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January 2018

During recent months, ASR has shared with clients the common nonconformance's written against recently revised standards. This article reviews AS9100D:2015 nonconformance's written within the last several months by ASR's aerospace auditors.

Few NC's were written against Sections 4 (3 NC's), 5 (NC's), 6 (3NC's) with no NC's written in section 10. A quick summary of the findings found in Sections 7, 8 and 9 may be helpful as organizations continue working with their AS9100D quality system.
Read more: AS9100D Common Nonconformance’s

All current AS9100 and AS9120 certified companies currently are required to have their audits and certificates entered and accurate in the OASIS database. Currently, this process is primarily managed by the Certification Body. ASR uploads and publishes all audit and certificate records after an audit is approved. On December 3, 2016, the IAQG will be releasing the next generation OASIS database.

Initially this will not change much from how the current process works, but once we begin conducting AS9100D or AS9120B audits in 2017 the process with change considerably. Below are some of the major changes in OASIS Next Generation:
Read more: OASIS Next Generation

The FDA has decided to replace its current system with ISO 13485, the organization has announced.  The purpose is to help streamline regulatory processes for medical devices across the world.

Published in 2016, ISO 13485 is the international standard for quality management systems for the medical device sector. The regulation is designed to work efficiently and transparently with other management systems across the world.

The FDA’s decision to use ISO 13485 is another step in helping the standard gain global recognition.
Read more: FDA & ISO 13485 for medical device...

Expect a first quarter release of ISO 13485 for medical device manufacturers. Voting on the Final Discussion version of ISO 13485 concluded December 29, 2015 and now the wait is on for the 2016 revision to be officially released.

ISO 13485 was last revised in 2003. The latest update of ISO 13485 is to the 2008 version of ISO 9001 NOT the 2015 version. Structurally, the updated ISO 13485 uses 8 sections rather than the 10 sections found in ISO 9001:2015.
Read more: Revised Medical Device Standard...

It has always been ASR’s belief that clients can benefit from the sharing of auditor findings. This article reviews some of the top AS9100 and ISO 14001 findings written this year by ASR’s aerospace quality management system auditors and ASR’s environmental management system auditors.

The AS9100 nonconformances highlighted below account for 28% of the total AS9100 findings written this year by ASR aerospace auditors:

10.2.1 & 10.2.2 Corrective action – 10 NC’s written that included lack of verification; root cause analysis not identified; lack of document sign-off/acceptance.
Read more: ISO 14001 Audit Findings in 2020

ANAB (ANSI-ASQ National Accreditation Board) recently issued a clarification from TC 207 addressing lifecycle requirements found in ISO 14001:2015.

This Q & A document is a long one and includes 2004 and earlier material, but skip to Section III page 26 and 27 to gain a better understanding of the new 2015 EMS lifecycle requirements as it impacts lifecycle assessments, outsourced processes, and an organization's significant aspects.
Read more: ISO 14001:2015 Life Cycle Requirements

ISO 45001 (Occupational Safety & Health) is unique in that it requires both conformance and compliance.

Organizations are required to analyze their hazards and risks. Additionally, they are required to develop plans and implement measures to mitigate risks to employees and the business that will provide for continuous improvement in the work environment.

The compliance portion of ISO 45001 requires third-party auditors to ensure organizations have in place an OS&H system to evaluate compliance, plus steps to correct issues that have been determined to be non-compliant by the organization.

As ASR clients begin to implement ISO 45001, we want to share some of the nonconformance issues clients have experienced:

Documentation Findings
Read more: ISO 45001 Findings - December 2020

ISO 45001 requires both conformance and compliance.

Conformance - several segments of ISO 45001(Occupational Safety & Health) require an organization to analyze their hazards and risks. Additionally, organizations are required to develop plans and implement measures to mitigate risks to employees and the business and set in motion continuous improvement of the work environment.

Some early ASR ISO 45001 audits reveal organizations are having issues with effectiveness relating to incident analysis (10.2) and their internal system to identify hazard (6.1.2.1).
Read more: ISO 45001 - Conformance or Compliance?

Online Standards Training has a course for ISO 45001 internal auditors.

ISO 45001:2018 specifies requirements for an occupational health and safety (OH&S) management system, and gives guidance for its use, to enable organizations to provide safe and healthy workplaces by preventing work-related injury and ill health, as well as by proactively improving its OH&S performance.
Read more: ISO 45001 Internal Auditor Course

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What are the best ways to build a team in business?

Building a successful team in business requires a combination of strong leadership, clear communication, and a focus on creating a collaborative and supportive environment. Here are some of the best strategies to build a high-performing team:

1. Clearly Define Roles and Responsibilities

Ensure that each team member understands their role and how it fits into the broader goals of the organization. Clear job descriptions and expectations help avoid confusion and foster accountability.

2. Hire the Right People

Focus on hiring individuals who not only have the necessary skills but also align with the company’s values and culture. A team with complementary strengths and a shared vision will work more cohesively.

3. Foster Open Communication

To foster open communication, encourage transparency, actively listen to team members, and provide regular feedback. Create a safe environment where everyone feels comfortable sharing ideas and concerns. Use inclusive language, hold open discussions, and make communication a core part of team culture through regular meetings and one-on-one check-ins.

4. Promote Collaboration and Trust

To promote collaboration and trust, encourage open communication where team members can freely share ideas and concerns. Set clear, shared goals to align efforts and create a sense of purpose. Lead by example, showing trust in others by delegating tasks and empowering team members. Celebrate successes and recognize individual contributions to build confidence. Provide opportunities for collaboration through team projects, encouraging cross-functional cooperation. Address conflicts openly and fairly, maintaining respect and transparency. By creating a supportive environment where everyone feels valued and respected, trust and collaboration will naturally develop, fostering a more productive and cohesive team.

5. Provide Opportunities for Development

Invest in the continuous development of your team members by offering training, mentorship, and opportunities for growth. This not only enhances skills but also boosts motivation and engagement.

6. Set Clear Goals and Metrics

To set clear goals and metrics, first define SMART goals—Specific, Measurable, Achievable, Relevant, and Time-bound. Break down each objective into actionable steps, ensuring everyone understands their role in achieving it. Establish key performance indicators (KPIs) to track progress, focusing on relevant metrics that align with business objectives. Communicate these goals clearly to the team, providing the necessary resources and timelines. Regularly monitor progress through reviews and adjust strategies if needed. Transparent tracking of metrics fosters accountability and helps ensure alignment between daily activities and long-term goals, motivating the team toward success.

7. Lead by Example

Leading by example means modeling the behavior and values you want your team to emulate. Show commitment to your work by being punctual, meeting deadlines, and maintaining a positive attitude. Demonstrate integrity by being honest, accountable, and transparent in decision-making. Actively listen to your team, offer constructive feedback, and remain open to suggestions. Prioritize continuous learning and development to show that improvement is a constant goal. Be respectful and compassionate, fostering a supportive work environment. By consistently displaying these qualities, you inspire your team to follow suit, building trust and enhancing overall team performance.

8. Adaptability and Flexibility

Encourage the team to be adaptable in the face of challenges and open to new ways of doing things. In a rapidly changing business environment, flexibility is key to staying competitive.

By focusing on these strategies, you can build a strong, cohesive team that works efficiently towards achieving business objectives.


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Like you, our accreditation bodies require us to use a Continual Improvement process.  Your feedback is the guidance and incentive for our efforts to improve.

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ASR's Referral Program

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Because of the overwhelming success of our 50% discount, we have extended the code until the end of October 2024.

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