Who or what is ISO?
The International Organization for Standardization (ISO) is the specialized international agency for standardization, at present comprising the national standards bodies of over 110 countries. Similar to the United Nations, ISO intends to promote the development of standardization and related world activities as a means to foster predictable,
free-trade internationally and level the playing field for all those who
participate in this trade. Thousands of standards are published and
maintained by this group in Geneva, Switzerland. A select few of the "ISO
Standards" can be adopted for accreditation, registration or certification
purposes.
The term iso also literally means "equal".
What are the ISO 9000 Series standards?
Take me to TS 16949
The ISO 9000 series is a set of 3 individual, but related, international standards
developed to assist organizations of all shapes and sizes in the development and
operation of effective quality management systems. The ISO 9000 series requirements can be used by manufacturing and service industries alike. These standards were developed with the goal of effectively documenting,
and more importantly, executing the quality management system processes needed in order to
meet customer expectation. The ISO 9000 series standards do not themselves specify the technology to be used for implementing the quality
management system
processes.
The objective of an ISO 9000 quality management system is to ensure that an organization's products - hardware, software, processed materials
- and/or services conform to specified requirements. Specified requirements is the term the Standard uses to mean the customer's expectations, both stated and unstated.
Similar to the ISO 9000 series for quality management, there are many other
series for the management of other systems (i.e. ISO 14000 series for
environmental management or ISO 18000 series for heath & safety management).
Are the standards readily understood?
The requirements within the ISO 9001 standard were designed to be user-friendly
and universal - focusing on the fundamental "common denominators" necessary for
success in a variety of organizations and sectors . Requirements are general
and broad in nature and follow a logical, easily-understood format
consist with the normal business process flow. However, each organization
is unique. There may be wide differences from one organization's readiness to implement the standards,
the number of documents required within the organization and the amount of time
it might take to effectively implement a new quality management system.
What is an accreditation body?
Accreditation bodies are organizations that evaluate, approve and generally
oversee the practices and procedures of registration bodies or "Registrars".
In general, accreditation bodies are government agencies or organizations
sanctioned by their respective national governments. You could say that
they are "the Auditors or the Auditors" used to ensure uniform practices with
the registration/accreditation community.
What are registration bodies or "Registrars"?
A registration body is an entity that audits an organization to verify
compliance with a given set of standard requirements or criteria.
Registration bodies differ with respect to accreditation status and scope of accreditation. For example, there are currently hundreds of
Registrars authorized to perform ISO 9000 series audits, but only a handful (less than 50 or so) that can perform the automotive addition to ISO 9001:2000 - which is the ISO/TS 16949:2002 standard.
How much will it cost and how long will it take to implement these standards?
There is no fixed answer to this question. Each organization is different based on size, system maturity, complexity of operations and several other variables. The answer really depends on how developed your present system is and the implementation strategy you adopt.
Standard daily auditing rates generally range from $1000 to $2000 with a minimum
number of "mandays" required per year. Some registrars also
include service fees
such as annual dues, travel expenses, document review time, etc. so it is
important that you do your homework and find a registrar that is right for you.
Many organizations use 3rd-party consultants to assist in minimizing the overall
implementation costs.
Contact us for a quote today.
Will my company be required to use these standards to do business globally?
ISO registration is not required by law for most products and services. The
possibility that compliance will be commercially driven, however, is already a
reality in many industries. For example, the Big 3 US automotive
giants Ford, GM and DaimlerChrysler require organizations within their
supply chain to be registered to ISO 9001:2000 at a MINIMUM almost without
exception. Therefore, many sectors are simply requiring these 3rd-party
registrations prior to accepting a quote for business.
What is the difference between quality control and quality assurance?
Quality assurance is much more comprehensive and proactive than quality control. Quality assurance embraces the planning and implementation of systems designed to ensure that quality requirements are met. Quality assurance
focuses on prevention (proactive) through the design of error-proof processes
and creating a common language of what is acceptable and what is not.
Quality control focuses on detection (reactive) in order to contain a quality
issues as opposed to fixing the cause of a potential or existing nonconformity.
What are the advantages or benefits of registration to ISO 9001:2000?
Implementation of an ISO 9000 quality system brings great benefits to your organization. A few of the many key benefits of ISO 9000 registration are:
immediate sales and marketing appeal, strengthened customer confidence, access to markets previously inaccessible, reduced operating costs, competitive advantage and a reduced number of customer audits.
Many organizations that use their management system beyond registration find
increased benefits such as employees that are more involved in the improvement
process and improved customer and supplier relations.
Does ISO 9000 ensure world-class quality?
Of course not - nor is it meant to. The quality system required in the ISO 9000 standards is only a beginning
and a new level of expectation internally and externally. These standards are the bare basics of planned, provable quality assurance.
It is relatively simple to "Look" like an ISO 9001 registered company. It
is much tougher to "Live" like an ISO 9001 registered company.
Does "99 billion served" on a McDonald's sign ensure world class quality?
Which ISO 9000 document is a good starting point for understanding?
