This article is not intended to be a full review of the requirements, just some highlights of the changes that affect the large number service and manufacturing organizations. There is a lot of free information available on the web. If you have any specific questions just contact us and we will assist you or point you in the correct direction for details.
Some of the changes that affect a lot of our clients are:
2020 Challenges: What should I be focusing on with my Management Systems (Quality, Environmental, Safety, Laboratory, Information Security…)
- What should I do to make sure my 3rd party audit goes well?
- What should I do to help my company through these challenging times?
With the pandemic and staff working from home, the management systems (ISO 9001, ISO 14001, ISO 45001 etc.) follow through can be a challenge, as well as the internal audit and improvement processes. Many organizations are working in smaller groups, performing more of the basic functions, and skipping some of the important documentation due to other important organizational needs. This does not leave us without opportunities to accomplish important tasks. Here are a few suggestions that will not only create improvements and risk reduction, but will also continue to support a management system’s requirements:
- Conduct internal audits focused on documentation and records. This can be done remotely and can also identify outdated language, redundant documentation that may not be consistent, and areas for improvement. These audits can be followed up with documentation and records process improvements. Future audits can always include increased production or manufacturing floor audits as a focus.
- Focus the audit and risk identification processes on contingency plans. This can allow an organization to document lessons learned and improve the organizations processes and contingency plans going forward. It will likely be some time before things in most organizations really return to normal, so improvements in these areas can be valuable for an organization.
- Management system staff and internal auditors can also assist departments and areas of the company organize and improve their processes in a changing environment. These staff are typically more trained and focused on this aspect of the work which can be of great value to many areas of an organization.
- Some specific areas to watch:
- IATF Temporary Change requirements
- Automotive PPAP requirements for internal changes
- IATF Shutdown and Startup requirements, where applicable
- Scheduling processes where order quantities are changing
- Changes to workflow and security requirements for staff working remotely
- Supplier management and development – many of the above items would also apply to the organization’s suppliers, and to protect your organization, you may want to ensure you are reviewing suppliers to determine if they are proactively addressing these changes and associated risks
We have been reviewing the data from many sources on the common nonconformances during transition audits for IATF 16949: 2016 as well as ISO 9001, ISO 14001, AS9100, ISO 13485 and now ISO 17025.
Some things stay the same
An analysis of the data identified many nonconformances that are consistent with audits conducted prior to the newly revised standards. These nonconformance are more common than those written to the new requirements for companies that spend more time addressing the new requirements explicitly in their management systems. Examples include:
- A gage that is past due for calibration without any extension records
- Control Plans and PFMEAs that do not match
- Work instructions that are not being followed or out of date…
Here is some very good advice on migrating to the new 16949 standard.
When you are looking at upgrading your management systems to meet the new requirements, you really need a solid approach to the project ahead. One important piece of advice that we have learned from experience is that when resources are needed for a project like this, it is critical to obtain the resources at the beginning of the project. If you are able to muddle your way through the process and achieve registration to the new standard which the hopes of finding resources to make the necessary improvement to the management system after certification, you will likely be disappointed. Here are some additional suggestions to the approach to the project:
What are notable changes?
The new ISO 9001 standard aligns with high-level organizational structure, requiring all new ISO management system standards to be aligned on a high-level structure with a set of common requirements.
Additionally, there is a greater emphasis on risk-based thinking as a basis for the management system, more focus on achieving value for the company and its customers, increased flexibility regarding use of documentation, and a more approachable structure for service businesses.
In addition to this, Lisa has recently worked as a quality manager managing an ISO 9001 certified quality management system. This has also given her the insight and understanding of the efforts and struggles that many of our clients experience on a daily basis. Lisa will be answering our phones every day, with a goal that we are more accessible to our clients, as well as assisting with our training and scheduling. Lisa is also qualified and may assist clients with internal audits, corrective actions and other related work. Just call 616-365-9822 if there is anything that Lisa can assist you with or questions you may have.
Take a look at all our team members.
Here is the upcoming Public Class Schedule:
March 20th ISO 9001:2015 Changes - 8:30am-12:00pm
ISO 14001:2015 1:00-4:30 pm