ISO 9001:2015 Transition FAQ
1. What are the general changes to the ISO 9001 standard?
Answer: The basics of quality will remain the same but with renewed emphasis on planning and management/leadership accountability. There will be 10 sections or clauses the last seven of which will be auditable. Many of the changes to the standard are to promote compatibility with other standards, to recognize the various ways management is capable of satisfying the basic requirements and to respond to quality assurance needs discovered over time.
The seven auditable clauses will be:
- Context of the organization: considers interested parties and business strategy.
- Leadership Engagement: replaces management representative and puts more emphasis on top management involvement in QMS.
- Planning: increased focus on context of organization, interested parties, risk, quality objectives and change management
- Support: considers resources, infrastructure, knowledge management, and documented information (previously known as quality manual).
- Operation: execution of process and plans to meet customer requirements.
- Performance Evaluation: requirements for monitoring, measurement, analysis, and evaluation. Internal audits and management review requirements remain.
- Improvement: identify opportunities to improve processes and customer satisfaction.
Risk will be better linked to prevention but no formal risk management process will be specifically required. Risk aversion will be considered an outcome of many areas of the QMS including planning meetings. The basic principles of control and process including effects on consistency and efficiency and customer satisfaction will not change but formal quality manuals or procedure manuals will not be required. The Management Representative will not be required as the focus is more on management leadership.
2. Where can I find more information about the changes?
Answer: We suggest visiting ISO.org to start. There are several resource materials available to you.
3. Will PRI send out additional supporting materials to help us better understand the changes?
Answer: Now that the standards have been published, we are developing materials to help support our clients. We expect to make these materials available before the end of November 2015.
4. When will PRI be able to conduct ISO 9001:2015 Audits?
Answer: PRI is in the process of submitting our transition plan to ANAB for approval and we hope to have approval by Nov/Dec 2015
5. How will PRI decide on the amount of time needed to conduct the transition audit?
Answer: The audit time will depend on the size, scope and complexity of your organization. We will firm up the amount of time needed prior to your upgrade audit. Generally speaking, for an organization with less than 50 employees it would be a .5 day additional time; for those with less than 500 it would be 1 day and for those above 500 employees, we would add 1.5 days to the upgrade audit.
6. When is the best time to transition to the new standard?
Answer: The best time is at your Recertification or Surveillance audit, however, you may also choose to do a special audit at any time before Sept 15, 2018. If you are also certified to an AS standard, you may want to wait until the revised standard is published in mid-2016 to plan your joint transition audit.
7. Who should we contact to plan our audit?
Answer: You may call your sales representative or client manager to discuss timing and the process for planning your transition audit.