ISO 9000-1, Quality Management and quality assurance standards - Part 1: Guidelines for Selection and Use, is known as "the road map for the ISO 9000 family." ISO 9000-1 touches on every essential element in the theory and practice of quality system management. It defines and discusses important concepts and provides guidance to other documents within the ISO 9000 family.
Do any of the ISO 9000 documents give guidelines for services?
Yes. Service quality differs significantly from, say, manufacturing quality and
ISO 9000 recognizes that by recommending a different array of quality system
components. ISO 9004-2 Guidelines for Service, describes the elements of a
quality system specifically for a process that is either partially or totally
devoted to providing services.
Is software covered by an ISO 9000 quality system guidance documents?
Yes. ISO 9000-3, Guidelines for the application of ISO 9001 to the development, supply and maintenance of software, provides quality management guidelines for processes that are involved in developing software as either part or all of the eventual product. Unlike other guidance documents, ISO 9000-3 provides specific guidance for the application of the ISO 9001 standard.
What ISO 9000 standards can a company become registered to?
ISO 9001:2000 published December, 2000 is the latest revision of the ISO 9000 Standards. ISO 9001, ISO 9002 and ISO 9003 (published in 1994) are the the previous quality system models which
have expired as of December, 2003. After this date companies will only be able to register their quality systems to ISO 9001:2000 standards
for quality management system purposes.
What quality tools and techniques are mandated by ISO 9000?
None. ISO 9000 does not describe techniques; it sets general objectives. There are no requirements for the use of scatter diagrams, FMEAs, design of experiments, Pareto charts, problem solving systems, fishbone diagrams, or any others
specific tools. Of course these tools, as well as others, may be important - if not essential - to
the proper execution of production and service processes.
Do the standards require organizations to set any type of formal qualifications for employees?
Yes. The Standard expects management to ensure that the necessary competency is
available for the effective and efficient operation of the organization.
Management should consider analysis of both the present and expected competency
needs as compared to the competence already existing in the organization.
What are the documentation requirements of the ISO 9001:2000 standard?
In general, organizations must maintain documentation sufficient to prove the implementation, effectiveness, and results of the quality system. The standard does however require each organization to prepare a documented quality manual and the documented procedures covering the tasks that affect quality:
Required documented procedures
| 4.2.3 |
Control of documents |
| 4.2.4 |
Control of records |
| 8.2.2 |
Internal audit |
| 8.3 |
Control of nonconforming product |
| 8.5.2 |
Corrective action |
| 8.5.3 |
Preventive action |
The extent of the documentation needed within a quality management system can
differ from company to company based on size, type of activities, complexity of
processes, turnover, competency of employees, etc. As a general rule, we
would recommend organizations evaluate the use of documentation WHERE THE
ABSENCE OF THAT PARTICULAR TOOL MAY ADVERSELY EFFECT PRODUCT OR SERVICE QUALITY.
What is the purpose of a quality manual?
The quality manual is a relatively short, controlled circulation document that describes the facility
and scope of the quality management system, including details of and
justification for any exclusions (see 1.2); cross references the documented procedures established for the quality systems and a description of the interaction between the processes of the quality management system. The quality manual typically lacks in detail and specifics. The details and specifics are found in the procedures and, possibly, the work instructions
or other lower-tiered documentation. Many companies choose to mirror the international standard and simply make reference to documents that contain further detail. A quality manual can be as complex as a 500 page detailed business handbook or as simple as a
tri-fold brochure.
What are work instructions?
Work instructions are task-level, step-by-step "how to" documents. Work instructions
may be required only where the absence of such documentation would adversely effect quality.
However, some companies choose to place their energy into robust training
programs in exchange for the development of work instructions - or a mixture of
the two. Work instructions are indeed working documents often found in regular use at employee work stations. Work instructions may be unnecessary and cause waste in your management system. A note added to clause 4.2 in the ISO 9001:2000 standard states:
"The extent of the quality management system documentation can differ from one organization to another due to a) the size of the organization and type of
activities, b) the complexity of processes and their interactions, and c) the competence of personnel." (Note 2)
What are the requirements for Document Control?
All documents used in the control and operation of the quality system or in
making "pass/fail" decisions must be controlled for a variety of reasons. Ultimately a document control system should assist in the implementation of planned tasks in order to meet organizational goals. If these goals can be met with additional training or other means to assure required results are achieved, an organization may be able to bypass the creation of non-valued documents. The creation, approval, distribution, updating and withdrawal of documents affecting the quality system must be planned, documented and controlled in any case.
What is the purpose of internal quality audits?
Under ISO 9000 requirements, internal quality audits must be conducted.
Internal audits are, by far, one of the best tools an organization can use to improve quality,
identify best practices and uncover potential risks for the sake of preventing
potential nonconformities. Internal quality audits are just one way that the ISO 9000 quality system manages, adjusts, and improves itself. The audits are carried out by
specially trained employees - many times acting in various roles and working
different shifts with in their full-time position - with the objective of
assessing the operations and providing a snap-shot report back to top management
of the current conditions of the system.
When is this ISO 9000 "thing" ever going to stop changing?
