SUMMARY OF CHANGES TO ISO 9001:2008 Vs. ISO 9001:2000
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There is nothing to worry about if you are already certified to ISO The good news is that the 2008 release will not have the same impact.
9001:2000. The only likely impact would be on organizations that had In fact, the ISO technical committee (TC176) who develops the ISO
previously misunderstood the intent of certain parts of the standard and, 9000 series of standards is purposely planning the next release as an
due to the clarifications in the 2008 version, it is recognized that the amendment rather than a formal revision. The difference is that an
standard had been mistakenly applied incorrectly. A process or quot;amendmentquot; is focused on making changes for clarification purposes
procedure here or there might need some minor modification in this only and for better alignment with ISO 14001, the standard for
case. environmental management. With the 2008 release, the committee is
purposely intending not to introduce substantive changes that will affect
the QMS processes and documentation of currently certified
So, the upcoming release of ISO 9001:2008 should be a fairly simple
organizations. Thus, the new ISO 9001:2008 standard should have
transition for most certified organizations. If you are currently preparing
limited impact on companies already certified. Here are a few examples
for your initial ISO 9001 certification, there is no reason to delay or to
of the types of changes in the currently available DIS ISO 9001:2008
change your approach. If you are correctly implementing an ISO
9001:2000 quality management system in preparation for your initial
certification audit, the new standard will not impact you significantly. As
usual, we expect there will be a 1 - 2 year quot;transition periodquot; following There are some terminology changes that are intended to
the release of the new revision to make any necessary changes to clarify ideas or make documentation more consistent - e.g.
comply with the new standard. But, as we have said, there aren't likely quot;devicesquot; is changed to quot;equipmentquot;.
to be any substantive changes anyway. There are several additional or revised quot;Notesquot; within the
standard. However, notes are not considered part of the
auditable requirements but are, instead, included for
Regardless of the schedule, most users of the ISO 9001:2000 standard
(whether certified, conforming or preparing) want to know what is going
• The phrase quot;where applicablequot; is used more extensively with
to change in 2008. Those who went through the previous transition from
regard to several requirements within the standard. This was
ISO 9001:1994 to ISO 9001:2000 know first-hand the disruption that
done to help more organizations in various industries more
was caused by the significant changes introduced by the last revision. It
easily apply the standard to their particular business.
was very costly for all certified companies to change over to the new
• A number of sentences and paragraphs have been re-worded
to be easier to understand and apply the
● ● ●
ISO 9001:2008 Quality Management Systems –
Requirements is intended for use in any organization which designs, develops, manufactures, installs and/or services any product or provides
any form of service. It provides a number of requirements which an organization needs to fulfill if it is to achieve custom er satisfaction through
consistent products and services which meet customer expectations. It includes a requirement for the continual (i.e. planned) improvement of the
Quality Management System, for which ISO 9004:2000 provides many hints. This is the only implementation for which third-party auditors may
grant certification. It should be noted that certification is not described as any of the 'needs' of an organization as a driver for using ISO 9001 (see
ISO 9001:2000 section 1 'Scope') but does recognize that it may be used for such a purpose (see ISO 9001:2000 section 0.1 'Introduction').
• The key focuses of the ISO 9001:2008 amendment were to enhance the clarity of ISO 9001:2000 and to enhance its compatibility
with ISO 14001:2004.
The changes incorporated in this ISO 9001:2008 edition were classified in terms of impact into the following categories:
o No changes or minimum changes on user documents, including records
o No changes or minimum changes to existing processes of the organization
o No additional training required or minimal training required
o No effects on current certifications
● ● ●
ISO 9001:2008 has been developed in order to introduce clarifications to the existing requirements of ISO 9001:2000 and to improve
compatibility with ISO 14001:2004. ISO 9001:2008 does not introduce additional requirements nor does it change the intent of the ISO
No new requirements were introduced in ISO 9001:2008 edition but, in order to benefit from the clarifications of ISO 9001:2008, users of the
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former version will need to take into consideration whether the clarifications introduced have an impact on their current interpretation of ISO
9001:2000, as changes may be necessary to their QMS.
