.
1.The certification agency should
be independent of your organization. No training or the consultancy
should have at any stage be taken from the certification body or their
assessors in any capacity.
2.The certification agency
should have sufficient experience in certifying companies operating
in a similar business situation and environment as yours.
3.The certification agencies
have a scope with in which they can operate and give accredited certificates.
You must ensure that your product or service does fall into their accredited
scopes.
4. Track record of the certification
agency is also critical for you to establish trust. All certification
bodies have a code of ethics and practices by which they should at all
times be fair and impartial. Assessment should be a learning exercise
and of benefit to the organization in more than just getting a certificate.
5.The certification agency
should be accredited to EN 45012 ( or equivalent) which is the standard
applicable to them and the standards they should be conforming to are
ISO 10011-I,II,III.
6.The accrediting board is
in which country and if that does coincide with the country to which
you have an export market or potential, if not then at least if any
bilateral agreements existing to ensure no need for re-certification
tomorrow by another agency.
7.The geographical coverage
of the organization. The probability of its acceptance internationally
is more if it is international.
Duration for Certification
Most assessors
(certification bodies) require a minimum of about three months from
the formal implementation date of the quality system to the certification
audit. It is necessary to have completed at least one complete internal
audit of all parts of the system and taken necessary corrective action
and preventive action. At least one management review must have taken
place after the audit and its decisions proved effective. This enables
the company to identify problems and to solve them before the assessor
finds them.
Our experience in getting ISO-9000 certification
When
our organization decided to go in for ISO certification, a team
was formed involving every member of the company in deriving the standards
and procedures.
The
most difficult task was tracking the activities, monitoring the progress.
Keeping
track of the ongoing activities became very difficult as we had 60 procedures
and 15 formats to be prepared in total, designed by 60 teams and verified
by another 60 members approximately.
The action plan began by assigning a procedure to be designed by every responsible member with an end date mentioned for completion. The "Project Planner" plug-in of Smartworks was used to plan all the activities related to ISO-9000 certification.
The
verifier had access to the latest document (available as an attachment
) which he verified and released to the quality dept.
This
was all mainly possible because of the early warning messages sent to
the individuals to take action before the due date. The entire organization
was aware of the progress and motivated to their goal as the progress
was well seen from the Project Planner available on each desktop.
Hence
Project Planner (A plug-in of Smartworks)
provided me the excellent tool in achieving ISO, by assisting
in tracking the activities, by helping me to monitor the progress, by
looking at the gantt chart, I was able to view the overall progress from
my desktop
How Smartworks helped us
I
would like to share with you how some of the general problems I faced
during audits, review meetings, optimizing, etc were solved using Smartworks.
As you know the documentation and documented evidence of compliance
covers the major activity in maintaining Quality System.
I observed against each activity the relevant document can be attached
in Project Planner and all could refer the latest document. The most
interesting part is I can now conduct audit from my desk, as
all the documents are available in Project Planner.
Using
Smartworks has now reduced lot of paper work.
a) Design and development verification (Clause 7.3.5)
b)
Design and development validation (Clause 7.3.6)
c)
Control of design and development changes (Clause 7.3.7)
The
evidence of verification, validation and control of changes had to be
maintained for three years for analyses by the management. This was
a daunting task, which was easily solved by the Smart tracker
of Smartworks.
This
list indicates the status of the defects filed, the type of the defects.
On double clicking the mouse cursor at a particular defect we get all
the details relevant to the defect.
The
submitter submits the defect / enhancement. The project leader assigns
the solver, which is later verified by the verifier. Hence this loop
is closed giving evidence for
the action taken.
The
Smart tracker can be effectively used for verification, validation and
control the design changes as well as in providing a proof for closing
the issue either be a defect or an enhancement.
The challenges like corrective and preventive action and evidence of
compliance, which is later measured and analyzed.
Consider a particular scenario like the audit non-conformities filed
by the auditor and the necessary corrective and preventive action to
be taken by the responsible person.
The problem faced here was having the records of the results of action
taken (Clause 8.5.2 e..) , reviewing and evaluating the need for
corrective action.
The
Smart tracker of Smartworks helped us in filing corrective and preventive
action against the key process area, which provided the record for having
taken the action.
Finally verified by the Quality Auditor, this way all action taken is
traced for compliance to the Quality System.
It was here I had to present the status of different projects with accurate
proofs and documents.
Some
of the metrics like Defects per kloc (kilo lines of code),
Time taken to solve the customer complaints
by the project leader, Time taken to solve employee suggestion or complaints,
Planned delivery vs actual delivery etc., which were sensitive issues
normally taken as a personal attack required accurate chart to report
to the management.
It
was here that the Smartworks tools, which had quality metrics plug-in,
helped us a lot, the data was collected from Smart tracker, where the
defects were filed by the developer and subsequently closed by the verifier
when it was solved.
This
helped in measuring the time taken to solve a particular defect type,
and how many defects were observed in a particular module.
The
Project Planner helped us in measuring the delay in delivery if any,
and analyzing the same.As the data collected was based on the inputs
keyed in by the developer or project leader, it was easy to avoid conflicts.
Hence
metrics measurement was very convenient and later we used the findings
at the management review meeting to improve the process or take
any corrective action if necessary.
I
am providing a few sample charts from the Smartworks Metric
plugin.
a)
Functional area (Module) vs defects.
Shyamala
heads the Quality Assurance effort at Accord Software & Systems.
She is responsible for ensuring Accord to continuously improve its
procedures and processes to ensure that it always delivers quality products.
You can reach the author at
.