P.G. Stein, Consultants in measurement and quality for science, business, and manufacturing

Measurement consulting in manufacturing and industry
Measurement Principles and Practices
Necessary accuracy and precision
Knowing the measurement uncertainty
ISO Measurement capability studies
ISO 9000, finding sources of uncertainty

ISO Traceability studies
Accreditation Services

The firm of Philip G. Stein, Consultants offers the following services in support of laboratory accreditation to the requirements of ISO/IEC 17025:

Please contact us for further details and for a price quote.

Practice Assessment
We will perform a complete initial assessment similar to that which could be expected from an assessor for any recognized accreditation body.

The results of this assignment will be two principal documents:

─ A deficiency report, citing in detail the requirements of the ISO/IEC 17025 standard, ANSI/NCSL Z-540-1, or current Accreditation body (A2LA, L-A-B, etc.) policies. Following each citation are our observations that indicate lack of conformance. This will be virtually identical to what you would receive from a regular 17025 assessment.

─ A corrective action recommendation report, indicating what, in our opinion, is needed to remedy each deficiency. These recommendations will contain all of the technical and quality detail necessary to enable your organization to carry out the actual work of changing your system or technical approach.

In addition, we will provide a short assessor report introducing the audit process and indicating what observations were made. This report should suffice, when accompanied by the deficiency report, as a second-party ňinternal╝ audit as required by ISO/IEC 17025 Clause 4.13.1. The auditors we use for this purpose are trained, qualified, and independent as required by the standard.

This work usually takes three days, including one to 1.5 days on-site.

Uncertainty Training
We will deliver a one-day course for one to forty students on the calculation of measurement uncertainty according to the required Guide to the Expression of Uncertainty in Measurement (the GUM), known in the US as ANSI/NCSL Z-540-2 and NIST Tech Note 1297.

This course, whose outline can be displayed by clicking HERE , has been taught many times both for public forums and privately to companies and laboratories. Although the course description is generalized, the course may be specially tailored for each customer to include examples of calculations of uncertainty in their particular field of endeavor.

Because an accreditation body will require you to demonstrate in-house competence in calculation of uncertainty, we will generally not simply perform these calculations on your behalf. Of course we will be glad to work with your staff to develop required uncertainty budgets and statements in the pursuit of improving your ability to do them on your own.

The course usually takes one day, including customization. The course itself consists of four 90-minute sessions.

Uncertainty budget assistance is charged according to time spent, with a minimum of 0.5 days.

click HERE for details of this course.

Procedure writing
We can help you write procedures and other documentation at any level from basic policy to work instructions and forms. Procedures we write will be conformant in form and content to the requirements of ISO/IEC 17025 and (for calibration procedures) the additional requirements of ANSI/NCSL Z-540-1.

This work is billed by actual time spent, with a minimum of one day.

If you need a complete ISO/IEC 17025 quality manual written from scratch, you might consider purchasing such a manual, customized to your organization. A colleague offers that as a product for about $3500.

Assuring the Quality of Calibration or Testing Results
Clause 5.9 of ISO/IEC 17025 requires a program of in-service checks, proficiency testing, measurement assurance, retesting of retained materials, or other effort to increase the probability that the calibration results delivered by your processes are stable and in control.

Philip G. Stein, Consultants is recognized as an expert firm in the field of measurement assurance and measurement assurance program implementation. Working with your technical staff, we will develop a process to utilize the principles of ISO 10012-2 and other documented standards, correctly and effectively applied to your measurement processes.

We will recommend or write procedures, identify check standards, set up manual or software control charts, and train your staff to carry out the program.

Proper implementation of measurement assurance will not only increase the stability of your work and decrease uncertainty; it will greatly simplify the calculation of uncertainty budgets as required by the GUM and by your accreditation body.

This work is billed by actual time spent, with a minimum of one day.

Staff Training in ISO/IEC 17025, Auditing, and Accreditation
Preparation for accreditation cannot be done by the quality manager alone.

Requirements of accreditation bodies include proper deployment of the entire quality system to all applicable managers and employees. Your assessor will determine that the quality system is fully operational é that it is known, understood, and followed by everyone who is affected by its requirements.

In the words of the standard, "The system documentation shall be communicated to, understood by, available to, and implemented by the appropriate personnel".

We will conduct training classes in the requirements of ISO/IEC 17025 and the requirements of your quality system for your 'appropriate personnel'.

Topics will include how to respond to an assessor's questions, how to react when a customer asks for special favors, and how to recognize proprietary information and keep it protected. The necessity of proper documentation, collection and retention of data, and how to make corrections will be stressed.

Proper documentation of this training, appropriate as evidence under Clause 5.2.1, will be supplied.

This work is usually accomplished in one-half day, and may be combined with a one-half day introduction to accreditation mathematics (tolerances, specifications, guardbands, and uncertainty).

Accreditation Success Guarantee
If we have been retained for at least five days of consulting work in conjunction with preparation for accreditation, if this work includes a practice assessment audit, and if your company follows the corrective actions recommended in good faith, we will guarantee successful accreditation to ISO/IEC 17025.

We will assist you with conforming to any further requirements and clearing any deficiencies cited during an assessment at no additional charge.

 

 


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