ISO 9000 is a series of International Standards for Quality Management & Quality Assurance. It is not a set of product standards Nor It is specific to one industry.

It is a provision of minimum system requirements which will help ensuring that items/ services are provided in accordance with a good management practice

It is certification of a system and not of any product.

•         ISO-International organization for standardization

•         A federation of National Standard Bod from over 135 countries-one representative from each country.

•         Non-governmental organization (NGO).

•         Established in 1947

•         Head Quarters at Geneva-Switzerland.

•         Head Quarters at Geneva-Switzerland.

•         Mission - Develop International Standards

•         Facilitate International Exchange

•         Promote Global Cooperation
 

TC-176 formed in late seventies Inaugural meeting held in Canada in 1980 Following Publications released
 

•         ISO 8042:1986-Quality Vocabulary

•         ISO 9000:1987-Guidelines for Selection & Use

•         ISO 9001:1987-Model for Quality Assurance in Design, production, installation &      Servicing.

•          ISO 9002:1987-Model for Quality Assurance in Production & Installation

•          ISO 9003:1987-Model for Quality Assurance in Inspection & Testing

•          ISO 9004:1987-Guidelines for Quality System Element.

•         9001, 9002 & 9003 were revised in 1994

ISO 9001, 9002 & 9003 revised & published as ISO 9001:2000 on December 15, 2000

New Revision is expected by the End of this year

1.    Customer satisfaction.

2.    Reduction in customer complaints.

3.    Reduction in wastage/reworking.

4.    Improvement in productivity (less re-working).

5.    Better work management due to Systems approach.

6.    Enhanced employee awareness & improvement in morals.

7.    Reduction in inspection effort both in-house and at customer end resulting reduction in cost

•         Make the system work for you and not the other way round. Describe what the people do in the Manual, rather than changing your work practices to comply with a Quality management System.

•         Don’t get a packaged system. Develop your own and, if you need outside help, be sure that the consultant knows your Business. Bought-in Systems are Cited as a Hindrance, often Bureaucratic and a common source of Failure on Implementation.

•         Products can definitely streamline the process of setting up a system and managing your Documentation and Records. But, again, make them work for you and remember that you’ll need time to set them up before you se the Benefits.

•         Don’t impose a System on the workforce, but rather Explain to Employees that the system describes what you do and makes it easier for everyone to work. In other words, Integrate the Quality Management System into your organization.

·        Similarly, don’t forget the Importance of Training. During Your initial reviews, identify your Strengths and Weakness and use a Training Program to fill the gaps when implementing the System.

•         Keep the Documentation Simple. An effective Quality Manual only needs to be a few pages long. Remember that the Standard says nothing about paper!

•         Motivate Employees by giving them Ownership of different parts of the Systems.

•         Get a large number of people involved in Internal Auditing, making sure that lots of people do a little auditing often, and integrate this with work processes. This can be far more efficient and effective than having a few auditors who spend a lot of assessments.

•         Don’t forget the Supply Chain. If your Suppliers are Critical to the success of your Quality Objectives, then use Standards to Specify Minimum Quality Criteria. At the same time, Encourage Suppliers through some form of Recognition Scheme.

1.0       Commitment to Quality Policy.

•          Motivation.

•          Team Work.

2.0       Establishment of Quality System.

•         Formulate.

•         Document.

•         Implement.

•         Maintain.

3.0       Sustenance of Quality System

•         Management Review.

•         Internal Audit

•         Approved Audit.

•         Surveillance Audit.

A new guidance document has been finalized by the ISO 9000 Advisory Group and published on www.iaf.nu

What are the risks to your business if you experience problems with this product?
How can you be sure that the product you receive will actually meet your requirements?
What do you know about the reputation and historical performance of your supplier?
What level of confidence do you need in your supplier’s ability to provide you with conforming product on a consistent basis?
If you decide that conformity to ISO 9001:2000 is important, (based on your assessment of the risks associated with the goods and services you are buying) how can you be sure that your supplier does have a QMS that meets ISO 9001:2000 requirements?
Are the goods and services you require covered by your supplier’s QMS? (You may need to ask for a copy of your supplier’s actual certificate or declaration of conformity to find this out!)
How can you have confidence that your supplier meets ISO 9001:2000?
There are various ways in which your supplier can claim that its QMS meets the requirements of ISO 9001:2000. These include:

