Tag: QMS

Top 5 Best Practice Tips: Implementing or Transitioning to ISO 9001:2015

–Guest blog post by Robert Jasper–

The well known magazine manufacturingnews.com and the Dallas Business Journal indicate that 85% of ISO registered firms report external benefits like higher perceived quality, greater customer demand, better market differentiation, greater employee awareness, increased operational efficiency, and reduced scrap expense. Results like 30% reduction in customer claims, 95% improvement in delivery time, reduced defects from 3% to 0.5%, 40% reduction in product cycle time, 20% increase in on-time delivery are achievable after correct implementation of an ISO 9001 based quality management system.

For those considering implementing ISO 9001:2015, or for those in the 2008 transition process, here are five best practice tips:

Tip 1: Conduct a Gap Analysis Audit

It is important to consider everything can be implemented quickly, with not many resources involved and of course ending in an successful ISO 9001 certification within reasonable cost and time frames. The best tip is to plan out your implementation/transition project right from the start in effective and efficient ways by conducting a 100% compliance Internal Gap Analysis Baseline Audit against all the existing requirements of the international quality management standard in relation to your existing quality management system. And, it does not matter whether you are an ISO 9001:2008 certified company or organization, as this approach will always provide you with the exact planning requirements for your implementation or transition project. A clear implementation structure based on how to close gaps in your existing quality management system with clear responsibilities and due dates for gap closure and ISO certification readiness always helps to keep projects of this importance on track and on time.  These findings and “gaps” will also give you project opportunities to reduce costs and improve your bottom line profitability. This way, you start to make your QMS work for you right from the start!

Tip 2: Create Process Compliance

Documenting all of your core processes is a way of describing current state and anticipated ISO 9001:2015 compliant future state will create compliance to existing ISO 9001:2015 requirements for having implemented a sound process approach. It may also create the first “A Plus” in the eyes of your Third Party Registrar later on during your ISO Certification Audit, as Registrars are required to audit organizations on detailed documentation of how the organization has created process compliance to the new ISO 9001:2015 standard requirements. This is a direct requirement the Registrars have by the International Accreditation Forum (IAF).

Tip 3: Document Development Data Mining and Definition of QMS Objectives

Also not directly required anymore by the new ISO 9001:2015, it makes sense to structure out a Quality Manual reflecting your Quality Policy, as well as listing all your Standard Operating Procedures to run your QMS. Well developed goals and objectives for your QMS are quantitative numbers that you set in order to measure your QMS performance along the way. Many firms collect data, but it’s what you do with it that gives you your best“Bang for the Buck” for your QMS! Don’t just collect data for the sake of collecting data….make it mean something to your firm!

During this stage of development, you should look thoroughly at the Risk Plans for your firm; in case of global supply chain a “holistic” global oriented Continuity Risk Plan but also think about a local Contingency Plan will cover the new “Risk Based Thinking” requirements of ISO 9001:2015 best. Failure Mode Effect Analysis (FMEA) alone cannot cover all operational risks, therefore any kind of sufficient developed Risk Plan/Register which covers also operational and management risk, might do the job much better – to keep you safe during Third Party Audits.  Changing the mindset from product risk to overall risk management is required here, which may save you cost in the long run anyway – right?

Tip 3: Training and Implementation Roll-Out

The KEY mistake that most firms make is the training and reporting of the ISO process only to all employees. Only with buy-in from the TOP of the org-chart, all the way down to all part-time and contract employees, ensuring complete understanding and participation is needed to make your system work for your firm. During this phase, you want to educate your entire staff on the ISO program and how their job functions affect the QMS. Defining objectives and goals for departmental managers to implement projects and action taking for improvements and corrective actions is a good thing to have in place as well. This is where you see the payback!

Tip 4: Readiness “Mock Audit” and QMS Management Review

Okay, you’ve worked hard and come a long way towards getting obtaining your ISO certification. At this phase, you should complete a full round of internal audits on your QMS and assign documented corrective actions on any findings that may have been transparent in the earlier reviews. These are good because they act as a guide for your measurable metrics defined in your QMS. Anything you find internally is a bonus for your QMS continual improvement process! Once the cycle is complete, it’s time to conduct your QMS Management Review. This is where Top Management will review the progress, goals, objectives and inter-company metrics of your entire quality management. Total Management support of the QMS is vital for the success of making your QMS system work for your organization, and not YOU work for the quality system.

Tip 5: Final Preparations 

You’ve come a long way, and you worked hard. Now it’s time to show what you have done as a team and obtain that recommendation for ISO Certification given by the Third Party Certification Registrar! Wrap up any outstanding customer complaints, non-conformities or audit findings. Celebrate your business success. You’re on the path towards making your company a benchmark for other companies to set their standards higher… GOOD JOB!

Robert Jasper is the author of the upcoming book “HIGH PERFORMANCE QMS™”, which elaborates how organizations of all sizes can use the new ISO 9001:2015 standard principles and requirements to create organizational performance improvement (Release summer 2016). Robert is a certified International Auditor and ISO Consultant/Trainer for ISO 9001 Quality Management Systems. He is specialized in result-based Quality Management Consulting and holds regular seminars/workshops on ISO 9001 matters. Robert has trained and consulted organizations of all sizes and various industries to develop, implement, and certify their QMS systems successfully by Third Party registrars. His QMS training style is effective, collaborative and focused on simplification of all ISO matters. Robert is a certified ISO 9001:2015 transition trainer, based on training provided by EXEMPLAR GLOBAL (formerly known as RABQSA), an international recognized authority body in all ISO matters providing professional credentialing programs and training certification programs.

