ISO 9001 Continual
What is Continual
Continual improvement is a recurring activity that seeks to increase the
organization’s effectiveness and efficiency in fulfilling the requirements of the organization as well as its
stakeholders - customers; suppliers; employees; investors; community; etc. The aim of
Improvement program is to improve your capability to meet requirements and satisfy
What are the ISO 9001 requirements
Clause 8.5.1, states:
The organization shall continually improve the effectiveness of
the quality management system (QMS) through the use of the quality policy, quality objectives, audit results,
analysis of data, corrective and preventive action, and management
Yes, improvement can and should be made throughout an organization, but from an ISO
9001 requirements perspective, the focus of continual improvement must be on improving the effectiveness of the
quality management system. Now this may not necessarily be restrictive. It depends on what the scope of the QMS is.
Increasingly, organizations are widening the scope of their QMS to include just about all business
The rationale is that by improving the effectiveness and efficiency of the QMS, the
organization will indeed directly and indirectly improve in other areas, such as product quality and cost;
profitability; competitiveness; employee relations and work environment; customer satisfaction;
The business world is highly competitive and dynamic. Customers
increasingly demand better quality products, service, support and costs. They will go elsewhere, if your
organization cannot keep pace with their expectations and requirements.
The expectations of other shareholders are equally demanding in terms of increasing
profitability and rewards. If businesses stand still, they will lose their competitive edge, so improvements must
be made to keep pace with stakeholder demands and expectations; and to be viable and grow.
ISO 9001 Continual
The continual improvement process can be conducted by:
1. Significant breakthrough projects that either revise or improve existing
or lead to new processes. These are usually done by
outside routine operations.
2. Small-step ongoing improvement activities conducted by personnel within
are the recurring activities or tools that the ISO 9001 standard requires for Continual
The CI tools or recurring activities referred to in the standard (clause
8.5.1) include: quality policy, quality objectives, audit results, analysis of data, corrective and preventive
action, and management review.
How can the ISO 9001
Quality Policy and objectives be used for Continual
If you recall clause 5.1 required top management to establish the quality
policy and clause 5.3.e required them to review it for continuing suitability. If your quality policy and related
quality objectives (clause 5.4.1) are not being achieved, then opportunities for CI exist. These opportunities
should surface at management review and operations meetings when quality measurement results are reviewed to
Changes in product, customer base, organization ownership, management, technology,
QMS standards, etc., may require changes to your quality policy and objectives. As a tool for continual
improvement, it requires top management to review and understand these changes; make changes, if necessary, to the
quality policy and objectives and use these changes to continue further improvement of the QMS and customer
How can Audit Results be used for
Results of product, process and QMS audits (clause 8.2.2) usually provide
many opportunities to improve QMS effectiveness and efficiency. Opportunities may relate to communications;
information systems; processes; controls; use of resources; technology; etc. The management representative must
report these opportunities to top management for management review. They can also be reported and reviewed at
regular operational meetings, etc.
Other Audits - Besides product, process and QMS audits, you might find it very
productive to conduct financial; health and safety; environmental; technology; product profitability; social
responsibility; information and communication systems audits. You will be amazed at what you will find and
improvement opportunities you will uncover.
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How can Analysis of Data be used
Analysis of QMS data (clause 8.4) may provide significant information on
operational performance and improvement opportunities. Management must review and make decisions and take actions
on the results provided by such data.
Examples of areas where data is gathered that may lead to improvement projects
include: machine set-up, die change, machine changeover times; process cycle time; scrap; non value-added use of
floor space; variation in process parameters; less than 100% first run capability; process averages not centered on
target values; testing requirements not justified by accumulated results; waste of labor and materials; difficult
manufacture, assembly and installation of product; excessive handling and storage;
How can Corrective Action be used for
Corrective action (clause 8.5.2) is action taken to eliminate
the cause of a detected nonconformity to
prevent recurrence. Most business experience problems on a day to day
basis (nonconformities in quality management lingo) that may relate to -
products; QMS processes; resources; suppliers and outsourced work; product shipped to customers; customer
They must define a process for analyzing these nonconformities and use
problem-solving techniques to eliminate their root cause(s) to prevent them from occuring again. They should apply
succcessful solutions to other similar situations, where the same or similar problem might occur.
