Introduction to ISO

Buena, Matthew Paulo B.

BBM – MBA
Management Consultancy
ISO Certification

 Introduction - ISO certification connects responsible business,

environmental and management practices with consumers and provides a
consistent, international basis for your, organization claims about the quality
of service you provide.
 What is ISO certification? - ISO certification is when your business is
“audited” by an independent third party, to assess
How well it complies with the following standards:
• ISO 9001 - Quality Management Systems
• ISO 14001 - Environmental Management Systems
• OHSAS 18001 - Health and Safety Management Systems
 These standards are international “templates for good business” practices.
What are the benefits of ISO
certification?
 The benefits of ISO certification for your organization are it:
1. Ensures that your product, or your service, is controlled, consistent & will improve
2. Gives your customers confidence that your business is well run
3. Is often a requirement before your business can tender for work
ISO 9001 - Quality Management
Systems

 ISO 9001 is suitable for any organization looking to improve the way it is
operated and managed, regardless of its size or sector.
 The advantages of ISO 9001 for your organization can include:
• Greater efficiency and consistent control of major business processes
• Regulation of successful working practices
• Increased customer satisfaction
• Greater consistency in the quality of products and services through better control
of processes
OHSAS 18001 - Health and Safety
Management Systems
 OHSAS 18001 is an international occupational health and safety
management system specification.
 Most organizations pursue OHSAS 18001 certification to improve Health and
safety to qualify for a tender or to achieve preferred supplier status: e.g. for
a Local Authority. However, there are many other benefits that can be
gained, including:
• Reduced risk to employees, customers and suppliers
• Reduction in the costs associated with accidents at work
• Enhanced staff morale and motivation
• Reduced insurance premiums
• Demonstrating legal compliance
What is ISO 9001?

 An international, globally recognized quality management standard, ISO

9001 is maintained by the International Organization for Standardization
and is administered by Accreditation Bodies (i.e. ANAB) who approve and
oversee Certification Bodies (Registrars)
 Benefits:
- Puts greater emphasis on leadership engagement
– Helps address organizational risks and opportunities in a structured way
– Uses simplified language and a common structure and terms, which are
particularly helpful to organizations using multiple management systems
– Addresses change management more effectively – Is more user-friendly for service
and knowledge-based organizations
– Easily integrated with other standards such as ISO 14001 (environmental)
Certification Process
What Occurs During Your Audit?

 Stage 1:
– Audit of the client’s management system documentation
– Evaluate the client’s location and site-specific conditions with client to
determine the preparedness for the Stage 2 audit
– Review the client’s status and understanding regarding requirements of the
standard, in particular with respect to the identification of the key
performance of processes, objectives and operation of the management
system
What Occurs During Your Audit?

 Stage 2:
– Information and evidence about conformity to all requirements of the
applicable management system standard
– Performance monitoring, measuring, reporting and reviewing against key
performance objectives and targets
– The client's management system and performance in regards to set
objectives
What Occurs During Your Audit?

 Surveillance
– Surveillance audits are a critical part of your certification because they
ensure your system is still performing to requirements of the standard. They also
verify any issues raised at your previous audit are corrected.
– Surveillance activities include on-site audits assessing the certified client’s
management system’s fulfillment of specific requirements relating to the
standard.
Understanding ISO 9001
Management Responsibility

Goals

Measurement, Resource
Checks Resources
Analysis, and Management
Improvement

Methods

Product
Realization
What Does ISO 9001 Require?

 Management is Responsible For:  Everyone Shares Responsibility For:

- Understanding Customers, Markets, - Understanding Objectives, and

Requirements
Competition
- Working According to Defined
- Defining Strategic Objectives Methods
- Setting Goals and Making Plans - Achieving and Maintaining
Required Competency
- Providing Money, People, and - Keeping Records as Required
Infrastructure to Support Plans.
- Measuring and Monitor Processes
- Communicating with Customers, and Products.
Suppliers, and Environments. - Identifying, Correcting, and
- Reviewing Performance and Preventing Problems
Systematically.
Making Decisions to Achieve Goals.
QMS Documentation Requirements

 ISO 9001 requires a documented procedure to control documentation:

Specifically, documents of the Quality Management System must be:
 Approved prior to use
 Reviewed and updated as necessary
 Available in their relevant versions
 Legible and readily identifiable

Also:
 Documents of external origin must be controlled
 Obsolete documents must be prevented from unintended use.
QMS Documentation Requirements

 ISO 9001 requires a documented procedure to control documentation:

Specifically, documents of the Quality Management System must be:
 Approved prior to use
 Reviewed and updated as necessary
 Available in their relevant versions
 Legible and readily identifiable

Also:
 Documents of external origin must be controlled
 Obsolete documents must be prevented from unintended use.
Documentation and Records

1. Documentation needs to be Just Right.

2. “Just Right” depends upon business needs.
3. Evaluate “Just Right” by the effectiveness of the documentation:
 Is the job consistently performed correctly, and is the documentation useful in
maintaining consistent performance?
Summary and Conclusion

1. Goals – Top Management establishes quality policy, objectives, plans, and

authority; make sure communication channels exist; review progress.
2. Resources – Management ensures the business has sufficient infrastructure,
work areas, and trained employees to achieve the defined objectives.
3. Product Realization – Plan and carry out processes for taking orders,
developing products, purchasing material and services, producing the
product or service under controlled conditions, and using calibrated
equipment where required.
4. Measurement, Analysis, and Improvement – Collect and analyze data on
customer satisfaction, product/services requirements fulfillment and process
effectiveness. Make changes to processes to eliminate causes of problems,
and ensure defects are removed.
5. Document business processes and keeps records of fulfillment of
requirements.