ISO 9000 standards are reviewed every 5-6 years. At that point, a decision is made by the members of the ISO committees to either extend, replace or modify the previously released version of the international standard. One of the major themes throughout the ISO 9000 series standards is "continuous improvement". With this is mind, organizations world-wide should view ISO 9000 as a journey as opposed to a destination.
ISO/TS 16949:2002 FAQs
Which organizations can obtain Certification/Registration to ISO/TS 16949:2002?
Any organization in the Automotive Supply Chain meeting the criteria below can obtain certification to ISO/TS 16949:2002.
- Scope 1.1 General
- This Technical Specification, in conjunction with ISO 9001:2000, defines the quality management system requirements for the design and development, production and, when relevant, installation and service of automotive-related products.
- This Technical Specification is applicable to sites of the organization where production and/or service parts specified by the customer are manufactured.
- 3.1.11 "Site" is defined as the location at which value added manufacturing processes occur.
- 3.1.6 "Manufacturing" is defined as the process of making or fabricating:
- Production materials
- Production or service parts
- Assemblies, or
- Heat treating, welding, painting, plating, or other finishing services
What are the requirements for supplier development clause 7.4.1.2?
From ISO/TS 16949:2002 and IATF Guidance to ISO/TS 16949:2002
7.4.1.2 Supplier quality management system development
"The organization shall perform supplier quality management system development with the goal of supplier conformity with this Technical Specification. Conformity with ISO 9001:2000 is the first step in achieving this goal.
Note: The prioritization of suppliers for development depends upon, for example, the supplier's quality performance and the importance of the product supplied.
Unless otherwise specified by the customer, suppliers to the organization shall be third party registered to ISO 9001:2000 by an accredited third-party certification body."
The burden is on the organization to demonstrate compliance of its suppliers to this requirement including evidence of alternative arrangements specified by the customer. In situations where there are multiple customers, customer
approval of alternative arrangements is based upon those customers impacted by that supplier.
Supplier in this clause (7.4.1.2) refers to sites where production and/or service parts specified by the customer are manufactured. See also the definition of
manufacturing, 3.1.6. Supplier quality management system development is the demonstrated performance of a process with the goal to achieve conformity with ISO/TS 16949:2002.
Indicators of performance include:
conformity with ISO 9001:2000
achievement of ISO 9001:2000 certification, as a minimum, unless otherwise specified by the customer
compliance with ISO/TS 16949:2002, unless otherwise specified by the customer
evidence of a process to achieve the above steps.
According to the IATF (International Automotive Task Force), supplier development was written purposely that way, with the provision that "unless otherwise agreed with the customer" - meaning - if not possible to do, get customer approval of a different approach. "Customer" in this context is defined in the guidance supplement as the "affected" customers. Also, guidance includes wording "a process to achieve the above" - meaning you could accept a plan to achieve the requirement - and as far as maximum timing of that plan - the view of the IATF is that it should be achievable during the three year life of the certificate. Surveillance visits shall monitor achievement of the plan.
What is the correct way to calculate audit days covering supporting functions for Corporate certificates?
Supporting functions (remote or not) employees shall be included as if they were a site (including appropriate corporate reduction). The resulting audit days shall be added to the normal site based audit days and then allocated to auditing activities of the supporting functions appropriately.
In addition to ISO/TS 16949:2002 requirements document are there additional reference manuals, which we should use?
As well as Rules, Guidance and the Checklist, additional manuals are those specified by customer-specifics requirements (i.e. the QS-9000 6-pack), either as stand alone documents or in their Purchase Agreement. If the customers to the organization do not have customer specifics then the organization is free to choose from the manuals available.
Less than 12 months Performance Data - How can a Site working towards ISO/TS 16949:2002 show 12 months performance data?
For an established facility, the last 12 months performance data should be provided against the products in production and the QMS being used.
Note: In the case of a new facility, the audit should be conducted once ISO/TS 16949:2002 QMS compliance is established and the Certification Body is permitted to issue a letter of conformance. After 12 months of production, when performance data is verified, the Certification process can proceed.
Can a site be issued an ISO/TS 16949 certificate if they are currently in a customer
special status condition, such as GM New Business Quality Hold, Ford Q1
Revocation or DaimlerChrysler Needs Improvement?
No. Unless written evidence of removal from that status is available from the customer, a certificate cannot be issued.
Are all the IATF documents protected by copyright?
Yes. All documents and the training material created by the IATF are protected by copyright worldwide. Many organizations print numerous copies of the standard and disseminate these copies to individuals throughout their site. In the past this may have been a little easier to do. Now, with the possibility of IATF witnessed audits, organization put themselves at a greater risk of copyright infringement.
What are IATF witnessed audits?
The IATF has the authority to monitor the activities of accreditation bodies without refusal from the organizations being audits. This means that it is possible to have members of the IATF accompany your registrar auditors during your initial or surveillance audits. Organizations can not refuse the entrance and participation of IATF witnessed audits without jeopardizing the status of their certification.
How can I receive more information on questions not answered on this page?
Contact us with any additional questions you might have. We would be happy to answer your questions or point you in the right direction.
