July 17th, 2016
ISO 9001:2015 clause 4.4 Quality management systems and its processes requires an organization to “maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confident that the processes are being carried out as planned.”
Clause 7.5.1 General explains that the quality management system documentation shall include: a) documented information required by this International standard; and b) documented information determined by the organization as being necessary for the effectiveness of the quality management system. QMS documented information can differ from one organization to another due to the: (1) size of organization and its type of activities, processes, products and services; (2) complexity of processes and their interactions, and (3) competence of persons.
Documented information maintained by the organization for the purpose of communicating the information necessary for the organization to operate (low level, specific documents). See 4.4. Although ISO 9001:2015 does not specifically requires any of them, examples of documents that can add value to a QMS may include:
- Organization charts
- Process maps, process flow charts and/or process descriptions
- Work and/or test instructions
- Documents containing internal communications
- Production schedules
- Approved supplier lists
- Test and inspection plans
- Quality plans
- Quality manuals
- Strategic plans
Where it exists, all the documentation that forms part of the QMS, including all that is maintained (records) has to be controlled in accordance with clause 7.5. Documented Information.
June 23rd, 2016
The new ISO 45001—Occupational Health and Safety Management Systems is expected to be published in October 2016. The latest draft of the International Organization for Standardization’s (ISO) new occupational health and safety management system (OHSMS) standard was released for public comment on Feb. 12, 2016. The original intent in developing ISO 45001 was to replace the Occupational Health and Safety Assessment Series (OHSAS) 18001 standard with an ISO standard.
Because OHSAS 18001 is a mature standard with more than 100,000 certifications worldwide, it seemed it would be easy to draft a new standard using the Annex SL structure, such as ISO 9001:2015 uses. That turned out not to be the case. More importantly, the draft international standard version of ISO 45001 (ISO/DIS 45001) bears little resemblance to OHSAS 18001.
There are a number of areas where the requirements in ISO/DIS 45001 represent a significant departure from those set out in OHSAS 18001 and Annex SL. These include the following key changes:
- Increased emphasis on worker participation and the inclusion of explicit requirements for involving workers’ representatives in organizational decision making.
- Complex planning requirements that would replace Annex SL’s risk-based thinking approach with requirements to control every risk and opportunity.
A major concern associated with ISO 45001 is that there may not be an opportunity to improve the language. Currently, the publication of ISO/DIS 45001 as the new ISO OHSMS standard is being voted on. Those participating in this standard’s development must decide whether the current language is good enough. We will keep you informed as to the vote and publication progression.
May 16th, 2016
The AS9100D:2016 Aviation, Space and Defense Standard was projected since the publication of ISO 9001:2015 last September to be released in April 2016. As of this post, the standard has not been released. The following is the latest information from the IAQG Website.
“The International Aerospace Quality Group (IAQG) has agreed to align transition to the forthcoming revised 9100:2016 series standards with the International Accreditation Forum’s (IAF) Resolution 2013-15, which requires transition to the ISO9001:2015 quality management system (QMS) standard no later than 15 September 2018.
The 9100:2016 series of standards will be published concurrently across Americas, Asia-Pacific, and European sectors. The timing of this concurrent release will result in the AS9100:2016 publishing starting in October 2016, 9101 and 9110 in November 2016 and 9120 in December 2016; given a worst case scenario. “Efforts are being made to shorten the publication time spans and publish concurrently as soon as possible”.
If the revised standard release remains with October 2016, the current requirement of all AS9100C organizations to transition NLT September 2018, may still remain – TBD. Considering that all certification body auditors will have to be formally trained prior to performing any transition audits, this will be a challenge. Stayed Tuned – we will keep you informed!
April 17th, 2016
AS9100 certified organizations must transition by June 2018. AS9100D:2016 is scheduled for release in April 2016. This also includes standards AS9110 Aviation Maintenance, and AS9120 Stockist Distributors.
A primary difference between the ISO 9001:2015 and AS9100D standards is the timeline for transition.
Certification body auditor training will be completed in August 2016. This provides less than 24 month window to transition to the new standard. Current AS9100 companies must also communicate to their certification body their transition plans by January 2017; and no certification body audits will be conducted to the current versions after June 15, 2017.
Based on current information, a Quality Manual will still be an AS9100 requirement. Also, unlike ISO 9001:2015, the requirement of a specific Management Representative remains. It is also unclear whether specific procedures will be required.
Some other changes include:
- Operational Planning and Control adds requirements for FOD and product obsolescence
- Clause 8.1.1 is changed to “Operation Risk Management” and clarifies that risk in this specific clause is only related to products and services
- New clause 8.1.4 on Prevention of Counterfeit Product. We have discussed this future requirement in past newsletters
- Maintained language about special processes
- Internal auditing now indicates that “performance indicators” can be used to assess QMS effectiveness
March 13th, 2016
ISO 13485:2016 establishes the requirements for a quality management system specific to the medical devices industry. It has been revised to respond to the latest developments in quality management, technology and regulatory requirements that relate to the industry.
Improvements in the new version of the standard include broadening its applicability to include all organizations involved in the life cycle of the product, from concept to end of life, greater alignment with regulatory requirements and a greater focus on post-market surveillance including complaint handling.
There is also a greater emphasis on having the appropriate infrastructure, particularly for the production of sterile medical devices, and more focus on risk management.
Some of the changes to the new standard avoid the ISO 9001:2015 standard new requirements. Examples include:
- No alignment to high level Annex SL
- No requirement for Context of the organization
- Emphasizes risk-based QMS, but not “risk-based thinking” as ISO 9001:2015
- Requires a Quality Manual
- Avoids the confusing term “documented information,” retains documents and records
- Maintains approach to preventive action
- New “design and development transfer” clause added
- Additional language on complaints handling and regulatory communication
The ISO 13485:2016 Standard is available for purchase through the ANSI Website
. Contact us with questions and for further information on how we can support your future ISO 13485:2016 Transition Needs.