ISO 9000& ISO 14000: Overview, Benefits, Elements, Step for Registration

ISO 9000

 ISO 9000 is defined as a set of international standards on quality management and

quality assurance developed to help companies effectively document the quality system
elements needed to maintain an efficient quality system. They are not specific to any one
industry and can be applied to organizations of any size.

 ISO 9000 can help a company satisfy its customers, meet regulatory requirements, and
achieve continual improvement. It should be considered to be a first step or the base level
of a quality system.

Benefits of ISO 9000:

 Increased marketability
 Reduced operational expenses
 Better management control
 Increased customer satisfaction
 Improved internal communication
 Improved customer service
 Reduction of product- reliability risks.
 Enhanced product quality and reliability at a reasonable price
 Improved health, safety and reduction of waste.

ELEMENTS OF ISO 9000:

1. Quality Objectives
Well-written objectives lend purpose to a QMS initiative and establish a customer-centric
culture in an organization. A pharmaceutical start up in the research phase may have
identified a customer need for affordable therapeutics to treat a common skin condition. Since
the product is being developed, the organization may create a quality policy with a stated goal
"To develop a safe, effective treatment for eczema patients which is available at a lower cost
than alternatives."

Quality objectives for this organization could include:

 To obtain total compliance with staff training requirements and raise average
assessment scores from 90% to 95%.
 To successfully implement a QMS software within three months and eliminate paper
and spreadsheet-based record keeping methods within six months.
 To achieve a successful initial synthesis of the drug and complete all necessary
processes for FDA initial review within 12 months.
2. Quality Manual
A quality manual is defined as the first documentation of a QMS. It states the motivation for
adopting a QMS framework and the role of quality within the organization. ISO 9000
requirements for a quality manual prescribe that this document should:

 Describe the scope of the QMS

 Detail the requirements of the QMS standard or framework
 List any elements of the QMS which are excluded from the implementation
 Reference specific quality procedures used within the organization
 Provide visual documentation of critical processes via flowchart
 Explain the organization’s quality policies and objectives

3. Organizational Structure and Responsibilities

A QMS should include a clear and updated model of the organization's structure and
responsibilities of all individuals within the organization. Documentation of structure and
responsibilities should include visual guides such as flowcharts and clear documentation.
Documenting organizational structure should address the entire product lifecycle using
techniques such as flowcharts which depict the “path of workflow.” Defining responsibilities
requires an organizational chart with clearly defined roles which can be linked to standard
operating procedures (SOPs).

4. Data Management
Data is at the core of modern approaches to total quality management. Data quality and
availability are critical to the success of a QMS framework to drive continuous improvement
and preventative quality control activities. Organizations with ineffective data management
practices can experience inconsistent product quality, operating inefficiencies, compliance
risks, poor customer satisfaction, and low profitability.

5. Processes
QMS are inherently process-driven approaches to quality control and assurance. Standards
for quality management require organizations to identify and define all organizational
processes which use any resource to transform inputs into outputs. Virtually every
responsibility in the organization can be tied to a process, including purchasing.

6. Customer Satisfaction with Product Quality

A core component of QMS is the requirement for organizations to monitor customer
satisfaction to determine if quality objectives are achieved. Some standards do not prescribe
specific methods for measuring customer satisfaction since the definition of product quality
and available data can vary significantly between organizations.

7. Continuous Improvement

Continuous improvement and adaptation are necessary for organizations to drive benefits
with the QMS and maintain customer satisfaction. QMS dictate that continual improvement
is an organization-wide responsibility. However, ISO 9001 is clear that leadership should
play a core role in implementing a quality-driven culture. Clause 5.1.1 states "top
management shall demonstrate leadership and commitment with respect to the quality
management system by taking accountability for effectiveness."

8. Quality Instruments

The control and calibration of tools used to measure quality are integral to the success of a
QMS. If machines or equipment are used to validate products or processes, this equipment
must be carefully controlled and calibrated according to industry standards. Depending on the
instrument, this could involve periodic calibrations or calibration before every measurement.

9. Document Control

The definition of a document in a quality-driven organization is broad, according to ISO. It

includes all records of:

 Communications
 Evidence
 QMS Conformity
 Knowledge Sharing

Steps for registration

These eight steps--along with their sub-steps--are based on what many major companies have
followed to achieve their own ISO 9000 registration. These steps are also useful for
companies simple seeking to conform to the ISO 900 standards, but not formally become
certified.
These steps are a good guide for establishing a timeline, schedule, and potential costs for the
process of becoming ISO 9000 certified.