ISO 9001:2008 is intended to be generic and applicable to all organizations, regardless of type, size and product category. It is recognized,
however, that not all the requirements of this standard will necessarily be relevant to all organizations. Under certain circumstances, an
organization may consider the exclusion of the application of some requirements of ISO 9001:2008 from its QMS. ISO 9001:2008 makes
allowance for such situations, through sub-clause 1.2 Application.
FAQs on ISO 9001:2008
1. What are the main changes in ISO 9001:2008?
ISO 9001:2008 has been developed in order to introduce clarifications to the existing requirements of ISO 9001:2000 and changes that are
intended to improve compatibility with ISO 14001:2004. ISO 9001:2008 does not introduce additional requirements nor does it change the
intent of the ISO 9001:2000 standard.
Certification to ISO 9001:2008 is not an ―upgrade‖, and organizations that are certified to ISO 9001:2000 should be afforded the same
status as those who have already received a new certificate to ISO 9001:2008
All changes between ISO 9001:2000 and ISO 9001:2008 will be explained by the Process Consultants engaged in the process of assisting
your Organization in generating Process Compliance with respect to ISO 9001 Certification.
2. What are the main benefits to be derived from implementing an ISO 9000 quality management system?
The ISO 9000 standards give organizations an opportunity to increase value to their activities and to improve their performance continually,
by focusing on their major processes. The standards place great emphasis on making quality management systems closer to the processes
of organizations and on continual improvement. As a result, they direct users to the achievement of business results, including the
satisfaction of customers and other interested parties.
The management of an organization should be able to view the adoption of the quality management system standards as a profitable
business investment, not just as a required certification issue.
Among the perceived benefits of using the standards are:
The connection of quality management systems to organizational processes
The encouragement of a natural progression towards improved organizational performance, via:
- The use of the Quality Management Principles
- The adoption of a quot;process approachquot;
- Emphasis of the role of top management
- Requirements for the establishment of measurable objectives at relevant functions and levels
- Being orientated toward quot;continual improvementquot; and quot;customer satisfactionquot;, including the monitoring of information on
quot;customer satisfactionquot; as a measure of system performance.
- Measurement of the quality management system, processes, and product
- Consideration of statutory and regulatory requirements.
- Attention to resource availability
3. How will the implementation of the amended standard help my organization to improve its efficiency?
ISO 9001:2008 aims at guaranteeing the effectiveness (but not necessarily the efficiency) of the organization. For improved
organizational efficiency, however, the best results can be obtained by using ISO 9004 in addition to ISO 9001:2008. The guiding
quality management principles are intended to assist an organization in continual improvement, which should lead to efficienc ies
throughout the organization.
4. How can the processes in an organization be determined?
Identify the organization's intended outputs, and the processes needed for achieving them. These will need to include processes for
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Management, Resources, Realization and Measurement and Improvement.
Identify all process inputs and outputs, along with the suppliers and customers, who may be internal or external.
Identify the sequence and interactions of the processes.
5. Should an organization define and document all its processes?
The main purpose of documentation is to enable the consistent and stable operation of an organization's processes.
Although statutory, standards' or customer requirements may require certain documentation, there is no defined ―catalogue‖, or list of processes
that has to be documented in ISO 9001, apart from the 6 indicated ones.
The organization should determine which processes are to be documented on the basis of:
The size of the organization and type of its activities,
The complexity of its processes and their interactions,
The criticality of the processes and
Availability of competent personnel.
A number of different methods can be used to document processes, such as graphical representations, written instructions, checklists, flow
charts, visual media, or electronic methods.
6. How much detail is required in process documentation?
The extent of detail is likely to depend upon factors such as:
The size of an organization and its types of activities,
The complexity of its processes and their interactions, and
The competence (level of education, training, skills and experience) of its personnel.
7. Is there a standard way of describing a process?
No, there is no standard way to describe a process. It depends on the culture, management style, staff literacy, personal attributes and their
A process may be described using a flow chart, block diagram, responsibility matrix, written procedures or pictures.
