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| Company | Description | Audits | Training | Surveys | Expert witness | Insp/Test | Procedure prep. |
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Gold Star Water Consultants, Inc. Mikel E.
Goldblatt, P.E.President & Principal Consultant 301 Holmecrest Road
Jenkintown, PA 19046 Phone: 215-498-5188 Email: info@goldstarh2o.com Website: www.goldstarh2o.com |
The mission of Gold Star Water Consultants,
Inc. is to provide water & wastewater systems problem-solving, training,
and innovative, site-specific practical improvements, increasing quality
and reliability of operations, while saving money and optimizing use of
resources. We will gladly take on work where we can provide excellent value. |
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X-Stream LEAN, LLC 1248 Queen Street Pottstown, PA 19464 Website: www.xstreamlean.com Phone: (484) 941-3877 Fax: (610) 705-1892 E-mail: info@xstreamlean.com
Measurable Improvements Oriented
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World wide assistance to companies requiring consulting in the areas of Lean Six Sigma; Executive Coaching and Mentoring; Organizational Development; and Supply Chain Management. Located here in PA |
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David J. Yamarick, President The Brookfield Group, LLC Outsource Services for Quality and Environmental Management Systems Suite 100, 205 Reeder Road Honey Brook, PA 19344 610-942-3164 484-319-8167 TheBrookfieldGroup@comcast.net |
Specializing in the “how to” of ISO, our focus is to increase your capability providing services to free up your company to spends its efforts on core business processes. Our extensive and transferable on-the-job ISO experience equips us to know what your company and the registrars are after. Add value to your QMS and EMS. It would be a delight to serve and assist you in your goals! | ● | ● | ● | ● | ||
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John R. Broomfield ASQ Senior Member Vice President Quality Management International, Inc. PO Box 271 Exton, PA 19341 800-666-9001 800-FAX-9004 jbroomfield@aworldofquality.com www.aworldofquality.com |
Quality Management International, Inc. is a firm of management systems consultants, certified lead auditors and certified trainers established in the UK in 1986 and in Philly in 1994. QMII delivers the people>processes>system™ approach to develop systems used to run client businesses so these systems can used to assure quality, add value faster, prevent loss sooner and assure sustainability while conforming to ISO 9001, ISO 14001, AS 9100, AS 9110, TS 16949, ISO 13485, ISO 22000, ISO 17799 and other derivative management systems standards. This approach substantially reduces the cost of implementing new policies, controls and processes and delivers faster benefits than "implementing an ISO standard". We are RABQSA and IATCA (IPC) certified to train management systems auditors and our consultants are certified lead auditors. | ● | ● | ● | ● | ● | ● |
| John J. Salera &
Associates Contact: John J. Salera 50 Grant Drive Holland PA 18966 Tel 215-968-0310 FAX 215-504-4884 |
Preparation of Quality System Manuals and Procedures to comply with ISO9000, QS9000 ad Department of Defense requirements. Design of SPC systems, including SPC management plans. Assistance in configuration management programs, failure analysis etc. | . | ● | ● | . | . | ● |
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Keystone
Regulatory Services, LLC Contact: William G. McLain 342 E. Main Street Suite 211 Leola, PA 17540 Ph: 717-656-9656 Fx: 717-656-3434 bill.mclain@keystoneregulatory.com |
We are a full-service regulatory affairs and
quality management system consulting organization for the medical device
industry. Our goal is to help you solve your regulatory and quality
system problems using a practical, yet thorough approach.
