Maintaining Your QMS and ISO Certification
Achieved ISO 9001 Certification, Now What?
Now that you have achieved ISO 9001 certification, you must maintain your Quality Management System (QMS) and make improvements. It is more important now, that the QMS doesn’t fall apart. Internal ownership by the process owners must be maintained, and buy-in needs to continue past the initial certification audit. One way to administer this is through ongoing monitoring of performance against goals, and another is through internal audits to show when processes are not being followed or not being performed as intended.
Maintaining Your QMS to Ensure…
- Internal audits are scheduled and conducted. In an effective audit, findings generate corrective actions, and opportunities for improvement generate improvement ideas. Audits are also used to educate the people and departments being audited, to help them understand ISO 9001 requirements, and better prepare them for future audits.
- Corrective actions are being written for all applicable issues, and are being monitored and closed out timely.
- Nonconforming product is properly identified and handled, with any customer impacts communicated with appropriate actions being taken and documented.
- Quality objectives are periodically monitored and reviewed, with an annual review of the need to adjust or change goals.
- Continual improvement, risk management and actions are demonstrated through monitoring and analysis.
- Changes to the QMS or business are adequately addressed, appropriate documentation is updated, and necessary awareness and training occur.
- Document and record control are maintained as an important part of a QMS by making sure that people have access to, and are using, the latest versions of forms and documents, and that records are complete to show the processes are working as intended (for good and bad results).
The Certification Body will return annually to perform ongoing audits to monitor the QMS status. Every audit will evaluate internal audit results, management review meeting status, evaluate performance against objectives, look at corrective action status since the last audit, and any customer feedback and satisfaction, which includes nonconforming products or services. Core processes will be sampled annually, with the entire QMS being audited every 3 years. Any changes to the QMS between audits will always be evaluated at the next audit. See our blog where we share the Top 10 ISO 9001 Findings from Certification Body DNV GL Business Assurance, NA. Review these nonconformances to see if there are any weaknesses in your QMS and quality processes.
It is important to have some type of ongoing analysis, audits and scrutiny to go from good to great. A full round of internal audits covering all elements of ISO 9001:2015 should be conducted yearly using the process audit approach. Be sure to follow ISO 19011 for guidance on completing your internal audit. Audits can be broken down into pieces or completed all at once. For a new quality management system there is no practical way to justify less frequent internal audits. Once there is some history and maturity, there will be enough information to assess the risks and determine whether there are some processes that can be audited less frequently than once a year, or whether some processes need to be audited multiple times a year
Good internal audits will help to prevent surprises and serve to manage and minimize your risks. A strong maintenance program will give you a more robust quality management system to keep your customers happy and avoid problems with your customers and certification body.
Knowledge. Expertise. Experience.
Outsource Your Internal Audits
Outsourcing QMS maintenance support is an option
Some companies just don’t have the resources to help to manage and maintain their quality system and they need outside help. By outsourcing the ongoing system maintenance, the business benefits from getting expert, objective, and unbiased feedback regarding the management system. An experienced consultant will be quicker to find out if requirements are being missed, as well as identify opportunities for improvement, as their specialist knowledge can bring valuable insights to ‘best practice’ and effective solutions that have worked elsewhere within the industry. SimpleQuE can provide varying levels of support to help you maintain your QMS:
- Performing internal audits
- Facilitating and helping to implement the package for management review
- Preparing for re-certification audit
- Prepare for outside 3rd party audits. (Some customers even want us on site to help during the 3rd Party certification body audits.)
- Assistance with corrective action and finding closure – from internal audits, or from the certification body, or from customer issues that have been identified.
- Facilitate and train for more effective Root Cause Analysis and problem solving to get to get to systemic corrective actions and fixes for the business
- Guidance on contingency plans development
- Assist with document and record control
- Calibrations and records assistance, along with any outsourcing of calibrations
- Continual improvement activities, helping to maintain the records and processes to do that.
- Risk management processes, tools, and records
- Support CAR closure
- Support change control processes
- Various trainings: for the executive management, internal auditors, process owners, etc.
Our consultants and internal auditors, have audited for certification bodies, and see hundreds of companies and a wide variety of scenarios. They see different and creative ways to address compliance to the different requirements of the standards. Our customers trust us. They know that we have the expertise and the knowledge to help them, and that’s where we’re successful. Think of us as an insurance policy to minimize problems with your customers, or surprises during an external audit with your certification body, and to help with your internal systems and processes, to reduce operational risk, and to maintain a more effective and efficient quality system. Partner with and trust simpleQuE to be your expert and an extension of your quality team.
SimpleQuE is a leader in AS, IATF® and ISO consulting, auditing and training. Whether you are just beginning the certification process or looking for a partner for ongoing maintenance and internal audits, simpleQuE makes the process easier and more efficient. Contact us for a consult and see the difference that simpleQuE can bring to your quality management process.
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