Process flowcharts or block diagrams can show how policies, objectives, influential factors, job functions, activities, material, equipment,
resources, information, people and decision making interact and/or interrelate in a logical order.
8. What is the impact of ISO 9001:2008 on certification?
Certification to ISO 9001:2008 is not an ―upgrade‖, and organizations that are certified to ISO 9001:2000 should be afforded the same status as
those who have already received a new certificate to ISO 9001:2008.
ISO and the International Accreditation Forum (IAF) have agreed the following ―Implementation Plan‖ with respect to accredited certification to
―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 I SO 9001:2008 (which
should take place before the end of 2008) and after a routine surveillance or re-certification audit against ISO 9001:2008.
SUCCESSFUL ISO 9001 : 2008
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Making the decision to become registered to ISO 9001 is often 2. UNDERSTAND THE PROCESS APPROACH
a very simple one, as the benefits are well documented.
A more difficult task is putting together and successfully completing
an implementation plan that balances the requirements of the ISO 9001 promotes a process approach to quality management
standard, your deadline to become registered and the normal systems. Successful management system implementation
pressures of your business. depends on understanding the process approach in addition to the
standard‘s requirements. Begin your understanding by ordering the
There is no single blueprint for implementing ISO 9001 that ISO 9000:2000, ISO 9001:2000 and ISO 9004:2000 family of
will work for every company, but there are however some common standards. Copies can be purchased through Dynamic Strategies
steps that will allow you to balance the often conflicting Management Systems at http://www.dynamicstrategies.co.in
requirements and prepare you for a successful registration
assessment. Before opening the ISO 9001 Requirements standard, review
the quality concepts described in the ISO 9000:2000 Fundamentals
This ‗Practical Guide‘ considers the key phases in your and Vocabulary standard.
implementation project from start to finish and suggests
‗best practice‘ for each while directing you to further helpful When you examine ISO 9001, pay particular attention to the
resources as you embark on your ISO 9001:2000 journey. process approach described in its Introduction section. A ‗process‘ is
a system of activities that uses resources to transform inputs into
1. THINK OF IMPLEMENTATION AS A PROJECT outputs. The ‗process approach‘ promoted by ISO 9001
requires that you systematically identify and manage these processes
and their interaction within a quality management system. An
The way to treat the implementation process is as a project, which advantage of the process approach is the ongoing control it
means appointing a project team with a project manager, preparing provides over the linkage between individual processes within a
a project plan and evaluating and monitoring progress according to system of processes, as well as their combination and interaction.
the plan. This demands certain prerequisites, including top According to Clause 4.2.2 in ISO 9001:2000, the quality manual
management commitment, good communications at all levels must describe the interaction of the processes within the quality
and ownership of the quality system by all. management system.
If ISO 9001 Management Systems are a completely new ISO 9004:2000 provides guidance on performance improvements
subject area for your organization, or you lack time, expertise or beyond the basic requirements of ISO 9001.
objectivity you may want to consider the use of a Quality
Management System Consultant to assist with implementation. Further guidance on processes and the process approach is available
An experienced consultant can be a very beneficial part of your from the ISO website www.iso.ch
project team, particularly if you have an implementation deadline
as they can undertake the project manager role. Please see the bordered area below ‗Key Concepts of ISO 9001‘ for
further information on the major principles of ISO 9001.
A consultant should not write your quality system for you, as
ownership of processes and procedures is important for a successful
management system. For more information on how to select and
use a consultant, download our free ‗Ten Tips for Selection and Use I. Understand the process approach
of a Quality Management System Consultant‘ from II. Read the standards
I. Approach Implementation as a project
II. Consider use of a consultant
● ● ●
Check—This means monitor and measure what you‘re doing so
KEY CONCEPTS OF ISO 9001 that you have data to evaluate and improve the processes and
In ISO 9001:2000, ‗continual improvement‘ is defined as: ‗Recurring Act—After you have data, you must do something with it to
activity to increase the ability to fulfill requirements.‘ It is a improve, and, of course, plan for the improvement (which begins
the cycle again). The ‗act‘ usually stems from management reviews,
continual process through the use of audit findings and audit
conclusions, analysis of data, management reviews or other means internal audits, customer audits, data gathering or even third-party
and generally leads to corrective or preventive action.‘ assessments.