‘Supplier’s declaration of conformity’: A declaration by your supplier itself affirming that its QMS meets ISO 9001:2000 requirements, usually supported by legally-binding signatures. This declaration can be based on your supplier’s internal audit system, or on second party or third party audits;
Second party assessment: your supplier has been assessed directly by its customer (for example by you, or by another customer, whose reputation you respect) to check if its QMS meets ISO 9001:2000 requirements and your own requirements - sometimes used in contractual “business-to-business” transactions;
Third party assessment: (Often referred to as certification or registration): your supplier hires an impartial third party (a certification body, or “registrar”) to conduct an assessment to verify conformity to ISO 9001:2000 requirements. This third party then issues a certificate to your supplier describing the scope of its QMS, and confirming that it conforms to ISO 9001:2000.
Additional confidence may be derived from the fact that some certification bodies (“registrars”) are accredited by nationally or internationally recognized accreditation bodies, who verify the certification body’s independence and competence to carry out the certification process. Many accreditation bodies have multi-lateral arrangements under the umbrella of the IAF (International Accreditation Forum) to promote worldwide mutual recognitions in support of WTO (World Trade Organization) free trade principles.
Figure 1 explains this in simple schematic terms. 

Figure 1 – Some ways of demonstrating conformity to ISO 9001:2000

Can suppliers claim that their goods or services meet ISO 9001:2000?
No. The reference to ISO 9001:2000 indicates that the supplier has a quality management system that meets the requirements of ISO 9001:2000. As mentioned earlier, this should provide you with confidence in your supplier’s ability to provide consistent, conforming goods or services. ISO 9001:2000 requires your supplier to monitor the levels of satisfaction of its customers (this includes you!), and to feed back this information in order to improve the effectiveness of its QMS.

What to do if things go wrong?
 

In the event you are not happy with specific goods or services you receive, you should first of all bring this to your supplier’s attention. You will typically do this via the normal technical and/or commercial communication channels that have been established. Your supplier is obliged to investigate your complaint, and should take appropriate actions to avoid or reduce the chances of it happening again.

If, however, you are dissatisfied with the overall performance of your supplier, (for example if they continue to provide non-conforming products, do not address your complaints, or are not taking appropriate corrective actions) then this is an indication of problems in their quality management system. Depending on the responses you receive, you should be aware that you can escalate your complaint as follows:

If your supplier has a QMS that meets ISO 9001:2000 requirements, they are required to have nominated a person (the “management representative”) to have the responsibility and authority to ensure the system is working properly. You should find out who this is, and make a formal complaint.
If you are still not satisfied with the response from your supplier, and if they are certified by an independent (third party) certification body (“registrar”), you should bring the matter to the certification body’s attention. You can find the certification body’s name by looking at your supplier’s certificate. The certification body will investigate the problems during their surveillance audits of your supplier’s QMS, or, in critical cases, may decide to carry out an additional specific investigation.
If you do not receive a satisfactory response from the certification body, and if it is accredited (see Figure 1), you should complain to the relevant accreditation body. Details of any such accreditation will appear on your supplier’s ISO 9001:2000 certificate. If you have difficulty in getting this information, you can consult the list of accreditation bodies who are members of the International Accreditation Forum on the IAF website (http://www.iaf.nu).
If you feel that you have not received a satisfactory response from the accreditation body, and if it is a member of the International Accreditation Forum (see Figure 1), you can complain to the IAF (http://www.iaf.nu).
Remember that none of the above will affect your statutory rights as a purchaser, and it may be appropriate to take legal action against your supplier instead of, or in parallel with the above channels. The way in which you do this may vary from one country to another.

 To summarize…..
ISO 9001:2000 is a useful basis for organizations to be able to demonstrate that they are managing their business so as to achieve consistent (good!) quality goods and services.

There are several ways in which your suppliers can claim conformity to ISO 9001:2000, and you need to ensure that the method chosen by your supplier provides you with the necessary degree of confidence.

If you are not satisfied with the performance of your supplier, you must provide them with the appropriate feedback. Learning from complaints helps organizations to improve their future performance – that is what ISO 9001:2000 is about.

ISO Secretary-General Alan Bryden commented: “Within the context of the growth of international trade and global supply chains, ISO 9001:2000 is being used by suppliers and customers located in different countries to establish initial confidence, or even to select partners in the supply chain.  This new ISO brochure will help them to avoid unpleasant surprises and to use ISO 9001:2000 to its full potential.”

