Writing ISO 9001:2015 Procedures

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Question

I am in the process of implementing ISO 9001:2015 at a heavy civil construction company. I do not have any prior experience implementing but did work in an ISO environment for 13 years. I am looking for assistance on how to go about writing procedures to ensure that they incorporate the ISO requirements.

Answer

Thanks for contacting ASQ’s Ask the Experts program.  Concerning writing procedures, there are a few things to consider.  In general, a procedure should be structured to define its purpose or scope.  If the procedure is intended to address an identified risk or opportunity, it should be stated.  Likewise, consider including specific references to customer, industry standards, and internal requirements that are being addressed in the procedure.

Other key points to consider include structuring the procedure to be consistent with the flow of the process or activities controlled by the procedure.  Also, if appropriate, include reference to acceptance criteria, identify who, when, and how these activities will be conducted.  References to any required records to be maintained to provide evidence of conformance should also be a part of the procedure.  The importance of ensuring the participation of the process owner as well as others responsible for performing the activities identified in the procedure can’t be overstated.  If possible, the process owner and other interested parties should be involved in the development, review and approval of the procedure.

I hope this helps.

Best regards,

Bill

Bill Aston, Managing Director
Aston Technical Consulting Services, LLC
Kingwood, TX 77339
Office: (281) 359-2827

ISO 9001 Implementation: Clarifications on Interpretation

Question:

We are in the process of implementing ISO 9001 for our Organization and have several questions regarding clarifications on the interpretation.

1.  We have an Engineer Requirements Document (ERD) that is written for every single feature for the product.  Sometimes it is just one ERD for a product.  What should this be classified under?  Currently we are classifying it as a Quality Record as this is generated every time we have a product or a feature.  Initially we wanted to classify it as a Level 2 document, however it is not static and happens every time we come up with feature or a product.  Is this the right way of classifying?  This applies to the Marketing Requirements Document, drawings, specification etc.

2.  Can a Quality record be amended, changed, or it should not be changed?  If we follow the above process, the ERD will keep changing during the entire product realization process.  Is this ok?

3.  For control of External documents, is it sufficient that we have all the standards under one location in a server and have authorized personnel access it?  Also, could you suggest how could be notified when any of the standards are changed or updated for a newer version?  Is it a manual process to check the standards periodically or is there a way to have this automated using any service?

Response:

Thank you for contacting ASQ’s Ask the Experts program.

With regard to your first question, based upon the information provided, your Engineering Requirement Document (ERD) should be classified as a form.  It is important to know that the purpose of a form is to provide a standard format for documenting information that may be related to in-house, customer or industry requirements.  The completed form will then serve as a record to provide evidence that requirements have been met. Consider assigning a form number to your standard ERD format.  Once this is accomplished, each ERD should be assigned a unique number such as a product, job, sales or contract number to facilitate tracking.

In response to the second question, a record is normally considered to be a static document and should not be changed or amended.  In most cases where changes are made, revised inputs should be signed/initialed and dated along with an explanation for the change.  As mentioned earlier, a record provides objective evidence that requirements have been met.  Most companies use a work order, shop traveler or other similar form to document and communicate product requirements that will be needed by the process owners during product realization.  This form may be updated as each process step is completed.  At the end of the product realization process, the completed form (work order, shop traveler or other) serves as evidence that all requirements have been met.

Regarding question number three, please be aware that the method selected to store external documents is strictly an in-house decision.  However, external documents must be identified and their distribution controlled (see ISO 9001:2008, clause 4.2.3, sub f).  One of the best ways to ensure that your organization is kept informed about the availability of the most current edition of external documents such as industry standards, is to sign up for “Standards Alert”.  This is a free service provided by the TECHSTREET Store at www.techstreet.com.

I hope this helps.

Best regards,

Bill Aston, Managing Director
Aston Technical Consulting Services
www.astontechconsult.com
Kingwood Texas

ISO 9001 Implementation

Question:

As Quality Manager I have been assigned the task of getting the company ISO Certified. Certification was granted in 2000, but their old system is in bad condition. The structure is incomplete, the organization and wording were created by an accountant and a shop foreman with little formal education. And it shows.

I have a copy of the ISO 9001:2008(E) International Standard, and attempting to integrate the old into the new is disheartening. Restructuring the system is the only answer, and so my question is:
Should all (8) sections, and all associated sub-sections of the ISO standard be the same in my standard?

I’m speaking in terms of the section and sub-section naming, and organization. The details of each I will define in accordance to our specific applications, but for ease of auditing am I on the right track?
Thank you for your time in this matter.

Response:

Thanks for contacting ASQ’s Ask the Experts program.  Based upon the information provided, I would suggest that you consider developing your new quality manual using the same or similar layout of sections and clauses found in ISO 9001:2008.  Although it is up to every company to select a format, or structure, for their QMS that will best support their own needs, using a format that is consistent with the layout of ISO 9001:2008 will help facilitate future audit activities.

Since your company was previously certified as mentioned in your inquiry, most of the work with regard to section and clause references should have already been completed.  Likewise, it should be noted that the structure, or format,  of ISO 9001:2000  vs. ISO 9001:2008 is essentially identical.  So, all section and clause references should already exist in your current quality manual.

To ensure that your objective of obtaining ISO 9001 recertification is accomplished in a timely and cost effective manner, I recommend that your company consider the following steps:

  1. Identify the timeline for completing the development, implementation and recertification of your QMS.
  2. Contact a Registrar to determine their costs, requirements and availability to meet your timeline for QMS recertification.
  3. Assess the availability of internal resources (personnel) that will be required for the development, implementation and maintenance of the QMS.
  4. Identify your company’s need to obtain external support from a qualified QMS consultant to assist with the recertification of your QMS.