PDCA Process Approach 4 Key Clauses of ISO 9001
The ISO 9001 requirements document follows a concept
called the Plan-Do-Check-Act model—a process that is designed for 5. Management Responsibility
continual improvement of any management system. This cycle is Top management has an ongoing commitment to the quality
critical to understand the new standard and its requirements. management system. They are responsible for identifying all of the
The basic concepts of the PDCA cycle are straightforward: relevant business requirements, communicating organizational
policy and providing resources to ensure implementation,
Plan—This is a critical stage, and ISO 9001 has planning maintenance and continual improvement of the quality
requirements and suggestions in nearly every clause. But the basic management system.
concept is simple—formulate a plan to fulfill your quality policy and
the objectives of the system. 6. Resource Management
The day-to-day management of quality and effectiveness relies on
Do—This is a fairly simple concept as well. It means implement the using the appropriate resources for each task. These include
processes you‘ve laid out in your plan. competent staff with relevant (and demonstrable) training, the
correct tools and supporting services.
7. Product Realization
This is the design (where applicable) and production of the products
and services you provide. In addition to production planning and
scheduling resources, product realization includes determining and
measurably meeting customer requirements.
8. Measurement, Analysis and Improvement
This is a key requirement for a successful business. It involves those
measurements being made to help improve your organization and
demonstrate product conformity. Statistical techniques should be
used where appropriate.
● ● ●
of meetings in the beginning for implementation planning, setting
3. ASSEMBLE AN IMPLEMENTATION TEAM
objectives and the quality policy, you should consider personnel who
work well together in groups. Group decisions can provide a lot of
Choosing the right team to implement your ISO 9001 based
creative feedback, which is often critical in providing more employee
quality management system is key to any successful quality
ownership and buy-in to the project. Other personality traits you
program, but it‘s not the easiest thing to do. There is no right or
should consider could include:
wrong way to choose a team because organizations vary in size,
• Action-oriented—The team needs to be ready to act and
scope and complexity. It is optimal to have people on the team with
different skill sets from cross-functional parts of the business that
• Experienced—It is a good idea to have team members who
can provide valuable input to the implementation process. This
know the business of the organization. People who have been
allows business synergies and communication to occur across the
around a while and know how things operate can be invaluable
to your team.
• Detail-driven—Documentation and implementation means
Team members for implementation and assessments should be
dotting the ‗is‘ and crossing the ‗ts‘, and deadlines are often
identified early in the process, but make sure you have people who
represent all relevant departments. It is vital that Senior absolute.
• Holistic thinkers—When implementing ISO 9001 for an
Management is represented on the team as overall responsibility
for the quality management system lies with them, but it is equally organization, team members must be able to see the ‗Big Picture.‘
important that staff from all levels form part of the team as
• Good communicators—Once the system begins, awareness and
everyone can provide a valuable insight. It is key to have team
understanding is crucial. This is where a strong team becomes
members who understand how the interdepartmental interfaces
essential, because spreading the word about quality is important.
function and processes link so that a process based management
Also ensure that the information that is communicated is
system can be effectively implemented.
consistent and relevant.
Additionally, it is a good idea to consider personality traits for the
members of the team. For example, because there will likely be a lot
4. GET MANAGEMENT SYSTEM TRAINING RECOMMENDED TRAINING ROUTE FOR
ISO 9001 IMPLEMENTERS
Many of your Implementation Team will require ISO 9001 Management
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System training to aid understanding of the requirements, and to plan
and develop your Management System. It is important to get training
early in the implementation project as in the long term it will bring
significant time and money savings to your organization if staff are
Dynamic Strategies Management Systems has created a
‗recommended training route‘ for Implementers. The ‗training route‘ is an
easy to use summarized model. More detailed course descriptions and
our class schedule are available at
I. Identify training requirements early
5. IMPLEMENTING THE SYSTEM
Now you are appropriately prepared with an understanding of the
fundamentals, have a project plan and a trained team assembled.
