course material

1. (Mt) – TU Week 3 Quality Management Systems Discussion
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QUALITY MANAGEMENT SYSTEMS: ISO 9000, anon SUPPLIER CERTIFICATION
REQUIREMENTS 16NR THE MALCOLM BALDRIGE AWARD, Curabi ot AND SIX SIGMA boot
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cobrihows Tahun mo mga no il gigoloboda semana Throughout this text, different concepts,
tools, and be 870 Strong brebnorm bonborg uboradi techniques will be presented.
Individually, each.9709 pogonadhaa wodobne bohou concept, tool, and technique has merit

2. and together WA they make up the supporting pieces of a total quality management system.
ISO 9000, supplier certification LEARNING OPPORTUNITIES requirements, Six Sigma, and
the Malcolm Baldrige 21 1. To become familiar with the ISO 9000 and ISO 14000 National
Quality Award provide guidelines for a unified standards approach to quality and
organizational management, 101 2. To become familiar with the requirements of the Mal-
encouraging companies to create their own quality sys- ad colm Baldrige National Quality
Award 3. To become familiar with the Six Sigma methodology tems. Each offers a road map
for companies to follow 10 Hotton in their quest for quality. to be 105 05 ton consistori tol
non ndababu bu bonsaiV51 01 Buninos ho to set 0000 01st IT slubila naslon prazo brow be
dolap bismo monitorini 1o ang lubos na sto si code 02 45 2Toe om onts i (13 NAT’L PARK .
96.b 19092 mo od to a gidebol 46 adop • Planning • Support • Operation Performance
evaluation • Improvement CHAPTER THREE The purpose QUALITY MANAGEMENT
SYSTEMS tions, organizations create and utilize quality management T systems. Within a
quality management system, the neces. to identify, design, develop, produce, deliver, and
support products or services that the customer wants. A quality management system is
dynamic. It is able to adapt and change to meet the needs, requirements, and expectations of
its customers. The principles supporting a quality manage- ment system include: creating
and maintaining a customer focus, involved leadership, an engaged workforce, pro- cess
management and improvement, and fact-based deci- sion-making. Managers of a quality
management system coordinate the efforts of those in the system to effectively provide
products or services for their customers. Quality management systems enable organizations
to enhance their of variation and waste. efficiency and effectiveness. Certification and
registration validates compliance to a nationally recognized standard. Management begins
to develop a system by creating a vision or mission that sets the direction for the company.
The vision is supported by strategies, which are in turn supported by goals and objectives.
Developing and shaping visions, missions, strategies, goals, and objectives is a com- plicated
process. Standards such as ISO 9000, methodolo- by gies like Six Sigma, and awards like the
Malcolm Baldrige National Quality Award provide guidance for establish- ing a quality
management system’s structure, maintain- ing records, and integrating the use of quality
techniques. Quality systems like ISO 9000 and TS 16949 are basi- cally asking that
organizations say what they are going to zations worldwide have attained certification. do
and then do what they say. These quality systems do not mandate particular policies,
procedures, and actions. However, they ask organizations to document the policies and
procedures they have and the actions they take. Com- prehensive methodologies like Six
Sigma create a mindset and an approach to doing business that has quality as its core.
Awards like the Malcolm Baldrige National Quality Award provide guidelines for excellence.
All will use the concepts, tools, and techniques provided in this text. est. 50 of the ISO
standards is to facilitate competing on a global basis find it necessary to To best fulfill
customer needs, requirements, and expectang a clear set of quality system requirements.
Com sary ingredients exist to enable the organization’s employees judged. This baseline has
as its foundation the achieve line against which an organization’s quality system can
ticipation in quality improvement efforts, document of customer satisfaction through
multidisciplinary me of systems and procedures, and the basic structural ments necessary