According to Dr Thomas Facklam, Chairman of IAF, “This document emphasizes the important role of a credible third party certification/registration process in providing confidence throughout the supply chain.  It explains very clearly the various ways in which an organization may choose to demonstrate its conformity to ISO 9001:2000, and the situations in which each of these may be appropriate.  Accredited certification provides an additional layer of confidence, and the worldwide network of accreditation bodies that operate under the umbrella of the IAF play a critical role in ensuring that certification bodies/registrars accredited by them are carrying out their assessments in a competent, impartial and consistent manner.” 
 

ISO 9001:2008 does not contain any new requirements

They have recognized that ISO 9001:2008 introduces no new requirements. ISO 9001:2008 only introduces clarifications to the existing requirements of ISO 9001:2000 based on eight years of experience of implementing the standard world wide with about one million certificates issued in 170 countries to date. It also introduces changes intended to improve consistency with ISO14001:2004

The agreed implementation plan in relation to accredited certification is therefore the following:

Accredited certification to the ISO 9001:2008 shall not be granted until the publication of ISO 9001:2008 as an International Standard.

Certification of conformity to ISO 9001:2008 and/or national equivalents shall only be issued after official publication of ISO 9001:2008 (which should take place before the end of 2008) and after a routine surveillance or recertification audit against ISO 9001:2008.

Validity of certifications to ISO 9001:2000

One year after publication of ISO 9001:2008 all accredited certifications issued (new certifications or recertification) shall be to ISO 9001:2008.

Twenty four months after publication by ISO of ISO 9001:2008, any existing certification issued to ISO 9001:2000 shall not be valid.

WHAT IS ISO 9000?

ISO 9000 is a series of International Standards for Quality Management & Quality Assurance. It is not a set of product standards Nor It is specific to one industry.

It is a provision of minimum system requirements which will help ensuring that items/ services are provided in accordance with a good management practice

It is certification of a system and not of any product.

BACKGROUND OF ISO

>>  ISO-International organization for standardization

>>  A federation of National Standard Bodies from over 135 countries-one representative from each country.

>>  Non-governmental organization (NGO).

>> Established in 1947

>> Head Quarters at Geneva-Switzerland.

>> Head Quarters at Geneva-Switzerland.

>> Mission - Develop International Standards

>> Facilitate International Exchange

>> Promote Global Cooperation

HISTORY OF QUALITY SYSTEMS

Quality requirements recognized after industrial revolution-1911

Chronological developments are as follows:

HACCP involves a system approach to identification of hazard, assessment of chances of occurrence of hazards during each phase, raw material procurement, manufacturing, distribution, usage of food products, and in defining the measures for hazard control.  In doing so, the many drawbacks prevalent in the inspection approach are provided and HACCP overcomes shortcomings of reliance only on microbial testing.

 

HACCP enables the producers, processors, distributors, exporters, etc, of food products to utilize technical resources efficiently and in a cost effective manner in assuring food safety.  Food inspection too would be more systematic and therefore hassle-free.  It would no doubt involve deployment of some additional finances initially but this would be more than compensated in the long run through consistently better quality and hence better prices and returns.

 

 

HACCP CERTIFICATION

 

BIS offers two Certification schemes to the food industry.

i)  HACCP Stand-alone Certification against IS 15000:1998

ii) HACCP based Quality System Certification provides for two Certification through one audit Certification of Quality System against IS/ISO 9000 and Certification of HACCP against IS 15000:1998

 

HOW TO OBTAIN LICENCE?

 

Establish a documented quality system and /or HACCP implementation plan and ensure its effectiveness

Submit application on prescribed proforma (Form IV) along with the questionnaire (Form XII) and necessary fees to Dy. Director General (of respective region).

Submit the quality manual and/ or concerned documents, when asked for

Arrange audit by BIS Assessment Team

Take actions on non-conformities observed by assessment team and get them verified.  If found satisfactory, grant of licence is recommended.

Obtain the Licence!!!

The licence will enable the company to compete effectively in national and international markets.

.PROCESS OF HACCP CERTIFICATION

ISO 14001 was first published in 1996 and specifies the actual requirements for an environmental management system. It applies to those environmental aspects which the organization has control and over which it can be expected to have an influence.

ISO 14001 is often seen as the corner stone standard of the ISO 14000 series. However, it is not only the most well known, but is the only ISO 14000 standard against which it is currently possible to be certified by an external certification authority. Having stated this, it does not itself state specific environmental performance criteria.

This standard is applicable to any organization that wishes to:

• implement, maintain and improve an environmental management system
• assure itself of its conformance with its own stated environmental policy (those policy commitments of course must be made)
• demonstrate conformance
• ensure compliance with environmental laws and regulations
• seek certification of its environmental management system by an external third party organization
• make a self-determination of conformance