Next is the hard part, the actual implementation.
Here we will present the three core elements of implementation:
5a. – Gap analysis
5b. – Write and develop documentation
5c. – Communicate implementation
These cannot be done in series, but must be done at the same time
and often done multiple times. They are presented here in no
5A. GAP ANALYSIS
A gap analysis is a process an organization goes through to
determine the difference between what the process or quality
management system is like now and what it should be when it
conforms to the requirements of ISO 9001 (or any management
At the early implementation phase a gap analysis should focus on:
❑ Whether procedures have been established when necessary
❑ Compliance to established procedures and processes
❑ Proper resource allocation
❑ Effective communication of objectives and responsibilities
❑ Competency of personnel and training programs
❑ The organization‘s ability to make changes when necessary
Once you have a full understanding of these issues you may realize
that you are a long way on the road to ISO 9001 already.
You can then evaluate the best way to formalize what you have and
make strategic decisions on how best to fill those gaps that were
discovered so that established requirements can be met and
customer satisfaction enhanced. I. Determine where your processes are now
II. Determine where they need to be
Later in the implementation process a gap analysis may include the
❑ The organization‘s quality culture.
❑ Knowledge of the quality management system and
❑ Awareness of the Quality Policy and quality objectives.
❑ The suitability and effectiveness of the quality system.
5B. WRITE AND DEVELOP DOCUMENTATION 5C. COMMUNICATE IMPLEMENTATION
Everyone on the team must have a clear understanding of what As you write your documentation you should also simultaneously
documentation needs to be created and this includes identifying the begin the process of implementing your quality management system.
needs and expectations of your customers as they form the basis for
many of your processes and procedures. All of the ISO 9001 The key to implementation is communication and training. During
documentation requirements are laid out clearly in Clause 4.2. The the implementation phase, everyone must operate to the procedures
table below details these and splits the required documents into a and collect records that demonstrate the organization is doing what
it says it‘s doing. Consequently, if personnel are to implement the
simple four level hierarchy.
system correctly, they need to be aware of what they‘re supposed
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Documented Procedures to do.
The six required documented procedures shown in the table below
are the minimum needed for your management system, and it may If staff have been involved in writing the documentation, implementation
be necessary to retain or write other procedures to ensure effective and compliance with the procedures should be easier. All staff
operation of the quality management system. For example, you may should be briefed accordingly of the procedures, although as the
wish to look at design, control of monitoring and measurement procedures should essentially be what they currently do, only
devices, and other areas, depending on the organization. changes need to be highlighted. Training can then be entered in
the training records as evidence that proper instruction has been
Other processes may or may not be documented, depending on provided.
whether the organization needs the documents for effective
planning, operation and control of its quality management system. Once the training process has been completed and staff are
implementing the procedures, periodically walk around the
There are other issues that you should consider during the business informally asking if the procedures are working or being
documentation phase as well. ISO 9004:2000 suggests that implemented
you should satisfy the ‗contractual, statutory and regulatory
requirements, and the needs and expectations of customers and
other interested parties‘ concerning the nature and extent of the
I. Communicate implementation
documentation. This means that items such as contracts, standards
II. Train Staff
used by the organization, applicable regulations and other information
regarding the needs of your stakeholders should be considered.
Dynamic Strategies Management Systems offers a Quality Systems
Documentation Course that gives practical guidance on how to write
readable and useable quality system documents. More information and
a class schedule is available at www.dynamicstrategies.co.in.
I. Identify customer needs
II. Develop documentation
Level Document Definition ISO 9001:2000 Required Documents
1 Overview of the company and its products and services; agreement a) Documented statements of a quality policy
Policy & to comply with applicable ISO 9001 requirements; system (5.3) and quality objectives (5.4.1)
Manual scope; exclusions; organization and responsibilities; sequence b) A quality manual (4.2.2)
and interaction of processes; documented procedures.