3. to quality systems. The generic natut the specifics of how the standards apply to its Orga the
standards allows the interested company to detetti tion. Many companies use ISO 9000 as
the foundations their continuous improvement efforts. ISO 9000 enco management system
that supports continuous impro ages organizations to develop, install, and utilize a quan
ment through the prevention of defects, and the reducir Accepted around the world, ISO
9000 is applicable nearly all organizations large and small, including manus developers of
software; producers of processed materiali facturers of pieces, parts, assemblies, and
finished gerade palities; logistics providers (e.g., UPS, FedEx, DHL); hos including liquids,
gases, solids, or combinations, murio, tals; and service providers. The ISO organization
estimates nents designed or manufactured under the ISO 9000:2015 certification system.
Since its inception, ISO 9000 bas business-to-business dealings. More than a million become
an internationally accepted standard for quality in In 2015, the ISO 9000 standards were
revised signifi way organizations manage processes. ISO 9001:2015 takes a process-
oriented approach rather than a product focus. Context of the orga requirements, and expec
panies the organization tion also sets the scope o The leadership clause he the effectiveness
of the ment roles, responsibil The planning clause a and opportunities as th port refers to
the inf monitoring and meas of the organization. functions and proce conformity of good
formance evaluation appropriate monito dures. The improve to continue to won
monitoring, measu formities (Figure Documentati aspects of ISO 90 plant activities, ir dures,
policies, a capability recor data; audit reco and equipment the ISO 9000 s tion that is us
Evidence that being followe organi cantly so that their structure more closely resembles the
tially the org say what the says it will A process approach applies to how an organization
does the work it does. A product approach focuses primarily on the product produced. The
standard encourages organiza: tions to understand and manage how each process’ perfor-
mance affects other related processes when those processes intersect and interact. Utilizing
a process approach enables an organization to consistently meet customer require- ments.
Process-focused organizations understand the importance of value-added activities and
effective process management. Broadly written, the ISO 9000 requirements describe what a
company must accomplish in order to meet customer expectations. However, how these
things are accomplished is left up to the particular company, Ten key clauses comprise the
ISO 9000:2015 standards. These clauses are: take action Docum ating proce informatio
purpose a zational e 1970 oilaguz.0002 021malaya inmershem ISO 9000 Mont bris,omgixia
anemovitost Continued growth in international trade revealed the need for a set of quality
standards to facilitate the relationship between suppliers and purchasers. The creation of
the ISO 9000 series of international standards began in 1979 with the formation of a
technical committee with participants from 20 countries. Named the International
Organiza- tion for Standardization, this Geneva-based association continues to revise and
update the standards on a regular schedule. The name “ISO 9000” has its origin in the Greek
word isos, meaning “equal.” The intent of the standards is to make comparisons between
companies equal. Note that ISO 9000 refers to the entire standard; when speaking of
specific certification requirements, ISO 9001 is used. the proce and desct detailed of the so
written what m Scope Normative references Terms and definitions Context of the
organization • Leadership (base le Th ments must tion V facilitate the 47 Context of the

4. organization refers to the needs, ces by provid Companies o adopt and vide a base stem can
be chievement inary par- mentation ctural ele nature of etermine rganiza ation for encour-
quality prove- uction requirements, and expectations of the people and com panies the
organization regularly interacts with. This sec tion also sets the scope of the quality
management system. ble to and opportunities as they relate to quality objectives. Sup-
monitoring and measuring devices, and knowledge needs hanu- pods; ials, nici- Spi- tes 0-
15 IS 2 ТО – Planning Quality Management Systems Support Operation ISO 9001:2015
Performance evaluation Clause 1. Scope • Improvement Clause Two: Normative Reference
Clause Three: Terms and Definitions Clause Four: Context of the Organization 4.1
Understanding the organization and its context 4.2 Understanding the needs and
expectations of interested parties 4.3 Determining the scope of the quality management
system 4.4 Quality management system and its processes The leadership clause holds
management accountable for the effectiveness of the organization. Within it, manage Clause
Five: Leadership ment roles, responsibilities, and authority are reviewed. 5.1 Leadership
and commitment 5.2 Policy The planning clause addresses the need to identify risks 5.3
Organizational roles, responsibilities and authorities port refers to the infrastructure,
process environment, Clause Six: Planning 6.1 Actions to address risks and opportunities of
the organization. The operation clause emphasizes the 6.2 Quality objectives and planning
to achieve them functions and processes of outside suppliers, including 6.3 Planning of
changes conformity of goods and services to requirements. Per- formance evaluation refers
to evaluating processes using Clause Seven: Support appropriate monitoring, measuring,
and analysis proce- 7.1 Resources dures. The improvement clause encourages organizations
7.2 Competence fou continue to work to a higher level of performance by 7. communication
Potional Son formities (Figure 3.1 and 3.2). monitoring, measuring, analyzing, and
preventing noncon- 7.5 Documented information – Documentation and record keeping are
important Clause Eight: Operationem orsvig bron banism aspects of ISO 9000, ISO 9000
requires records of many 8.1 Operational planning and controlin abcon pil plant activities,
including employee training records; proce- 8.2 Requirements for products and services
dures, policies, and instructions; process control charts and 8.3 Design and development of
products and services capability records; purchasing records; test and reliability 8.4 Control
of externally provided processes, products, and data; audit records; incoming and final
inspection records; services ubong virul.room lomotxo batabiano and equipment
calibration records. Companies following 8.5 Production and service provision 09120o
abubn the ISO 9000 system need to keep records of any informa- 8.6 Release of products
and services 8.7 Control of nonconforming outputs bob antvloe-mol tion that is useful in the
operation of the organization. moonmoob pinup-dgid A Evidence that procedures, policies,
and instructions are Clause Nine: Performance Evaluation van 18 turba ebron being
followed must also accompany these records. Essen- 9.1 Monitoring, measurement,
analysis, and evaluation be tially the organization’s quality management system must: 9.2
Internal auditum nouens solaineanno what the organization does, do what the organization
9.3 Management Reviews 1000 02 sta daw spunila says it will do, record what it did, verify
the results, and von revod: E. Estraigst buiting 0002 Ozime take action on the
difference.ciboks 1200 nepogon Clause Ten: Improvement 2007 noteiian logisto

