IMPLEMENTATION OF QUALITY SYSTEMTEM (STEPS TO REGISTRATION)

Implementation 0f ISO 9000 QMS in any organisation generally requires the following
steps.

Step 1: Top Management Commitment

❖ The most important step in implementing a quality stem is to get the full support of upper
management.
❖ The top management must be willing to commit the resources necessary to achieve
certification.

Step 2: Appoint the Management Representative

❖ The next step is the appointment of a management representative. The representative can
be a member of the top management group.
❖ The management representative is responsible for coordinating the implementation and
maintenance of the quality system. Also he is the contact Person for all parties involved in
the process, both internal and external.

Step 3: Awareness

❖ The next step is to create awareness about the ISO 9000 QMS.
❖ Since the implementation of the quality system requires involvement of all members in the
organisation, the members should understand the process and implications of ISO program.

Step 4: Appoint an Implementation team

❖ Now the implementation team should be formed. This team should be drawn from all levels
and areas of the organisation.
❖ The team should identify the QMS processes and their sequence and interaction.

Step 5: Training

❖ The implementation team, supervisors, and internal audit team should be trained.
❖ This activity can be accomplished through in-house training programs, seminars,
workshops, etc.
Step 6: Time Schedule

❖ This activity develops a time schedule for the implementation and registration of the
system.
❖ This time frame will vary, depending on the size and type of organisation.

Step 7: Select Element Owners

❖ The implementation team selects owners for each of the system elements. Many of these
owners will be members of the implementation team.
❖ Each owner has the option of selecting a team to assist in the process.

Step 8: Review the Present System

❖ A review of the present quality system should be performed.

❖ Copies of all the quality manuals, procedures, work instructions, and forms presently in
use are obtained.
❖ This activity is a gap analysis and can be performed by the element owners and their teams
or by an external consultant.

Step 9: Write the Documents

❖ Written quality policy and procedure manuals should be prepared.

❖ This documentation of work instructions should be done by the employee who performs
the job.

Step 10: Install the New System

❖ The policies, procedures, and work instructions should be integrated into the day-to-day
workings of the organisation.
❖ Now the new system is installed.

Step11: Internal Audit

❖ An internal audit of the quality system should be conducted.

❖ This step ensures that the system is working effectively and to provide management with
information for the comprehensive management review.
Step 12: Management Review

❖ The management review should be conducted in order to determine the effectiveness of the
system in achieving the stated quality goals.

Step 13: Preassessment

❖ The preassessment is an optional step. If a good job has been done on the previous steps,
then preassessment is not necessary..

Step 14: Registration

❖ The registration activity includes: choosing a registrar, submitting an application, and

conducting the registrar’s system audit.
❖ While choosing a registrar, one should consider so many factors such as cost, lead time,
customer’s acceptance of the registrar, the registrar’s accreditation, and familiarity with the
industry.
❖ The application for registration should also include supplying the registrar with the policy
and procedure manuals for their review.
❖ The time involved in the registrar’s system audit will vary depending on the size and
complexity of the organisation and the number of auditors involved.

Step 15: Award of ISO 9000 Certificate

❖ After accepting the application and setting a time frame for registration, the registrar will
review the quality system documentation.
❖ Based on the satisfactory report of the assessment team, licence i.e., ISO certificate will be
granted to the organisation by ISO/BIS to use the certification mark in letter heads, quality
certificates, etc.
❖ The certificate awarded is normally valid for 3 years. During the period of validity,
surveillance audits are conducted to ensure that the document quality system is being
effectively maintained.
❖ The surveillance audits will not be full audits but random checks of some elements to
ensure that the system continues to function.
 DOCUMENTATION OF QUALITY SYSTEM

Necessity for Documentation

➢ It is understood that the proper documentation is the pre requisite for implementing quality
system.
➢ The documentation serves as a reference for the management, the staff and other agencies
whose involvement is essential for implementation of the quality system.

Advantages of having a documented quality system:

a) serves as a reference;
b) brings about clarity of objectives and targets;
c) provides standardisation in work procedures
d) brings about consistency in operations;
e) develops confidence amongst employees;
f) generates customer’s confidence;
g) provides a basis for continuous1mprovement, etc. Documents to be Prepared

The documents requires by most organisations are:

1) Quality Policy Manual

2) Quality System Procedures (QSPs)
3) Work Instructions (WIS)
4) Records/ Formats/Forms

The above system documentation can be viewed as a documentation hierarchy or pyramid

containing four levels as shown in figure
 Documentation Pyramid

1. Quality Policy Manual

✓ Quality policy manual is the first level of documentation. This is the document that defines
'what will be done' and 'why’.
✓ The ‘why’ can be stated just once as a quality policy statement. This statement should be a
short and simple definition of the organisation’s quality intentions. The remainder of the
policy manual addresses what will be done to comply with the standard being used.
✓ The policy manual communicates the quality policy and objectives of an organisation.
✓ This manual is a living document. Because it reflects the current system being followed in
the organisation.

2. Quality System Procedures (QSPs)

✓ The second level of documentation is the quality procedures. "These procedures describe
the methods that will be used to implement and perform the stated policies."
✓ These procedures define who should perform specific tasks, when the task should be done,
and where documentation will be made.
✓ These documents collectively define the organisation’s operations from receiving an
enquiry to delivering a completed product or service.
✓ These procedures are confidential documents of the organisation and therefore need not be
revealed to outsiders.

3. Work Instructions (WIS)

✓ This third level of documentation is generally company specifications. "It gives details of
how individual work processes (for example, machining, welding, casting .etc.) are carried
out within a company."
✓ Work instructions should also specify how the work should be done; who should undertake
the work and what records are to be maintained.
✓ The work instructions may be in the forth of a detailed drawing, recipe, routing sheet,
specific job function, photograph, video, or simply a sample for comparison of conformity.
 ✓ The work instructions should be written by the employee who performs the task.

4. Records/Formats/Forms

✓ "Records provide evidence of activity having been performed in compliance with quality
system procedure."
✓ Records may be forms that are filled out, a stamp of approval on a product, or a signature
and date on some type of document.
✓ Records are used to provide traceability of actions taken on a specific product or batch of
products.

Benefits of Documentation

The documentation of quality systems serves the following benefits:

▪ Documentation regularises the method of performing the day to-day

activities.
▪ It provides formats for standardising practices.
▪ It provides reference for assessing degree of enforcement in practice.
▪ It facilitates trouble shooting for tracing back on the processes.
▪ It demonstrates the ISO quality system certification.