ISO 2015 in Plain English: Support Part 2

Requirement: Clause 7 is called Support, which is basically all of the resources required to support the organization’s primary business. This weeks review is on Monitoring and Measurement.

7.1.5 Monitoring and measuring resources (Calibration in Plain English)

7.1.5.1 General requires the organization to determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements. This includes ensuring that the resources provided are suitable for the specific type of monitoring and measurement activities being undertaken, and are maintained to ensure their continuing fitness for their purpose. CalibrationFinally, it requires the organization to retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources.


7.1.5.2 Measurement traceability refers to standards traceable to international or national measurement standards; and also requires that measuring equipment be identified in order to determine their status, and safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results. Finally, it requires the organization to determine if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and to take appropriate action as necessary.

This last sentence is driving an industry practice of identifying the measurement equipment ID on inspection/measurement records to trace product to measurement devices.

Contact me for my free ISO 9001:2015 Readiness Checklist and perform a quick self-assessment to gage your preparedness for the new standard. Then call to see how I can help.

920-841-3478

Steve@TheRightApproachConsulting.com

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ISO 2015 in Plain English: Support Part 1

Clause 7 is called Support, which is basically all of the resources required to support the organization’s primary business. Resources are broken down into a number of areas: General, People, Infrastructure, Environment, Monitoring/Measurement, Organizational Knowledge and Communication.

General refers to the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system. In simple terms, this is management’s commitment to provide people, time and systems to support the QMS.Support

People requires the organization to determine and provide the people necessary for effective implementation of QMS the operation and control of its processes.

Infrastructure requires the organization to determine, provide and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services. Maintenance is a primary aspect of infrastructure, including buildings, utilities, equipment, transportation, and information and communication technology.

Environment means the work environment and includes a combination of human and physical factors, such as social, psychological and physical (e.g. temperature, heat, humidity, light, airflow, hygiene, noise).

Contact me for my free ISO 9001:2015 Readiness Checklist and perform a quick self-assessment to gage your preparedness for the new standard. Then call to see how I can help.

920-841-3478

Steve@TheRightApproachConsulting.com

 

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Steve & Dan Talking ISO: The Impact of ISO 2015 on Companies

Dan Beaulieu interviews Steve Williams of The Right Approach Consulting (Watch the interview here  http://realtimewith.com/rtwboot/show.php?id=91&vid=3970 ) on REALTIME with IPC to talk about what companies need to change to comply with the just released 2015 version and why companies need to start NOW!

IPCinterviewContact me for my free ISO 9001:2015 Readiness Checklist and perform a quick self-assessment to gage your preparedness for the new standard. Then call to see how I can help.

920-841-3478

Steve@TheRightApproachConsulting.com

 

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Increase Profits by Minimizing Inspection

Inspection Is Evil

A wise man once said “Inspection is Evil”; …actually it was me and I didn’t say it just once, I say it every chance I get. Inspection is a non value-add activity and companies tend to use it to hide many sins. Traditionally, leaders of American industry have had a one-size fits all solution to just about any manufacturing problem they encounter; throw more inspectors at it. Customer returns increase … Read the entire white paper here:  http://iconnect007.uberflip.com/i/649323-pcb-mar2016/11

Inspection

Contact me for my free ISO 9001:2015 Readiness Checklist and perform a quick self-assessment to gage your preparedness for the new standard. Then call to see how I can help.

920-841-3478

Steve@TheRightApproachConsulting.com

 

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Geek-a-Palooza

Don’t miss THE PCB industry social networking event of the year! Steve Williams interviews Tara Dunn and Judy Warner on their brainchild, what it’s about, and how you can attend or sponsor one of this year’s three regional events. Watch the interview here…

http://realtimewith.com/rtwboot/show.php?id=91&vid=3988

GeekaPalooza

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ISO 2015 in Plain English: Planning

Planning has always been required and buried in other areas, but is now a stand-alone requirement. The basic function of Planning is simply to meet customer requirements through the processes you have put in place to manufacture your product. This is where the standard really makes a major change by focusing on Risk Based Thinking.

In addition to this clause, the terms ‘risk’ and ‘opportunity’ are made throughout the standard. The path to Risk Based Thinking has three paths:

  1. Actions taken to identify, analyze and address any potential risk:
    • Quoting
    • Up front engineering
    • pFMEAs
  2. Quality objectives and planning to achieve them:
    • Requirements for objective planning had been very loose but are now greatly tightened up
    • An objective should include a description of who is responsible, what is the target, when is it planned to be achieved
    • Progress must be monitored
    • Objectives must be set for relevant processesPlanning
  3. Planning of changes:
    • A very robust Change Management process is required
    • Revisions, Processes, Technology

 Contact me for my free ISO 9001:2015 Readiness Checklist and perform a quick self-assessment to gage your preparedness for the new standard. Then call to see how I can help.