2 Describes the quality processes and interdepartmental controls c) Documented procedures that are required
that address the ISO 9001 requirements; may be in ISO 9001 by ISO 9001:2000. These are:
order or process order; reference lower-level documentation. 4.2.3—Control of Documents
ISO 9001 mandates six specific procedures. 4.2.4—Control of Records
8.3—Control of Nonconforming Product
3 Explains details of specific tasks or activities: the how of performing d) Documents needed by the organization to
Instructions a specific task. This level may include quality plans, ensure the effective planning, operation and
work instructions, drawings, flowcharts, workmanship standards, control of its processes
product specifications, machine manuals, etc.
4 Forms, tags, labels and other documents that prompt the e) Records required by ISO 9001:2000 (see
documents recording of evidence (per levels 1,2 and 3 documentation) of 4.2.4)
(Records) compliance to requirements. Records may be mandatory or
implied for each ISO 9001 clause.
6. IMPLEMENTATION TIME SCALE 8. CHOOSE A REGISTRAR
The time scale to implement a quality management system that Registration to ISO 9001 takes place when an accredited 3rd party
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conforms to the requirements of ISO 9001 depends on a such as Dynamic Strategies Management Systems visits an
number of factors such as resources, a sound plan, commitment organization, assesses the management system and issues a certificate
from top management and personnel and the complexity of the to show that the organization meets the requirements of ISO 9001. A
system. It is very important that you consider all of these issues number of factors should be considered when choosing a registrar
during the planning phase. You also need to take into account including industry experience, geographic locations, price and service
time constraints if you are implementing ISO 9001due to a level offered.
Ideally, the implementation phase should last about six months to I. Choose a Registrar appropriate for your organization
allow you sufficient time to collect enough records to verify that the
system is working, but you should be getting data back for analysis
within two to three months. Some good examples of records are
purchase orders, sales records, contracts, internal audits, meeting
minutes, test data and anywhere ISO 9001 requires a record
to be maintained. Records must be legible and retrievable in a
reasonable timeframe (You decide what is reasonable to your
Also, registrars usually want to see at least three months of system
operation before conducting a third party audit. This operating
period should also include an entire internal audit cycle and a
management review. You will need to collect records as evidence
your system is complying with planned arrangements, meeting
requirements and effectively achieving the planned results.
I. Plan Implementation to allow sufficient time to collect records
II. Ensure you meet your Registrar‘s minimum requirements REASONS TO CHOOSE
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7. REVIEW MANAGEMENT
Dynamic Strategies Management Systems has several registered
clients in various countries, making us one of the leading and most
experienced ISO Consultants. This places Dynamic Strategies in an
unrivalled position of knowledge about companies' needs, irrespective of
One of the final stages of implementation and also a continual
size and industry sector.
improvement process is to check that your system is working
effectively and conforming to the requirements of ISO 9001.
The breadth of Dynamic Strategies‘ services allows you to purchase the
This is the check and act part of the PDCA cycle and involves
standards, train your staff and gain registration - all from one committed
monitoring your system by recording and interpreting data and
conducting internal audits.
Dynamic Strategies‘ range of course offerings is among the most
ISO 9001 requires that data generated as a result of
comprehensive available and addresses the needs of quality
monitoring and measurement should be analyzed as a means of
professionals across the Americas. Add to this, the large number of
determining where continual improvement can occur. Specific areas
dates in convenient locations and you have a network of excellence,
where data should be collected are customer satisfaction, product
dedicated to your development.
conformity, processes and products trends including opportunities
for preventive action, and suppliers.
If you would like to find out more about how we can help you
implement your ISO 9001 Quality Management System
For more information regarding planning and undertaking internal
please contact Dynamic Strategies.
audits, download our free ‗Ten Tips for Internal Auditing‘ from
www.dynamicstrategies.co.in. Dynamic Strategies Management
Systems also offers a RAB Accredited ISO 9001Internal Quality
Systems Auditor, more details are available at
http://www.dynamicstrategies.co.in. or contact us
at email@example.com .
I. Review Management System to determine effectiveness
II. Continual Improvement
SUMMARY OF THE
I M P L E M E N TAT I O N P R O C E S S
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