ISO 9001:2015 & Determining External & Internal Issues

QUESTION: From: Adolpho P., April, 21, 2017 – My question is regarding ISO 9001:2015 requirements for reporting external and internal issues as a part of the management review process.  Which subjects should be analyzed as the inputs, subclause 9.3.2.b?  I don’t think the standard is clear enough.  As a comment, I think subclause 9.3.2.c5. is redundant.  Your feedback will be appreciated. REPLY: From: ATCS, Ask the Experts, April 24, 2017 Hello Adolpho, Thanks for submitting your comment and question. As you know, ISO 9001:2015 is a generic standard that defines quality management system requirements used by a large variety of industries, organizations, and (more…)

Estimating the cost for API Q1 certification & API 6A Monogram License

QUESTION: From: Eugene P., March 6, 2017 – During the past months, we have received several inquiries asking if our company was API Q1 certified or if we had an API 6A monogram.  How much does it cost to get API Q1 certified and get an API 6A monogram license?  We are a small shop that has a total of 50 employees, so knowing the estimated cost upfront is important. REPLY: From: ATCS, Ask the Experts, March 6, 2017 Hi Eugene, Excellent question and one that’s frequently asked. To accurately estimate a cost to obtain API Q1 certification and API 6A product monogram license, (more…)

Are Exclusions to ISO 9001:2015, Permitted?

Inquiry:  Our organization provides mobile crane rental services. We recently received a request from a client to deliver a crane to their site location. This was the extent of the services provided to the client.  Can we exclude ISO 9001:2015, subclause 8.3 requirements since no design and development was required? Answer: Qasim, thanks for submitting this question.  As you are ware, ISO 9001:2015, subclause 4.3, requires the organization to apply all applicable requirements that are within the scope of the quality management system (QMS).  ISO 9001:2015, subclause 4.3, also requires the scope of the QMS to be maintained as documented information that identifies the (more…)

Leaders of Change

LEADERS OF CHANGE – Leadership begins at the top. Although ISO 9001:2015, subclause 5.3 requires C-level or top management to assign relevant persons to ensure quality management system (QMS) requirements are communicated and understood, the responsibility to provide the leadership needed to champion the effectiveness of the QMS remains with top management. The responsibilities to provide direction and to ensure the effectiveness of the QMS stay with top management. QMS implementation is not an individual activity. The successful implementation of a QMS is a team effort that requires the leadership of top management. It can be a major mistake to (more…)

API 6A Monogram Restricts Remanufactured Equipment

Inquiry:  My question is regarding application of the API monogram. Our company is an API 6A licensee. We manufacture valves and other related equipment at our facilities here in the USA and overseas.  During a recent re-certification audit, the Auditor told us that we could not monogram valves if they had been disassembled and reassembled. These are new valves, so why is this even a concern, especially since the valves were manufactured at our overseas facility that is also API 6A licensed?  I Look forward to your reply. Reply:  Thanks for submitting this question to us.  In my opinion, the (more…)

Risk Based Thinking

Using the process approach and RBT are hot topics for organizations implementing ISO 9001 for the first time and others transitioning to its revised requirements. There’s nothing new about RBT. In fact, ISO 19011:2011—Guidelines for auditing management systems highlighted the need for organizations to identify risk as associated with QMSs, environmental management systems, and occupational health and safety management. ISO 19011:2011 also included a reference to using risk-based auditing (RBA). RBT is ingrained in product and service planning processes for a majority of organizations. Although it may not be recognized as such, RBT is a natural part of the planning (more…)

Certified Enterprise Risk Manager

A firm working knowledge of risk management has become an essential part of being an effective Auditor. Unfortunately, those that don’t ungraded their skills in this area will begin to find themselves at a disadvantage when compared to other fellow quality professionals. For this reason, every Auditor should consider improving their knowledge and skills on the subject of risk management. During February 2015, I attended a 5-day CERM Workshop. This workshop included lecture, group and individual exercises. The workshop’s facilitator, Greg Hutchins, PE, CERM Academy, provided books “Value Added Auditing” and “Risk Based Thinking” and encouraged attendees to read specific (more…)

ISO 9001:2008 vs. 2015, Receiving Insp.

Question: Referring to ISO 9001:2008 clause 7.4.3, Verification of Purchased Product; since we are only a trading company that recieves a limited amount of purchased items at our site, please advise if this requirement is applicable to our organization. Thank You, Razif Reply: Hello Razif, Thanks for contacting us.  Regarding ISO 9001:2008, clause 7.4.3, verification of purchased product requirements; it’s important to remember the primary purpose of conducting a receiving inspection is to verify received goods meet your organization’s stated purchase order description.  An effective receiving inspection process is needed to minimize the potential risk of accepting supplier provided nonconforming (more…)

Tools for Auditing ISO 9001: 2015, Risk Based Thinking

Inquiry: Question received via ASQ’s Ask the Experts Blog, Published 10/21/2015 In addressing clause 4 of ISO 9001:2015 regarding organization context and interested parties, what type of tool (spreadsheet,diagram,flowchart,etc), would you recommend to use to simplify the practice and to give a proper  understanding for auditors?  I understand that risk evaluation (ISO 9001:2015) should be accomplished not only at a high level of establishing and planning objectives, but also at the processes level. If this is right, could organization use some criteria to select processes to be evaluated? AG Reply: Hello AG, Regarding your inquiry, your selection of tools such as (more…)

API Q2 Risk Assessment, Contingency Planning & MOC

Inquiry: Where can examples of how to implement API Q2 requirements for risk assessments, contingency planning and management of change be found? Suggestions are appreciated. Maxwell Reply: Hello Maxwell, ISO 31000 can provide some general guidance regarding  risk management terminologies and methods.  However, to fully understand what is actually required to meet API Q2 requirements for risk assessment, contingency planning and management of change (MOC), the best approach would be to consider getting actual hands on experience in these areas by working through individual and group scenarios.  This can be accomplished by attending our next API Q2 training course that (more…)

When Will ISO 9001:2015 Certifications Start To Be Issued?

Inquiry: Our company currently holds dual certifications to API Q1 and ISO 9001:2008 that are not set to expire until November 2017. When making the transition to ISO 9001:2015 and re-certifying in November 2017, will we be able to do dual certifications or will we have to do API Q1 separate from ISO 9001:2015? Thanks! Brian Reply: Hello Brian, in response to your inquiry, the timing for transitioning your existing QMS from ISO 9001:2008 to ISO 9001:2015 is dependent upon your Registrar’s timeline to begin issuing ISO 9001:2015 certifications. I highly recommend that you discuss this subject with your Registrar (more…)

API Q1, Risk Management, Contingency Planning & MOC

In the event of changes that affect the QMS or organizational structure, does API Q1 require a corrective/preventive action to be initiated to document the MOC action? Inquiry: Hi Bill, Firstly, going through the different queries on this site has been very helpful and greatly appreciated, that being said, I have still been in the grey about the whole MOC process. I know that a change in the QMS or organization structure will initiate an MOC but how do I document it? Will a risk assessment suffice? Do I have to initiate a CAPA? Also on another note, can you (more…)