920-841-3478

Steve@TheRightApproachConsulting.com

 

 

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ISO 2015 in Plain English: Leadership & Management Commitment Pt. 2

How can you meet the requirements?

As discussed last week, the good news is that the new requirements are very similar to the current version, so major changes are not required in the way top management must be involved in the QMS. The below list are ways to demonstrate that top management has a commitment to the QMS, typically through the Management Review process:
Top Management is responsible for:

  • The measurement of the QMS effectiveness
  • The Quality Policy and Quality Objectives
    • Communicating throughout the organization
    • Measuring actual to plan
  • Assuring the QMS is part of the business processes, not just the “quality department”
  • Providing needed resources
  • Continual improvement
  • Ensuring customer, statutory, and regulatory requirements are understood and met, and employees understand why this is importantQMS
  • An organizational focus on customer satisfaction
  • Establishing organizational roles, responsibilities, and authorities
    • Accountability

Contact me for my free ISO 9001:2015 Readiness Checklist and perform a quick self-assessment to gage your preparedness for the new standard. Then call to see how I can help.

920-841-3478

Steve@TheRightApproachConsulting.com

 

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ISO 2015 in Plain English: Leadership & Management Commitment

Requirement

A major change in ISO 2015 is more focus on the company supporting the quality system. “Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction” (7.2.1 and 8.2.1).

Management Commitment has always been a major part of ISO, but the 2015 version places more emphasis on this requirement. Total “Top Management” involvement is not optional! Section 5 of the new standard is all about leadership, and most of these requirements are very close to those in the current version of the standard under the management responsibility requirements.leadership

The first subsection is about the ways that top management needs to demonstrate leadership and commitment with respect to the QMS, such as being accountable for the effectiveness of the QMS, ensuring resources are available, promoting continual improvement, and ensuring the Quality Policy and objectives are in place and consistent with the goals of the organization and the QMS. The other three subsections cover the need for customer focus, requirements for the Quality Policy, and the organization’s roles, responsibilities, and authorities.

Next week we will discuss the things you need to do to comply with the Leadership & Management Commitment requirement.

Contact me for my free ISO 9001:2015 Readiness Checklist and perform a quick self-assessment to gage your preparedness for the new standard. Then call to see how I can help.

920-841-3478

Steve@TheRightApproachConsulting.com

 

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Learn more about Lean with Steve Williams during IPC APEX EXPO® 2016

Published on Feb 23, 2016

Watch Course Video Here: https://youtu.be/GnWf1vHL_LU

Steve Williams, President of The Right Approach Consulting, will be teaching the Professional Development course PD23: Lean: 10 Things Every Manager Should Know – for Improved Organizational Performance and Competitive Advantage at IPC APEX EXPO® 2016 the week of March 13th in Las Vegas.

Attendees will learn that Lean is the most powerful tool your company can use to improve organizational performance and competitiveness. This course will provide an overview of lean to help managers understand how the program can help any organization survive. Lessons learned from experience over 38 years in manufacturing will be shared. Hear about common mistakes and myths as well as what it takes to successfully implement a lean program. The course includes hands-on, workshop format exercises to reinforce the content discussed.

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ISO 2015 in Plain English: Process-Based Structure and Clauses

The revised 2015 version continues to be consistent with the plan-do-check-act (PDCA) improvement cycle, and continues to use the process management structure widely used in business today. It introduces several new clauses intended to drive Risk Based Thinking.

What the heck is a process-based system, or the process approach? ISO, and frankly good business practices, believes that desired results are achieved more efficiently when activities and related resources are managed as processes within a coherent system. In the context of ISO 9001:2015, the “processes” are the auditable clauses of the standard. We have already reviewed Context of the Organization, and will review the remaining six (6) in upcoming issues. The Seven (7) “auditable” processes are:

  1. Context of the Organization (4 clauses)
  2. Leadership (3 clauses)
  3. Planning (3 clauses)
  4. Support (5 clauses)
  5. Operation (7 clauses)
  6. Performance Evaluation (3 clauses)
  7. Improvement (3 clauses)

Contact me for my free ISO 9001:2015 Readiness Checklist and perform a quick self-assessment to gage your preparedness for the new standard. Then call to see how I can help.

920-841-3478

Steve@TheRightApproachConsulting.com

ProcessBasedApproach

 

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