 

For more information regarding our ISO consulting and auditing, or to discuss your 2015 transition process, please contact us. 

ISO 9001:2015 – What You Should Know

A myriad of industries are buzzing about the newly released ISO 9001 revision. With a greater focus on stakeholders and a risk-based thinking approach, the anticipated revision is said to have greatly improved the scope and ultimately the benefits associated. A more detailed comparison and additional useful resources are found here.

With the revision so widely discussed, we have received several inquiries from organizations wanting to know about the standard and asking for advice regarding the benefits of certification. While Pro QC is not a certifying body, we do work with organizations to prepare them for final audits.  We also work with many organizations that are not seeking certification, but rather are looking for a standard to apply in order to better manage their business.  The ISO 9000 family of standards provides “guidance and tools for companies and organizations who want to ensure that their products and services consistently meet customer’s requirements, and that quality is consistently improved.”

Standards in the ISO 9000 family include:

  • ISO 9001:2015 – sets out the requirements of a quality management system
  • ISO 9000:2005 – covers the basic concepts and language
  • ISO 9004:2009 – focuses on how to make a quality management system more efficient and effective
  • ISO 19011:2011 – sets out guidance on internal and external audits of quality management systems

There’s a great ISO Made Easy article here via Quality Progress. Also, discover the new ISO 9001:2015 standard here:

https://youtu.be/vuvsH2T_9HY

Why does standardization even matter?

  • Ensures positive change.
  • Harmonizes global best practices.
  • Companies have increased confidence in the quality and reliability of suppliers who use standards.
  • Eliminates technical barriers to trade.
  • Companies actively involved in standards more frequently reap short- and long-term cost-savings than those that do not participate.
  • Having influence in the content of a standard is an important factor in gaining competitive advantage.
  • Standardization can lead to lower transaction costs in the economy as a whole, as well as to savings for individual businesses.
  • Standards can help businesses avoid dependence on a single supplier because the availability of standards opens up the market. The result is a broader choice for businesses and increased competition among suppliers.
  • More choices for the consumer.
  • Standardization encourages cooperation between businesses atthe same stage in the value chain.
  • Businesses not only reduce the economic risk of their R&D activities by participating in standardization, but can also lower their R&D costs.

Organizations certified to the previous ISO 9001 revision will be provided a three year transition period. Contact us for assistance with this process!

Did you know? October 14th is World Standards Day. The theme this year is “Standards – The World’s Common Language.”

ISO 14001:2015 – Who Needs Environmental Management?

aa6efe67-5c6a-4d07-862e-1cb1ab7145a4-largeThe quality industry is buzzing this week as the International Organization for Standardization released the latest revision of the ISO 14001 environmental management standard.

“ISO 14001:2015 is an internationally agreed standard that sets out the requirements for an environmental management system. It helps organizations improve their environmental performance through more efficient use of resources and reduction of waste, gaining a competitive advantage and the trust of stakeholders”

Notable revisions per the news release include:

  • A greater commitment from leadership
  • An increased alignment with strategic direction
  • Greater protection for the environment, with a focus on proactive initiatives
  • More effective communication, driven through a communications strategy
  • Life-cycle thinking, considering each stage of a product or service, from development to end-of-life

With the latest release, ISO discussed the benefits of incorporating the standard.  Described as a way of helping organizations identify, manage, monitor and control their environmental issues in a holistic manner, issues considered include:

  • Air pollution
  • Water & sewage issues
  • Waste management
  • Soil contamination
  • Climate change mitigation & adaption
  • Resource use & efficiency

So, who needs environmental management? The upside of 14001 is that it’s easily integrated into the existing ISO QMS, so any organization can benefit.  While Pro QC does not certify to ISO standards, we add value by getting our clients ready.  Our 14001 based audit gives clients assurance for certification, or a general assurance to stakeholders.  Many organizations not seeking certification continue to incorporate this standard simply to enjoy the associated benefits.

What are the benefits? According to ISO case studies, users of the standard indicate that it helps:

  • Demonstrate compliance with current and future statutory and regulatory requirements
  • Increase leadership involvement and engagement of employees
  • Improve company reputation and the confidence of stakeholders through strategic communication
  • Achieve strategic business aims by incorporating environmental issues into business management
  • Provide a competitive and financial advantage through improved efficiencies and reduced costs
  • Encourage better environmental performance of suppliers by integrating them into the organization’s business systems

Pro QC’s ISO 14001 based audit goes through a detailed checklist developed with the use of the standard (4:Quality Management System). We incorporate the following to provide clients with assurance in their suppliers’ environmental management.

  • Factory (supplier) profile
    • Markets, key clients/personnel, QMS, equipment, etc.
  • Environmental policy
  • Planning – environmental aspects
  • Legal and other requirements
  • Objectives, targets and programs
  • Resources, roles, responsibility and authority
  • Competence, training and awareness
  • Communication
  • Documentation
  • Control of documents
  • Operational control
  • Emergency preparedness and response
  • Monitoring and measuring
  • Evaluation of compliance
  • Nonconformity, corrective action and preventive action
  • Control of records
  • Internal audit
  • Management review

An audit result indicates scores represented as a percentage of the following:

  • Complies with the requirements
  • Improvement needed
  • Non-conformances found

Our reports provide the detailed information clients need to make imperative sourcing decisions. Whether it’s an evaluation to determine supplier selection, part of a supplier management initiative, or for internal evaluation purposes, the benefits of incorporating an EMS are relevant to organizations across all industries.

Contact us to schedule an ISO 14001: 2015 audit, or ask us questions. Download an example report here.