Our services include quality system (21 CFR 820; ISO 13485:2003) and risk management (ISO 14971:2000) system analysis, auditing, implementation and training, premarket regulatory strategy and support, agency dispute resolution plus many others. |
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Master Quality Consulting Contact: Michael J. McMaster ASQ CQA, CQE, CQMgr 63 Jonquil Way Sicklerville, NJ 08081 Phone: 609-304-6314 masterquality@comcast.net |
Providing the pharmaceutical, biotechnology and medical device industries proven Auditing, CGMP Training, Quality System and Regulatory Compliance consulting services. | ● | ● | ● | |||
| Nash Associates Robert J. Nash, Ph.D. 17 Karrens Way Downingtown, PA 19335 Tel 610-363-6147 Fax 610-524-5347 drrjnash@comcast.net |
Consulting and training in quality matters: ISO 9000, FDA cGMP, FMEA, SPC, Design of Experiments, applied statistics and statistical reports, survey construction and analysis, sustainable excellence. More than 100 corporate clients since 1986. | ● | ● | ● | ● | . | ● |
| Optima Performance, Inc. Contact: Arthur W. Crowley & John V. Lawson PO Box 1450 Exton, PA 19380 Tel. 610-212-2336 Fax 877-343-3264 artcrowley@comcast.net |
Management Services, business performance assessing, planning, and implementing, QM System methods and processes to assure optimized performance. Prepare clients for ISO 9000 registration and provide associated tools and software. A certified Plexus training Company. | ● | ● | . |
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| QBEK Contact: Larry McAnallen 242 Chapman Road Newark, DE 19702 Tel 302-452-9257 FAX 302-452-9006 |
Provides supplier QA and quality consulting. Supplier QA includes equipment inspection, supplier qualification and quality system auditing. Designs supplier quality improvement programs and provides implementation assistance. | ● | ● | ● | . | ● | ● |
| Quality Systems Contact: Tom Davis P O Box 41 Flourtown, PA 19032 Tel 610-828-1650 FAX 610-828-3417 |
Provides proven customized TQM consulting and training services, including compliance with ISO & QS standards. With management participation, Facilitators and Teams are trained to continually lower costs and increase productivity. | . | ● | ● | . | ● | ● |
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Stelex Contact: Dan Matlis Two Greenwood Square, Ste. 300 3331 Street Road Bensalem, PA 19020 Tel 215-638-9700 FAX 215-638-9333 sales@stelex.com
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Stelex provides enterprise-wide compliance solutions to regulated industries in the Pharmaceutical, Medical Device, Diagnostic and Biotechnology sectors. The firm delivers a comprehensive suite of Validation, Technology, Regulatory and Business solutions. Services include Computer System Validation, Process Validation and Equipment Qualification, Infrastructure Qualification, Laboratory Systems Validation, Automation and Controls Validation, System Integration, Implementation and Software Development, as well as Security and PKI services, Quality Assurance, Auditing, Program Management and Best Practice Consulting. In addition to technical training and professional education provided through its accredited Stelex University, Stelex offers ComplianceBuilder, the compliance infrastructure solution. | ● | ● | ● | ● | ● | |
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Storti Quality Consulting, Inc. Contact: Ralph J. Storti 800 Bartram Road Willow Grove, PA 19090 Tel (215) 657-0837 Fax (215) 657-0837 stortiqci@verizon.net |
Storti Quality Consulting, Inc. provides Quality Program Development, Audit and Consulting Services to utility, construction, manufacturing and industrial companies. Twenty years of Quality Assurance/Quality Control experience, as well as successful completion of ANSI-RAB Accredited Internal and Lead Auditor Courses. Develop and provide indoctrination and training in the areas of Quality Assurance and Quality Control. Perform surveys/assessments of existing programs and processes. Conduct Audits, and write policies and procedures. | ● | ● | ● | ● | ||
| The Quality Mgt. Company Contact: Arnold Soslow 8844 Manchester Street Philadelphia, PA 19152 Tel 215-969-3510 FAX 215-969-3510 tqmco@att.net |
The Quality Management Company is a Quality Advisor, providing onsite training of employees, at all levels and implementation of Quality systems that meet ISO 9000, QS 9000, cGMP, and ISO 14000. Additional training in Total Quality Management | ● | ● | ● | ● | . | ● |
| Total Quality Management
Contact: Joseph Siegel 500 Oxford Road Bala Cynwyd, PA 19004 Tel 610-664-8816 FAX 610-664-1280 joesiegel@verizon.net |
Helping clients comply with ISO9000, using six sigma tools to create an environment stressing reduction of variability of key manufacturing elements through FMECA, Pareto analysis, Quality Function Deployment, sampling plans, control charting, and designed experiments. Provide SPC training of these concepts. | ● | ● | ● | ● | ● | ● |
| Validation Associates, Inc. Contact: Nancy Tucker 305 E. Pennsylvania Blvd., Feasterville, PA 19053-7846 Tel 215-354-1720 Fax 215-354-1725 nancy.tucker@validassoc.com |
Validation Associates, Inc. provides the pharmaceutical, biotechnology, and medical device industries with computer system validation project consulting and training services. | ● | ● | . | . | ● | ● |
Note: this listing does not signify endorsement by ASQ.
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