1. Get top management commitment

1. Top management considers ISO 9000 registration
2. Quality steering committee meets to evaluate process
3. Committee informs top management of ISO 9000 costs, schedule, etc.
4. Top management commits to pursue ISO 9000 registration

2. Train personnel
1. Hold basic quality and ISO 9000training for all employees
2. Select and train personnel to be internal auditors

3. Prepare Quality Policy Manual

1. Study and understand ISO 9000 requirements as they apply to your company
2. Write (or re-write) company Vision and Mission statements
3. Write basic Quality Policy Manual outline
4. Complete first draft of Quality Policy Manual
5. Send copy of manual to customer desiring ISO 9000 compliance (if necessary)

4. Prepare Operating Procedures

1. Define responsibilities, using Quality Manual as a guide
2. Have those responsible for functions outline their procedures
3. Interview managers and fine-tune procedures
4. Compare Operating Procedures with Quality Manual for consistency

5. Hold internal audit

1. Hold internal audit of ISO 9000 manual vs. ISO 9000 compliance
2. Implement corrective action items from audit

6. Select registrar
1. Research registrars and their cost
2. Qualify possible registrars
3. Select third party registrar

7. Go through registration process

1. Apply for registration and audits
2. Agree to audit process etc. with registrar
3. Hold pre-assessment audit
4. Take any needed corrective action
5. Have ISO 9000 registration audit
6. Take any needed corrective action
7. Re-audit as needed
8. Take any needed corrective action

8. Obtain ISO 9000 registration

This verifies that you operate your business in compliance to the ISO 9000 requirements.

ISO 14000
ISO 14000 is defined as a series of international environmental management standards,
guides, and technical reports. The standards specify requirements for establishing an
environmental management policy, determining environmental impacts of products or
services, planning environmental objectives, implementing programs to meet objectives, and
conducting corrective action and management review.

BENEFITS OF ISO 14000:

 Lower Measurement cost
 Lower treatment/Disposal cost
 Reduced Energy Consumption
 Increased productivity
 Auditing and reprts Savings
 Reduced Regulatory Exposures
 Improved relationship with Regulators
 Increased Compliance
 Increased Revenue and Profitability
 Enhanced Image through Environmental Stewardship
 Meet Supplier/Customeer needs
 Enhanced Export Potential
 ELEMENTS OF ISO14000:
1. Environmental Management System(EMS)

EMS is a name for an entire environmental program planned by a company. It

also forms the main component of the company’s registration plan for ISO 14001.
The EMS maybe documented in an environmental manual, or maintained in
sections of the company quality or operation manual.

2. Environmental Auditing (EA)

The ISO 14000 series relies heavily on Auditing to ensure that the standards
requirements are met. The standard states that, “Audits must be performed by
personnel from within the organisation (but they should be independent of
function to be audited) or by external persons”

3. Environmental Performance Evaluation (EPE)

These are detailed in ISO 14030, a supporting document of ISO 14000. It defined
the evaluation of environmental performance by management systems, and
provides general information about the process. The goal of this is to allow for
performance evaluation for internal progress analysis and for external
benchmarking.

4. Environmental Labelling (EL)

Many businesses uses environmental claims as an enticement for buyers to
purchase their products. It is also anticipated that ISO 14000 registration will
provide similar labelling opurtunity.

5. Life-Cycle Asessment (LCA)

The support documents providing guidance about LCA detail procedures to
examine raw material, generation, storage, manufacture, sales, use, disposal and
resulting environmental impacts associated with a company’s product or survey.
The ISO 14040,14041,14042 and 14043 provide information regarding LCA.

6. Environmental Aspects in Product Standards (EAPS)

These guidelines are contained in ISO 14060. The objective is to develop
guidance for standards writers to consider environmental impacts in their
standards –writing process for reducing environmental effects, while ensuring that
products perform to quality standards.

Steps for registration:

Understanding the entire ISO 14001:2015 process can be overwhelming. Here are five key
steps that organizations typically go through to achieve EMS certification:

STEP ONE: Plan Well

Any organization who wishes to be ISO certified needs serious planning and preparation to
ensure that effort, money and time is not wasted. Take time to re-assess your business
processes. Check and review all significant data and documents.

STEP TWO: Review the ISO 14001:2015 Standard

Be equipped by getting familiar with the entire ISO 14001:2015 certification process.
Identify legal requirements. Define the EMS scope and procedures.

STEP THREE: Disseminate and Train

It is important that all employees know what goals you are trying to achieve and the process
involved to improve the EMS. Next step is to provide training on understanding the ISO
standards, developing management systems, dealing with non-conformances, and so on.

STEP FOUR: Perform Internal Audits

The best way to evaluate if the EMS is effective is to perform internal audits and self-
assessments. Use digital ISO 14001 checklists to assist with documenting and tracking the
improvement of your processes.

STEP FIVE: Get Certified

Choose a notable third-party certification body that will come in to assess the EMS process
for adherence with the ISO 14001:2015 requirements.