Before beginning your QMS recertification project, it is highly recommended that your company first conduct a gap analysis of the present quality management system and all related processes.  This will greatly help to identify what actually needs to be done to meet ISO 9001 certification requirements. This information can be used to establish a realistic project timeline, and estimate required man-hours and associated costs for recertification.

Please review ASQ’s Ask the Experts, Blog for other related posts such as “The Cost of ISO 9001 Implementation”.  I hope this helps.

Best regards,

Bill Aston, Managing Director
Aston Technical Consulting Services, LLC
Kingwood, Texas
www.astontechconsult.com

ISO 9001 Cost of Implementation

Question:

What are the estimated costs of implementing ISO 9001?

We are a company of five divisions, Contract Manufacturing, Structural Fabrication (AISC & ASME cert), Steel Service Ctr, Rebar (CRSI vert) & Metal Castings. We employ approximately 200 people and operate out of two facilities. Our Metal Casting division is a separate location from our other operations. I am trying to generate an ROI and a time frame of implementation.

Answer:

The effect of ISO 9000 certification on financial perfomance

Thank you for contacting ASQ’s Ask for Experts program.  This is an excellent question and one that is often asked by companies that are considering ISO 9001:2008 certification.  In order to accurately estimate those costs that will be associated with obtaining ISO 9001 certification, the following approach should be considered:

The first step should include contacting a Registrar to identify the following:

  1. Cost of application fee.
  2. Cost associated with conducting required stage 1 and stage 2 audits for ISO 9001 certification.
  3. Hourly and per day rates charged for offsite and onsite audit activities.
  4. Administrative fees, if any.
  5. Travel time costs (minimum and maximum daily charges).
  6. Other associated costs for airfare, hotel, meals and car rental.
  7. Frequency and cost for surveillance audits to maintain certification.
  8. Cost for quality management system re-certification.

Discuss your company’s plans and timeline with the Registrar to obtain QMS certifications at separate locations.  There may be an opportunity to share or save costs.  As an example, consider establishing a single corporate quality manual and QMS procedures that will be common to both facilities.  Also discuss the availability and location of potential Auditors that the Registrar may assign to your facilities, usually the closer they are, the better.

In addition to determining the Registrar’s costs, it is equally important to determine the Registrar’s certification requirements.  Some require that at least four (4) months of records be available to provide evidence of conformance and implementation of the QMS. Consider contacting a couple of Registrars, and compare their costs and requirements. Another important point is to select a Registrar that is familiar with your industry or business sector.  Be picky and ensure that the Registrar can assign an Auditor that has past experience that relates to your QMS processes or product line.

Step number two is to determine the availability of in-house expertise that will be required to develop and implement a quality management system for certification.  If these activities are going to be outsourced, contact an experienced QMS consultant and request that a quote for a gap analysis be provided.  Do your homework before selecting a QMS Consultant!  Contact a few QMS Consultants, compare their rates and request contact information for past clients, or other references, to verify their experience and reliability. Again, select a Consultant who has past experience with your industry, processes and/or product line.

Confirm that the results of the gap analysis will document all areas that meet certification requirements as well as those that do not, preferably by clause number.  The results of this gap analysis will be used by the Consultant to estimate the number of the man-hours that will be required to develop and assist with the implementation of the QMS for certification.

The bottom line is that the cost to obtain ISO 9001 QMS certification cannot be effectively estimated without knowing these four (4) items:

  1. The Registrar’s cost for ISO 9001 registration.
  2. The company’s current level of conformance with ISO 9001 requirements.
  3. The amount of resources that the company will dedicate to this project for development and implementation.
  4. The amount of support that will be required from a Consultant and the associated costs.

The following link to a flow chart provides a general overview of the ISO 9001:2008 QMS certification process.

ISO9001.2008.Cert.Process

I hope this helps.

Best regards,

Bill Aston, Managing Director
Aston Technical Consulting Services,
Kingwood, TX
Website: www.astontechconsult.com
email: quality@astontechconsult.com

Is ISO 9004:2009 an Implementation Guide?

ISO documentation practices, requirements

Q: I am looking to purchase the latest ISO 9001:2008 Quality management systems–Requirements. However, in the past, ISO 9004:2000 Managing for the sustained success of an organization — A quality management approach,  included the ‘requirements’ of ISO 9001 in boxes as a reference in ISO 9004 (used for implementation assistance). Is that still the case? I would much rather buy the revision, ISO 9004:2009 if the ISO 9001 requirements were in the standard…it’d be one less standard to have around.

A: We have consistently promoted the concept that ISO 9004 is NOT an implementation guide to ISO 9001. It is designed to provide guidance to organizations that desire to go beyond meeting minimum requirements towards achieving higher levels of performance.

There is much that is required of organizations today to sustain themselves and the next edition did try to focus on addressing issues that were essential to sustainability, perhaps at the expense of revisiting the old ground of content related to 9001 compliance which, by now, have become well understood by many organizations.

So, ISO 9004 is about going beyond ISO 9001. ISO 9004 is still consistent with ISO 9001, but it places more intensity on going beyond and less on hard line-by-line congruence.

Charlie Cianfrani
Consulting Engineer
Green Lane Quality Management Services
Green Lane, PA
ASQ Fellow; ASQ CQE, CRE, CQA, RABQSA Certified QMS-Auditor (Q3558)
ASQ Quality Press Author