Corrective action is your day to day tool to improve the effectiveness of your QMS by
tackling and eliminating problems and their root cause as they occur.
How can Preventive Action
be used for Continual
Preventive action (clause 8.5.3) is action taken to eliminate
the cause of a potential nonconformity or other undesirable
situation, to prevent occurrence. Sources of for finding potential QMS nonconformities may include -
analyses of data; audit results; cost of quality reports; quality records; service reports; supplier performance;
customer satisfaction feedback; FMEA’s; management review records; lessons learned from past experience; SPC charts
Organizations must define a process for analyzing these potential nonconformities and
use problem-solving techniques to eliminate their root cause(s) to prevent them from occuring at all. Preventive
action is your proactive business planning and risk reduction tool to improve organizational capability in order to
enhance stakeholder satisfaction.
While preventing potential QMS nonconformities is our focus for ISO 9000, it might be
more useful to think of preventive action in a wider context, i.e. the entire business. Think in terms
of actions needed to prevent - loss of market share; loss of product profitability; loss due to lack of product
diversity; loss of business opportunities due to lack of capacity, inadequate or older facilities, production
equipment, technology or information systems; loss of key or competent personnel; inadequate business financing;
inadequate staffing, etc.
These issues may have far more serious consequences than QMS issues. Consider a
process that involves developing a business plan covering these issues, based on - gathering relevant research data
on these issues; use of appropriate risk evaluation and management methods; developing proactive strategies and
action; monitoring and reviewing performance against the business plan. This would constitute the ultimate CI
How can Management
Reviews be used for Continual
The purpose of conducting management reviews (clause 5.6) of the QMS is to
gauge the health of the QMS. The review must determine QMS suitability, adequacy and effectiveness. Are the QMS
resources and controls that were planned and implemented, suitable and adequate for the QMS to be effective in
achieving customer and regulatory requirements; and in achieving quality objectives? Are changes needed to improve
product, processes and use of resources?
Top management must evalute qms data to answer these questions and then take
appropriate actions to improve products, processes, resources and customer satisfaction, based on opportunities
identified through such review. Clause 5.6 requires that top management must perform these reviews at planned
Are there other tools that are also useful for
Other tools that are often used to continually improve, include: capability
studies; design of experiments; risk analysis; SPC; FMEA’s; fishbone analysis; supplier evaluation; test and
measurement technology; theory of constraints; overall equipment effectiveness; technology; benchmarking; analysis
of motion/ergonomics and error-proofing. Ensure that personnel applying these tools are competent and
How might the effectiveness of the ISO 9001 CI process
Performance indicators to measure the effectiveness of the CI process may
include - quality objectives being met sooner than planned;; achieving and exceeding business and quality
objectives; improved efficiency in use of resources; cost reduction; improved product quality;
Who in the organization,
should be responsible for Continual
Everyone in the organization has a contributing role. Top management must
provide the leadership, support and resources and prioritize CI projects. Process owners and functional managers
must organize and focus the resources and efforts, and review progress. Employees may identify opportunities as
well as participate in CI implementation projects.
CI programs are most often carried out by teams that either - identify problems, find
solutions, or implement changes. These teams may be from within processes or cross-functional. An organization may
often use external expertise to facilitate the process and project. However, top management must provide the
leadership, visibility, involvement, resources to direct the teams towards their goal, and above all, provides the
environment for success.
What are useful steps for
an ISO 9001Continual
The following steps provide a practical approach to undertaking
1. Identify the opportunity - using the tools identified above
2. Evaluate the current situation - existing controls, resources, risks,
3. Select appropriate diagnostic and problem-solving tools
4. Analysis - the root cause of the problem should be identified and
5. Where possible, do a cost/benefit analysis to establish economic
6. Obtain management and process owner commitment, adequate resources; and
define the improvement objective.
7. Identify solutions and implement the optimal solution to achieve
8. Evaluate the effects of the implemented solution - has root cause been
eliminated and improvement objective achieved?
9. Standardize and formalize the change - implement new technology,
communication, documentation, records, change management,
10. Apply successful improvements to other similar products, processes and
situations in the