5. Documentation often takes the form of standard oper- 10.1 General rigor o nositi sa ang
whorl gnimoa ating procedures (SOP). An SOP will generally provide 10.2 Management
review inputs they ou sibuo riguozot information at three levels. The overview level covers
the 10.3 Continual improvement purpose and the scope of the SOP. It may discuss organi-
olmibuon giovanog FIGURE 3.1 ISO 9001:2015 zational expectations and responsibilities as
they relate to imob bna nousta nismo alado of otibus the procedure. The mid-level details
definitions, policies, britannibynsMabtabutz dwonloo to lovala products. Documents serve
as guides and ensure that work and describes the process at a high level. At the third level,
is performed consistently. Sound documentation can be detailed information, including a
step-by-step description used to determine and correct the causes of poor quality, of the
specific tasks in the process, are provided. Well- Documentation defines existing work
methods and pro- written SOPs tell people why it must be done (top level), what must be
done (mid-level), and how it is to be done vides a foundation for improvement. 6 ust. bs In
ISO 9000 a great deal of emphasis is placed on the (base level). 105 asingmoonning Olmoni
need for excellent record keeping. In most cases, since the The advantages of a fully
documented quality manage- product has left the manufacturing facility or the service ment
system are many. Documentation describes how work has been performed, only clearly
kept records can serve as must be accomplished. Structured correctly, documenta- evidence
of product or service quality. Sloppy or poorly tion will apply to a variety of situations, not
just specific say Customer and Stakeholder Noods, Requirements and Expectations (Clause
4) CHAPTER THREE 48 Planning Clause PLAN Support (Clause 77 ACT Leadership (Clause
5) Operation (Clause B) movement lause 10 DO STUDY J Performance Evaluation (Clause 9)
FIGURE 3.2 ISO 9000 Clauses Related to the PDSA Cycle vald 59 .br umane bor maintained
records give the impression of poor quality, High-quality records are easy to retrieve,
legible, appro- priate, accurate, and complete. Necessary records may originate internally or
be produced externally. Customer or technical specifications and regulatory requirements
are considered external records. Internally produced records include forms, reports,
drawings, meeting minutes, prob- lem-solving documentation, and process control charts. A
high-quality documentation control system will contain records that are easily identified
and used in the decision- contact a registrar and plan his or her visit… Par making process.
Uno Me Companies seeking registration must have their com- pliance with the ISO 9001
criteria judged by an independ- ent ISO 9000 certified registrar. Figure 3.3 shows the flow
of a typical registration process. Before the ISO 9000 governing body grants certification, a
registrar conducts a thorough audit to verify that the company does indeed meet the
requirements as set forth in ISO 9001. When the company desiring accreditation feels it is
ready, it invites an auditor to observe the company’s operations and determine achieved,
surveillance audits are conducted, often nounced, approximately every six months. These
audits intended to ensure continued compliance. When preparing for a certification audit, a
company must develop an imple mentation plan that identifies the people involved and and
budgets. Once created, the plan is managed through defines their roles, responsibilities,
deliverables, timelines, frequent review meetings to determine the progress. Once the
system has been fully documented, the company will – Companies wishing to implement
ISO 9000 should determine management’s level of commitment. Manage compliance. Assess

6. the company’s current situation. What are the present costs associated with poor quality as
evi denced by scrap or rework or lost customers? What new markets could open up if
certification were achieved: The beini oto – 9001 certification will benefit the bottom line.
its level of compliance with the standards. Many firms find that conducting an internal audit
before the actual reg- istrar visit is more effective than a single audit. During this pre-audit ,
deficiencies in the company’s methods can be identified and corrected prior to the
registrar’s official visit . Registrars seek to determine if the actions taken by an organization
have been effective at meeting or exceed- ing the requirements established by the standard.
They investigate whether the organization effectively operates and controls processes.
Management systems are reviewed to determine their effectiveness. Once registration has
been Obtaining ISO 9001 certification provides many benefits. Companies that have
achieved certification cite increased revenue as a major benefit. Since ISO 9000 is
recognized globally, certification allows these companies to expand their geographic
markets. They are also able to service new customers who require ISO 9000 compliance
from their suppliers. Additionally, existing customers bene- fit from ISO 9001 certification.
Companies complying with ISO 9001 requirements have been able to improve their product
and service quality and pass the benefits on to their customers. Internally, companies
benefit from com- pliance. Reduced costs are evidenced through decreased